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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03982251
Other study ID # HSEARS20140226001-03
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 28, 2017
Est. completion date August 28, 2018

Study information

Verified date June 2019
Source The Hong Kong Polytechnic University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date August 28, 2018
Est. primary completion date June 28, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. a diagnosis of stroke

2. stroke onset >6 months

3. >18 years of age

4. able to walk for short distance independently with or without walking aid

5. able to understand simple verbal commands

Exclusion Criteria:

1. neurological conditions other than stroke

2. significant musculoskeletal conditions (e.g. amputations)

3. metal implants in the lower extremity

4. previous fracture of the lower extremity

5. are currently taking bone resorption inhibitors or were taking the same before stroke.

6. significant peripheral vascular disease

7. vestibular disorders

8. pregnancy

9. Other serious illnesses that preclude the person from participating in the study

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
High frequency whole body vibration
1 single session ( 8 minutes) of whole body vibration therapy at 30 Hz
Low frequency whole body vibration
1 single session ( 12 minutes) of whole body vibration therapy at 20 Hz

Locations

Country Name City State
Hong Kong The Hong Kong Polytechnic University Hongkong

Sponsors (1)

Lead Sponsor Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary bone resorption marker Serum level of aminoterminal crosslinked telopeptide pre-test (week 0)
Primary bone resorption marker Serum level of aminoterminal crosslinked telopeptide post-test (week8)
Secondary Six Minute Walk Test endurance test pre-test (week 0)
Secondary Six Minute Walk Test endurance Test post-test (week8)
Secondary Gait velocity 10-meter walking test pre-test (week 0)
Secondary Gait velocity 10-meter walking test post-test (week8)
Secondary Spasticity H-reflex on tibial nerve and modified ashworth scale pre-test (week 0)
Secondary Spasticity H-reflex on tibial nerve and modified ashworth scale post-test (week8)
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