Chronic Ischemic StrokeTST-BIO-STROKENCT07125157
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 study testing Task-Specific Training with Biofeedback, Task-Specific Training without Biofeedback and conventional stroke rehabilitation in people with Chronic Ischemic Stroke and Balance Impairment, run by Syed Ali Behram Subazwari at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Ischemic Stroke, Balance Impairment, Risk of Fall
- What is being tested?
- Task-Specific Training with Biofeedback, Task-Specific Training without Biofeedback and conventional stroke rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Feb 2026to 12 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Shadman Medical Center
Lahore, Punjab Province, 54000
Syed Ali Behram Subazwari, Phd physiotherapy, +92 315 8284631, subazwari@lincoln.edu.my
Montiha Azeem, DPT, +92 347 9717317, muntahaazeem9@gmail.com
About this study
Official title: 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
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.
Read the detailed 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.
- Conditions
- Chronic Ischemic Stroke, Balance Impairment, Risk of Fall
- Being tested
- Task-Specific Training with Biofeedback, Task-Specific Training without Biofeedback, conventional stroke rehabilitation
- Keywords
- stroke rehabilitation, biofeedback, task specific training, balance training, fall prevention, berg balance scale, time up and go
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Task-Specific Training with BiofeedbackBehavioural
Also called Biofeedback-assisted task training
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.
Task-Specific Training without BiofeedbackBehavioural
Also called Conventional 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.
conventional stroke rehabilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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). Receives: Behavioral: conventional stroke rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Baseline, Post-intervention (12 weeks), and Follow-up (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start10 Feb 2026 (estimated)
- Primary completion10 Mar 2026 (estimated)
- Study completion12 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Syed Ali Behram Subazwari
- Sponsor type
- University, hospital or other
- Collaborators
- Lincoln University College Malaysia
- Responsible party
- Sponsor-investigator, Syed Ali Behram Subazwari, Lincoln University College
- Investigators
- Syed Ali Behram Subazwari, Phd physiotherapy, Principal investigator, Lincoln University College Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07125157
- Sponsor's protocol ID
- LUC/Ethc/Admin/SP/004/726
- Acronym
- TST-BIO-STROKE
- Status last verified
- Jan 2026
- First submitted
- 8 Aug 2025
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07125157
- Acronym / sponsor ID
- TST-BIO-STROKE / LUC/Ethc/Admin/SP/004/726
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Syed Ali Behram SubazwariUniversity, hospital or other
- Collaborators
- Lincoln University College Malaysia
- Study start
- 10 Feb 2026 (estimated)
- Primary completion
- 10 Mar 2026 (estimated)
- Study completion
- 12 Mar 2026 (estimated)
- First posted
- 15 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Task-Specific Training with Biofeedback | Experimental | Behavioral: Task-Specific Training with BiofeedbackParticipants 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. |
| Task-Specific Training without Biofeedback | Experimental | Behavioral: Task-Specific Training without BiofeedbackParticipants 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. |
| Control Group | Active comparator | Behavioral: conventional stroke rehabilitationParticipants 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). |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Task-Specific Training with BiofeedbackAlso: Biofeedback-assisted task trainingParticipants 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. | Behavioural | Task-Specific Training with Biofeedback |
| Task-Specific Training without BiofeedbackAlso: Conventional task trainingParticipants 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. | Behavioural | Task-Specific Training without Biofeedback |
| conventional stroke rehabilitationParticipants 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. | Behavioural | Control Group |
Primary outcome
Balance performance as measured by Berg Balance Scale (BBS)
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.
1 secondary outcome
Risk of falls as measured by the Timed Up and Go (TUG) test
Time frame: Baseline, Post-intervention (12 weeks), and Follow-up (3 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Syed Ali Behram Subazwari, Phd physiotherapy principal investigator
Lincoln University College Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Task-Specific Training with Biofeedback, Task-Specific Training without Biofeedback and conventional stroke rehabilitation in people with Chronic Ischemic Stroke and Balance Impairment, run by Syed Ali Behram Subazwari at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Syed Ali Behram Subazwari, Phd physiotherapy (+92 315 8482631, subazwari@lincoln.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance performance as measured by Berg Balance Scale (BBS) (time frame: Baseline (T0), Post-intervention (12 weeks, T2), and Follow-up (3 months post-intervention, TX)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.