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Effectiveness of Telerehabilitation in Improving Walking and Balance Among Stroke Survivors?

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Home-based exercise program
Sponsored by
King Saud University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • King Saud university

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stroke survivors participants

Arm Description

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

Outcomes

Primary Outcome Measures

Change of balance confidence -The Activities- specific balance confidence (ABC) scale
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

Secondary Outcome Measures

Change in lower extremity function - The lower extremity functional scale (LEFS)
consisted of 20 question to evaluate the lower limb functional impairment.The lower score equates greater disability
Change in Quality of life - Stroke Specific Quality Of Life scale (SS-QOL
measure aspects related to quality of life and designed specifically for stroke survivors

Full Information

First Posted
May 1, 2021
Last Updated
May 3, 2021
Sponsor
King Saud University
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1. Study Identification

Unique Protocol Identification Number
NCT04875910
Brief Title
Effectiveness of Telerehabilitation in Improving Walking and Balance Among Stroke Survivors?
Official Title
Could Telerehabilitation be a Promising Tool in Improving Walking and Balance Among Stroke Survivors? "Case Study"
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
April 28, 2021 (Actual)
Study Completion Date
April 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Saud University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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 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.
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.

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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stroke survivors participants
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Home-based exercise program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of balance confidence -The Activities- specific balance confidence (ABC) scale
Description
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
Time Frame
pre and post intervention (1st and 4th week)
Secondary Outcome Measure Information:
Title
Change in lower extremity function - The lower extremity functional scale (LEFS)
Description
consisted of 20 question to evaluate the lower limb functional impairment.The lower score equates greater disability
Time Frame
pre and post intervention (1st and 4th week)
Title
Change in Quality of life - Stroke Specific Quality Of Life scale (SS-QOL
Description
measure aspects related to quality of life and designed specifically for stroke survivors
Time Frame
pre and post intervention (1st and 4th week)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Almarwani, PhD
Organizational Affiliation
Assistant professor at King Saud university
Official's Role
Study Director
Facility Information:
Facility Name
King Saud university
City
Riyadh
ZIP/Postal Code
11451
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effectiveness of Telerehabilitation in Improving Walking and Balance Among Stroke Survivors?

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