StrokeNCT06192485
Proactive and Reactive Balance Training Effects on Balance and Functional Performance Among Chronic Stroke Survivors
A study testing proactive balance training and Reactive balance training in people with Stroke and Chronic Stroke, run by Al-Quds University at 1 site in Palestinian Territories.
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… Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Stroke, Chronic Stroke, Balance
- What is being tested?
- proactive balance training and Reactive balance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 1 Jun 2023to 28 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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:
- Sitting training
- Standing training
- Walking training The sequences of the training will be based on a balance training protocol.
- Conditions
- Stroke, Chronic Stroke, Balance
- Being tested
- proactive balance training, Reactive balance training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proactive balance trainingOther
20 participants will receive a proactive balance training program
Reactive balance trainingOther
20 participants will receive a Reactive balance training program
| Study group | Role | What they receive |
|---|---|---|
| Proactive balance training group | Active comparator | Not described Receives: Other: proactive balance training |
| Reactive balance training group | Active comparator | Not described Receives: Other: Reactive balance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Jun 2023
- Primary completion31 Jan 2024
- Study completion28 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Quds University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192485
- Sponsor's protocol ID
- RESC/2023-11
- Status last verified
- Jun 2023
- First submitted
- 21 Dec 2023
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proactive and Reactive Balance Training Effects on Balance and Functional Performance Among Chronic Stroke Survivors
- ClinicalTrials.gov ID
- NCT06192485
- Acronym / sponsor ID
- RESC/2023-11
- Conditions
- Stroke, Chronic Stroke, Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Al-Quds UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 28 May 2024 (actual)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Sitting training
- Standing training
- Walking training The sequences of the training will be based on a balance training protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proactive balance training group | Active comparator | Other: proactive balance training |
| Reactive balance training group | Active comparator | Other: Reactive balance training |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| proactive balance training20 participants will receive a proactive balance training program | Other | Proactive balance training group |
| Reactive balance training20 participants will receive a Reactive balance training program | Other | Reactive balance training group |
Primary outcome
International Physical Activity Questionnaire
Time frame: 1 minute
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
Time Up and Go (TUG)
Time frame: 1 minute
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
10 Meters walking test (MWT)
Time frame: 5 minutes
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.
The Falls Efficacy Scale (FES)
Time frame: 2 minutes
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
Tinetti Balance Assessment tool or Tinetti Performance-Oriented Mobility Assessment (POMA)
Time frame: 10 minutes
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
Mini-BESTest Balance Evaluation System Test (BEST)
Time frame: 5 minutes
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.
2 Minutes Walking test
Time frame: 2 minutes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing proactive balance training and Reactive balance training in people with Stroke and Chronic Stroke, run by Al-Quds University at 1 site in Palestinian Territories.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Palestinian Territories. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Physical Activity Questionnaire (time frame: 1 minute). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.