Back to resultsFES VS Constrained Induced MT Recovery and Spasticity in Upper Limb Hemiparetic Ischemic Patients
Primary Purpose
Stroke
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Functional Electrical Stimulation
Constrained Induced Movement Therapy
Sponsored by
About this trial
This is an interventional health services research trial for Stroke
Eligibility Criteria
Inclusion Criteria: Clinically diagnosed chronic ischemic stroke patients. Patients from both genders Age 45 year and older. Patients having upper limb spasticity equal to 2 or less than 2 according to modified ash worth scale. Patients having active cognitive scoring on Mini Mental State Examination. Exclusion Criteria: Having pacemaker and other stimulation devices. Prosthesis of bones, joints in targeted region of treatment. Patients presenting the history of recurrent stroke. Patients having history of bilateral hemiparesis. Co-morbid history of tumor, heart disease, hypertensive. Patients presenting with skin lesions, wounds, discoloration will be excluded from this research.
Sites / Locations
- Shadman Medical CareRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Functional Electrical Stimulation
Constrained Induced Movement Therapy
Arm Description
Outcomes
Primary Outcome Measures
Scale Modified Ash worth
Motor Function assessment test
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05854121
Brief Title
FES VS Constrained Induced MT Recovery and Spasticity in Upper Limb Hemiparetic Ischemic Patients
Official Title
Functional Electrical Stimulation Versus Constrained Induced Movement Therapy for Motor Recovery and Spasticity in Upper Limb Hemiparetic Chronic Ischemic Stroke Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Superior University
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
To determines the effects of Functional Electrical Stimulation versus Constrained Induced Movement Therapy for motor recovery and spasticity in Upper Limb Hemiparetic Chronic Ischemic 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
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Functional Electrical Stimulation
Arm Type
Other
Arm Title
Constrained Induced Movement Therapy
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Functional Electrical Stimulation
Intervention Description
Functional Electrical Stimulation for Motor Recovery and Spasticity in Upper Limb Hemiparetic Chronic Ischemic Stroke Patients
Intervention Type
Diagnostic Test
Intervention Name(s)
Constrained Induced Movement Therapy
Intervention Description
Constrained Induced Movement Therapy for Motor Recovery and Spasticity in Upper Limb Hemiparetic Chronic Ischemic Stroke Patients
Primary Outcome Measure Information:
Title
Scale Modified Ash worth
Time Frame
6 Months
Title
Motor Function assessment test
Time Frame
6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinically diagnosed chronic ischemic stroke patients. Patients from both genders Age 45 year and older. Patients having upper limb spasticity equal to 2 or less than 2 according to modified ash worth scale.
Patients having active cognitive scoring on Mini Mental State Examination.
Exclusion Criteria:
Having pacemaker and other stimulation devices. Prosthesis of bones, joints in targeted region of treatment. Patients presenting the history of recurrent stroke. Patients having history of bilateral hemiparesis. Co-morbid history of tumor, heart disease, hypertensive. Patients presenting with skin lesions, wounds, discoloration will be excluded from this research.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Salwa Jamil, DPT
Phone
+923209458491
Email
Salwajamil998@gmail.com
Facility Information:
Facility Name
Shadman Medical Care
City
Lahore
State/Province
Punjab
Country
Pakistan
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
FES VS Constrained Induced MT Recovery and Spasticity in Upper Limb Hemiparetic Ischemic Patients
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