Proactive and Reactive Balance Training Effects on Balance and Functional Performance Among Chronic Stroke Survivors

NCT06192485 | Completed

• 1 other identifier: RESC/2023-11
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The study is an RCT study, comparing the proactive and reactive balance training among stroke survivors, the participants will be chronic stroke patients aged between 50- 75 years old, and the participants will receive a balance training program for 8 weeks 3 sessions in the week, the participants will randomly be allocated in two groups proactive group and the reactive group, at the end of the study will compare the different effects between proactive and reactive balance training

Conditions

Stroke; Chronic Stroke; Balance

Outcome Measures

Primary Outcomes (7)

• International Physical Activity Questionnaire

  This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in min-hours/week and time spent sitting. The short form consists of 7 questions, the questions ask about the time that patients spent being physically active in the last 7 days. The sequence of questions is from vigorous to moderate activities to walking then to sitting. And it is a valid and reliable questionnaire

  1 minute

• Time Up and Go (TUG)

  Is a reliable and valid outcome measure.and it's a sensitive and specific test to measure balance and risk of fall among elderly. The patient will be sitting on chair with arm rest then will stand up and walk in straight line 3 m then will turns around and back to the chair and sit down, the timing will start when patient stand up from chair and ends when back to the chair and sit down.\[33\] The score of the TUG: 1. ≤10s → completely independent 2. ≤ 2s → Independent for main transfers

  1 minute

• 10 Meters walking test (MWT)

  It is a reliable and vailed outcome measure, it is evaluated by measuring speed and counting the steps and time. The steps and time will be measured when patient start to walk from beginning point. Individual walks without assistance 10 meters (32.8 feet) and the time is measured for the intermediate 6 meters (19.7 feet) to allow for acceleration and deceleration.

  5 minutes

• The Falls Efficacy Scale (FES)

  The FES was developed through a series of meetings between members of the Prevention of Falls. FES IS A confidence measure in performing a range of activities of daily living without falling. This scale has excellent reliability, is correlated with measures of balance and gait, and predicts future falls and decline in functional capacity. Most importantly, the FES has proven sensitive to change in fears following clinical interventions

  2 minutes

• Tinetti Balance Assessment tool or Tinetti Performance-Oriented Mobility Assessment (POMA)

  It is a balancing tool with both a balance and a gait component that was created for the elderly. The balance component of the test evaluates the patient's ability to maintain postural control while standing, sitting statically, rising from a chair, immediately after standing, standing with eyes open and closed, turning 360 degrees, and during perturbation. The gait component evaluates the following during gait: symmetry, initiation, continuation, path, base of support, and postural sway. measures reactive balance by asking the patient to react to a perturbation. The test comprises 16 items: * 9 balance-related items and * 7 gait-related items

  10 minutes

• Mini-BESTest Balance Evaluation System Test (BEST)

  The Mini-BESTest, the shorter version of the BESTest, was developed to reduce the assessment time. - 14-item Mini-BESTest is scored on a 3-level ordinal scale: * 0 : poor balance performance * 2: no balance impairment. Several studies have shown that the Mini-BESTest also was reliable and valid and useful for fall prediction. The use of the Mini-BESTest in community-dwelling people with chronic stroke has recently been reported, with excellent interrater and intrarater reliability and validity.

  5 minutes

• 2 Minutes Walking test

  There are 5 versions of walking tests available in the stroke population, the 12-, 6-, 5-, 3-, and 2-Minute Walk Tests. Will use 2 MWT: * To assess exercise tolerance in chronic airflow limitation. * Highly correlated with the 6 and 12 MWTs. A valid measure of self-selected walking speed. * The most time efficient.

  2 minutes

Study Arms (2)

Proactive balance training group

ACTIVE COMPARATOR

Other: proactive balance training

Reactive balance training group

ACTIVE COMPARATOR

Other: Reactive balance training

Interventions

proactive balance training OTHER

20 participants will receive a proactive balance training program

Proactive balance training group

Reactive balance training OTHER

20 participants will receive a Reactive balance training program

Reactive balance training group

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• chronic stroke patients
• Males and females
• Age from 50-75 years old
• Able to follow up on instructions
• Able to walk at least 10 meters continuously
• Able to perform sub-maximal physical activity
• stable health condition

You may not qualify if:

• Acute stage or Subacute stage (less than 3 months)
• stroke patients with other severe diseases
• Head injuries
• patients with mental problems
• patients with vestibular problems
• Patients refuse to sign the consent form

Sponsors & Collaborators

• Al-Quds University: lead

Study Sites (1)

Amany

Hebron, West Bank, p714, Palestinian Territories

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 5, 2024
• Study Start: June 1, 2023
• Primary Completion: January 31, 2024
• Study Completion: May 28, 2024
• Last Updated: January 22, 2025

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)