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

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

Study Overview

• Status: Completed
• Conditions: Stroke; Chronic Stroke; Balance
• Intervention / Treatment: Other: proactive balance training; Other: Reactive balance training

Detailed Description

The objectives of the study are: (1) To investigate the effect of reactive balance training on balance and functional performance, (2) To investigate the effect of proactive balance training on functional activity and balance stroke survivors, and (3) To study the reactive balance training versus the proactive balance on balance and functional performance among stroke survivors.

The study will be a single-blinded RCT study will consist of 40 chronic stroke patients and will allocate randomly into 2 groups, the first intervention group n=20 will have proactive-balance training, and the second group n= 20 will have reactive balance training, the two groups will be blinded.

The study population will be chronic stroke patients discharged from Bethlehem Arab Society for Rehabilitation (BASR), Alahli Hospital, Al Mezan Hospital, and Alehsan Society for Rehabilitation, and lives in Hebron City and their villages.

The program will consist of 24 sessions in 8 weeks, through 3 sessions weekly. The sessions will be 45 minutes, starting with a 10 Min warm-up exercise and then the balance training and the sessions will end with 5 Min cool-down exercise.

The session will be individualized, the program has sequences depending on the patient's ability.

The program consists of:

1. Sitting training
2. Standing training
3. Walking training The sequences of the training will be based on a balance training protocol.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Palestinian Territory, occupied
  • West Bank
    • Hebron, West Bank, Palestinian Territory, occupied, p714
      • Amany

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. chronic stroke patients
2. Males and females
3. Age from 50-75 years old
4. Able to follow up on instructions
5. Able to walk at least 10 meters continuously
6. Able to perform sub-maximal physical activity
7. stable health condition

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Proactive balance training group	Other: proactive balance training; 20 participants will receive a proactive balance training program
Active Comparator: Reactive balance training group	Other: Reactive balance training; 20 participants will receive a Reactive balance training program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: ≤10s → completely independent; ≤ 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

Collaborators and Investigators

• Sponsor: Al-Quds University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): January 31, 2024
• Study Completion (Actual): May 28, 2024

Study Registration Dates

• First Submitted: December 21, 2023
• First Submitted That Met QC Criteria: December 21, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 20, 2025
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: RESC/2023-11

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