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Effects of Whole Body Vibration in People With Chronic Stroke
This study has been completed.

First Received on July 10, 2009.   Last Updated on August 16, 2011   History of Changes
Sponsor: The Hong Kong Polytechnic University
Information provided by: The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT00937339
  Purpose

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.


Condition Intervention
Stroke
 Device: Whole body vibration therapy
Device: Exercise on the vibration platform with the device turned off

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness
U.S. FDA Resources

Further study details as provided by The Hong Kong Polytechnic University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 82
Study Start Date: July 2009
Study Completion Date: July 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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)
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.
 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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00937339

Locations
China
Hong Kong Polytechnic University
Hong Kong, China
Sponsors and Collaborators
The Hong Kong Polytechnic University
Investigators
Principal Investigator: Marco YC Pang, PhD Hong Kong Polytechnic University
  More Information

No publications provided

Responsible Party: Marco Y.C. Pang, Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT00937339     History of Changes
Other Study ID Numbers: HSEARS20090520002-01
Study First Received: July 10, 2009
Last Updated: August 16, 2011
Health Authority: Hong Kong: Hong Kong Polytechnic University Research Committee

Keywords provided by The Hong Kong Polytechnic University:
cerebrovascular accident
bone
muscle
vibration

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on February 09, 2012



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