Whole Body Vibration in Chronic Stroke

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by The Hong Kong Polytechnic University
Sponsor:
Information provided by (Responsible Party):
Marco Yiu-Chung Pang, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT01822704
First received: March 28, 2013
Last updated: April 1, 2013
Last verified: April 2013

March 28, 2013
April 1, 2013
March 2013
November 2014   (final data collection date for primary outcome measure)
  • Isometric knee muscle strength [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
  • Isometric knee muscle strength [ Time Frame: week 10 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01822704 on ClinicalTrials.gov Archive Site
  • Eccentric knee muscle strength at a velocity of 60 degrees per second [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
  • Eccentric knee muscle strength at a velocity of 60 degrees per second [ Time Frame: week 10 ] [ Designated as safety issue: No ]
  • Concentric knee muscle strength at a velocity of 60 degrees per second [ Time Frame: week 0 ] [ Designated as safety issue: No ]
  • Concentric knee muscle strength at a velocity of 60 degrees per second [ Time Frame: week 10 ] [ Designated as safety issue: No ]
  • Distance walked in the Six Minute Walk Test [ Time Frame: week 0 ] [ Designated as safety issue: No ]
  • Distance walked in the Six Minute Walk Test [ Time Frame: week 10 ] [ Designated as safety issue: No ]
  • Average oxygen consumption rate during the Six Minute Walk Test [ Time Frame: week 0 ] [ Designated as safety issue: No ]
  • Average oxygen consumption rate during the Six Minute Walk Test [ Time Frame: week 10 ] [ Designated as safety issue: No ]
  • Time taken to complete the Timed Up and Go Test [ Time Frame: week 0 ] [ Designated as safety issue: No ]
  • Time taken to complete the Timed Up and Go Test [ Time Frame: week 10 ] [ Designated as safety issue: No ]
  • Time taken to complete the Five-times-sit-to-stand test [ Time Frame: week 0 ] [ Designated as safety issue: No ]
  • Time taken to complete the Five-times-sit-to-stand test [ Time Frame: week 10 ] [ Designated as safety issue: No ]
  • Distance reached in the Functional Reach test [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
  • Distance reached in the Functional Reach test [ Time Frame: week 10 ] [ Designated as safety issue: No ]
  • Balance score as measured by the Mini-Balance Evaluation Systems Test [ Time Frame: week 0 ] [ Designated as safety issue: No ]
  • Balance score as measured by the Mini-Balance Evaluation Systems Test [ Time Frame: week 10 ] [ Designated as safety issue: No ]
  • Walking ability as measured by the Functional Ambulation Category [ Time Frame: week 0 ] [ Designated as safety issue: No ]
  • Walking ability as measured by the Functional Ambulation Category [ Time Frame: week 10 ] [ Designated as safety issue: No ]
  • Balance confidence scores as measured by the Activities-specific Balance Confidence Scale [ Time Frame: week 0 ] [ Designated as safety issue: No ]
  • Balance confidence scores as measured by the Activities-specific Balance Confidence Scale [ Time Frame: week 10 ] [ Designated as safety issue: No ]
  • Quality of life score as measured by the 12-item Short Form Health Survey [ Time Frame: week 0 ] [ Designated as safety issue: No ]
  • Quality of life score as measured by the 12-item Short Form Health Survey [ Time Frame: week 10 ] [ Designated as safety issue: No ]
  • Level of activity participation as measured by the Frenchay Activities Index [ Time Frame: week 0 ] [ Designated as safety issue: No ]
  • Level of activity participation as measured by the Frenchay Activities Index [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
  • Level of perceived environmental barriers as measured by the Craig Hospital Inventory of Environmental Factors [ Time Frame: week 0 ] [ Designated as safety issue: No ]
  • Level of perceived environmental barriers as measured by the Craig Hospital Inventory of Environmental Factors [ Time Frame: week 10 ] [ Designated as safety issue: No ]
  • Ankle spasticity score as measured by the Modified Ashworth Scale [ Time Frame: week 0 ] [ Designated as safety issue: No ]
  • Ankle spasticity score as measured by the Modified Ashworth Scale [ Time Frame: week 10 ] [ Designated as safety issue: No ]
  • Eccentric knee muscle strength [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
  • Eccentric knee muscle strength [ Time Frame: week 10 ] [ Designated as safety issue: No ]
  • Concentric knee muscle strength [ Time Frame: week 0 ] [ Designated as safety issue: No ]
  • Concentric knee muscle strength [ Time Frame: week 10 ] [ Designated as safety issue: No ]
  • Six Minute Walk Test distance [ Time Frame: week 0 ] [ Designated as safety issue: No ]
  • Six Minute Walk Test distance [ Time Frame: week 10 ] [ Designated as safety issue: No ]
  • Oxygen consumption during Six Minute Walk Test [ Time Frame: week 0 ] [ Designated as safety issue: No ]
  • Oxygen consumption during Six Minute Walk Test [ Time Frame: week 10 ] [ Designated as safety issue: No ]
  • Timed Up and Go Test [ Time Frame: week 0 ] [ Designated as safety issue: No ]
  • Timed Up and Go Test [ Time Frame: week 10 ] [ Designated as safety issue: No ]
  • Five-times-sit-to-stand test [ Time Frame: week 0 ] [ Designated as safety issue: No ]
  • Five-times-sit-to-stand test [ Time Frame: week 10 ] [ Designated as safety issue: No ]
  • Functional Reach [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
  • Functional Reach [ Time Frame: week 10 ] [ Designated as safety issue: No ]
  • Mini-Balance Evaluation Systems Test [ Time Frame: week 0 ] [ Designated as safety issue: No ]
  • Mini-Balance Evaluation Systems Test [ Time Frame: week 10 ] [ Designated as safety issue: No ]
  • Functional Ambulation Category [ Time Frame: week 0 ] [ Designated as safety issue: No ]
  • Functional Ambulation Category [ Time Frame: week 10 ] [ Designated as safety issue: No ]
  • Activities-specific Balance Confidence Scale [ Time Frame: week 0 ] [ Designated as safety issue: No ]
  • Activities-specific Balance Confidence Scale [ Time Frame: week 10 ] [ Designated as safety issue: No ]
  • 12-item Short Form Health Survey [ Time Frame: week 0 ] [ Designated as safety issue: No ]
  • 12-item Short Form Health Survey [ Time Frame: week 10 ] [ Designated as safety issue: No ]
  • Frenchay Activities Index [ Time Frame: week 0 ] [ Designated as safety issue: No ]
  • Frenchay Activities Index [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
  • Craig Hospital Inventory of Environmental Factors [ Time Frame: week 0 ] [ Designated as safety issue: No ]
  • Craig Hospital Inventory of Environmental Factors [ Time Frame: week 10 ] [ Designated as safety issue: No ]
  • Modified Ashworth Scale [ Time Frame: week 0 ] [ Designated as safety issue: No ]
  • Modified Ashworth Scale [ Time Frame: week 10 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Stroke
  • Device: Low intensity whole body vibration
  • Device: High intensity whole body vibration
  • Behavioral: Leg exercises
  • Active Comparator: Control
    This group will undergo three 45-minute exercise sessions per week for 10 weeks. No whole body vibration will be given.
    Intervention: 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).
    Interventions:
    • Device: Low intensity whole body vibration
    • Behavioral: Leg exercises
  • 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).
    Interventions:
    • Device: High intensity whole body vibration
    • Behavioral: Leg exercises
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
81
May 2015
November 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Marco YC Pang, PhD 852-2766-7156 Marco.Pang@polyu.edu.hk
Hong Kong
 
NCT01822704
HSEARS20130209001
Yes
Marco Yiu-Chung Pang, The Hong Kong Polytechnic University
The Hong Kong Polytechnic University
Not Provided
Principal Investigator: Marco YC Pang, PhD The Hong Kong Polytechnic University
The Hong Kong Polytechnic University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP