Effect of BRACE on Balance, Cognition and Mobility Among Stroke Patients

NCT ID: NCT06663709

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-24
• Study Completion Date: 2025-03-10

Brief 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 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.

Conditions

Stroke Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Balance Resistance Aerobic Cognitive Exercises (BRACE)

BRACE include combination of exercises including, Balance, Resistance, Aerobic, Cognition Exercises.

Group Type: EXPERIMENTAL

BRACE

Intervention Type: OTHER

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 Oriented

Task Oriented protocol is combination of warm up, balance,,and cognition exercises.

Group Type: EXPERIMENTAL

TASK-oriented

Intervention Type: OTHER

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)

Interventions

BRACE

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

Intervention Type: OTHER

TASK-oriented

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)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nadia Azhar, MS-NMPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

NIRM

Islamabad, Federal, Pakistan

Countries

Pakistan

References

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.

Reference Type: BACKGROUND

PMID: 33235553 (View on PubMed)

Khallaf 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.

Reference Type: BACKGROUND

PMID: 33294224 (View on PubMed)

Other Identifiers

Sadia Bashir

Identifier Type: -

Identifier Source: org_study_id