Effects of whole-body vibration training on balance and ankle awareness in stroke survivors
| ISRCTN | ISRCTN64602845 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN64602845 |
| Secondary identifying numbers | Funder grant numbers: ZD125_0013, 202004h07020017, WK9110000134 |
- Submission date
- 22/07/2024
- Registration date
- 29/07/2024
- Last edited
- 02/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Although whole-body vibration (WBV) training is acknowledged for its benefits in enhancing motor functions across several neurological disorders, its precise influence on ankle joint proprioception (the body's ability to sense movement, action, and location) and balance in stroke patients is still not well understood. This research seeks to assess the impact of WBV training on ankle joint proprioception and balance in stroke patients, thereby filling this important research void.
Who can participate?
Patients aged ≥30 years old after their first-episode stroke, defined as individuals with no prior stroke events.
What does the study involve?
Thirty-five stroke patients will be randomly assigned to either the WBV group (n = 17) or a control group (n = 18) using a random number table method. The control group will receive daily general rehabilitation for four weeks, while the WBV group will receive an additional 30 minutes of WBV training each day with the Trunsan S110 Vibration Training System. Assessments will be conducted at baseline and after four weeks of intervention, using various scales and tests for ankle joint proprioception and balance.
What are the possible benefits and risks of participating?
The possible benefit of the WBV training is to help restore ankle joint proprioception and balance in stroke patients. No serious or other adverse events are expected during the follow-up of studies.
Where is the study run from?
The Rehabilitation Medicine Department, the First Affiliated Hospital of the University of Science and Technology of China
When is the study starting and how long is it expected to run for?
February 2020 to May 2022
Who is funding the study?
This research was funded by a grant from Anhui Province Twelfth Five-Year Clinical Medicine Key Specialty (Grant No. ZD125_0013), Key Technologies R&D Program of Anhui Province (Grant No. 202004h07020017), and the Fundamental Research Funds for the Central Universities (Grant No. WK9110000134).
Who is the main contact?
Jingsong Mu, jsmu@ustc.edu.cn
Contact information
Public, Scientific, Principal Investigator
17 Lujiang Road, Luyang District
Hefei, Anhui Province
230001
China
| Phone | +86 0551-62283114 |
|---|---|
| jsmu@ustc.edu.cn |
Study information
| Study design | Single-center prospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Efficacy |
| Participant information sheet | 45819 PIS.pdf |
| Scientific title | Impact of whole-body vibration training on ankle joint proprioception and balance in stroke patients: A prospective cohort study |
| Study objectives | Whole-body vibration (WBV) training will significantly improve both balance and proprioceptive abilities |
| Ethics approval(s) |
Approved 03/04/2022, Ethics Committee of the First Affiliated Hospital of the University of Science and Technology of China (17 Lujiang Road, Luyang District, Hefei, Anhui Province, 230001, China; +86 0551-62282931; ahslyyllwyh@163.com), ref: XJS2020-1-5 (NK) |
| Health condition(s) or problem(s) studied | Restoration of ankle joint proprioception and balance in stroke patients |
| Intervention | Thirty-five stroke patients will be randomly assigned to either the (whole body vibration) WBV group (n = 17) or a control group (n = 18) using a random number table method. The control group will receive daily general rehabilitation for four weeks, while the WBV group will receive an additional 30 minutes of WBV training each day with the Trunsan S110 Vibration Training System. Blinded outcome assessments will be conducted at baseline and post-treatment, using the Berg balance scale (BBS), functional reach test (FRT), Romberg test length (RTL) and area (RTA), and completion rates of ankle joint dorsiflexion-plantar flexion (DP) and inversion-eversion (IE) tests. Follow-up assessments will be performed after four weeks of intervention. Data will be analyzed using SPSS 26.0 (SPSS, Inc., Chicago, IL). The measurement data will be expressed as mean ± standard deviation (SD). Upon confirming the homogeneity of variances, independent samples t-tests will be used for inter-group analyses, while paired-sample t-tests will be employed for intra-group comparisons. For data sets not following the normal distribution, Mann-Whitney U tests and Wilcoxon signed-rank tests will be employed. A correlation analysis will be performed to explore the correlation between DP (times) and IE (times). Moreover, multiple linear regressions will be conducted to explore the existence of confounders. A P-value of less than 0.05 will be deemed indicative of statistical significance. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Measured using the TecnoBody PROKIN System (PK252) at baseline and after four weeks of intervention: 1. Balance measured using the Romberg test length (RTL). 2. Stability measured using the Romberg test area (RTA). 3. Ankle joint flexibility measured using the completion rates of ankle joint dorsiflexion-plantar flexion (DP). 4. Foot stability measured using the inversion-eversion (IE) tests. |
| Secondary outcome measures | Assessed at baseline and after four weeks of intervention: 1. Aspects of balance, such as sitting to standing and standing on one foot, measured using the Berg balance scale (BBS) score 2. Maximum reach distance beyond arm's length in a standing position measured using the functional reach test (FRT) |
| Overall study start date | 10/02/2020 |
| Completion date | 20/05/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 30 Years |
| Upper age limit | 100 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 58 |
| Key inclusion criteria | 1. Eligible participants (≥30 years of age) were first-episode stroke patients, defined as individuals with no prior stroke events 2. Stroke diagnosis was confirmed through CT or MRI, with characteristic imaging features: low attenuation in ischemic strokes or high/mixed-intensity signals in hemorrhagic strokes, accompanied by hemiplegia 3. Participants had stable vital signs (heart rate: 60–100 bpm; blood pressure: 90/60 to 120/80 mmHg; respiration: 16–26 breaths per minute; temperature: 36.5–37.3 °C) and cognitive function (mini-mental state examination (MMSE) score > 27) 4. Additionally, they were required to maintain an independent standing balance |
| Key exclusion criteria | 1. Severe complications such as major neurological deficits or severe aphasia that could impede study involvement 2. Severe cardiovascular conditions posing significant health risks, including hypertension (systolic ≥ 180 mmHg or diastolic ≥ 120 mmHg), heart failure with an ejection fraction < 35%, symptomatic coronary artery disease, and severe valvular heart disease, following the American College of Cardiology and American Heart Association guidelines 3. Advanced bone and joint diseases affecting participation, such as severe osteoarthritis, rheumatoid arthritis, recent or unhealed fractures, or significant post-surgical limitations 4. Recent lower extremity venous thrombosis, defined as episodes within the last six months, which could be aggravated by study activities 5. Cognitive impairments severe enough to interfere with understanding instructions or providing informed consent, like advanced dementia or significant intellectual disability, regardless of MMSE scores |
| Date of first enrolment | 01/03/2020 |
| Date of final enrolment | 15/05/2022 |
Locations
Countries of recruitment
- China
Study participating centre
Hefei, Anhui Province
230001
China
Sponsor information
Hospital/treatment centre
First Affiliated Hospital of the University of Science and Technology of China (USTC)
17 Lujiang Road, Luyang District
Hefei, Anhui Province
230001
China
| Phone | +86 0551-62283583 |
|---|---|
| ahslyyrlzyb2021@163.com | |
| Website | http://en.ustc.edu.cn/ |
"ROR" |
https://ror.org/04c4dkn09 |
Funders
Funder type
Not defined
No information available
Government organisation / Local government
- Alternative name(s)
- Key Technologies R & D Program of Anhui Province
- Location
- China
Government organisation / Local government
- Alternative name(s)
- Fundamental Research Funds for the Central Universities of China, Fundamental Research Fund for the Central Universities
- Location
- China
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The type of data that will be shared: Data for analysis in Microsoft Word (.xlsx). (see outputs table) Timing for availability: Immediately after publication Whether consent from participants was required and obtained: Yes, consent was obtained from participants (Informed Consent Form in Chinese). Comments on data anonymization: All data will be anonymized to ensure participant privacy. Any ethical or legal restrictions: Data sharing will be in compliance with ethical guidelines and institutional policies. Any additional comments: The datasets generated during and/or analysed during the current study will be available upon request from Jingsong Mu, jsmu@ustc.edu.cn |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Dataset | 29/07/2024 | No | No | ||
| Participant information sheet | 29/07/2024 | No | Yes | ||
| Results article | 01/10/2024 | 02/10/2024 | Yes | No |
Additional files
Editorial Notes
02/10/2024: Publication reference added.
29/07/2024: Trial's existence confirmed by Ethics Committee of the First Affiliated Hospital of the University of Science and Technology of China.
