Back to resultsComparison of Tele-rehabilitation Versus In-clinic Rehabilitation for Upper Limb Motor Function Stroke Patients
Primary Purpose
Stroke
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
In-clinic Rehabilitation
Tele-rehabilitation
Sponsored by
About this trial
This is an interventional health services research trial for Stroke
Eligibility Criteria
Inclusion Criteria: • Patients from both genders. Patients with chronic ischemic stroke i.e. 6 months or more. Patients with 45 years old and above. On modified Ashworth scale, patient with limb spasticity equal to 2 or less than 2. On Mini Mental State Examination (MMSE), patients with good cognitive function minimum 24 or more. Exclusion Criteria: • Patients with any recurrent stroke history. Cognitive deficit patients (on Folstein Mini Mental state Examination score of less than 24) Patient having other neurological diseases.
Sites / Locations
- Chaudary Muhammad Akram Teaching HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Tele-rehabilitation
In-clinic Rehabilitation
Arm Description
Outcomes
Primary Outcome Measures
Fugal Myer assessment scale (FMAS)
Fugal Myer assessment scale (FMAS) to check the pain and funcationality in stroke
Modified Ashworth Scale (MAS)
Modified Ashworth Scale (MAS) to check the pain and funcationality in stroke
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05875818
Brief Title
Comparison of Tele-rehabilitation Versus In-clinic Rehabilitation for Upper Limb Motor Function Stroke Patients
Official Title
Comparison of Effects of Tele-rehabilitation Versus In-clinic Rehabilitation for Upper Limb Motor Function in Chronic 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 determine the effects of Tele-rehabilitation versus in-clinical rehabilitation for upper limb motor function and spasticity in 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
68 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tele-rehabilitation
Arm Type
Other
Arm Title
In-clinic Rehabilitation
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
In-clinic Rehabilitation
Intervention Description
Effects of In-clinic Rehabilitation for Upper Limb Motor Function in Chronic Stroke Patients
Intervention Type
Diagnostic Test
Intervention Name(s)
Tele-rehabilitation
Intervention Description
Effects of Tele-rehabilitation for Upper Limb Motor Function in Chronic Stroke Patients
Primary Outcome Measure Information:
Title
Fugal Myer assessment scale (FMAS)
Description
Fugal Myer assessment scale (FMAS) to check the pain and funcationality in stroke
Time Frame
6 Months
Title
Modified Ashworth Scale (MAS)
Description
Modified Ashworth Scale (MAS) to check the pain and funcationality in stroke
Time Frame
6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• Patients from both genders.
Patients with chronic ischemic stroke i.e. 6 months or more.
Patients with 45 years old and above.
On modified Ashworth scale, patient with limb spasticity equal to 2 or less than 2.
On Mini Mental State Examination (MMSE), patients with good cognitive function minimum 24 or more.
Exclusion Criteria:
• Patients with any recurrent stroke history.
Cognitive deficit patients (on Folstein Mini Mental state Examination score of less than 24)
Patient having other neurological diseases.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hina Riaz, DPT
Phone
+923364795589
Email
dptm-f18-168@superior.edu.pk
Facility Information:
Facility Name
Chaudary Muhammad Akram Teaching Hospital
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
Comparison of Tele-rehabilitation Versus In-clinic Rehabilitation for Upper Limb Motor Function Stroke Patients
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