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

July 2, 2025 updated by: Riphah International University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Federal
      • Islamabad, Federal, Pakistan, 04403
        • NIRM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Balance Resistance Aerobic Cognitive Exercises (BRACE)
BRACE include combination of exercises including, Balance, Resistance, Aerobic, Cognition Exercises.
Other: 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
Experimental: Task Oriented
Task Oriented protocol is combination of warm up, balance,,and cognition exercises.
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
9 weeks
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.
9 weeks
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.
9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Nadia Azhar, MS-NMPT, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2024

Primary Completion (Actual)

March 10, 2025

Study Completion (Actual)

March 10, 2025

Study Registration Dates

First Submitted

October 28, 2024

First Submitted That Met QC Criteria

October 28, 2024

First Posted (Actual)

October 29, 2024

Study Record Updates

Last Update Posted (Estimated)

July 8, 2025

Last Update Submitted That Met QC Criteria

July 2, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sadia Bashir

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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