Back to resultsEfficacy of Modified Constraint-Induced Movement Therapy on the Upper Limb Function of Sub-acute Stroke Patients in Peshawar Pakistan
Primary Purpose
Stroke
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Modified Constraint-Induced Movement Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental Group
Control Group
Arm Description
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
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05570461
Brief Title
Efficacy of Modified Constraint-Induced Movement Therapy on the Upper Limb Function of Sub-acute Stroke Patients in Peshawar Pakistan
Official Title
Efficacy of Modified Constraint-Induced Movement Therapy on the Upper Limb Function of Sub-acute Stroke Patients in Peshawar Pakistan: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 4, 2022 (Anticipated)
Primary Completion Date
August 12, 2023 (Anticipated)
Study Completion Date
September 25, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NCS University System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Modified Constraint-Induced Movement Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Wolf Motor function test
Description
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.
Time Frame
4weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Efficacy of Modified Constraint-Induced Movement Therapy on the Upper Limb Function of Sub-acute Stroke Patients in Peshawar Pakistan
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