Effects of Whole Body Vibration in People With Chronic Stroke

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marco Yiu-Chung Pang, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT00937339
First received: July 10, 2009
Last updated: April 1, 2013
Last verified: April 2013

July 10, 2009
April 1, 2013
July 2009
December 2010   (final data collection date for primary outcome measure)
  • Paretic knee concentric muscle strength [ Time Frame: pre-test (week 0) ] [ Designated as safety issue: No ]
  • Paretic knee concentric muscle strength [ Time Frame: Post-test (week 8) ] [ Designated as safety issue: No ]
  • Paretic knee concentric muscle strength [ Time Frame: Follow-up (week 12) ] [ Designated as safety issue: No ]
  • leg muscle strength [ Time Frame: week 0, 4, 8, 12 ] [ Designated as safety issue: No ]
  • Balance ability [ Time Frame: week 0, 4, 8, 12 ] [ Designated as safety issue: No ]
  • leg spasticity [ Time Frame: week 0, 4, 8, 12 ] [ Designated as safety issue: No ]
  • serum bone formation marker level [ Time Frame: week 0, 4,8,12 ] [ Designated as safety issue: No ]
  • serum bone resorption marker level [ Time Frame: week 0, 4, 8, 12 ] [ Designated as safety issue: No ]
  • 6 minute walk test [ Time Frame: week 0, 4, 8, 12 ] [ Designated as safety issue: No ]
  • leg motor recovery [ Time Frame: week 0, 4, 8, 12 ] [ Designated as safety issue: No ]
  • ankle arm index [ Time Frame: week 0, 4, 8, 12 ] [ Designated as safety issue: No ]
  • leg sensation to light touch [ Time Frame: week 0, 4, 8, 12 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00937339 on ClinicalTrials.gov Archive Site
  • Non-paretic concentric knee muscle strength [ Time Frame: Pre-test (week 0) ] [ Designated as safety issue: No ]
  • Non-paretic knee concentric muscle strength [ Time Frame: Post-test (week 8) ] [ Designated as safety issue: No ]
  • Non-paretic knee concentric muscle strength [ Time Frame: Follow-up (week 12) ] [ Designated as safety issue: No ]
  • Paretic knee eccentric muscle strength [ Time Frame: pre-test (week 0) ] [ Designated as safety issue: No ]
  • Paretic knee eccentric muscle strength [ Time Frame: Post-test (week 8) ] [ Designated as safety issue: No ]
  • Paretic knee eccentric muscle strength [ Time Frame: WFollow-up (week 12) ] [ Designated as safety issue: No ]
  • Non-paretic knee eccentric muscle strength [ Time Frame: Pre-test (week 0) ] [ Designated as safety issue: No ]
  • Non-paretic knee eccentric muscle strength [ Time Frame: Post-test (week 8) ] [ Designated as safety issue: No ]
  • Non-paretic knee eccentric muscle strength [ Time Frame: Follow-up (week 12) ] [ Designated as safety issue: No ]
  • Paretic knee isometric muscle strength [ Time Frame: Pre-test (week 0) ] [ Designated as safety issue: No ]
  • Paretic knee isometric muscle strength [ Time Frame: Post-test (week 8) ] [ Designated as safety issue: No ]
  • Paretic knee isometric muscle strength [ Time Frame: Follow-up (week 12) ] [ Designated as safety issue: No ]
  • Non-paretic knee isometric muscle strength [ Time Frame: Pre-test (week 0) ] [ Designated as safety issue: No ]
  • Non-paretic knee isometric muscle strength [ Time Frame: Post-test (week 8) ] [ Designated as safety issue: No ]
  • Non-paretic knee isometric muscle strength [ Time Frame: Follow-up (week 12) ] [ Designated as safety issue: No ]
  • Limit of stability test [ Time Frame: Pre-test (week 0) ] [ Designated as safety issue: No ]
  • Limit of stability test [ Time Frame: Post-test (week 8) ] [ Designated as safety issue: No ]
  • Limit of stability test [ Time Frame: Follow-up (week 12) ] [ Designated as safety issue: No ]
  • Berg balance test [ Time Frame: Pre-test (week 0) ] [ Designated as safety issue: No ]
  • Berg balance test [ Time Frame: Post-test (week 12) ] [ Designated as safety issue: No ]
  • Berg balance test [ Time Frame: Follow-up (week 12) ] [ Designated as safety issue: No ]
  • Activities-specific Balance Confidence Scale [ Time Frame: Pre-test (week 0) ] [ Designated as safety issue: No ]
  • Activities-specific Balance Confidence Scale [ Time Frame: Post-test (week 8) ] [ Designated as safety issue: No ]
  • Activities-specific Balance Confidence Scale [ Time Frame: Follow-up (week 12) ] [ Designated as safety issue: No ]
  • Six Minute Walk Test [ Time Frame: Pre-test (week 0) ] [ Designated as safety issue: No ]
  • Six Minute Walk Test [ Time Frame: Post-test (week 8) ] [ Designated as safety issue: No ]
  • Six Minute Walk Test [ Time Frame: Follow-up (week 12) ] [ Designated as safety issue: No ]
  • Self-selected gait velocity [ Time Frame: Pre-test (week 0) ] [ Designated as safety issue: No ]
  • Self-selected gait velocity [ Time Frame: post-test (week 8) ] [ Designated as safety issue: No ]
  • Self-selected gait velocity [ Time Frame: Follow-up (week 12) ] [ Designated as safety issue: No ]
  • Bone formation marker level [ Time Frame: pre-test (week 0) ] [ Designated as safety issue: No ]
  • Bone formation marker level [ Time Frame: Post-test (week 8) ] [ Designated as safety issue: No ]
  • Bone resorption marker level [ Time Frame: pre-test (week 0) ] [ Designated as safety issue: No ]
  • Bone formation marker level [ Time Frame: Follow-up (week 12) ] [ Designated as safety issue: No ]
  • Bone resorption marker level [ Time Frame: post-test (week 8) ] [ Designated as safety issue: No ]
  • Bone resorption marker level [ Time Frame: Follow-up (week 12) ] [ Designated as safety issue: No ]
  • fall rate [ Time Frame: 6 months after termination of treatment ] [ Designated as safety issue: No ]
  • Knee spasticity [ Time Frame: Pre-test (week 0) ] [ Designated as safety issue: No ]
  • Knee spasticity [ Time Frame: Post-test (week 8) ] [ Designated as safety issue: No ]
  • Knee spasticity [ Time Frame: Follow-up (week 12) ] [ Designated as safety issue: No ]
  • Ankle spasticity [ Time Frame: Pre-test (week 0) ] [ Designated as safety issue: No ]
  • Ankle spasticity [ Time Frame: Post-test (week 8) ] [ Designated as safety issue: No ]
  • Ankle spasticity [ Time Frame: Follow-up (week 12) ] [ Designated as safety issue: No ]
  • Level of satisfaction [ Time Frame: Post-test (week 8) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Effects of Whole Body Vibration in People With Chronic Stroke
The Effects of Exercise and Whole Body Vibration Training on Bone Health, Physical Fitness, and Neuromotor Performance in Individuals With Chronic Stroke: A Randomized Controlled Trial.

The overall aim of the proposed study is to determine whether whole body vibration is beneficial in promoting bone health, physical fitness and neuromotor performance in patients with chronic stroke.

Subjects in the experimental group will undergo whole body vibration therapy (1 session per day, 3 sessions per week) for 8 weeks. The vibration frequency used in this study will be 30Hz. The total duration of exposure to vibration for the experimental group will be 10 minutes. While standing on the vibration platform, patients will be instructed to repeat the following set of light exercises: (1) light squatting,(2) deep squatting, (3) side-to-side weight-shift, (4) Forward and backward weight-shift, (5) forward lunge, (6) marching on the spot. The control exercise group, on the other hand, will perform the same exercise program on the platform, but no vibration will be given. The training will be conducted by a qualified personnel with physiotherapy background.

The outcome measurement will be performed 4 times: (1) immediately before the commencement of intervention, (2) immediately after termination of treatment, (3) at 1 month after termination of treatment. Each subject will be evaluated for bone markers, leg muscle strength, balance, spasticity, and walking ability.

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: Whole body vibration therapy
    Experimental group: One session per day, 3 sessions per week, for consecutive 8 weeks. The total duration of whole body vibration therapy will be about 10 minutes per session.
    Other Name: Jet-Vibe System (Danil SMC Co., Ltd., Seoul, Korea)
  • Device: Exercise on the vibration platform with the device turned off
    Control group: One session per day, 3 sessions per week, for consecutive 8 weeks. The subjects will perform the same exercises on the vibration platform but no vibration will be applied.
    Other Name: Jet-Vibe System (Danil SMC Co., Ltd., Seoul, Korea)
  • Active Comparator: Control
    The control group will perform the same exercises on the vibration platform, as in the experimental group. However, the vibration device will be turned off during the exercises.
    Intervention: Device: Exercise on the vibration platform with the device turned off
  • Experimental: Whole body vibration
    Subjects in the experimental group will undergo whole body vibration (1 session per day, 3 sessions per week) for 8 weeks. The vibration loading will be carried out using the Jet-Vibe System (Danil SMC Co., Ltd., Seoul, Korea). The vibration protocol used in this study will be 30Hz. While standing on the vibration platform, patients will be instructed to repeat the following set of light exercises: (1) light squatting,(2)deep squatting , (3) side-to-side weight-shift, (4) Forward and backward weight-shift, (5) forward lunge, (6) marching on the spot. The total duration of exposure of whole body vibration per session will be about 10 minutes.
    Intervention: Device: Whole body vibration therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
82
July 2011
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • a diagnosis of stroke more than 6 months
  • medically stable
  • able to understand verbal commands
  • Abbreviated mental test score 6 or above
  • age >18
  • able to stand with or without aids for at least 1.5 minutes

Exclusion Criteria:

  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00937339
HSEARS20090520002-01
Yes
Marco Yiu-Chung Pang, The Hong Kong Polytechnic University
The Hong Kong Polytechnic University
Not Provided
Principal Investigator: Marco YC Pang, PhD 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