The Effects of Whole Body Vibration in People With Chronic Stroke
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
High frequency whole body vibration
Low frequency whole body vibration
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring vibration, bone, mucle, cerebrovascular accident, rehabilitation
Eligibility Criteria
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
Sites / Locations
- The Hong Kong Polytechnic University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
High frequency whole body vibration
low frequency whole body vibration
Arm Description
This group will receive a single 8-minute session of WBV therapy. The frequency of the vibration signals will be set at 30Hz.
This group will receive a single 12-minute session of WBV. The frequency of the vibration signals will be set at 20 Hz.
Outcomes
Primary Outcome Measures
bone resorption marker
Serum level of aminoterminal crosslinked telopeptide
bone resorption marker
Serum level of aminoterminal crosslinked telopeptide
Secondary Outcome Measures
Six Minute Walk Test
endurance test
Six Minute Walk Test
endurance Test
Gait velocity
10-meter walking test
Gait velocity
10-meter walking test
Spasticity
H-reflex on tibial nerve and modified ashworth scale
Spasticity
H-reflex on tibial nerve and modified ashworth scale
Full Information
NCT ID
NCT03982251
First Posted
June 6, 2019
Last Updated
June 9, 2019
Sponsor
The Hong Kong Polytechnic University
1. Study Identification
Unique Protocol Identification Number
NCT03982251
Brief Title
The Effects of Whole Body Vibration in People With Chronic Stroke
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
June 28, 2017 (Actual)
Primary Completion Date
June 28, 2018 (Actual)
Study Completion Date
August 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
vibration, bone, mucle, cerebrovascular accident, rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High frequency whole body vibration
Arm Type
Experimental
Arm Description
This group will receive a single 8-minute session of WBV therapy. The frequency of the vibration signals will be set at 30Hz.
Arm Title
low frequency whole body vibration
Arm Type
Active Comparator
Arm Description
This group will receive a single 12-minute session of WBV. The frequency of the vibration signals will be set at 20 Hz.
Intervention Type
Procedure
Intervention Name(s)
High frequency whole body vibration
Other Intervention Name(s)
Whole body vibration therapy (30Hz)
Intervention Description
1 single session ( 8 minutes) of whole body vibration therapy at 30 Hz
Intervention Type
Procedure
Intervention Name(s)
Low frequency whole body vibration
Other Intervention Name(s)
Whole body vibration therapy (20Hz)
Intervention Description
1 single session ( 12 minutes) of whole body vibration therapy at 20 Hz
Primary Outcome Measure Information:
Title
bone resorption marker
Description
Serum level of aminoterminal crosslinked telopeptide
Time Frame
pre-test (week 0)
Title
bone resorption marker
Description
Serum level of aminoterminal crosslinked telopeptide
Time Frame
post-test (week8)
Secondary Outcome Measure Information:
Title
Six Minute Walk Test
Description
endurance test
Time Frame
pre-test (week 0)
Title
Six Minute Walk Test
Description
endurance Test
Time Frame
post-test (week8)
Title
Gait velocity
Description
10-meter walking test
Time Frame
pre-test (week 0)
Title
Gait velocity
Description
10-meter walking test
Time Frame
post-test (week8)
Title
Spasticity
Description
H-reflex on tibial nerve and modified ashworth scale
Time Frame
pre-test (week 0)
Title
Spasticity
Description
H-reflex on tibial nerve and modified ashworth scale
Time Frame
post-test (week8)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco YC Pang, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hongkong
Country
Hong Kong
12. IPD Sharing Statement
Learn more about this trial
The Effects of Whole Body Vibration in People With Chronic Stroke
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