Peer Group Regulated mCIMT Program for Adult Stroke Patients: Effects on Functional Activities
Keywords
Abstract
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.
Dates
| Last Verified: | 01/31/2020 |
| First Submitted: | 01/30/2020 |
| Estimated Enrollment Submitted: | 02/06/2020 |
| First Posted: | 02/10/2020 |
| Last Update Submitted: | 02/06/2020 |
| Last Update Posted: | 02/10/2020 |
| Actual Study Start Date: | 10/26/2018 |
| Estimated Primary Completion Date: | 01/29/2019 |
| Estimated Study Completion Date: | 03/24/2020 |
Condition or disease
Intervention/treatment
Other: Constraint-induced movement therapy
Other: Bimanual manipulation
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Constraint-induced movement therapy Constraint-induced movement therapy (PEPS-MIT) | Other: Constraint-induced movement therapy 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. |
| Active Comparator: Bimanual manipulation Bimanual manipulation (PEPS-Bimanual) | Other: Bimanual manipulation 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. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - Acute (four weeks- three months) to chronic (above three months to one year) stage post stroke patients. - Diagnosis of a first stroke. - Unilateral hand impairment. - Must have more than 10 to 20 degrees active wrist extension and 10 degrees active finger extension. - Having 20 points or more on the Mini-Mental State Examination scale. - Age range 18-75 years and first stroke. - Willing to participate in the study and signed the informed consent form. Exclusion Criteria: - Persons with other neurological disorders. - Bilateral stroke. - Recurrent stroke history. - Unstable cardiovascular diseases is excluded from the study. |
Outcome
Primary Outcome Measures
1. Wolf Motor Function Test - Functional Ability (WMFT-FA) [Changes between score from pre-treatment, immediately post-treatment and at 3, 6, 9 and 12 months follow-up.]
Secondary Outcome Measures
1. Nine Holes Peg Test (NHPT) [Changes between score from pre-treatment, immediately post-treatment and at 3, 6, 9 and 12 months follow-up.]
2. Action Research Arm Test (ARAT) [Changes between score from pre-treatment, immediately post-treatment and at 3, 6, 9 and 12 months follow-up.]
3. Motor activity Log scale (MAL) [Changes between score from post-treatment and at 3, 6, 9 and 12 months follow-up.]
4. Fugl -Meyer assessment (FMA-Upper Extremity Motor Section) [Changes between score from pre-treatment, immediately post-treatment and at 3, 6, 9 and 12 months follow-up.]
5. Functional Independence measure (FIM: Self-care Section) [Changes between score from pre-treatment, immediately post-treatment and at 3, 6, 9 and 12 months follow-up.]
