Peer Group Regulated mCIMT Program for Adult Stroke Patients: Effects on Functional Activities

NCT04264195 | Completed DMC

• 1 other identifier: CRP.MRS.Iris.2019
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Wolf Motor Function Test - Functional Ability (WMFT-FA)

  The WMFT-FA consists of 15 timed arm movement tasks (outcomes in seconds; maximum time to complete a task:120 sec.) plus 2 strength tasks (outcomes in lbs and kg(s) lifted). All items are scored on a six point functional ability scale (minimum score is 0 and maximum score is 5 ).

  Changes between score from pre-treatment, immediately post-treatment and at 3, 6, 9 and 12 months follow-up.

Secondary Outcomes (5)

• Nine Holes Peg Test (NHPT)

  Changes between score from pre-treatment, immediately post-treatment and at 3, 6, 9 and 12 months follow-up.

• Action Research Arm Test (ARAT)

  Changes between score from pre-treatment, immediately post-treatment and at 3, 6, 9 and 12 months follow-up.

• Motor activity Log scale (MAL)

  Changes between score from post-treatment and at 3, 6, 9 and 12 months follow-up.

• 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.

• 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.

Study Arms (2)

Constraint-induced movement therapy

EXPERIMENTAL

Constraint-induced movement therapy (PEPS-MIT)

Other: Constraint-induced movement therapy: PEPS-MIT

Bimanual manipulation

ACTIVE COMPARATOR

Bimanual manipulation (PEPS-Bimanual)

Other: Bimanual manipulation exercises (PEPS-Bimanual)

Interventions

Constraint-induced movement therapy: PEPS-MIT OTHER

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.

Constraint-induced movement therapy

Bimanual manipulation exercises (PEPS-Bimanual) OTHER

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.

Bimanual manipulation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Persons with other neurological disorders.
• Bilateral stroke.
• Recurrent stroke history.
• Unstable cardiovascular diseases is excluded from the study.

Sponsors & Collaborators

• Centre for the Rehabilitation of the Paralysed, Bangladesh: lead
• Jahangirnagar University: collaborator
• Midwestern University: collaborator
• University of Dhaka, Bangladesh: collaborator

Study Sites (1)

Centre for the Rehabilitation of the Paralysed

Dhaka, 1343, Bangladesh

Location

Related Links

• PEPS training programme full description
• PEPS training programme full description

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fatema Tuj Johra, M.Sc.

  Centre for the Rehabilitation of the Paralysed

  PRINCIPAL INVESTIGATOR

• Clara Dorothea (Dorine) Van Ravensberg, PhD

  Centre for the Rehabilitation of the Paralysed

  STUDY CHAIR

• Md. Forhad Hossain, PhD

  Department of Statistics, Jahangirnagar University, Bangladesh

  STUDY CHAIR

• Mark Kovic, PhD

  Associate Program Director,Occupational Therapy Department,Midwestern University ,USA

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masking of Patients: patients are unaware if they are participating in a control or experimental group; groups didn't have contact Masking of investigator: Allocation of patients to treatment group and control group by using sealed envelopes. Masking of Assessors: Four assessors (qualified occupational therapists) from both clinical and academic side of CRP were recruited for outcome measurement. Each group had an individual assessor and the same assessor was assigned in pretest, posttest and follow-up assessments. Assessors were not allowed to ask patients for details of the treatment. Masking of Therapist: Therapists were randomly allocated into groups before they get (separated) group-specific training in application of the protocol and treatment modality. Therapists have no idea about which is the control group treatment and which is the experimental group treatment. Both groups have got a new, specific way of exercising by a peer regulated group treatment program.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator,B.Sc. in Occupational Therapy,M.Sc. in Rehabilitation Science

Model Details: 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.

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 11, 2020
• Study Start: October 27, 2018
• Primary Completion: January 30, 2019
• Study Completion: March 25, 2020
• Last Updated: March 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Starting 10 months after trial result publication till 1 year later.
• Access Criteria: Researchers having already published studies in stroke and CIMT trials. For secondary analyses of data,preferably for eligibility and predictive outcome model for the peer regulated group exercise program (PEPS) and the PEPS-MIT intervention. Requests will be reviewed by the principle investigator and facility contact person.

Locations

BA (1)