NCT03982251

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 28, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 11, 2019

Completed
Last Updated

June 11, 2019

Status Verified

June 1, 2019

Enrollment Period

1 year

First QC Date

June 6, 2019

Last Update Submit

June 9, 2019

Conditions

Keywords

vibrationbonemuclecerebrovascular accidentrehabilitation

Outcome Measures

Primary Outcomes (2)

  • bone resorption marker

    Serum level of aminoterminal crosslinked telopeptide

    pre-test (week 0)

  • bone resorption marker

    Serum level of aminoterminal crosslinked telopeptide

    post-test (week8)

Secondary Outcomes (6)

  • Six Minute Walk Test

    pre-test (week 0)

  • Six Minute Walk Test

    post-test (week8)

  • Gait velocity

    pre-test (week 0)

  • Gait velocity

    post-test (week8)

  • Spasticity

    pre-test (week 0)

  • +1 more secondary outcomes

Study Arms (2)

High frequency whole body vibration

EXPERIMENTAL

This group will receive a single 8-minute session of WBV therapy. The frequency of the vibration signals will be set at 30Hz.

Procedure: High frequency whole body vibration

low frequency whole body vibration

ACTIVE COMPARATOR

This group will receive a single 12-minute session of WBV. The frequency of the vibration signals will be set at 20 Hz.

Procedure: Low frequency whole body vibration

Interventions

1 single session ( 8 minutes) of whole body vibration therapy at 30 Hz

Also known as: Whole body vibration therapy (30Hz)
High frequency whole body vibration

1 single session ( 12 minutes) of whole body vibration therapy at 20 Hz

Also known as: Whole body vibration therapy (20Hz)
low frequency whole body vibration

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Marco YC Pang, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 6, 2019

First Posted

June 11, 2019

Study Start

June 28, 2017

Primary Completion

June 28, 2018

Study Completion

August 28, 2018

Last Updated

June 11, 2019

Record last verified: 2019-06

Locations