Effects of Whole Body Vibration in People With Chronic Stroke

Stroke Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00937339
• Other study ID #: HSEARS20090520002-01
• Status: Completed
• Phase: N/A
• First received: July 10, 2009
• Last updated: April 1, 2013
• Start date: July 2009
• Est. completion date: July 2011

Study information

• Verified date: April 2013
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Hong Kong Polytechnic University Research Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: July 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Hong Kong Polytechnic University	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Paretic knee concentric muscle strength		pre-test (week 0)	No
Primary	Paretic knee concentric muscle strength		Post-test (week 8)	No
Primary	Paretic knee concentric muscle strength		Follow-up (week 12)	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	Non-paretic knee concentric muscle strength		Follow-up (week 12)	No
Secondary	Paretic knee eccentric muscle strength		pre-test (week 0)	No
Secondary	Paretic knee eccentric muscle strength		Post-test (week 8)	No
Secondary	Paretic knee eccentric muscle strength		WFollow-up (week 12)	No
Secondary	Non-paretic knee eccentric muscle strength		Pre-test (week 0)	No
Secondary	Non-paretic knee eccentric muscle strength		Post-test (week 8)	No
Secondary	Non-paretic knee eccentric muscle strength		Follow-up (week 12)	No
Secondary	Paretic knee isometric muscle strength		Pre-test (week 0)	No
Secondary	Paretic knee isometric muscle strength		Post-test (week 8)	No
Secondary	Paretic knee isometric muscle strength		Follow-up (week 12)	No
Secondary	Non-paretic knee isometric muscle strength		Pre-test (week 0)	No
Secondary	Non-paretic knee isometric muscle strength		Post-test (week 8)	No
Secondary	Non-paretic knee isometric muscle strength		Follow-up (week 12)	No
Secondary	Limit of stability test		Pre-test (week 0)	No
Secondary	Limit of stability test		Post-test (week 8)	No
Secondary	Limit of stability test		Follow-up (week 12)	No
Secondary	Berg balance test		Pre-test (week 0)	No
Secondary	Berg balance test		Post-test (week 12)	No
Secondary	Berg balance test		Follow-up (week 12)	No
Secondary	Activities-specific Balance Confidence Scale		Pre-test (week 0)	No
Secondary	Activities-specific Balance Confidence Scale		Post-test (week 8)	No
Secondary	Activities-specific Balance Confidence Scale		Follow-up (week 12)	No
Secondary	Six Minute Walk Test		Pre-test (week 0)	No
Secondary	Six Minute Walk Test		Post-test (week 8)	No
Secondary	Six Minute Walk Test		Follow-up (week 12)	No
Secondary	Self-selected gait velocity		Pre-test (week 0)	No
Secondary	Self-selected gait velocity		post-test (week 8)	No
Secondary	Self-selected gait velocity		Follow-up (week 12)	No
Secondary	Bone formation marker level		pre-test (week 0)	No
Secondary	Bone formation marker level		Post-test (week 8)	No
Secondary	Bone resorption marker level		pre-test (week 0)	No
Secondary	Bone formation marker level		Follow-up (week 12)	No
Secondary	Bone resorption marker level		post-test (week 8)	No
Secondary	Bone resorption marker level		Follow-up (week 12)	No
Secondary	fall rate		6 months after termination of treatment	No
Secondary	Knee spasticity		Pre-test (week 0)	No
Secondary	Knee spasticity		Post-test (week 8)	No
Secondary	Knee spasticity		Follow-up (week 12)	No
Secondary	Ankle spasticity		Pre-test (week 0)	No
Secondary	Ankle spasticity		Post-test (week 8)	No
Secondary	Ankle spasticity		Follow-up (week 12)	No
Secondary	Level of satisfaction		Post-test (week 8)	No