NCT04264195: PEPS-MIT

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

Completed NA Last updated 10 March 2021

What this trial tests

NA trial testing Constraint-induced movement therapy: PEPS-MIT in Weakness of Extremities as Sequela of Stroke in 140 participants. Completed in 25 March 2020.

Timeline

27 October 2018

Primary endpoint
30 January 2019

25 March 2020

Quick facts

Lead sponsor	Centre for the Rehabilitation of the Paralysed, Bangladesh
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	140
Start date	27 October 2018
Primary completion	30 January 2019
Estimated completion	25 March 2020
Sites	1 location across Bangladesh

Drugs / interventions tested

• Constraint-induced movement therapy: PEPS-MIT
• Bimanual manipulation exercises (PEPS-Bimanual)

Conditions studied

• Weakness of Extremities as Sequela of Stroke — all drugs for Weakness of Extremities as Sequela of Stroke →
• Modified Constraint Induced Movement Therapy After Stroke — all drugs for Modified Constraint Induced Movement Therapy After Stroke →
• Upper Extremity Functional Performance After Stroke — all drugs for Upper Extremity Functional Performance After Stroke →

Sponsor

Centre for the Rehabilitation of the Paralysed, Bangladesh

Who can join

Adults 18 to 75, any sex, with Weakness of Extremities as Sequela of Stroke or Modified Constraint Induced Movement Therapy After Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.