Clinical trial NCT04264195: Peer Group Regulated mCIMT Program for Adult Stroke Patients: Effects on Functional Activities
Official title: Socially Interactive and Peer Group Regulated Upper Extremity Rehabilitation Following Stroke: Bilateral Activities Compared to Activities With Forced Use of the Paretic Hand (mCIMT) - a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weakness of Extremities as Sequela of Stroke
Modified Constraint Induced Movement Therapy After Stroke
Upper Extremity Functional Performance After Stroke
Keywords: Stroke
Upper extremity paresis
Recovery of function
Modified CIMT
Lead sponsor: Centre for the Rehabilitation of the Paralysed, Bangladesh
Sponsor class: OTHER
Collaborators: name: Jahangirnagar University
name: Midwestern University
name: University of Dhaka, Bangladesh
First posted: 2020-02-11
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Wolf Motor Function Test - Functional Ability (WMFT-FA)
timeFrame: Changes between score from pre-treatment, immediately post-treatment and at 3, 6, 9 and 12 months follow-up.
Secondary outcomes:
measure: Nine Holes Peg Test (NHPT)
timeFrame: Changes between score from pre-treatment, immediately post-treatment and at 3, 6, 9 and 12 months follow-up.
measure: Action Research Arm Test (ARAT)
timeFrame: Changes between score from pre-treatment, immediately post-treatment and at 3, 6, 9 and 12 months follow-up.
measure: Motor activity Log scale (MAL)
timeFrame: Changes between score from post-treatment and at 3, 6, 9 and 12 months follow-up.
measure: Fugl -Meyer assessment (FMA-Upper Extremity Motor Section)
timeFrame: Changes between score from pre-treatment, immediately post-treatment and at 3, 6, 9 and 12 months follow-up.
measure: Functional Independence measure (FIM: Self-care Section)
timeFrame: Changes between score from pre-treatment, immediately post-treatment and at 3, 6, 9 and 12 months follow-up.
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Centre for the Rehabilitation of the Paralysed
Study officials:
affiliation: Centre for the Rehabilitation of the Paralysed
name: Fatema Tuj Johra, M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for the Rehabilitation of the Paralysed
name: Clara Dorothea (Dorine) Van Ravensberg, PhD
role: STUDY_CHAIR
affiliation: Department of Statistics, Jahangirnagar University, Bangladesh
name: Md. Forhad Hossain, PhD
role: STUDY_CHAIR
affiliation: Associate Program Director,Occupational Therapy Department,Midwestern University ,USA
name: Mark Kovic, PhD
role: STUDY_CHAIR
References: