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Effect Of Task-Specific Training With And Without Biofeedback On Balance And Risk Of Falls In Chronic Ischemic Stroke Patients Of Central Lahore, Pakistan (TST-BIO-STROKE)

S

Syed Ali Behram Subazwari

Status

Withdrawn

Conditions

Chronic Ischemic Stroke
Balance Impairment
Risk of Fall

Treatments

Behavioral: Task-Specific Training with Biofeedback
Behavioral: Task-Specific Training without Biofeedback

Study type

Interventional

Funder types

Other

Identifiers

NCT07125157
LUC/Ethc/Admin/SP/004/726

Details and patient eligibility

About

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.

Full description

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.

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

0 participants in 2 patient groups

Task-Specific Training with Biofeedback
Experimental group
Description:
Participants in this group will receive task-specific training combined with biofeedback. The intervention will focus on functional activities that challenge balance and mobility, while real-time feedback will be provided to improve motor control and postural stability. Training will be conducted under supervision for a set duration and frequency over the intervention period.
Treatment:
Behavioral: Task-Specific Training with Biofeedback
Task-Specific Training without Biofeedback
Active Comparator group
Description:
Participants in this group will receive the same task-specific training protocol without biofeedback. Functional tasks will be practiced to enhance balance and reduce fall risk. Training will be identical in duration and intensity to the experimental group but will not include feedback mechanisms.
Treatment:
Behavioral: Task-Specific Training without Biofeedback

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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