Clinical trial NCT07010185: Effect of Supervised Versus Unsupervised Strength Training on Balance and Functional Performance Among Post Stroke Ambulatory Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebro-vascular Accident
Keywords: cerebrovascular accident
Stroke
Post Stroke Ambulatory Patients
Lead sponsor: Majmaah University
Sponsor class: OTHER
First posted: 2025-06-08
Enrollment: 61
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: two-arm randomized control approach
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Berg balance scale
timeFrame: 12 weeks
measure: Physiological cost index
timeFrame: 12 week
measure: 6-minute walk distance test
timeFrame: 12 Week
measure: Short form-36 questionnaire
timeFrame: 12 Week
Secondary outcomes:
Other outcomes:
Locations:
city: Al-Majmaah
country: Saudi Arabia
facility: Majmaah University
state: Riyadh
Study officials:
References: