Plain English Summary
Background and study aims
Chronic stroke is common in elderly people throughout the world. Aging causes a loss of posture control and balance that can affect daily activities. Older people would be expected to have more difficulties in physical ability following a stroke than younger stroke patients. Some research suggests that whole body vibration (WBV) training can improve balance when standing on one leg, ability to stand up from a chair and walking speed. Other studies have shown no positive effects of WBV training on balance and mobility. This study aims to investigate the effect of WBV training on balance and physical performance in elderly people who have had a stroke. The study also aims to investigate which frequency of WBV has the best effects.
Who can participate?
People aged 65 years or above with chronic stroke who are being treated in the Department of Rehabilitation of Wuhan Brain Hospital (General Hospital of the Yangtze River Shipping) . The stroke must have happened at least 6 months before the study. The person must be able to stand independently with or without aids for at least 2 minutes and walk independently with or without aids for at least 10 meters.
What does the study involve?
WBV training will be held at the Department of Rehabilitation of Wuhan Brain Hospital (General Hospital of the Yangtze River Shipping). All training sessions will be supervised by a physical therapist and will be implemented at 5 days/week for 2 weeks. Each training session consists of 360 seconds (4 bouts of 90 seconds). 1 minute of rest will be given between training sessions to avoid over-exertion of the participants. No warm-up exercises will be given before WBV training. The frequencies of the low-frequency group and high-frequency group will be 13 Hz and 26 Hz, respectively. Participants will be asked to place their foot in the same place on the WBV machine each time. During training, the participants will stand barefoot with knee angle of 80° on the platform of the WBV machine (GalileoDelta A, Novotech, Germany). A manual goniometer will be used to measure the knee joint angle before and after each training session. All participants will also receive the conventional rehabilitation program at 5 days/week for 2 weeks. The conventional rehabilitation program comprises physical therapy (PT) - exercises focusing on muscle-stretching, relaxation, and body perception, occupational therapy (OT) and acupuncture. In the conventional rehabilitation program, each therapy will last 30 minutes. Meanwhile, we will advise the participants to keep their lifestyle and physical activities as usual during the study period. The treatments will be assessed using tests of balance and mobility, including the five-repetition sit-to-stand test (5STS), the 10-meter walking test (10MWT), the timed-up-and-go test (TUG) and the Berg Balance Scale (BBS). These assessments will be conducted before the treatment starts and 2 weeks later, after the treatment has been completed, by the same researcher, who will not know which treatment group each person was in.
What are the possible benefits and risks of participating?
Participants will gain WBV training as additional therapy, which might improve their physical performance. WBV training is free for all participants. The control group will receive WBV training after the study. All participants will receive the usual rehabilitation therapy as well.
Where is the study run from?
This study is being run by Wuhan Polytechnic University and will take place in Wuhan Brain Hospital (General Hospital of the Yangtze River Shipping).
When is the study starting and how long is it expected to run for?
October 2017 to December 2019
Who is funding the study?
Hubei Province Education Office
Who is the main contact?
Ning Wei, Nicole.weining@whpu.edu.cn
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
L20170010
Study information
Scientific title
The effects of whole body vibration on balance and physical performance in the older people with chronic stroke: A randomized controlled trial
Acronym
Study hypothesis
1. Whole body vibration (WBV) training programme is effective for improving balance and physical performance in elderly subjects with chronic stroke
2. Different frequencies would affect balance and physical performance in elderly subjects with chronic stroke.
Ethics approval
Current ethics approval as of 01/05/2019:
Human Ethics Review Board of Wuhan Brain Hospital (General Hospital of the Yangtze River Shipping), 26/03/2018, L20180010
Previous ethics approval:
Human Ethics Review Board of Wuhan Brain Hospital (General Hospital of the Yangtze River Shipping), 26/03/2018, L20170010
Study design
Randomised parallel-group study
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
No participant information sheet available
Condition
Chronic stroke
Intervention
Hospital in-patients aged 65 years or above with ischemic or hemorrhagic stroke in Department of Rehabilitation of Wuhan Brain Hospital (General Hospital of the Yangtze River Shipping) will be invited to a screening process. Eligible participants will be recruited and randomly assigned into three groups (Low-frequency group (LFG), high-frequency group (HFG) and control group (CG)) by a computer program (Research Randomizer Form www.randomizer.org). WBV training will be held at Department of Rehabilitation of Wuhan Brain Hospital (General Hospital of the Yangtze River Shipping). All training sessions will be supervised by a physical therapist and implemented at 5 days/week for 2 weeks. Each training session consists of 360 seconds (4 bouts of 90 seconds). One minute of rest will be given between training sessions to avoid over-exertion of the participants. No warm-up exercises will be given before WBV training.
The frequencies of low-frequency group and high-frequency group will be 13 Hz and 26 Hz, respectively. Participants will be asked to place their foot at the standard distance from the axis of rotation to have the same peak-to-peak amplitude. During training, the participants will stand barefoot with knee angle of 80° on the platform of WBV machine (GalileoDelta A, Novotech, Germany). A manual goniometer will be used to monitor the knee joint angle before and after each training session.
All participants will receive a conventional rehabilitation program at 5 days/week for 2 weeks. The conventional rehabilitation program comprises physical therapy (PT) exercises focusing on muscle-stretching, relaxation, and body perception), occupational therapy (OT) and acupuncture. In the conventional rehabilitation program, each therapy will last 30 minutes. Meanwhile, we will advise the participants to keep their lifestyle and physical activities as usual during the study period.
Intervention type
Device
Phase
Not Specified
Drug names
Primary outcome measure
Physical ability assessed using five-repetition sit-to-stand test (5STS), 10-m walking test (10MWT) and timed-up-and-go test (TUG) at baseline and post-intervention (2 week) by the same researcher, who will be blinded to the intervention
Secondary outcome measures
Berg Balance Scale (BBS)
Overall trial start date
19/10/2017
Overall trial end date
30/12/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Hospital in-patient at Department of Rehabilitation of Wuhan Brain Hospital (General Hospital of the Yangtze River Shipping)
2. Aged 65 years or above
3. Ischemic or hemorrhagic stroke with stroke onset at least 6 months before the study
4. Able to stand independently with or without aids for at least 2 minutes
5. Able to walk independently with or without aids at least 10 m
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
51
Participant exclusion criteria
1. Metal implant
2. Severe heart problem
3. Neuro-degenerative diseases
4. Peripheral vascular disease
5. Vestibular disorders
6. Cognitive impairment
7. Severe osteoporosis with fractures within 1 year prior to the study
Recruitment start date
08/08/2018
Recruitment end date
01/07/2019
Locations
Countries of recruitment
China
Trial participating centre
Wuhan Brain Hospital (General Hospital of the Yangtze River Shipping)
Wuhan
430010
China
Funders
Funder type
Not defined
Funder name
Hubei Province Education Office
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
The datasets generated and/or analysed during this study will be included in the subsequent results publication.
Intention to publish date
30/12/2021
Participant level data
Available on request
Basic results (scientific)
Publication list