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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06192485
• Other study ID #: RESC/2023-11
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: February 10, 2024

Study information

• Verified date: June 2023
• Source: Al-Quds University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: February 10, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Balance
• Chronic Stroke
• Stroke

Intervention

Other:
• proactive balance training
20 participants will receive a proactive balance training program
• Reactive balance training
20 participants will receive a Reactive balance training program

Locations

Country	Name	City	State
Palestinian Territory, occupied	Amany	Hebron	West Bank

Sponsors (1)

Lead Sponsor	Collaborator
Al-Quds University

Country where clinical trial is conducted

Palestinian Territory, occupied, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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