StrokeNCT04875910
Effectiveness of Telerehabilitation in Improving Walking and Balance Among Stroke Survivors?
A study testing Home-based exercise program in people with Stroke, run by King Saud University at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Home-based exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Mar 2021to 28 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Could Telerehabilitation be a Promising Tool in Improving Walking and Balance Among Stroke Survivors? "Case Study"
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Home-based exercise program
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based exercise programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Stroke survivors participants | Experimental | 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 Receives: Other: Home-based exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: pre and post intervention (1st and 4th week)
Secondary outcomes (2)
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
Measured: pre and post intervention (1st and 4th week)
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
Measured: pre and post intervention (1st and 4th week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start1 Mar 2021
- Primary completion28 Apr 2021
- Study completion28 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emtenan Alsadhan, King Saud University
- Investigators
- Almarwani, PhD, Study director, Assistant professor at King Saud university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04875910
- Sponsor's protocol ID
- Tele-rehabilitaion exercises
- Status last verified
- Mar 2021
- First submitted
- 1 May 2021
- Last updated
- 6 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Could Telerehabilitation be a Promising Tool in Improving Walking and Balance Among Stroke Survivors? "Case Study"
- ClinicalTrials.gov ID
- NCT04875910
- Acronym / sponsor ID
- Tele-rehabilitaion exercises
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 28 Apr 2021 (actual)
- Study completion
- 28 Apr 2021 (actual)
- First posted
- 6 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke survivors participants | Experimental | Other: Home-based exercise programSubjects 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 |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based exercise programThe 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. | Other | Stroke survivors participants |
Primary outcome
Change of balance confidence -The Activities- specific balance confidence (ABC) scale
Time frame: pre and post intervention (1st and 4th week)
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
2 secondary outcomes
Change in lower extremity function - The lower extremity functional scale (LEFS)
Time frame: pre and post intervention (1st and 4th week)
Change in Quality of life - Stroke Specific Quality Of Life scale (SS-QOL
Time frame: pre and post intervention (1st and 4th week)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Almarwani, PhD study director
Assistant professor at King Saud university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based exercise program in people with Stroke, run by King Saud University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of balance confidence -The Activities- specific balance confidence (ABC) scale (time frame: pre and post intervention (1st and 4th week)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2021.