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

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

Interventions

OTHER

Constraint-induced movement therapy: PEPS-MIT

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.

OTHER

Bimanual manipulation exercises (PEPS-Bimanual)

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.

Sponsors & Collaborators

• Jahangirnagar University

  collaborator OTHER

• Midwestern University

  collaborator OTHER

• University of Dhaka, Bangladesh

  collaborator OTHER

• Centre for the Rehabilitation of the Paralysed, Bangladesh

  lead OTHER

Principal Investigators

• Fatema Tuj Johra, M.Sc. · Centre for the Rehabilitation of the Paralysed

• Clara Dorothea (Dorine) Van Ravensberg, PhD · Centre for the Rehabilitation of the Paralysed

• Md. Forhad Hossain, PhD · Department of Statistics, Jahangirnagar University, Bangladesh

• Mark Kovic, PhD · Associate Program Director,Occupational Therapy Department,Midwestern University ,USA

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-10-27

Primary Completion

2019-01-30

Completion

2020-03-25

Countries

• Bangladesh

Study Locations