Hand Therapy 2009; 14: 60–68. DOI: 10.1258/ht.2009.009017
Original article
An approach to standardize, quantify and record progress of routine upper limb therapy for stroke subjects: the Action Medical Research Upper Limb Therapy protocol ¨ cher,† Christine Roffe‡ and Anand D Pandyan† Sheeba B Rosewilliam,* Catherine Bu *School of Health and Population Sciences, University of Birmingham, Birmingham; †School of Health and Rehabilitation & Research Institute for Life Course Studies, Keele University, Keele; ‡University Hospitals of North Staffordshire, Stoke-on-Trent, UK Correspondence: Sheeba B Rosewilliam, School of Health and Population Sciences, No. 52 Pritchatts Road, University of Birmingham, Edgbaston, Birmingham B15 2TT, UK. Email:
[email protected]
Abstract Introduction. Explicitly describing therapy for research purposes, in terms of content and quantity, improves the validity of research and facilitates evidence-based clinical practice. However, such descriptions are not common in therapy research. The aim was to develop an upper limb therapy protocol which reflected local clinical practice in the stroke unit, and a recording form to document the content, quantity and progression of therapy. Methods. This was a multi-method study. A list of interventions commonly used for the rehabilitation of the stroke upper limb was compiled following a systematic literature search. This was then refined into the Action Medical Research Upper Limb Therapy (AMRULT) protocol in a two-stage process involving a survey and a group discussion. Six physical therapists and three occupational therapists supported its development. The AMRULT protocol was then piloted in a two-arm randomized controlled trial with 90 stroke patients for therapy and recording purposes. Results. The protocol classified therapies based on therapy input as passive, active assisted, active/strengthening and functional. Using this form it was possible to not only summarize the content of therapy but also objectively document progression (e.g. 14% of the participants progressed to functional exercises between the 5th and 8th weeks after stroke onset). Discussion. The AMRULT protocol and associated recording form were useful in both standardizing the delivery and quantification (content and progression) of therapy. While the AMRULT protocol was devised for a specific purpose, the method used can be adapted to develop protocols to support other research studies. Keywords: Upper limb, stroke, therapy, protocol, standardization
Introduction Therapy for the rehabilitation of the upper quadrant deficits, irrespective of aetiology, must 60
be evidence based.1 Current evidence suggests that common clinical practice is normally informed by experience and education as Hand Therapy Vol. 14 No. 3 September 2009
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opposed to research-based evidence.2,3 Although various attempts have been undertaken to facilitate the introduction of research evidence into practice,4 it is surprising that recent papers still suggest that evidence-based practice is uncommon.5,6 At this stage, it may be worth exploring whether the evidence being produced by researchers lends itself to easy clinical translation. There is some evidence that one such reason for research evidence not being included into routine clinical practice may be the quality of research being produced.7 Barriers to evidence-based practice can be attributed to three significant gaps in research related to therapy and rehabilitation: (i) the description of the therapies (i.e. content of therapy) is not explicit,8,9 (ii) the quantity, in terms of intensity and duration, and progression of therapy content over time are rarely reported10,11 and (iii) index and control therapy can be confounded by non-study-related co-interventions, which are rarely described.11,12 Although only two studies10,11 have been highlighted for the purpose of the paper, similar confounding factors apply to most clinical trials in rehabilitation. A number of researchers have recommended that therapy research should be more explicit in terms of content so that the tested therapy can be translated into clinical practice.13,14 Given the increasing pressure to follow evidence-based practice,15,16 there is a need to improve research methodologies in experimental studies to ensure that the results are comparable and clinically usable.17 This study was designed to identify a possible solution that enables standardized therapy delivery and allows explicit documentation of therapy content and therapy progression over time. Although this particular problem is prevalent in all fields of upper limb therapy, we have used upper limb therapy after stroke as a means of addressing this. While there are several trials that have evaluated the effectiveness of upper limb rehabilitation for stroke, most do not standardize the content and quantity of experimental and control therapy or describe the intervention(s) in sufficient detail to allow for meaningful comparison across trials (e.g. meta analyses) and clinical implementation.18,19 The aim of this study was to develop a clinically usable therapy protocol that reflects current local practice and that can be explicitly described and quantified (in terms of content and progression). Hand Therapy Vol. 14 No. 3 September 2009
Methods Study design The study involved multiple research methods as recommended by Campbell et al. 20 and was conducted in five steps:
Step 1 A literature search was undertaken to identify the common upper limb therapies administered after brain injury. The literature search was done in Medline, CINAHL and AMED. The search terms used were (upper limb OR arm) AND (stroke OR brain injury) AND (therapy OR rehabilitation). Based on the literature search a first therapy protocol was developed. This protocol listed common problems after stroke affecting the upper limb, the corresponding aims of treatment and the common methods used for treating the identified problems.
Step 2 Locally practising physical and occupational therapists were asked to identify, from the first therapy protocol, the treatment methods normally used in daily clinical practice. They were also requested to add any other means of therapy that they considered important to a problem, if this was not already described.
Step 3 The results from the first therapy protocol were analysed to identify the therapies that were commonly used in the local centres (i.e. any method selected by all therapists was considered a common treatment approach). These therapies were then included in the second therapy protocol.
Step 4 Nominal group discussions were held, with therapists from the stroke unit and stroke rehabilitation wards, to deliberate on the second therapy protocol. A nominal group technique was chosen since this process is helpful to pool expert judgements at a round table discussion within a short time of approximately 90 minutes.21 The discussions helped to clarify the therapists’ 61
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choice of treatment methods and to arrive at a consensus. This version was further restructured under the following headings: (i) list of problems, (ii) aim of therapy and (iii) the methods used to deliver the therapies. This formed the basis of the final therapy protocol designated as the Action Medical Research Upper Limb Therapy (AMRULT) protocol. The therapies described in the protocol were clustered into four major groups: (1) passive input, (2) active assisted input, (3) active input and strengthening and (4) functional therapy.
Step 5 The final AMRULT protocol was piloted in a randomized controlled trial comparing routine therapy on its own and a combination of surface neuromuscular electrical stimulation (SNMES) and routine therapy for the treatment of the upper limb. This study was approved by the local research ethics committee of North Staffordshire (LREC approval ref no. 04/Q2604/1) and was conducted between September 2004 and February 2008.
Study setting Patients and professionals included in the study were recruited from the combined stroke unit of a district general hospital.
Participants, inclusion and exclusion criteria Therapists
Professional participants (6 physiotherapists, 3 occupational therapists) were recruited from the therapy staff working at the stroke unit using a convenience sampling technique and were included in the study if they were willing to participate. All the professionals approached were senior therapists and were specialized in stroke care. Patients
All the stroke patients admitted to the district general hospital between January 2005 and June 2007 were screened for eligibility. Adult patients were eligible for inclusion if they were within four weeks of a first stroke, medically stable and had no arm function on the affected side (defined as an Action Research Arm test score of 0). Subjects with contraindications to functional electrical stimulation, major upper limb pathology (e.g. 62
symptomatic osteoarthritis or rheumatoid arthritis, fractures, soft tissue injury, contractures) and individuals where consent could not be obtained or was refused were excluded. All 90 patients from both the experimental group and the control group were given 30 minutes of routine therapy from the AMRULT protocol.
Data analysis Each patient had a protocol sheet filled in for each week of therapy (6 sheets per participant). All data were transferred to a database file and analysed using the Statistical Package for the Social Sciences version 15.0.
Results Protocol development The literature search yielded 142 relevant articles from which therapies were listed for the first therapy protocol (which is available on request from the first author). The therapy literature was not screened for methodological rigour, that is, no assessment of quality was undertaken and all therapies were included to give a comprehensive list of existing upper limb therapies in practice. Therapies that were not relevant to our study sample or not congruent with local clinical practice, such as constraint-induced therapy or robotics, were excluded. The first therapy protocol contained 16 aims of therapy, e.g. facilitation, maintenance of soft tissue length, etc. Each aim had between five and 20 therapy methods listed. For example, interventions listed under facilitation are brushing, tapping, joint compression, weight bearing, vibration and fast passive stretching. Six senior physiotherapists and three occupational therapists were given the first therapy protocol. All of them had to identify, from the list provided, the therapies they commonly used in practice. The therapies chosen were mostly hands-on and clinically feasible. Some treatment methods were chosen by all or most of the therapists. Following steps two and three, the second therapy protocol consisted of interventions that were common to all therapists and were grouped according to the problems they were intended to address. The problem list in the second therapy protocol had three major sections: sensory, motor and functional. There were 15 problems in total Hand Therapy Vol. 14 No. 3 September 2009
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that were listed, three problems under sensory, nine problems under motor and three problems under functional. The protocol had eight treatment options for sensory problems, 11 treatment options for motor problems and four treatment options for functional deficits. Following the group discussions, the finalized AMRULT protocol was developed based on consensus agreement through group discussions with all the practising therapists. Three problems identified in the second therapy protocol were removed from the final protocol, because their treatment overlapped with the management of other problems. For example, loss of reciprocal movements was removed since it would be managed by isolation of movements and by training coordination. Another problem that was removed was hyper-reflexia, the treatment of which overlapped with management of spasticity and associated reactions. The problem of loss of endurance in upper limb activities was left out since the training of endurance would not be feasible within the predetermined therapy time. The final AMRULT protocol is attached as Appendix A.
Protocol implementation in the randomized trial The AMRULT protocol was used to record the content and quantity of therapy delivered by the research therapist (the time in this instance was fixed to 30 minutes). The participants were clinically assessed and their problems were identified and marked in the first column in the protocol – the problem list. The therapist selected the relevant aims for the identified problems from the second column in the protocol. The corresponding therapies were chosen from the third column in the AMRULT protocol, administered to the patient and recorded in the protocol sheet (Appendix A). Owing to the prerequisite for standardization of therapy for the study, only therapies predetermined in the protocol were used except in rare situations where the patient could benefit from therapies not listed in the protocol, for example, warm soaks. As this was a controlled trial standard notes were also added in the patients medical records as per local guidelines.
Recording progression using the AMRULT protocol Patient characteristics The AMRULT protocol was piloted in a randomized controlled trial of SNMES (SNMES study). The characteristics of the patients with whom the protocol was piloted are described as follows. The mean age of participants was 74.8 years (standard deviation [SD] 10.9, range 66) and there were 45 (50%) men and 45 (50%) women. Forty-four (48.8%) participants had a left hemi-paresis and 46 (51.1%) participants had a right hemi-paresis. The mean time of onset after stroke at recruitment was 3.7 weeks (SD 1.3). Based on the Oxfordshire Community Stroke Project Classification, 61 patients (67.8%) had a total anterior circulation syndrome, 19 (21.1%) had a partial anterior circulation syndrome, nine (10%) had a lacunar syndrome and one (1.1%) had a posterior circulation syndrome. The mean ARAT total score at baseline was 0.2, which indicates very minimal upper limb activity. Five participants died during the six weeks of therapy input following recruitment. Three patients did not complete the full six-week intervention, of whom two were discharged early from the ward due to improved mobility, and one could not comply because of impaired cognition. Hand Therapy Vol. 14 No. 3 September 2009
The protocol was used to deliver therapy five times a week for each participant over the six-week study period. Each participant was clinically assessed by the research therapist at each week of the study intervention. This weekly review of the patients’ status determined the problems, aims of treatment and treatments from the protocol on a weekly basis. This led to therapy alteration or progression as required based on individual needs. The AMRULT protocol sheets were used to record therapy, one for each week for six weeks. Thus, each participant ideally had six protocol sheets for the period of participation. Interventions recorded in the AMRULT protocol were clearly highlighted in bold as to whether they were predominantly passive, active assisted, active/strengthening or functional therapy. This was a means of representing progression by shifting from one type of therapy that was less demanding to another type of therapy that was more demanding in line with the recovery process. An analysis of the recorded interventions in bold in the protocol reflected therapy progression or the lack of it for each individual participant over the six-week study period. Attritions due to death, severe illness or therapy not 63
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delivered for other reasons, e.g. participants’ non-compliance due to depression and other such factors, were recorded.
Usefulness of the AMRULT protocol The layout of the protocol helped to outline problems, determine relevant treatment aims and choose pertinent therapies in a simplified manner. By marking in the protocol sheets it was useful as a quick recording tool. With the highlighting of therapy classification, it was possible to document and identify therapy progression from the tool since it has clusters of therapy in the hierarchy of recovery, for example, when a patient moved on from a bold P ( passive therapy) to a bold F (functional therapy). During the analysis phase, unlike when using Subjective Objective Assessment Plan notes, it was straightforward and easy to list the weeks from one to six and tabulate the therapy input for each participant over the weeks. These data from the protocol sheets were a simple frequency count and are presented in Table 1 and graphically in Figure 1. During week 1, most (78.9%) of the patients were given passive therapy only, 14.4% were given active-assisted therapy and 5.6% active/strengthening therapy, none were given functional exercises, and one participant refused baseline measures after consent because of cognitive problems and hence could not have therapy. The usefulness of the AMRULT protocol as a recording tool can be illustrated by the following examples: (1) Over the six weeks of treatment, 32 (35%) participants gained better activity, 50 (55%) participants remained static and five (6%) died (Table 1);
Figure 1 Frequency of therapy programme
(2) Twenty-one subjects (23%) improved to a level of performance capable of coping with functional therapy at the end of six weeks of therapy (Table 1); (3) Fifteen (17%) participants with no activity gained activity of varying levels at the end of six weeks and 15 (17%) participants with mild activity (ability to perform activeassisted exercises) moved on to higher levels of activity (Table 2); (4) Thirteen participants (14%) regained some activity (active assisted) within the fourth to sixth week after stroke onset; the time period of progression to do substantial activity (functional exercises) in 13 (14%) study participants was between the fifth and eighth weeks after stroke onset and this fell
Table 1 Frequency distribution of different therapies within the AMRULT protocol in study participants over six weeks Therapies
Passive Active assisted Active/strengthening Functional exercises Unable to treat Attrition Total
Number of patients receiving therapy Week 1*
Week 2
Week 3
Week 4
Week 5
Week 6
71 13 5 0 1 0 90
60 12 7 7 1 3 90
53 12 8 12 2 3 90
52 8 7 16 3 4 90
51 5 7 19 3 5 90
50 6 5 21 3 5 90
AMRULT, Action Medical Research Upper Limb Therapy *Week 1 of AMRULT protocol corresponds to 3–5 weeks after the onset of stroke
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S B Rosewilliam et al. Standardizing and quantifying routine physiotherapy Table 2 Progression of therapies given within the AMRULT protocol between weeks 0 and 6 of the study Progression categories
No. of participants who progressed (%)
1. 2.
52 (58) 4 (4)
No progression Passive to active-assisted exercises Passive to active/ strengthening exercises Passive to functional exercises Active assisted to functional exercises Active/strength to functional exercises Attrition (death or unable to treat) Total
3. 4. 5. 6. 7.
4 (4) 7 (8) 10 (11) 5 (6) 8 (9) 90 (100)
AMRULT, Action Medical Research Upper Limb Therapy
Table 3 Analysis of time taken to progress to active assisted (AA) and functional therapies (F) within the AMRULT protocol Study period (week)
No. of participants who progressed to active assisted
No. of participants who progressed to functional therapies
1 2 3 4 5 6
13 8 6 1 0 1
0 7 6 3 3 2
to two percent in the ninth to 11th week after stroke onset (Table 3). In summary, the AMRULT protocol in this study proved a useful recording tool to: (i) describe the therapy input; (ii) determine progression or the lack of it among this patient cohort; (iii) analyse the time taken to progress from the level of minimal activity (AA) to a higher level of functional activity (F), thus giving an indication of recovery profiles in such a severely impaired patient cohort.
Discussion We have demonstrated that it is possible to identify and record therapy interventions delivered as ‘routine therapy’ to participants in an experimental randomized controlled trial. We have described how the AMRULT protocol, which was based on published evidence and prevalent local practice, was developed. Hand Therapy Vol. 14 No. 3 September 2009
The AMRULT protocol describes the commonest upper limb treatment components used in local stroke rehabilitation practice. Owing to the reduced documentation time, it was possible to spend more time on treating the participant. In an environment of staffing and other resource constraints, relevant standardized clinical protocols can help to minimize workload and improve record keeping. Such protocols may also be useful when delegating responsibilities to assistants and students. Inclusion of therapies in a hierarchical order in the AMRULT protocol can also help to plan treatment progression for patients, in line with their recovery. If practitioners designed and used therapy protocols relevant to the conditions being treated, then these protocols can be assimilated into future research studies. In research, such a protocol can be useful in the standardization of therapy, particularly in multicentre trials. Documentation of the content of routine therapy by means of a protocol in research may help with identifying components of therapy that are useful. A simple count of the therapies from the records can help with quantifying the therapy input to participants over a period of time. A number of other models for standardizing the delivery and/or documentation of therapy have been published. Pomeroy et al. 22 described treatment schedules to improve lower limb function both for research and for clinical practice. Such generalizable schedules also make it possible to carry out further research relevant to clinical practice. The mobilization and tactile stimulation treatment schedule developed by Hunter et al. 17 uses multiple methodologies and describes a specific treatment programme. The protocol developed in the present study does not prescribe a treatment plan or strategy, unlike the study described above, but documents the content of the therapy given and its progression in a standardized form. Its specific content has been shaped by local practice, but the principle can be adapted to describe therapy more widely and to include other practices. A similar approach to developing a standardized treatment protocol for the prevention of shoulder hand syndrome in stroke patients was developed by Kondo et al.,23 and this protocol has been shown to be effective. Although Kondo et al. 23 have not described the methodology used for protocol development, they have provided some evidence that protocolbased therapies can help with translating research to clinical practice. The AMRULT protocol was developed through multiple methodologies and 65
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has a wider scope of application to the entire upper limb in stroke and not just to a particular syndrome, such as the shoulder hand syndrome. A similar approach has been taken for the Stroke Physiotherapy Intervention Recording Tool (SPIRIT)24 to describe different aspects of stroke rehabilitation and focus on postural control. Even though the clear description of Bobath therapy interventions for stroke by Lennon25 is not a protocol, it effectively informs clinical reasoning and practice for Bobath-oriented therapists and hence is clinically applicable evidence. The approach used in the AMRULT protocol is not limited to a specific therapeutic approach, but allows documentation of mixed therapeutic interventions, as used in clinical practice. In this study we aimed to standardize our therapy protocol for research reasons, but since this was a single site study generalizability cannot be assumed. The AMRULT protocol developed here should be tested in a future study involving several sites. Some problems identified with the use of the protocol were that, as a clinical tool, it can curtail procedural clinical reasoning in junior professionals since it lays out therapies pertaining to the problems instead of the professionals reasoning out what needs to be done. Since it was developed with the input of all therapists, they were well oriented to the protocol. Any new therapy professional who moved into the study set-up had to be oriented to the application of this protocol, which could be avoided with attached instructions for the tool. Once oriented, it is understood and applied easily and quickly. An overall limitation of the protocol was that it was made for a specific stroke study, but the stroke study was only an example to demonstrate the principles of development of therapy protocols relevant to both physiotherapy and occupational therapy practices. However, similar work in therapy practices to describe the content and quantity of therapy can go a long way to enhance the validity of clinical trials in rehabilitation fields. If undertaken as a short-term project, the formulation of a protocol relevant to the practice area is possible since the time taken to format the AMRULT protocol excluding ethical approval was approximately three months. Another limitation of the AMRULT protocol is that the therapies included do not necessarily have high-level evidence but reflect procedures common to local practice. We did not limit the therapies, in the AMRULT protocol, to those that were supported 66
with strong evidence from the literature, as our aim was to mirror local practice. Anecdotal evidence, i.e. the lack of a competitive therapy bias, suggests that our strategy was appropriate. The study aimed to overcome certain barriers in rehabilitation research such as using a method of describing therapy interventions, studying existing practices for their effectiveness and building evidence for them as recommended by Wade.26 The protocol is an attempt to generate a reproducible way of describing therapy. It missed out some common practices, for example, a warm soak for an oedematous hemiplegic limb, due to prevailing time restrictions that were a requirement for the main study. However, any relevant therapy that addressed patients’ needs and expressed goals was delivered in the sessions since the protocol provided for patients’ individualized goals and should be accommodated in future therapy protocols that are developed in any practice. In this particular instance, the therapy duration was predetermined by the main study protocol. But the AMRULT protocol can be modified with the option for recording time duration for everyday clinical practice. If the duration of therapy was defined then the protocol can also be used for estimating therapy cost and thus can be used as an auditing tool. In conclusion, we have shown that a simple model to describe the routine therapy protocol can be developed as part of the preparatory stage for a research study comparing therapies. This approach can help reduce the confounding factors in interpreting the contribution of the interventions to the outcome. This therapy protocol can also be used for clinical purposes to standardize the provision of therapy in specific care pathways. Acknowledgements: The authors thank the physiotherapists and occupational therapists from the stroke unit at University Hospital of North Staffordshire and Bucknall who participated in the framing of the protocol. The authors gratefully acknowledge the patients who participated in the study. Sources of funding: The randomized controlled trial on efficacy of functional electrical stimulation was funded by the Barnwood House Trust and Action Medical Research Grant (AP0993). Dr ADP has received unrestricted educational support from Allergan UK and Biometrics limited UK. Hand Therapy Vol. 14 No. 3 September 2009
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Competing interests: None declared. Accepted: 8 April 2009
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S B Rosewilliam et al. Standardizing and quantifying routine physiotherapy APPENDIX A AMRULT protocol Sensory/perceptual problems 1. Sensory loss – complete Sensory loss – partial 2. Hemi-neglect 3. Hypersensitivity
! ! ! ! ! !
Sensory education Facilitation Early sensory stimulation Cross facilitation B/l activities stimulation Desensitization
Weight bearing P Weight bearing P Reaching across affected side A Assist arm movement AA Massage P
Motor Problems 1. Reduced tone 2. Impaired muscle activation/weakness
! Facilitation ! Elicit muscle activity
3. Secondary soft tissue changes
! Strengthening ! Main tissue length
4. Spasticity (Resistance to PM)
! Decrease resistance to PM
5. Involuntary movements/associated reactions
! Relaxation
6. Loss of isolated movements
! Isolation of movements
7. Loss of coordination/eye hand coordination
! Train coordination ! Fine motor control/dexterity
Weight bearing AA Simple active exercise AA Minimal assisted exercise AA Placing A/AA Reaching A/AA Resist isolated movements ST Stretching P Positioning P Massage P Weight bearing P Slow stretch P Weight bearing P Positioning P Massage P Alter position Rule out cause Isolate elbow movements A/A Finger extension AA/A Assisted wrist extension AA/A Supination and pronation AA/A Finger tapping A Grasp and release A Fine finger activity F Pick using finger and thumb F Button/pegs/cards F Pinches/write/draw F
Functional problems 1. Loss of function
! Stimulation of functional movement
2. Dependence in ADL
! Patient-oriented goal
Simple active exercises F Minimal assisted functional exercises F Placing/reaching F . . .. . .. . .. . .. . .. . .. . .. . .. . ..F
Passive (P), Active-assisted therapy (AA), Active (A)/strengthening, (ST), Functional activities (F), PM ¼ passive movements, ADL ¼activities of daily living
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