NCT01822704

Brief Summary

This study is a randomized controlled trial aimed to assess the efficacy of a 10-week whole body vibration training program on physical functioning, societal participation and quality of life in individuals with chronic stroke. It is hypothesized that the whole body vibration program will induce significantly more gain in physical functioning, societal participation, and quality of life in chronic stroke patients, compared with the control group.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
81

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2013

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

March 28, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 2, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

April 4, 2013

Status Verified

April 1, 2013

Enrollment Period

1.7 years

First QC Date

March 28, 2013

Last Update Submit

April 1, 2013

Conditions

Stroke

Keywords

StrokeExerciseRehabilitationVibration

Outcome Measures

Primary Outcomes (2)

  • Isometric knee muscle strength

    Week 0

  • Isometric knee muscle strength

    week 10

Secondary Outcomes (28)

  • Eccentric knee muscle strength at a velocity of 60 degrees per second

    Week 0

  • Eccentric knee muscle strength at a velocity of 60 degrees per second

    week 10

  • Concentric knee muscle strength at a velocity of 60 degrees per second

    week 0

  • Concentric knee muscle strength at a velocity of 60 degrees per second

    week 10

  • Distance walked in the Six Minute Walk Test

    week 0

  • +23 more secondary outcomes

Study Arms (3)

Control

ACTIVE COMPARATOR

This group will undergo three 45-minute exercise sessions per week for 10 weeks. No whole body vibration will be given.

Behavioral: Leg exercises

Low intensity vibration

EXPERIMENTAL

This group will receive three 45-minute whole body vibration training sessions for 10 consecutive weeks. The vibration will be of low intensity (frequency: 20 Hertz, amplitude: 1mm).

Device: Low intensity whole body vibrationBehavioral: Leg exercises

High intensity vibration

EXPERIMENTAL

This group will receive three 45-minute whole body vibration training sessions per week for 10 consecutive weeks.The vibration will be of higher intensity than the low intensity vibration group (frequency: 30 Hertz, amplitude: 1mm).

Device: High intensity whole body vibrationBehavioral: Leg exercises

Interventions

Low intensity whole body vibrationDEVICE
Low intensity vibration
High intensity whole body vibrationDEVICE
High intensity vibration
Leg exercisesBEHAVIORAL
ControlHigh intensity vibrationLow intensity vibration

Eligibility Criteria

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

You may qualify if:

  • diagnosis of a hemispheric stroke
  • chronic stroke (onset of 6 months or more)
  • aged 18 years or older
  • medically stable
  • able to stand for at least 1 minute with hand support
  • Abbreviated Mental Test score at 6 or more
  • Chedoke McMaster Stroke Assessment leg or foot score less than 7 points

You may not qualify if:

  • recurrent stroke
  • brainstem or cerebellar stroke
  • other neurological conditions
  • significant musculoskeletal conditions (e.g. amputations)
  • vestibular disorders
  • peripheral vascular disease
  • other serious illnesses
  • other contraindications to exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Hung Hom, Kowloon, Hong Kong

RECRUITING

Related Publications (1)

  • Lau RW, Yip SP, Pang MY. Whole-body vibration has no effect on neuromotor function and falls in chronic stroke. Med Sci Sports Exerc. 2012 Aug;44(8):1409-18. doi: 10.1249/MSS.0b013e31824e4f8c.

    PMID: 22330025BACKGROUND

MeSH Terms

Conditions

StrokeMotor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Study Officials

  • Marco YC Pang, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco YC Pang, PhD

CONTACT

852-2766-7156Marco.Pang@polyu.edu.hk

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
Associate Professor

Study Record Dates

First Submitted

March 28, 2013

First Posted

April 2, 2013

Study Start

March 1, 2013

Primary Completion

November 1, 2014

Study Completion

May 1, 2015

Last Updated

April 4, 2013

Record last verified: 2013-04

Locations

HK(1)