Condition category
Nervous System Diseases
Date applied
19/06/2018
Date assigned
03/08/2018
Last edited
01/05/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Ning Wei

ORCID ID

Contact details

Room 309
Department of Rehabilitation Sciences
College of health science & Nursing
Wuhan Polytechnic University
Wuhan
430023
China

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

Sponsor information

Organisation

Wuhan Polytechnic University

Sponsor details

Wuhan Polytechnic University
DongXi District
Wuhan
Hubei Province
Wuhan
430023
China

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes

01/05/2019: The following changes have been made: 1. The recruitment start date has been changed from 01/08/2018 to 08/08/2018. 2. The ethics approval field has been updated.