NCT Number: NCT07125157
This randomized controlled trial aims to evaluate the effects of task-specific training with and without biofeedback compared to conventional physical therapy on balance and fall risk in chronic ischemic stroke patients in Lahore, Pakistan. Sixty-six participants will be randomly allocated into three groups: Group 1 (task-specific training with biofeedback), Group 2 (task-specific training without biofeedback), and Group 3 (conventional physical therapy). The intervention will span 12 weeks, consisting of 36 sessions. Key outcome measures include the Berg Balance Scale, Timed Up and Go Test, and the Barthel Index. Assessments will be conducted at baseline, post-intervention, and three-month follow-up. The study hypothesizes that the use of biofeedback in task-specific training will produce significantly greater improvements in balance and reduced fall risk compared to conventional rehabilitation strategies. The study is being conducted at Shadman Medical Center in Lahore and is part of a PhD project from Lincoln University College.
Interested in participating?
Request Info40 year and older
All sexes
Interventional
Not applicable
Lahore, Punjab Province, 54000, Pakistan
Location status: Recruiting
Montiha Azeem, DPT
CONTACT
Syed Ali Behram Subazwari, Phd physiotherapy
CONTACT
Syed Ali Behram Subazwari, Phd physiotherapy
PRINCIPAL_INVESTIGATOR
This randomized controlled trial investigates the comparative effectiveness of task-specific training with biofeedback, without biofeedback, and conventional physical therapy in improving balance and reducing fall risk among chronic ischemic stroke patients. The study consists of 66 participants, randomly assigned to three groups. Group 1 receives task-specific training using the Motor Relearning Program (MRP) principles, augmented with virtual reality-based biofeedback. Group 2 follows the same task-specific training without biofeedback. Group 3 receives conventional physical therapy following standard post-stroke rehabilitation protocols.
Participants will undergo 36 treatment sessions over a 12-week period, with three one-hour sessions per week. All interventions are delivered by qualified physiotherapists at the Department of Neurological and Functional Rehabilitation, Shadman Medical Center, Lahore.
Outcomes will be assessed using the Berg Balance Scale (BBS), Timed Up and Go (TUG) test, and the Barthel Index (BI) at baseline, post-intervention, and a 3-month follow-up. Randomization will be computer-generated, with blinding applied to assessors and data analysts.
The primary objective is to examine whether task-specific training with biofeedback significantly improves dynamic and static balance and reduces fall risk more effectively than the other two methods. Data will be analyzed using SPSS v21.0, applying repeated measures ANOVA and Cohen's d for effect size. A p-value ≤ 0.05 will be considered statistically significant.
The study has received ethical approval from Lincoln University College and is conducted under informed consent. Results will contribute to doctoral research and be submitted for peer-reviewed publication and presentation at scientific forums.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Chronic ischemic stroke patients (more than 3 months after stroke) Both Male and Female Patients Patients of 40 or above years of age Patients with Burnstorm stage 3 or above.) Patients with good cognitive function (score of 20 or more on MMSE) Patients who can ambulate 10 m (with or without the assistive device)
Exclusion criteria
Patients undergoing concurrent therapy or treatment that could influence the effectiveness of this study will be excluded from participation Patients presenting with contraindications to rehabilitation, such as severe uncontrolled hypertension, uncontrolled diabetes, or unstable angina, will be excluded from the study.
Individuals with prior neurological impairments apart from stroke.
Participants in this group will undergo task-specific training focused on improving balance and reducing fall risk. Real-time biofeedback (e.g., visual or auditory cues) will be integrated into the training to enhance motor learning and postural adjustments. Sessions will be supervised and conducted multiple times per week over the intervention period.
Other names: Biofeedback-assisted task training
Participants will receive task-specific training aimed at improving balance and fall prevention without any biofeedback assistance. The same set of functional exercises and session frequency will be followed as in the experimental group, ensuring the only difference is the absence of feedback stimuli.
Other names: Conventional task training
Participants in this group will receive conventional post-stroke physical therapy following standard rehabilitation protocols. Interventions will include strengthening, stretching, balance exercises, and functional mobility tasks. Sessions will be conducted three times per week for 12 weeks, with each session lasting approximately one hour. The duration and frequency will match the experimental groups, ensuring comparability.
Time frame: Baseline (T0), Post-intervention (12 weeks, T2), and Follow-up (3 months post-intervention, TX)
The BBS will assess balance performance across 14 items related to functional tasks such as sitting, standing, reaching, and turning. It is a widely validated tool in stroke rehabilitation.
Time frame: Baseline, Post-intervention (12 weeks), and Follow-up (3 months)
The TUG test measures functional mobility and fall risk. The time (in seconds) to rise from a chair, walk 3 meters, turn, return, and sit is recorded. Lower times indicate better mobility and lower fall risk.
Contact information is provided by the study sponsor or research team.
Montiha Azeem, DPT
CONTACT
Syed Ali Behram Subazwari, Phd physiotherapy
CONTACT
Syed Ali Behram Subazwari
Other
Effect Of Task-Specific Training With And Without Biofeedback On Balance And Risk Of Falls In Chronic Ischemic Stroke Patients Of Central Lahore, Pakistan, A Randomized Controlled Trial
Acronym: TST-BIO-STROKE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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