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

NCT07125157 | Recruiting

• 1 other identifier: LUC/Ethc/Admin/SP/004/726
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Ischemic Stroke; Balance Impairment; Risk of Fall

Keywords

stroke rehabilitation; biofeedback; task specific training; balance training; fall prevention; berg balance scale; time up and go

Outcome Measures

Primary Outcomes (1)

• Balance performance as measured by Berg Balance Scale (BBS)

  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.

  Baseline (T0), Post-intervention (12 weeks, T2), and Follow-up (3 months post-intervention, TX)

Secondary Outcomes (1)

• Risk of falls as measured by the Timed Up and Go (TUG) test

  Baseline, Post-intervention (12 weeks), and Follow-up (3 months)

Study Arms (3)

Task-Specific Training with Biofeedback

EXPERIMENTAL

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.

Behavioral: Task-Specific Training with Biofeedback

Task-Specific Training without Biofeedback

EXPERIMENTAL

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.

Behavioral: Task-Specific Training without Biofeedback

Control Group

ACTIVE COMPARATOR

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. The duration and frequency will match the experimental groups (three 1-hour sessions per week for 12 weeks).

Behavioral: conventional stroke rehabilitation

Interventions

Task-Specific Training with Biofeedback BEHAVIORAL

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.

Also known as: Biofeedback-assisted task training

Task-Specific Training with Biofeedback

Task-Specific Training without Biofeedback BEHAVIORAL

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.

Also known as: Conventional task training

Task-Specific Training without Biofeedback

conventional stroke rehabilitation BEHAVIORAL

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.

Control Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Syed Ali Behram Subazwari: lead
• Lincoln University College Malaysia: collaborator

Study Sites (1)

Shadman Medical Center

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

MeSH Terms

Interventions

Biofeedback, Psychology

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Syed Ali Behram Subazwari, Phd physiotherapy

  Lincoln University College Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Syed Ali Behram Subazwari, Phd physiotherapy

CONTACT

+92 315 8482631; subazwari@lincoln.edu.my

Montiha Azeem, DPT

CONTACT

+92 347 9717317; muntahaazeem9@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be blinded to group allocation. Due to the nature of the intervention, therapists and participants cannot be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are randomly assigned to one of two groups: one receiving task-specific training with biofeedback and the other receiving task-specific training without biofeedback.

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 15, 2025
• Study Start: February 10, 2026
• Primary Completion: March 10, 2026
• Study Completion: March 12, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)