Comparative Effects of Intensive and Distributed CIMT on Upper Extremity Function in Stroke Patients

June 11, 2024 updated by: Riphah International University

Comparative Effects of Intensive and Distributed Constraint-induced Movement Therapy on Upper Extremity Function in Stroke Patients

The main question this clinical trial is aims to answer is whether intensive and distributed constraint-induced movement therapy has similar effects on upper extremity function in participants with stroke. Participants will receive intensive protocol of CIMT for 6 hours for 6 days to make total of 36 hours while distributed protocol participants will receive 2.25 hours of training two times a week for 8 weeks making total of 36 hours.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Many studies have examined the effects of constraint-induced movement therapy (CIMT) in upper extremity function in stroke patients. Literature has shown effectiveness of different CIMT protocols for stroke patients. Emerging research have demonstrated comparative efficacy of constraint-induced movement therapy with different physical therapy approaches i.e. bimanual intensive training, motor relearning programme for improving upper extremity function. But according to researcher's knowledge, the gap of current knowledge is that no study has directly investigated the comparative effectiveness of intensive and distributed CIMT in stroke patients and if intensive and distributed CIMT had similar motor outcomes in upper limb function after stroke

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Recruiting
        • Hameed Latif Hospital
        • Contact:
        • Principal Investigator:
          • Rabia Hussain, MsPT(NMPT)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 40-70 years
  • ischemic or hemorrhagic stroke
  • Both genders eligible
  • Gcs score ≥ 13
  • Able to extend at least 10° at the fingers
  • Able to extend at least 20° at the wrist
  • Patients diagnosed with one side more affected(hemiplegia)
  • Modified Ashworth scale score ≤2

Exclusion Criteria:

  • severe, chronic systemic illness
  • Epilepsy
  • History of fall past 6 months
  • Injections of botulinum toxin type A or operations on the UE within 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intensive constraint-induced movement therapy
intensive protocol of CIMT of total 36 hours will be given in a week
Other: Intensive constraint-induced movement therapy
Intensive protocol of CIMT will be given for 6hrs for 6 days to make total of 36 hours
Experimental: Distributed constraint-induced movement therapy
Distributed participants will total of 36 hours treatment for 8 weeks
Other: Distributed constraint-induced movement therapy
Distributed protocol of CIMT will be given for 2.25hrs two times a week for 8 weeks making total of 36 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Assessment-Upper Extremity
Time Frame: 8th week
It is designed to assess reflex activity, movement control and muscle strength in the upper extremity of people with post-stroke hemiplegia. It consists of 30 items assessing motor function and 3 items assessing reflex function. The score most applicable to task performance is given from "0, inability," "1, beginning ability," to "2, normal" (total score range, 0-66).
8th week
Wolf motor function test
Time Frame: 8th week
This test was designed to assess the motor ability of patients with moderate to severe upper extremity motor deficits in the laboratory and clinic. The original version of this test was developed by Dr. Steven L. Wolf, Emory University School of Medicine. The original version consisted of 21 items; the widely used version of the wolf motor function test consists of 17 items. it uses a Uses a 6-point ordinal scale i.e."0" means "does not attempt with the involved arm" to "5" means "arm does participate; movement appears to be normal."
8th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Wajiha Shahid, PhD, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

June 11, 2024

First Submitted That Met QC Criteria

June 11, 2024

First Posted (Actual)

June 14, 2024

Study Record Updates

Last Update Posted (Actual)

June 14, 2024

Last Update Submitted That Met QC Criteria

June 11, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR & AHS/23/0279

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Intensive constraint-induced movement therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe