Stroke PatientsNCT06663709
Effect of BRACE on Balance, Cognition and Mobility Among Stroke Patients
A study testing BRACE and TASK-oriented in people with Stroke Patients, run by Riphah International University at 1 site in Pakistan.
Trial summary
The Objective of the is to determine effect of balance, resistance, aerobic, cognitive exercises (BRACE) protocol on balance, cognition and mobility among stroke patients and to compare the effect of Balance, Resistance, Aerobic, and Cognitive Exercise (BRACE) and task-oriented training on balance cognition and… Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Stroke Patients
- What is being tested?
- BRACE and TASK-oriented
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- 24 Oct 2024to 10 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hemiplegic stroke patients
- Both genders
- Age:30-65years
- ischemic and hemorrhagic stroke patients
- Sub-acute and chronic patients
- Balance impairment with Berg Balance Scale (BBS) Scores 41-56 score between 18-25 on MoCA (mild cognitive impairment)
Who cannot join
- Patients who are not willing
- Patients with vision and hearing issue
- A history of serious or unstable cardiac condition
- Orthopedic injuries that could impair locomotion
- History of fall
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Balance, Resistance, Aerobic, Cognitive Exercises(BRACE)on Balance, Cognition and Mobility Among Stroke Patients
The Objective of the is to determine effect of balance, resistance, aerobic, cognitive exercises (BRACE) protocol on balance, cognition and mobility among stroke patients and to compare the effect of Balance, Resistance, Aerobic, and Cognitive Exercise (BRACE) and task-oriented training on balance cognition and mobility in stroke patients. The study will be randomized control trial including 2 experimental groups with estimated 21 individual in each group.
Read the detailed description
Stroke is a major and growing global health concern. According to the most current estimates of the Global Burden of Disease (GBD) (2019) stroke burden, stroke continues to be the world's second-leading cause of death and the third-leading cause of death and disability. Stroke is the second most prevalent cause of disability worldwide, and survivors frequently experience impairments to their hands and cognitive functions. Because strokes and sudden cerebrovascular accidents occur so often and have such fatal effects, they remain among the most dangerous global health concerns.
Generally, stroke patients experience diminished motor abilities, as well as impairments to their senses, cognition, and visual perception. In addition, they experience compromised physical function, which makes walking independently challenging because of reduced gait endurance, speed of walking, and balance. Patients with such a decrease in their ability to maintain balance find challenging to walk and perform useful movements, which can cause problems in day-to-day living. Moreover, a stroke patient's ability to walk may be even worse if they fall.
Another major cause of stress for survivors of stroke is the cognitive effect, since they may experience issues with concentration, working memory, and remembering.
Trunk function impairments tend to occur in survivors of strokes. Impaired center of pressure control when sitting, muscular weakness and prolonged trunk muscle activation, severe errors in trunk position awareness, poor trunk performance, and trunk imbalance during walking have all been documented in prior research.
Rehabilitative treatment is a particularly effective therapy in terms of improving recovery from impairment. The objective of rehabilitation is "to achieve and sustain maximum performance in the emotional, mental, and physical domains" .A greater awareness of the neurological underpinnings of therapeutic restoration has occurred with a greater awareness of the former.
Numerous publications that focus on balancing training exercises, strength exercises, and aerobic activities independently have been published in the past several years. BRACE, which stands for Balance, Resistance, Aerobic, and Cognition Exercises, is a new treatment protocol meant to reduce fall risk and improve mobility in older adults. There has not been much work done on the BRACE procedure, therefore we will be focusing on it in this study. Our research compares how Balance Resistance Aerobic Cognitive Exercises (BRACE) affect stroke patients' balance, cognition, and mobility.
- Conditions
- Stroke Patients
- Being tested
- BRACE, TASK-oriented
- Keywords
- BRACE Protocol, Task Oriented Protocol, Stroke Population, Balance Impairments
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRACEOther
Study will be conducted after the approval of Ethical review board. The BRACE exercise training would be perform in 3 times a week for 9 weeks, lasting approximately 40-60 minutes each time. Week 0-3 : Balance: Romberg, tandem standing, single leg stance TUG test Resistance: chair rise, Stair climbing Aerobic exercises: 6mint walk, count reverse from 30, push wall and reverse count from 20 Cognitive: count reverse from 50. Week 4-6: Balance: Sit to stand, functional reach, Tug Test, Perturbation, Kick a ball Resistance: stair climbing Aerobic Exercises: Marching in space, Cycling Cognitive: Remember 5 words, spell backward, remember 5 animals Week 7-9: Balance: Combination of all Resistance: Combination of all Aerobic Exercises: Cycling , Marching, 6 min Walk Cognitive: Combination of all
TASK-orientedOther
Study will be conducted after the approval of Ethical review board. Task oriented training would be perform in 3 times a week for 9 weeks, lasting approximately 40-60 minutes each time. Week 1-3 Warm Up (sit to stand,5 reps)(cycling 3-5 min) , Single leg stand with eye open 15 sec, with eye close 10sec, forward, backward, and side stepping (5 reps) reaching, Transition from sit to stand, Walk then back to sit (3 min),Walk with even steps(3min) Walk with carrying objects. (3min) Week 4-6 Warm up Period, Task oriented training (7 Reps of each task) Week 7-9 Warm up Period, Task oriented training (9Reps of each task)
| Study group | Role | What they receive |
|---|---|---|
| Balance Resistance Aerobic Cognitive Exercises (BRACE) | Experimental | BRACE include combination of exercises including, Balance, Resistance, Aerobic, Cognition Exercises. Receives: Other: BRACE |
| Task Oriented | Experimental | Task Oriented protocol is combination of warm up, balance,,and cognition exercises. Receives: Other: TASK-oriented |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg And Balance scale
changes from the baseline, Berg balance scale (BBS) is used for assessment of balance and fall risk, Higher scores on the BBS indicate greater independence and better ability to balance. In contrast, lower scores indicate a greater fall risk Items DESCRIPTION SCORE (0-4) Sitting to standing, Standing unsupported, Sitting unsupported, Standing to sitting, Transfers , Standing with eyes closed , Standing with feet together, Reaching forward with outstretched arm, Retrieving object from floor, Turning to look behind, Turning 360 degrees, Placing alternate foot on stool, Standing with one foot in front, Standing on one foot, TOTAL __/56
Measured: 9 weeks
Time Up And Go
changes from the baseline, Timed up and go test is used for the assessment of falls risk among the elderly population. The Timed "Up and Go" (TUG) Test measures, in seconds, the time is taken by an individual to stand up from a standard armchair (approximate seat height of 46 cm, arm height 65 cm), walk a distance of 3 meters (approximately 10 feet), turn, walk back to the chair, and sit down. Normal healthy elderly usually complete the task in 10 seconds or less. Very frail or weak elderly with poor mobility may take 2 minutes or more. Clinical guide: <10 seconds = normal <20 seconds = good mobility, can go out alone, mobile without a gait aid <30 seconds = problems, cannot go outside alone, requires a gait aid A score of more than or equal to 14 seconds has been shown to indicate a high risk of falls.
Measured: 9 weeks
MOCA
The Montreal Cognitive Assessment (MOCA) is a cognitive screening instrument developed to detect mild cognitive impairment (MCI). It is a simple 10 min paper and pencil test that assesses multiple cognitive domains including memory, language, executive functions, visuo-patial skills, calculation, abstraction, attention, concentration, and orientation.
Scores on the MoCA range from zero to 30. A score of 26 and higher is considered normal.
In the initial study data, normal controls had an average score of 27.4. People with mild cognitive impairment (MCI) scored an average of 22.1. People with Alzheimer's disease had an average score of 16.2.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start24 Oct 2024
- Primary completion10 Mar 2025
- Study completion10 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stroke PatientsStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadia Azhar, MS-NMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06663709
- Sponsor's protocol ID
- Sadia Bashir
- Status last verified
- Jul 2025
- First submitted
- 28 Oct 2024
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sherin A, Ul-Haq Z, Fazid S, Shah BH, Khattak MI, Nabi F. Prevalence of stroke in Pakistan: Findings from Khyber Pakhtunkhwa integrated population health survey (KP-IPHS) 2016-17. Pak J Med Sci. 2020 Nov-Dec;36(7):1435-1440. doi: 10.12669/pjms.36.7.2824.
PubMed 33235553Khallaf ME. Effect of Task-Specific Training on Trunk Control and Balance in Patients with Subacute Stroke. Neurol Res Int. 2020 Nov 17;2020:5090193. doi: 10.1155/2020/5090193. eCollection 2020.
PubMed 33294224
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Balance, Resistance, Aerobic, Cognitive Exercises(BRACE)on Balance, Cognition and Mobility Among Stroke Patients
- ClinicalTrials.gov ID
- NCT06663709
- Acronym / sponsor ID
- Sadia Bashir
- Conditions
- Stroke Patients
- Keywords
- BRACE Protocol, Task Oriented Protocol, Stroke Population, Balance Impairments
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- 10 Mar 2025 (actual)
- Study completion
- 10 Mar 2025 (actual)
- First posted
- 29 Oct 2024 (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.
The Objective of the is to determine effect of balance, resistance, aerobic, cognitive exercises (BRACE) protocol on balance, cognition and mobility among stroke patients and to compare the effect of Balance, Resistance, Aerobic, and Cognitive Exercise (BRACE) and task-oriented training on balance cognition and mobility in stroke patients. The study will be randomized control trial including 2 experimental groups with estimated 21 individual in each group.
Detailed description
Stroke is a major and growing global health concern. According to the most current estimates of the Global Burden of Disease (GBD) (2019) stroke burden, stroke continues to be the world's second-leading cause of death and the third-leading cause of death and disability. Stroke is the second most prevalent cause of disability worldwide, and survivors frequently experience impairments to their hands and cognitive functions. Because strokes and sudden cerebrovascular accidents occur so often and have such fatal effects, they remain among the most dangerous global health concerns.
Generally, stroke patients experience diminished motor abilities, as well as impairments to their senses, cognition, and visual perception. In addition, they experience compromised physical function, which makes walking independently challenging because of reduced gait endurance, speed of walking, and balance. Patients with such a decrease in their ability to maintain balance find challenging to walk and perform useful movements, which can cause problems in day-to-day living. Moreover, a stroke patient's ability to walk may be even worse if they fall.
Another major cause of stress for survivors of stroke is the cognitive effect, since they may experience issues with concentration, working memory, and remembering.
Trunk function impairments tend to occur in survivors of strokes. Impaired center of pressure control when sitting, muscular weakness and prolonged trunk muscle activation, severe errors in trunk position awareness, poor trunk performance, and trunk imbalance during walking have all been documented in prior research.
Rehabilitative treatment is a particularly effective therapy in terms of improving recovery from impairment. The objective of rehabilitation is "to achieve and sustain maximum performance in the emotional, mental, and physical domains" .A greater awareness of the neurological underpinnings of therapeutic restoration has occurred with a greater awareness of the former.
Numerous publications that focus on balancing training exercises, strength exercises, and aerobic activities independently have been published in the past several years. BRACE, which stands for Balance, Resistance, Aerobic, and Cognition Exercises, is a new treatment protocol meant to reduce fall risk and improve mobility in older adults. There has not been much work done on the BRACE procedure, therefore we will be focusing on it in this study. Our research compares how Balance Resistance Aerobic Cognitive Exercises (BRACE) affect stroke patients' balance, cognition, and mobility.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balance Resistance Aerobic Cognitive Exercises (BRACE) | Experimental | Other: BRACEBRACE include combination of exercises including, Balance, Resistance, Aerobic, Cognition Exercises. |
| Task Oriented | Experimental | Other: TASK-orientedTask Oriented protocol is combination of warm up, balance,,and cognition exercises. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Hemiplegic stroke patients
- Both genders
- Age:30-65years
- ischemic and hemorrhagic stroke patients
- Sub-acute and chronic patients
Key exclusion criteria (5 listed)
- Patients who are not willing
- Patients with vision and hearing issue
- A history of serious or unstable cardiac condition
- Orthopedic injuries that could impair locomotion
- History of fall
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 |
|---|---|---|
| BRACEStudy will be conducted after the approval of Ethical review board. The BRACE exercise training would be perform in 3 times a week for 9 weeks, lasting approximately 40-60 minutes each time. Week 0-3 : Balance: Romberg, tandem standing, single leg stance TUG test Resistance: chair rise, Stair climbing Aerobic exercises: 6mint walk, count reverse from 30, push wall and reverse count from 20 Cognitive: count reverse from 50. Week 4-6: Balance: Sit to stand, functional reach, Tug Test, Perturbation, Kick a ball Resistance: stair climbing Aerobic Exercises: Marching in space, Cycling Cognitive: Remember 5 words, spell backward, remember 5 animals Week 7-9: Balance: Combination of all Resistance: Combination of all Aerobic Exercises: Cycling , Marching, 6 min Walk Cognitive: Combination of all | Other | Balance Resistance Aerobic Cognitive Exercises (BRACE) |
| TASK-orientedStudy will be conducted after the approval of Ethical review board. Task oriented training would be perform in 3 times a week for 9 weeks, lasting approximately 40-60 minutes each time. Week 1-3 Warm Up (sit to stand,5 reps)(cycling 3-5 min) , Single leg stand with eye open 15 sec, with eye close 10sec, forward, backward, and side stepping (5 reps) reaching, Transition from sit to stand, Walk then back to sit (3 min),Walk with even steps(3min) Walk with carrying objects. (3min) Week 4-6 Warm up Period, Task oriented training (7 Reps of each task) Week 7-9 Warm up Period, Task oriented training (9Reps of each task) | Other | Task Oriented |
Primary outcome
Berg And Balance scale
Time frame: 9 weeks
changes from the baseline, Berg balance scale (BBS) is used for assessment of balance and fall risk, Higher scores on the BBS indicate greater independence and better ability to balance. In contrast, lower scores indicate a greater fall risk Items DESCRIPTION SCORE (0-4) Sitting to standing, Standing unsupported, Sitting unsupported, Standing to sitting, Transfers , Standing with eyes closed , Standing with feet together, Reaching forward with outstretched arm, Retrieving object from floor, Turning to look behind, Turning 360 degrees, Placing alternate foot on stool, Standing with one foot in front, Standing on one foot, TOTAL __/56
Time Up And Go
Time frame: 9 weeks
changes from the baseline, Timed up and go test is used for the assessment of falls risk among the elderly population. The Timed "Up and Go" (TUG) Test measures, in seconds, the time is taken by an individual to stand up from a standard armchair (approximate seat height of 46 cm, arm height 65 cm), walk a distance of 3 meters (approximately 10 feet), turn, walk back to the chair, and sit down. Normal healthy elderly usually complete the task in 10 seconds or less. Very frail or weak elderly with poor mobility may take 2 minutes or more. Clinical guide: <10 seconds = normal <20 seconds = good mobility, can go out alone, mobile without a gait aid <30 seconds = problems, cannot go outside alone, requires a gait aid A score of more than or equal to 14 seconds has been shown to indicate a high risk of falls.
MOCA
Time frame: 9 weeks
The Montreal Cognitive Assessment (MOCA) is a cognitive screening instrument developed to detect mild cognitive impairment (MCI). It is a simple 10 min paper and pencil test that assesses multiple cognitive domains including memory, language, executive functions, visuo-patial skills, calculation, abstraction, attention, concentration, and orientation. Scores on the MoCA range from zero to 30. A score of 26 and higher is considered normal. In the initial study data, normal controls had an average score of 27.4. People with mild cognitive impairment (MCI) scored an average of 22.1. People with Alzheimer's disease had an average score of 16.2.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Background: PubMed 33235553Sherin A, Ul-Haq Z, Fazid S, Shah BH, Khattak MI, Nabi F. Prevalence of stroke in Pakistan: Findings from Khyber Pakhtunkhwa integrated population health survey (KP-IPHS) 2016-17. Pak J Med Sci. 2020 Nov-Dec;36(7):1435-1440. doi: 10.12669/pjms.36.7.2824.
- Background: PubMed 33294224Khallaf ME. Effect of Task-Specific Training on Trunk Control and Balance in Patients with Subacute Stroke. Neurol Res Int. 2020 Nov 17;2020:5090193. doi: 10.1155/2020/5090193. eCollection 2020.
- 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. This study is not recruiting at the moment.
Nadia Azhar, MS-NMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BRACE and TASK-oriented in people with Stroke Patients, run by Riphah International University 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 8 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg And Balance scale (time frame: 9 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06663709, which also lists 2 linked publications.
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 8 Jul 2025.