Effect of Supervised Versus Unsupervised Strength Training on Balance and Functional Performance Among Post Stroke Ambulatory Patients

NCT07010185 | Completed DMC

• 2 other identifiers: SHasanMajmaah University
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cerebro-vascular Accident

Keywords

cerebrovascular accident; Stroke; Post Stroke Ambulatory Patients

Outcome Measures

Primary Outcomes (4)

• 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

  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.

  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

  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.

  12 Week

Study Arms (1)

Supervised training

EXPERIMENTAL

supervised strength training

Behavioral: home based exercise

Interventions

home based exercise BEHAVIORAL

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)

Also known as: stretching, warm up

Supervised training

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Those with a history of previous strokes, other neurological conditions, mobility issues, severe medical conditions, or significant visual field loss were excluded.

Sponsors & Collaborators

• Majmaah University: lead

Study Sites (1)

Majmaah University

Al-Majmaah, Riyadh Region, Saudi Arabia

Location

MeSH Terms

Conditions

Stroke

Interventions

Warm-Up Exercise

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: two-arm randomized control approach

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: June 8, 2025
• Study Start: January 30, 2025
• Primary Completion: May 15, 2025
• Study Completion: May 15, 2025
• Last Updated: June 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: 4 week

Locations

SA (1)