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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Saudi Arabia1 site
  • Majmaah University

    Al-Majmaah, Riyadh Region

Other trials in Saudi Arabia

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.

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 groups in NCT07010185
Study groupRoleWhat they receive
Supervised trainingExperimentalsupervised strength training
Receives: Behavioral: home based exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. 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

  3. 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

  4. 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.

  1. First posted8 Jun 2025
  2. Study start30 Jan 2025
  3. Primary completion15 May 2025
  4. Study completion15 May 2025

Resources

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)
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.

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.

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