Effects of Whole Body Vibration in People With Chronic Stroke

NCT ID: NCT00937339

Last Updated: 2013-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2011-07-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Exercise on the vibration platform with the device turned off

Intervention Type: DEVICE

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.

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.

Group Type: EXPERIMENTAL

Whole body vibration therapy

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Jet-Vibe System (Danil SMC Co., Ltd., Seoul, Korea); Jet-Vibe System (Danil SMC Co., Ltd., Seoul, Korea)

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Marco Yiu-Chung Pang

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marco YC Pang, PhD

Role: PRINCIPAL_INVESTIGATOR

Hong Kong Polytechnic University

Locations

Hong Kong Polytechnic University

Hong Kong, , China

Countries

China

Other Identifiers

HSEARS20090520002-01

Identifier Type: -

Identifier Source: org_study_id