Cerebro-vascular AccidentRCTNCT07010185
Effect of Supervised Versus Unsupervised Strength Training on Balance and Functional Performance Among Post Stroke Ambulatory Patients
A study testing home based exercise in people with Cerebro-vascular Accident, run by Majmaah University at 1 site in Saudi Arabia.
Trial summary
Objective: This single-blinded randomized controlled trial compared the effects of supervised clinic-based versus unsupervised home-based balance and strength training on functional outcomes in ambulatory post-stroke patients. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Cerebro-vascular Accident
- What is being tested?
- home based exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 30 Jan 2025to 15 May 2025
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- participants aged 25 to 65 who had suffered a stroke between one and 24 months prior and were medically stable without complications were screened to be included in this study.
- They should have scored 3 or lower on the Modified Ashworth Scale for muscle spasticity and reported lower limb pain levels of 5 or less on a 10-point visual analog scale.
- They should have been able to tolerate 45 minutes of physical activity, including rest period, and walk independently for at least 40 meters, with or without assistive devices.
Who cannot join
- Those with a history of previous strokes, other neurological conditions, mobility issues, severe medical conditions, or significant visual field loss were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Supervised Versus Unsupervised Strength Training on Balance and Functional Performance Among Post Stroke Ambulatory Patients: A Single-Blinded Randomized Controlled Study
Objective:
This single-blinded randomized controlled trial compared the effects of supervised clinic-based versus unsupervised home-based balance and strength training on functional outcomes in ambulatory post-stroke patients.
Read more
Methods:
This study implemented a single-blinded; two-arm randomized control approach to evaluate rehabilitation interventions for stroke patients. It was conducted at the Prince Sultan Military Medical City in the Riyadh region, which features a specialized physiotherapy center for neurology patients.
Design: RCT with two parallel arms (N=48; 24/group). Participants: Ambulatory stroke survivors (1-24 months post-stroke) aged 25-65 years.
Interventions:
Supervised group: 45-minute therapist-led sessions (3x/week for 12 weeks), including strength/balance exercises.
Unsupervised group: Identical exercises performed at home with remote guidance (videos, diaries, follow-up calls).
Outcomes: Berg Balance Scale (BBS), Physiological Cost Index (PCI), 6-minute walk test (6MWT), and Short Form-36 (SF-36) at baseline and 12 weeks.
Read the detailed description
Stroke, often referred to as a cerebrovascular accident, is a significant global health concern and a leading cause of long-term disability, particularly among the elderly. Stroke occurs when there is a sudden disruption of blood flow to the brain, causing the death of cerebral tissue [1]. Globally, stroke affects around 15 million individuals each year, resulting in 5 million deaths and 5 million cases of permanent disability, making it a leading cause of mortality and morbidity (World Health Organization). In Europe alone, there are 41.5 million new stroke cases each year, with only 15% of patients achieving full recovery [2]. In Saudi Arabia it remains a significant health concern with an incidence of 29.8 cases per 100,000 individuals annually [3]. The incidence rates of stroke vary regionally, with 15.1 per 100,000 in Jizan city and up to 29.8 per 100,000 in the Eastern region and urban areas experiencing higher rates than rural ones [4, 5]. Although these rates are lower than rates in many high-income countries, there is a pressing need for a nationwide stroke registry to enhance healthcare services for survivors [3]. Ischemic strokes are the most common subtype, while hemorrhagic strokes, particularly those related to hypertension, also present significant challenges [6]. The risk factors for stroke in the Saudi population include hypertension, diabetes mellitus, hypercholesterolemia, obesity, physical inactivity, heredity, and smoking [7]. These factors contribute significantly to the overall burden of stroke and highlight the need for targeted prevention strategies.
Stroke leads to significant mobility challenges, balance difficulties, and a diminished quality of life, making it the leading cause of walking and balance disabilities in older adults [8]. Approximately 75% of stroke survivors experience mobility limitations each year, with 40% requiring assistance for walking [9]. Among those who regain some independence, 60% face challenges with community ambulation [10]. The American Stroke Association notes that 87% of strokes are ischemic, causing symptoms such as paralysis, balance loss, and post-stroke cramping [11]. Many post-stroke individuals encounter substantial impairments in muscle strength, balance, and postural control due to decreased sensory feedback and weaker motor responses, which increase the risk of falls and functional limitations [12]. Balance issues often arise from reduced muscle power, coordination deficits, and impaired sensory integration. Motor deficits, including hemiparesis, affect about 80% of stroke survivors [13]. These balance problems stem from challenges in proprioception, trunk muscle strength, and coordination, which can restrict independence and lead to social isolation and depression [14]. A study by Rudberg et al. (2020) emphasized that balance and walking difficulties are major concerns for stroke patients, underscoring the necessity for effective rehabilitation strategies [15].
Rehabilitation programs focusing on strength and balance training are essential for improving functional outcomes. Evidence suggests that these interventions can enhance ambulation, mobility, and overall functional performance in stroke survivors [16, 17]. While supervised training under the guidance of a physical therapist has been shown to be effective, many stroke survivors and their caregivers prefer home-based exercises due to comfort, a sense of autonomy and lack of access to the training centers. Despite rapid changes, accessing consistent professional healthcare support remains crucial in Saudi Arabia. Patients face challenges due to limited resources, staffing shortages, and barriers that hinder recovery. Additionally, cultural perceptions and social stigma surrounding disability and gender segregation affects the willingness to seek help and follow rehabilitation programs, complicating the recovery efforts [18-20]. This study aims to investigate the comparative effects of supervised versus unsupervised strength and balance training on balance and functional performance in ambulatory stroke patients. The hypothesis is that compared to supervised training, unsupervised training under remote guidance can also achieve significant improvements in post-stroke patients. This research is crucial for developing effective rehabilitation protocols that cater to the needs of stroke survivors, particularly those who may have difficulty accessing consistent professional support. Understanding the impact of different training modalities on stroke recovery will help inform best practices in rehabilitation and ultimately enhance the quality of life for individuals living with the after effects of stroke.
- Conditions
- Cerebro-vascular Accident
- Being tested
- home based exercise
- Keywords
- cerebrovascular accident, Stroke, Post Stroke Ambulatory Patients
- 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 exerciseBehavioural
Also called stretching, warm up
warm-up Exercises (5 minutes), dynamic Stretching (5 to 10 repetitions), strengthening exercises focused on lower limb muscles, such as bridging, clamshells, and various leg exercises (5-10 repetitions across 2-3 sets, based on patient tolerance)
| Study group | Role | What they receive |
|---|---|---|
| Supervised training | Experimental | supervised strength training Receives: Behavioral: home based exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg balance scale
Berg Balance Scale assesses patient's balance through 14 tasks, scored from 0 to 4. A change of 4 points indicates a significant improvement in balance, particularly in elderly populations
Measured: 12 weeks
Physiological cost index
Physiological Cost Index, evaluates the heart rate during rest and walking to assess the physiological cost of ambulation. It is calculated as the difference between walking heart rate and resting heart rate divided by the average walking speed.
Measured: 12 week
6-minute walk distance test
6-minute walk distance test, developed by the American Thoracic Society, measures aerobic capacity and endurance by recording the distance walked in six minutes, providing insights into functional capacity across various physiological systems
Measured: 12 Week
Short form-36 questionnaire
36-Item Short Form Survey is a widely-used questionnaire assesses health-related quality of life across eight domains, including physical and emotional well-being. It is a validated tool for measuring overall health status.
Measured: 12 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start30 Jan 2025
- Primary completion15 May 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebro-vascular AccidentStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- two-arm randomized control approach
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Majmaah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahnaz Hasan, PhD, Majmaah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07010185
- Sponsor's protocol ID
- SHasan
- Other IDs
- Majmaah University
- Acronym
- RCT
- Status last verified
- May 2025
- First submitted
- 21 May 2025
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available to the principal investigator and furnished upon request.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Supervised Versus Unsupervised Strength Training on Balance and Functional Performance Among Post Stroke Ambulatory Patients: A Single-Blinded Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07010185
- Acronym / sponsor ID
- RCT / SHasan
- Conditions
- Cerebro-vascular Accident
- Keywords
- cerebrovascular accident, Stroke, Post Stroke Ambulatory Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Majmaah UniversityUniversity, hospital or other
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 8 Jun 2025 (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.
Objective:
This single-blinded randomized controlled trial compared the effects of supervised clinic-based versus unsupervised home-based balance and strength training on functional outcomes in ambulatory post-stroke patients.
Methods:
This study implemented a single-blinded; two-arm randomized control approach to evaluate rehabilitation interventions for stroke patients. It was conducted at the Prince Sultan Military Medical City in the Riyadh region, which features a specialized physiotherapy center for neurology patients.
Design: RCT with two parallel arms (N=48; 24/group). Participants: Ambulatory stroke survivors (1-24 months post-stroke) aged 25-65 years.
Interventions:
Supervised group: 45-minute therapist-led sessions (3x/week for 12 weeks), including strength/balance exercises.
Unsupervised group: Identical exercises performed at home with remote guidance (videos, diaries, follow-up calls).
Outcomes: Berg Balance Scale (BBS), Physiological Cost Index (PCI), 6-minute walk test (6MWT), and Short Form-36 (SF-36) at baseline and 12 weeks.
Detailed description
Stroke, often referred to as a cerebrovascular accident, is a significant global health concern and a leading cause of long-term disability, particularly among the elderly. Stroke occurs when there is a sudden disruption of blood flow to the brain, causing the death of cerebral tissue [1]. Globally, stroke affects around 15 million individuals each year, resulting in 5 million deaths and 5 million cases of permanent disability, making it a leading cause of mortality and morbidity (World Health Organization). In Europe alone, there are 41.5 million new stroke cases each year, with only 15% of patients achieving full recovery [2]. In Saudi Arabia it remains a significant health concern with an incidence of 29.8 cases per 100,000 individuals annually [3]. The incidence rates of stroke vary regionally, with 15.1 per 100,000 in Jizan city and up to 29.8 per 100,000 in the Eastern region and urban areas experiencing higher rates than rural ones [4, 5]. Although these rates are lower than rates in many high-income countries, there is a pressing need for a nationwide stroke registry to enhance healthcare services for survivors [3]. Ischemic strokes are the most common subtype, while hemorrhagic strokes, particularly those related to hypertension, also present significant challenges [6]. The risk factors for stroke in the Saudi population include hypertension, diabetes mellitus, hypercholesterolemia, obesity, physical inactivity, heredity, and smoking [7]. These factors contribute significantly to the overall burden of stroke and highlight the need for targeted prevention strategies.
Stroke leads to significant mobility challenges, balance difficulties, and a diminished quality of life, making it the leading cause of walking and balance disabilities in older adults [8]. Approximately 75% of stroke survivors experience mobility limitations each year, with 40% requiring assistance for walking [9]. Among those who regain some independence, 60% face challenges with community ambulation [10]. The American Stroke Association notes that 87% of strokes are ischemic, causing symptoms such as paralysis, balance loss, and post-stroke cramping [11]. Many post-stroke individuals encounter substantial impairments in muscle strength, balance, and postural control due to decreased sensory feedback and weaker motor responses, which increase the risk of falls and functional limitations [12]. Balance issues often arise from reduced muscle power, coordination deficits, and impaired sensory integration. Motor deficits, including hemiparesis, affect about 80% of stroke survivors [13]. These balance problems stem from challenges in proprioception, trunk muscle strength, and coordination, which can restrict independence and lead to social isolation and depression [14]. A study by Rudberg et al. (2020) emphasized that balance and walking difficulties are major concerns for stroke patients, underscoring the necessity for effective rehabilitation strategies [15].
Rehabilitation programs focusing on strength and balance training are essential for improving functional outcomes. Evidence suggests that these interventions can enhance ambulation, mobility, and overall functional performance in stroke survivors [16, 17]. While supervised training under the guidance of a physical therapist has been shown to be effective, many stroke survivors and their caregivers prefer home-based exercises due to comfort, a sense of autonomy and lack of access to the training centers. Despite rapid changes, accessing consistent professional healthcare support remains crucial in Saudi Arabia. Patients face challenges due to limited resources, staffing shortages, and barriers that hinder recovery. Additionally, cultural perceptions and social stigma surrounding disability and gender segregation affects the willingness to seek help and follow rehabilitation programs, complicating the recovery efforts [18-20]. This study aims to investigate the comparative effects of supervised versus unsupervised strength and balance training on balance and functional performance in ambulatory stroke patients. The hypothesis is that compared to supervised training, unsupervised training under remote guidance can also achieve significant improvements in post-stroke patients. This research is crucial for developing effective rehabilitation protocols that cater to the needs of stroke survivors, particularly those who may have difficulty accessing consistent professional support. Understanding the impact of different training modalities on stroke recovery will help inform best practices in rehabilitation and ultimately enhance the quality of life for individuals living with the after effects of stroke.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- two-arm randomized control approach
| Arm | Type | Receives |
|---|---|---|
| Supervised training | Experimental | Behavioral: home based exercisesupervised strength training |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- participants aged 25 to 65 who had suffered a stroke between one and 24 months prior and were medically stable without complications were screened to be included in this study.
- They should have scored 3 or lower on the Modified Ashworth Scale for muscle spasticity and reported lower limb pain levels of 5 or less on a 10-point visual analog scale.
- They should have been able to tolerate 45 minutes of physical activity, including rest period, and walk independently for at least 40 meters, with or without assistive devices.
Key exclusion criteria (1 listed)
- Those with a history of previous strokes, other neurological conditions, mobility issues, severe medical conditions, or significant visual field loss were excluded.
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 exerciseAlso: stretching, warm upwarm-up Exercises (5 minutes), dynamic Stretching (5 to 10 repetitions), strengthening exercises focused on lower limb muscles, such as bridging, clamshells, and various leg exercises (5-10 repetitions across 2-3 sets, based on patient tolerance) | Behavioural | Supervised training |
Primary outcome
Berg balance scale
Time frame: 12 weeks
Berg Balance Scale assesses patient's balance through 14 tasks, scored from 0 to 4. A change of 4 points indicates a significant improvement in balance, particularly in elderly populations
Physiological cost index
Time frame: 12 week
Physiological Cost Index, evaluates the heart rate during rest and walking to assess the physiological cost of ambulation. It is calculated as the difference between walking heart rate and resting heart rate divided by the average walking speed.
6-minute walk distance test
Time frame: 12 Week
6-minute walk distance test, developed by the American Thoracic Society, measures aerobic capacity and endurance by recording the distance walked in six minutes, providing insights into functional capacity across various physiological systems
Short form-36 questionnaire
Time frame: 12 Week
36-Item Short Form Survey is a widely-used questionnaire assesses health-related quality of life across eight domains, including physical and emotional well-being. It is a validated tool for measuring overall health status.
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 8 Jun 2025.
- Individual participant dataSharing planned: Yes. Data will be available to the principal investigator and furnished upon request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Cerebro-vascular Accident, run by Majmaah 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 3 inclusion and 1 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 8 Jun 2025. 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?
Berg balance scale (time frame: 12 weeks). The study lists 4 primary outcomes in all. 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 8 Jun 2025.