Effects of Whole Body Vibration in People With Chronic Stroke

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: Exercise on the vibration platform with the device turned off; Device: Whole body vibration therapy

• Registration Number: NCT00937339
• Lead Sponsor: The Hong Kong Polytechnic University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-10
• Study First Submitted QC: 2009-07-10
• Study First Posted: 2009-07-13
• Primary Completion: 2010-12
• Study Completion: 2011-07
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-01
• Last Update Posted: 2013-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Exercise on the vibration platform with the device turned off	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.
Whole body vibration	Whole body vibration therapy	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.

Primary Outcome Measures

Name	Time	Method
Paretic knee concentric muscle strength	Follow-up (week 12)

Secondary Outcome Measures

Name	Time	Method
Limit of stability test	Follow-up (week 12)
Non-paretic concentric knee muscle strength	Pre-test (week 0)
Non-paretic knee concentric muscle strength	Follow-up (week 12)
Paretic knee eccentric muscle strength	WFollow-up (week 12)
Berg balance test	Follow-up (week 12)
Activities-specific Balance Confidence Scale	Follow-up (week 12)
Six Minute Walk Test	Follow-up (week 12)
Non-paretic knee eccentric muscle strength	Follow-up (week 12)
Paretic knee isometric muscle strength	Follow-up (week 12)
Non-paretic knee isometric muscle strength	Follow-up (week 12)
Self-selected gait velocity	Follow-up (week 12)
Bone formation marker level	Follow-up (week 12)
Bone resorption marker level	Follow-up (week 12)
fall rate	6 months after termination of treatment
Knee spasticity	Follow-up (week 12)
Ankle spasticity	Follow-up (week 12)
Level of satisfaction	Post-test (week 8)

Trial Locations

Locations (1)

Hong Kong Polytechnic University; 🇨🇳 Hong Kong, China