Peer Group Regulated mCIMT Program for Adult Stroke Patients: Effects on Functional Activities
Condition: Weakness of Extremities as Sequela of Stroke; Modified Constraint Induced Movement Therapy After Stroke; Upper Extremity Functional Performance After Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Each year more than 17 million people in the world are experiencing a stroke. Stroke is a
      major cause of mortality and one of the prevalent causes of serious disablement.

      Stroke sufferers often will have restricted participation in various domains e.g. not being
      able to fulfill the job requirements. That is why they are losing social contacts and are at
      risk for social deprivation.

      They also show limitations in common daily activities, which implies that they often need
      help or must use assistive devices because of muscle weakness, spasticity and impaired
      control over one of the hands, which are very common after stroke. Functional hand recovery
      will be only minimal at 6 months after stroke in most of the patients. Therefore, patients
      mainly rely on their unaffected hand to perform daily activities and refrain from using the
      impaired hand. However, it is known that also after a stroke new connection could be made in
      the brain when training tasks strenuously. This mechanism is applied in our program by
      constraint induced movement therapy (CIMT). In CIMT using the unaffected hand is hindered by
      a mitten, so that patients are forced to perform tasks predominantly with the paretic hand.

      The original CIMT protocol includes three main elements:

        -  Constraining of the non-paretic hand to force the use of paretic hand.

        -  Repetitive task-oriented training of the paretic hand.

        -  Adherence-enhancing behavioral methods, to promote the use of this technique in the
           daily environment.

      Although CIMT trials are showing variations in the kind of tasks, the duration of practice
      per day and the intensity, they all published significant effects of CIMT compared to
      traditional therapy.

      Currently CIMT is worldwide considered the most effective rehabilitation treatment for
      improving the functioning of the paretic hand in stroke, but this treatment is not applied in
      Bangladesh. To overcome this,the investigators have made a protocol for CIMT application with
      the purpose to study the effects in stroke patients in the Bangladesh situation.

      Method

      Beside the CIMT program the investigators also developed a method for getting maximal social
      interaction in groups of stroke patients. That may help them to exercise on their own with
      support of their peers. The investigators call that a 'peer group regulated training' and
      stroke patients got that training in addition to the usual individually focused
      rehabilitation. This extra training includes the following elements:

        -  Stroke patients perform repetitive tasks in a group together (groups 6-8 persons, max
           15).

        -  One of them is assigned as a 'leader', who announces the next task while the therapist
           is there mainly for helping and correcting patients.

        -  Tasks are fine-tuned to the Bangladesh' situation regarding gender-specific clothing,
           manipulation of objects and tasks that needs cognitive solutions.

        -  Within the training there are socializing tasks like singing, sharing of experiences,
           complimenting and encouraging each other.

        -  Patients were asked to perform the tasks by themselves at home as well, and to report
           about that.

      This method was applied in two separate groups. The group that is indicated as the control
      group mainly performed the exercise tasks bilaterally, as in as usual therapy sessions. The
      experimental group performed the tasks with forced use of the paretic hand, wearing a mitten
      at the non-paretic hand.

      The investigators will be compared the performances of the two study groups at the start of
      the group therapy, at the finish one month later, and at 3, 6, 9 and 12 months afterwards.

      The hypothesis is that the applied adherence-enhancing behavioral method will have dominant
      effects, and that the methods: 'bilaterally' versus 'forced use of paretic arm/hand' (CIMT)
      will show equal improvements in the short and longer term.
    

Detailed description: 
      Research Question. To compare the performances of the experimental and control groups at the
      start of the PEPS program, at the finish 1 month later and at 3, 6, 9 and 12 months follow
      up.

      Hypothesis. Null Hypothesis H0: µ1- µ2 = 0 or μ1=μ2; where μ1= mean of experimental group and
      μ2= mean of control group.

      PEPS-MIT is not more effective than PEPS-bimanual training in Restoration of upper limb
      functioning following stroke.

      Alternative Hypothesis Ha: µ1- µ2> 0 or µ1> µ2 PEPS-MIT is more effective than PEPS-bimanual
      training in Restoration of upper limb functioning following stroke.

      Ethical Considerations. The Bangladesh Health Professions Institute Institutional Review
      Board (IRB) judged the ethical issues and they gave the permission for data collection. All
      data and assessment files were stored in security and files were maintained with patient data
      held anonymously.

      All patients were given information about the trial and they were secured that withdrawing
      from the trial didn't give any consequences for their normal treatment. All eligible patients
      wish to participate and they all signed informed consent forms.

      Study design. The study is a double blind randomized clinical trial with baseline assessment,
      post-treatment assessment and three-month, 6 months, 9 months and 12 months follow-up, two
      group comparison design.

      Sample Size. The study sample was all the CRP rehabilitation center patients who meet the
      inclusion criteria within the study time frame (10.08.18 to 25.12.18). Total 140 patients
      meet the criteria, and all are allocated to the study. Through simple random techniques
      patients were allocated into control group and experimental group according to a 1:1 ratio.
      Thus, after randomization 70 patient were allocated into control group and 70 were allocated
      into experimental group. Sealed envelope was used for randomization that was carried out by
      the director of the Spinal Cord Injury Rehabilitation unit of Occupational Therapy
      Department. Patients are blinded for the therapy group.

      Interventions. The fundamental PEPS-method (Please see PEPS training programme full
      description, URL link- https://www.crp-bangladesh.org/standard-treatment-program) was applied
      in both the control and experimental group.

      The control group mainly performed the exercise tasks bimanually, as in as usual' therapy
      sessions (PEPS-bimanual), whereas the experimental group performed the exercise tasks with
      forced use of the most affected hand (wearing a specially designed mitten at the non-paretic
      hand; PEPS-MIT).

      Treatment sessions. Two hours in 5 days per week; Total 4 weeks. Assessments. Trained
      assessors who were blinded for the intervention had assessed the functioning of the upper
      limb before the start of the treatment, at the end and at follow-up after 3, 6, 9 and 12
      months.

      Therapists. Therapists were only facilitator of the peer lead training sessions. Six
      qualified therapists were randomly (through sealed envelope) allocated to either the
      experimental or the control group. Therapists of both groups have got a 7 days training in
      the core PEPS program. Both groups of therapists were forbidden to share their training
      knowledge with each other as part of study protocol. Therapists are unaware which group is
      the control and which is the experimental group: they were blinded for the intervention.

      Quality assurance. Pilot trial: Investigators conducted a pilot trial (20 days with 4
      patients) before conducting the study for checking feasibility of the program and outcome
      measures.

      Each session therapist asked the patients for experiencing adverse events, and registered
      these.

      Monitoring the process of training and data registration regarding the home-exercising was
      done during three days each week by the first and third author.

      The statistics department of Jahangirnagor University (JU) and MRS program, BHPI, CRP helps
      in site monitoring and auditing, and in controlling the accuracy and completeness of the
      data, in data validation and registry procedure. All data were checked by Statistics
      department of JU and rechecked by MRS program, BHPI, CRP.

      Investigators have made a log-book with descriptions of each variable and the normal range of
      scores per test, and the codes to indicate the individual patients to keep the patient data
      anonymously.

      All data were put into SPSS files and checked. Missing data. There are no missing data in
      initial assessments.For missing data in follow-up assessments (no show of patients, or
      because of passing away of patients) will be used the 'intention-to-treat' analysis.

      Statistical analysis: 1. Independent t tests and Chi- Square (χ2) tests will be used to
      compare the control and experimental group on sociodemographic and disease variables. Changes
      in test scores within each group were evaluated with paired t tests, and between groups with
      independent t-test. Repeated measure ANOVA (factorial ANOVA) model will be used to see
      whether group differences existed or not and how group scores changes over time and
      interaction between Group*Time.
    

Intervention name(s): Constraint-induced movement therapy: PEPS-MIT; Bimanual manipulation exercises (PEPS-Bimanual)
Intervention type(s): Other; Other
Intervention description(s): All participants of control and experimental groups received standard stroke rehabilitation. After regular office time, a 2 hours' peer group session was provided, 5 days/week, 4 consecutive weeks, to both groups. One patient 'leads' the group exercises under a therapist's supervision. The therapist is mainly helping and correcting patients during the various exercise tasks.
• Specific for the experimental group was that patients performed all manipulation tasks with forced use of the paretic hand/arm by wearing a soft-padded mitten at the non-paretic hand, preventing manipulation with that hand. Patients were encouraged to wear the mitten also for 3 hours/day at home, while performing ADL and learned exercises. Behavioural strategies included a treatment contract and daily use of the home activity checklist which was checked by patient's caregiver and signed by both patient and caregiver. Each treatment day the activity checklist was submitted to the therapist who gives feedback.; All participants of control and experimental groups received standard stroke. After regular office time, a 2 hours' peer group session was provided, 5 days/week, 4 consecutive weeks, to both groups. One patient 'leads' the group exercises under a therapist's supervision. The therapist is mainly helping and correcting patients during the various exercise tasks.
Specific for the control group was that patients performed all manipulation tasks bimanually, as they used to do in occupational therapy activities. Patients were also asked to document their 'at home' activities in an activity checklist that was regularly checked by the therapists.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The main element of this model is randomization where participants were randomly assigned into a control group and an experimental group. Both groups got their treatment at the same time for 2 hours for 4 days in a week. The experimental group practiced the tasks with the paretic hand only - the non-paretic hand being constrained by the use of a mitten - where the control group practiced the tasks bimanually.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke; Upper extremity paresis; Recovery of function; Modified CIMT