Clinical trial NCT00937339: Effects of Whole Body Vibration in People With Chronic Stroke
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: cerebrovascular accident
bone
muscle
vibration
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2009-07-13
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Paretic knee concentric muscle strength
timeFrame: pre-test (week 0)
measure: Paretic knee concentric muscle strength
timeFrame: Post-test (week 8)
measure: Paretic knee concentric muscle strength
timeFrame: Follow-up (week 12)
Secondary outcomes:
measure: Non-paretic concentric knee muscle strength
timeFrame: Pre-test (week 0)
measure: Non-paretic knee concentric muscle strength
timeFrame: Post-test (week 8)
measure: Non-paretic knee concentric muscle strength
timeFrame: Follow-up (week 12)
measure: Paretic knee eccentric muscle strength
timeFrame: pre-test (week 0)
measure: Paretic knee eccentric muscle strength
timeFrame: Post-test (week 8)
measure: Paretic knee eccentric muscle strength
timeFrame: WFollow-up (week 12)
measure: Non-paretic knee eccentric muscle strength
timeFrame: Pre-test (week 0)
measure: Non-paretic knee eccentric muscle strength
timeFrame: Post-test (week 8)
measure: Non-paretic knee eccentric muscle strength
timeFrame: Follow-up (week 12)
measure: Paretic knee isometric muscle strength
timeFrame: Pre-test (week 0)
measure: Paretic knee isometric muscle strength
timeFrame: Post-test (week 8)
measure: Paretic knee isometric muscle strength
timeFrame: Follow-up (week 12)
measure: Non-paretic knee isometric muscle strength
timeFrame: Pre-test (week 0)
measure: Non-paretic knee isometric muscle strength
timeFrame: Post-test (week 8)
measure: Non-paretic knee isometric muscle strength
timeFrame: Follow-up (week 12)
measure: Limit of stability test
timeFrame: Pre-test (week 0)
measure: Limit of stability test
timeFrame: Post-test (week 8)
measure: Limit of stability test
timeFrame: Follow-up (week 12)
measure: Berg balance test
timeFrame: Pre-test (week 0)
measure: Berg balance test
timeFrame: Post-test (week 12)
measure: Berg balance test
timeFrame: Follow-up (week 12)
measure: Activities-specific Balance Confidence Scale
timeFrame: Pre-test (week 0)
measure: Activities-specific Balance Confidence Scale
timeFrame: Post-test (week 8)
measure: Activities-specific Balance Confidence Scale
timeFrame: Follow-up (week 12)
measure: Six Minute Walk Test
timeFrame: Pre-test (week 0)
measure: Six Minute Walk Test
timeFrame: Post-test (week 8)
measure: Six Minute Walk Test
timeFrame: Follow-up (week 12)
measure: Self-selected gait velocity
timeFrame: Pre-test (week 0)
measure: Self-selected gait velocity
timeFrame: post-test (week 8)
measure: Self-selected gait velocity
timeFrame: Follow-up (week 12)
measure: Bone formation marker level
timeFrame: pre-test (week 0)
measure: Bone formation marker level
timeFrame: Post-test (week 8)
measure: Bone resorption marker level
timeFrame: pre-test (week 0)
measure: Bone formation marker level
timeFrame: Follow-up (week 12)
measure: Bone resorption marker level
timeFrame: post-test (week 8)
measure: Bone resorption marker level
timeFrame: Follow-up (week 12)
measure: fall rate
timeFrame: 6 months after termination of treatment
measure: Knee spasticity
timeFrame: Pre-test (week 0)
measure: Knee spasticity
timeFrame: Post-test (week 8)
measure: Knee spasticity
timeFrame: Follow-up (week 12)
measure: Ankle spasticity
timeFrame: Pre-test (week 0)
measure: Ankle spasticity
timeFrame: Post-test (week 8)
measure: Ankle spasticity
timeFrame: Follow-up (week 12)
measure: Level of satisfaction
timeFrame: Post-test (week 8)
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Hong Kong Polytechnic University
Study officials:
affiliation: Hong Kong Polytechnic University
name: Marco YC Pang, PhD
role: PRINCIPAL_INVESTIGATOR
References: