Clinical trial NCT06192485: Proactive and Reactive Balance Training Effects on Balance and Functional Performance Among Chronic Stroke Survivors
Official title: Proactive and Reactive Balance Training Effects on Balance and Functional Performance Among Chronic Stroke Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Chronic Stroke
Balance
Lead sponsor: Al-Quds University
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: International Physical Activity Questionnaire
timeFrame: 1 minute
measure: Time Up and Go (TUG)
timeFrame: 1 minute
measure: 10 Meters walking test (MWT)
timeFrame: 5 minutes
measure: The Falls Efficacy Scale (FES)
timeFrame: 2 minutes
measure: Tinetti Balance Assessment tool or Tinetti Performance-Oriented Mobility Assessment (POMA)
timeFrame: 10 minutes
measure: Mini-BESTest Balance Evaluation System Test (BEST)
timeFrame: 5 minutes
measure: 2 Minutes Walking test
timeFrame: 2 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Hebron
country: Palestinian Territory, occupied
facility: Amany
state: West Bank
Study officials:
References: