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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04875910
Other study ID # Tele-rehabilitaion exercises
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date April 28, 2021

Study information

Verified date March 2021
Source King Saud University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 2
Est. completion date April 28, 2021
Est. primary completion date April 28, 2021
Accepts healthy volunteers No
Gender All
Age group 40 Years to 85 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Home-based exercise program
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.

Locations

Country Name City State
Saudi Arabia King Saud university Riyadh

Sponsors (1)

Lead Sponsor Collaborator
King Saud University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 pre and post intervention (1st and 4th week)
Secondary 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 pre and post intervention (1st and 4th week)
Secondary 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 pre and post intervention (1st and 4th week)
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