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

NCT06663709 | Completed

• 1 other identifier: Sadia Bashir
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke Patients

Keywords

BRACE Protocol; Task Oriented Protocol; Stroke Population; Balance Impairments

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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.

  9 weeks

Study Arms (2)

Balance Resistance Aerobic Cognitive Exercises (BRACE)

EXPERIMENTAL

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

Other: BRACE

Task Oriented

EXPERIMENTAL

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

Other: TASK-oriented

Interventions

BRACE 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

Balance Resistance Aerobic Cognitive Exercises (BRACE)

TASK-oriented 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)

Task Oriented

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

NIRM

Islamabad, Federal, 04403, Pakistan

Location

Related Publications (2)

• 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.

  PMID: 33235553 BACKGROUND

• 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.

  PMID: 33294224 BACKGROUND

MeSH Terms

Interventions

Braces

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Nadia Azhar, MS-NMPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: October 29, 2024
• Study Start: October 24, 2024
• Primary Completion: March 10, 2025
• Study Completion: March 10, 2025
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)