- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03982251
The Effects of Whole Body Vibration in People With Chronic Stroke
The Effects of Whole Body Vibration Training With Different Frequencies on Bone Health and Neuromotor Performance in Individuals With Chronic Stroke: A Randomized Controlled Trial.
Whole body vibration (WBV) has been found to be useful in promoting bone health and muscle performance in older adults. To date, no study has examined the effects of different WBV frequencies on the properties of the muscle-bone unit in stroke patients. The overall aim of the proposed study is to compare the efficacy of different vibration frequencies on properties of the muscle function and bone turnover among people with chronic stroke.
It is hypothesized that the higher-vibration frequency protocol will lead to significantly better outcomes related to the bone turnover and muscle function.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Whole body vibration (WBV) has been found to be useful in promoting bone health and muscle performance in older adults. To date, no study has examined the effects of different WBV frequencies on the properties of the muscle-bone unit in stroke patients. The overall aim of the proposed study is to compare the efficacy of different vibration frequencies on properties of the muscle function and bone turnover among people with chronic stroke.
It is hypothesized that the higher-vibration frequency protocol will lead to significantly better outcomes related to the bone turnover and muscle function in people with chronic stroke.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hongkong, Hong Kong
- The Hong Kong Polytechnic University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- a diagnosis of stroke
- stroke onset >6 months
- >18 years of age
- able to walk for short distance independently with or without walking aid
- able to understand simple verbal commands
Exclusion Criteria:
- neurological conditions other than stroke
- significant musculoskeletal conditions (e.g. amputations)
- metal implants in the lower extremity
- previous fracture of the lower extremity
- are currently taking bone resorption inhibitors or were taking the same before stroke.
- significant peripheral vascular disease
- vestibular disorders
- pregnancy
- Other serious illnesses that preclude the person from participating in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: High frequency whole body vibration
This group will receive a single 8-minute session of WBV therapy.
The frequency of the vibration signals will be set at 30Hz.
|
1 single session ( 8 minutes) of whole body vibration therapy at 30 Hz
Other Names:
|
Active Comparator: low frequency whole body vibration
This group will receive a single 12-minute session of WBV.
The frequency of the vibration signals will be set at 20 Hz.
|
1 single session ( 12 minutes) of whole body vibration therapy at 20 Hz
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
bone resorption marker
Time Frame: pre-test (week 0)
|
Serum level of aminoterminal crosslinked telopeptide
|
pre-test (week 0)
|
bone resorption marker
Time Frame: post-test (week8)
|
Serum level of aminoterminal crosslinked telopeptide
|
post-test (week8)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Six Minute Walk Test
Time Frame: pre-test (week 0)
|
endurance test
|
pre-test (week 0)
|
Six Minute Walk Test
Time Frame: post-test (week8)
|
endurance Test
|
post-test (week8)
|
Gait velocity
Time Frame: pre-test (week 0)
|
10-meter walking test
|
pre-test (week 0)
|
Gait velocity
Time Frame: post-test (week8)
|
10-meter walking test
|
post-test (week8)
|
Spasticity
Time Frame: pre-test (week 0)
|
H-reflex on tibial nerve and modified ashworth scale
|
pre-test (week 0)
|
Spasticity
Time Frame: post-test (week8)
|
H-reflex on tibial nerve and modified ashworth scale
|
post-test (week8)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Marco YC Pang, PhD, The Hong Kong Polytechnic University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSEARS20140226001-03
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stroke
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.RecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, CryptogenicSingapore, Philippines
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
-
Vanderbilt University Medical CenterPatient-Centered Outcomes Research Institute; University of Alabama at BirminghamEnrolling by invitationStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Engagement, Patient | Stroke HemorrhagicUnited States
-
University of MinnesotaAmerican Occupational Therapy FoundationRecruitingStroke | Stroke Sequelae | Stroke Hemorrhagic | Stroke IschemicUnited States
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Michael Smith Foundation for...RecruitingStroke | Stroke, Ischemic | Stroke Hemorrhagic | Chronic StrokeCanada
-
University of CincinnatiMedical University of South Carolina; University of California, Los Angeles; University...RecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke HemorrhagicUnited States
-
University of LiegeCompletedStroke, Acute | Stroke Hemorrhagic | Stroke, ComplicationBelgium
-
Turkish Stroke Research and Clinical Trials NetworkElectroCore INC; Turkish Neurological SocietyCompletedStroke | Stroke, Ischemic | Stroke, Acute | Stroke, HemorrhagicTurkey
Clinical Trials on High frequency whole body vibration
-
The Hong Kong Polytechnic UniversityUnknown
-
The Hong Kong Polytechnic UniversityUnknown
-
Gazi UniversityGulhane Training and Research HospitalRecruitingArthropathy of Knee | Whole-body Vibration | Swelling/ EdemaTurkey
-
Schön Klinik Berchtesgadener LandCompletedChronic Obstructive Pulmonary DiseaseGermany
-
OHSU Knight Cancer InstituteOregon Health and Science UniversityCompletedHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid Neoplasm | Chemotherapy-Induced Peripheral NeuropathyUnited States
-
University of the Balearic IslandsUnknown
-
University of SevilleAsociación de Enfermos de Parkinson de SevillaNot yet recruiting
-
Florida State UniversityCompleted
-
University of CologneCompleted