Effects of Whole Body Vibration in People With Chronic Stroke

Completed

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Whole body vibration therapy Device
    Other Names: Jet-Vibe System (Danil SMC Co., Ltd., Seoul, Korea)
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Whole body vibration
    Description: 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.
  • Exercise on the vibration platform with the device turned off Device
    Other Names: Jet-Vibe System (Danil SMC Co., Ltd., Seoul, Korea)
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Control
    Description: 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.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Paretic knee concentric muscle strength pre-test (week 0) No
Secondary Non-paretic concentric knee muscle strength Pre-test (week 0) No
Secondary Non-paretic knee concentric muscle strength Post-test (week 8) No
Secondary Paretic knee eccentric muscle strength pre-test (week 0) No
Secondary Non-paretic knee eccentric muscle strength Pre-test (week 0) No
Secondary Paretic knee isometric muscle strength Pre-test (week 0) No
Secondary Non-paretic knee isometric muscle strength Pre-test (week 0) No
Secondary Limit of stability test Pre-test (week 0) No
Secondary Berg balance test Pre-test (week 0) No
Secondary Activities-specific Balance Confidence Scale Pre-test (week 0) No
Secondary Six Minute Walk Test Pre-test (week 0) No
Secondary Self-selected gait velocity Pre-test (week 0) No
Secondary Bone formation marker level pre-test (week 0) No
Secondary Bone resorption marker level pre-test (week 0) No
Secondary fall rate 6 months after termination of treatment No
Secondary Knee spasticity Pre-test (week 0) No
Secondary Ankle spasticity Pre-test (week 0) No
Secondary Level of satisfaction Post-test (week 8) No

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