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Whole Body Vibration in Chronic Stroke

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Low intensity whole body vibration
High intensity whole body vibration
Leg exercises
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Exercise, Rehabilitation, Vibration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • The Hong Kong Polytechnic UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Control

Low intensity vibration

High intensity vibration

Arm Description

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

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).

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).

Outcomes

Primary Outcome Measures

Isometric knee muscle strength
Isometric knee muscle strength

Secondary Outcome Measures

Eccentric knee muscle strength at a velocity of 60 degrees per second
Eccentric knee muscle strength at a velocity of 60 degrees per second
Concentric knee muscle strength at a velocity of 60 degrees per second
Concentric knee muscle strength at a velocity of 60 degrees per second
Distance walked in the Six Minute Walk Test
Distance walked in the Six Minute Walk Test
Average oxygen consumption rate during the Six Minute Walk Test
Average oxygen consumption rate during the Six Minute Walk Test
Time taken to complete the Timed Up and Go Test
Time taken to complete the Timed Up and Go Test
Time taken to complete the Five-times-sit-to-stand test
Time taken to complete the Five-times-sit-to-stand test
Distance reached in the Functional Reach test
Distance reached in the Functional Reach test
Balance score as measured by the Mini-Balance Evaluation Systems Test
Balance score as measured by the Mini-Balance Evaluation Systems Test
Walking ability as measured by the Functional Ambulation Category
Walking ability as measured by the Functional Ambulation Category
Balance confidence scores as measured by the Activities-specific Balance Confidence Scale
Balance confidence scores as measured by the Activities-specific Balance Confidence Scale
Quality of life score as measured by the 12-item Short Form Health Survey
Quality of life score as measured by the 12-item Short Form Health Survey
Level of activity participation as measured by the Frenchay Activities Index
Level of activity participation as measured by the Frenchay Activities Index
Level of perceived environmental barriers as measured by the Craig Hospital Inventory of Environmental Factors
Level of perceived environmental barriers as measured by the Craig Hospital Inventory of Environmental Factors
Ankle spasticity score as measured by the Modified Ashworth Scale
Ankle spasticity score as measured by the Modified Ashworth Scale

Full Information

First Posted
March 28, 2013
Last Updated
April 1, 2013
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT01822704
Brief Title
Whole Body Vibration in Chronic Stroke
Official Title
Application of Vertical Whole Body Vibration in Stroke Patients: Neuromuscular Effects, and Clinical Efficacy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
November 2014 (Anticipated)
Study Completion Date
May 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Exercise, Rehabilitation, Vibration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
81 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
This group will undergo three 45-minute exercise sessions per week for 10 weeks. No whole body vibration will be given.
Arm Title
Low intensity vibration
Arm Type
Experimental
Arm Description
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).
Arm Title
High intensity vibration
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Low intensity whole body vibration
Intervention Type
Device
Intervention Name(s)
High intensity whole body vibration
Intervention Type
Behavioral
Intervention Name(s)
Leg exercises
Primary Outcome Measure Information:
Title
Isometric knee muscle strength
Time Frame
Week 0
Title
Isometric knee muscle strength
Time Frame
week 10
Secondary Outcome Measure Information:
Title
Eccentric knee muscle strength at a velocity of 60 degrees per second
Time Frame
Week 0
Title
Eccentric knee muscle strength at a velocity of 60 degrees per second
Time Frame
week 10
Title
Concentric knee muscle strength at a velocity of 60 degrees per second
Time Frame
week 0
Title
Concentric knee muscle strength at a velocity of 60 degrees per second
Time Frame
week 10
Title
Distance walked in the Six Minute Walk Test
Time Frame
week 0
Title
Distance walked in the Six Minute Walk Test
Time Frame
week 10
Title
Average oxygen consumption rate during the Six Minute Walk Test
Time Frame
week 0
Title
Average oxygen consumption rate during the Six Minute Walk Test
Time Frame
week 10
Title
Time taken to complete the Timed Up and Go Test
Time Frame
week 0
Title
Time taken to complete the Timed Up and Go Test
Time Frame
week 10
Title
Time taken to complete the Five-times-sit-to-stand test
Time Frame
week 0
Title
Time taken to complete the Five-times-sit-to-stand test
Time Frame
week 10
Title
Distance reached in the Functional Reach test
Time Frame
Week 0
Title
Distance reached in the Functional Reach test
Time Frame
week 10
Title
Balance score as measured by the Mini-Balance Evaluation Systems Test
Time Frame
week 0
Title
Balance score as measured by the Mini-Balance Evaluation Systems Test
Time Frame
week 10
Title
Walking ability as measured by the Functional Ambulation Category
Time Frame
week 0
Title
Walking ability as measured by the Functional Ambulation Category
Time Frame
week 10
Title
Balance confidence scores as measured by the Activities-specific Balance Confidence Scale
Time Frame
week 0
Title
Balance confidence scores as measured by the Activities-specific Balance Confidence Scale
Time Frame
week 10
Title
Quality of life score as measured by the 12-item Short Form Health Survey
Time Frame
week 0
Title
Quality of life score as measured by the 12-item Short Form Health Survey
Time Frame
week 10
Title
Level of activity participation as measured by the Frenchay Activities Index
Time Frame
week 0
Title
Level of activity participation as measured by the Frenchay Activities Index
Time Frame
Week 10
Title
Level of perceived environmental barriers as measured by the Craig Hospital Inventory of Environmental Factors
Time Frame
week 0
Title
Level of perceived environmental barriers as measured by the Craig Hospital Inventory of Environmental Factors
Time Frame
week 10
Title
Ankle spasticity score as measured by the Modified Ashworth Scale
Time Frame
week 0
Title
Ankle spasticity score as measured by the Modified Ashworth Scale
Time Frame
week 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marco YC Pang, PhD
Phone
852-2766-7156
Email
Marco.Pang@polyu.edu.hk
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
Hung Hom
State/Province
Kowloon
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alan Liao, MPT
Phone
852-2766-4845
Email
lr-liao@126.com
First Name & Middle Initial & Last Name & Degree
Marco Y Pang, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
22330025
Citation
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.
Results Reference
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Whole Body Vibration in Chronic Stroke

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