Efficacy of Modified Constraint-Induced Movement Therapy on the Upper Limb Function of Sub-acute Stroke Patients in Peshawar Pakistan

Efficacy of Modified Constraint-Induced Movement Therapy on the Upper Limb Function of Sub-acute Stroke Patients in Peshawar Pakistan: A Randomized Controlled Trial

This RCT will also help the clinicians to provide the best treatment to their patients for better outcomes.

The objective of the study is to determine the efficacy of Modified Constraint-induced movement therapy on the Upper Limb function of Sub-acute stroke patients in Peshawar Pakistan.

Alternative Hypothesis: There will be a difference in the means of Modified Constraint-induced movement therapyand traditional physical therapy on the upper limb function of subacute stroke patients.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: Modified Constraint-Induced Movement Therapy

• Study Type: Interventional
• Enrollment (Anticipated): 46
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 1. Age 30 to 60 years
• 2. Both female & male will be included.
• 3. Cognitive and lingual ability to communicate with the research staff.
• 4. A minimum of 10 degrees of active finger extension and 20 degrees of active wrist extension(16).
• 5. A history of a single stroke resulting in a hemiparesis

Exclusion Criteria:

• 1. Recurrent stroke during the training period.
• 2. Neurological or orthopedic disorders prohibiting the use of the paretic arm.
• 3. Patients who doesn't show willingness to participate in the study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; Experimental group will receive Modified Constraint-Induced Movement Therapy and traditional physical therapy to the impaired upper limb based on the repetitive training of functional activities and behavioral shaping and a task-oriented approach, while the unaffected arm of subjects in the Modified Constraint-Induced Movement Therapy group will be constrained by wearing a mitten during the treatment session	Other: Modified Constraint-Induced Movement Therapy; Experimental group will receive Modified Constraint-Induced Movement Therapyand traditional physical therapy to the impaired upper limb based on the repetitive training of functional activities and behavioral shaping and a task-oriented approach, while the unaffected arm of subjects in the mCIMT group will be constrained by wearing a mitten during the treatment session and for 3 hours/day outside the therapy hours, 6(six) days/week for two weeks by an experienced Physical therapist.The time duration for Group A will be 40 minutes.
Active Comparator: Control Group; Control group therapy will consist of increasing upper limb function with the use of both hands. The session include active or active assistive range of motion exercises, unilateral and bimanual activities, balance and strength training or coordination exercises depending on the severity of motor impairment. Similar to group A, daily therapy will be conducted for 40 min/day, 6 days/ week for upto 2 weeks.	Other: Modified Constraint-Induced Movement Therapy; Experimental group will receive Modified Constraint-Induced Movement Therapyand traditional physical therapy to the impaired upper limb based on the repetitive training of functional activities and behavioral shaping and a task-oriented approach, while the unaffected arm of subjects in the mCIMT group will be constrained by wearing a mitten during the treatment session and for 3 hours/day outside the therapy hours, 6(six) days/week for two weeks by an experienced Physical therapist.The time duration for Group A will be 40 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wolf Motor function test	Use mainly for post-stroke patients with impaired upper limb motor ability. The purpose of this test is to enumerate upper limb motor ability through a series of functional tasks. The WMFT is an instrument with high internal consistency, interrater reliability and test-retest reliability. The quality of movement during the task is measured by functional ability scale, a 6-point ordinal scale, where 0 = does not attempt with the impaired arm and 5 = arm movement appear to be normal. Higher the value higher will be the normal function.	4weeks

Collaborators and Investigators

• Sponsor: NCS University System

Study record dates

Study Major Dates

• Study Start (Anticipated): November 4, 2022
• Primary Completion (Anticipated): August 12, 2023
• Study Completion (Anticipated): September 25, 2023

Study Registration Dates

• First Submitted: October 3, 2022
• First Submitted That Met QC Criteria: October 3, 2022
• First Posted (Actual): October 6, 2022

Study Record Updates

• Last Update Posted (Actual): October 6, 2022
• Last Update Submitted That Met QC Criteria: October 3, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: KMU/IPMR/MS/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No