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Clinical Trials/NCT04264195
NCT04264195CompletedNot Applicable

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

Centre for the Rehabilitation of the Paralysed, Bangladesh2 sites in 1 country140 target enrollmentStarted: October 27, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
140
Locations
2
Primary Endpoint
Wolf Motor Function Test - Functional Ability (WMFT-FA)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description

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.

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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

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

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 ).

Secondary Outcomes

  • 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.)
  • Action Research Arm Test (ARAT)(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.)
  • Nine Holes Peg Test (NHPT)(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.)

Investigators

Sponsor
Centre for the Rehabilitation of the Paralysed, Bangladesh
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Fatema Tuj Johra

Principle Investigator,B.Sc. in Occupational Therapy,M.Sc. in Rehabilitation Science

Centre for the Rehabilitation of the Paralysed, Bangladesh

Study Sites (2)

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