Whole Body Vibration in Chronic Stroke

Application of Vertical Whole Body Vibration in Stroke Patients: Neuromuscular Effects, and Clinical Efficacy

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.

Study Overview

• Status: Unknown
• Conditions: Stroke
• Intervention / Treatment: Behavioral: Leg exercises; Device: Low intensity whole body vibration; Device: High intensity whole body vibration

• Study Type: Interventional
• Enrollment (Anticipated): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Kowloon
    • Hung Hom, Kowloon, Hong Kong
      • Recruiting
      • The Hong Kong Polytechnic University
      • Contact: Alan Liao, MPT; Phone Number: 852-2766-4845; Email: lr-liao@126.com
      • Principal Investigator: Marco Y Pang, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; This group will undergo three 45-minute exercise sessions per week for 10 weeks. No whole body vibration will be given.	Behavioral: Leg exercises
Experimental: Low intensity vibration; 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).	Behavioral: Leg exercises; Device: Low intensity whole body vibration
Experimental: High intensity vibration; 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).	Behavioral: Leg exercises; Device: High intensity whole body vibration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Isometric knee muscle strength	Week 0
Isometric knee muscle strength	week 10

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Distance walked in the Six Minute Walk Test	week 10
Average oxygen consumption rate during the Six Minute Walk Test	week 0
Average oxygen consumption rate during the Six Minute Walk Test	week 10
Time taken to complete the Timed Up and Go Test	week 0
Time taken to complete the Timed Up and Go Test	week 10
Time taken to complete the Five-times-sit-to-stand test	week 0
Time taken to complete the Five-times-sit-to-stand test	week 10
Distance reached in the Functional Reach test	Week 0
Distance reached in the Functional Reach test	week 10
Balance score as measured by the Mini-Balance Evaluation Systems Test	week 0
Balance score as measured by the Mini-Balance Evaluation Systems Test	week 10
Walking ability as measured by the Functional Ambulation Category	week 0
Walking ability as measured by the Functional Ambulation Category	week 10
Balance confidence scores as measured by the Activities-specific Balance Confidence Scale	week 0
Balance confidence scores as measured by the Activities-specific Balance Confidence Scale	week 10
Quality of life score as measured by the 12-item Short Form Health Survey	week 0
Quality of life score as measured by the 12-item Short Form Health Survey	week 10
Level of activity participation as measured by the Frenchay Activities Index	week 0
Level of activity participation as measured by the Frenchay Activities Index	Week 10
Level of perceived environmental barriers as measured by the Craig Hospital Inventory of Environmental Factors	week 0
Level of perceived environmental barriers as measured by the Craig Hospital Inventory of Environmental Factors	week 10
Ankle spasticity score as measured by the Modified Ashworth Scale	week 0
Ankle spasticity score as measured by the Modified Ashworth Scale	week 10

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Investigators: Principal Investigator: Marco YC Pang, PhD, The Hong Kong Polytechnic University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Anticipated): November 1, 2014
• Study Completion (Anticipated): May 1, 2015

Study Registration Dates

• First Submitted: March 28, 2013
• First Submitted That Met QC Criteria: March 28, 2013
• First Posted (Estimate): April 2, 2013

Study Record Updates

• Last Update Posted (Estimate): April 4, 2013
• Last Update Submitted That Met QC Criteria: April 1, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Rehabilitation; Exercise; Stroke; Vibration
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: HSEARS20130209001