- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04875910
Effectiveness of Telerehabilitation in Improving Walking and Balance Among Stroke Survivors?
Could Telerehabilitation be a Promising Tool in Improving Walking and Balance Among Stroke Survivors? "Case Study"
Study Overview
Detailed Description
Background: Rehabilitation program is commonly provided after stroke to improve functional outcomes. A good rehabilitation program may not be accessible for all individuals living with stroke due to cost, transportation and compliance. Telerehabilitation is an alternative health care program that has been used to provide therapy for stroke survivors living in rural areas. With COVID-19 pandemic, many stroke survivors have lost their access to rehabilitation. Therefore, telerehabilitation may help in overcoming this issue. In this study we aim to find if the use of telerehabilitation in Saudi Arabia would improve balance and walking in stroke survivors during this pandemic.
Methods: 2 stroke survivors ( male and female/ >6 months post stroke) are included in this case study. Participants will receive a task-specific activity training (3days/week moderate exercises for 4 weeks) Both participants will provide feedback through questionnaires pre and post the 4 weeks intervention. We will use the Activities- specific balance confidence (ABC) scale, Lower limb functional scale (LEFS) and Stroke severity quality of life scale ( SS-Qol).
• Intervention: The participants will follow a home-based exercise through videos with follow up from the therapists for 4 weeks.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Riyadh, Saudi Arabia, 11451
- King Saud University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects who have been diagnosed with stroke 6 months or more.
- Either right or left hemiparesis.
- Subjects able to walk with or without assistive device.
- age between 40-70. 5) Subjects can understand and follow commands.
Exclusion Criteria:
- subjects with uncontrolled Blood pressure, heart rate or breathing problems.
- Having an orthopedic problem or pain that limits walking and standing.
- Subject with vestibular disorders.
- Subjects with cognitive disorders. 5) Subjects with hemi spatial neglect
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Stroke survivors participants
Subjects who have been diagnosed with stroke 6 months or more. 1)Either right and left hemiparesis. 2) Subjects able to walk with or without assistive device. 3) age between 40-80. 4) Subjects can understand and follow commands. Exclusion criteria is: 1) subjects with uncontrolled Blood pressure, heart rate or breathing problems. 2) Having an orthopedic problem or |
The exercise program will include task specific training to improve balance and the training will progress every two weeks. A Physical therapist will be following up and monitoring the participants adherence to the training by audio or video call. The exercise program for Week 1: Sit to Stand 5 times, Steps forward, backward and to the sides 5 times, 10 meters walk. 45 minutes session /3 times per week. Week 2: Sit to stand 10 times, Steps forward, backward and to the sides 5 times , Sit and reach 5 min for each hand and walk for 15 meters. 45 minutes session, 3 times per week. Week3 Sit to stand 10 times, Step on bench 5 times, Stand and reach 5 and walk for 15 meters. 45 minutes session, 3 times per week. Week 4 Stand and reach 5 times, Step on bench 10 times, climbing stairs (5 steps flight stairs up and down) and walk for 20 meters. 50 minutes session, 3 times per week. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change of balance confidence -The Activities- specific balance confidence (ABC) scale
Time Frame: pre and post intervention (1st and 4th week)
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Consists of 16 items scored from 0% to 100%, with 0 % equate no confidence and 100% equate total confidence.
The higher score indicates higher balance confidence
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pre and post intervention (1st and 4th week)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in lower extremity function - The lower extremity functional scale (LEFS)
Time Frame: pre and post intervention (1st and 4th week)
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consisted of 20 question to evaluate the lower limb functional impairment.The lower score equates greater disability
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pre and post intervention (1st and 4th week)
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Change in Quality of life - Stroke Specific Quality Of Life scale (SS-QOL
Time Frame: pre and post intervention (1st and 4th week)
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measure aspects related to quality of life and designed specifically for stroke survivors
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pre and post intervention (1st and 4th week)
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Almarwani, PhD, Assistant professor at King Saud university
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Tele-rehabilitaion exercises
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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