NCT00937339

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Jul 2009

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 13, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

April 4, 2013

Status Verified

April 1, 2013

Enrollment Period

1.4 years

First QC Date

July 10, 2009

Last Update Submit

April 1, 2013

Conditions

Keywords

cerebrovascular accidentbonemusclevibration

Outcome Measures

Primary Outcomes (3)

  • Paretic knee concentric muscle strength

    pre-test (week 0)

  • Paretic knee concentric muscle strength

    Post-test (week 8)

  • Paretic knee concentric muscle strength

    Follow-up (week 12)

Secondary Outcomes (44)

  • Non-paretic concentric knee muscle strength

    Pre-test (week 0)

  • Non-paretic knee concentric muscle strength

    Post-test (week 8)

  • Non-paretic knee concentric muscle strength

    Follow-up (week 12)

  • Paretic knee eccentric muscle strength

    pre-test (week 0)

  • Paretic knee eccentric muscle strength

    Post-test (week 8)

  • +39 more secondary outcomes

Study Arms (2)

Control

ACTIVE COMPARATOR

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.

Device: Exercise on the vibration platform with the device turned off

Whole body vibration

EXPERIMENTAL

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.

Device: Whole body vibration therapy

Interventions

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.

Also known as: Jet-Vibe System (Danil SMC Co., Ltd., Seoul, Korea)
Whole body vibration

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.

Also known as: Jet-Vibe System (Danil SMC Co., Ltd., Seoul, Korea)
Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hong Kong Polytechnic University

Hong Kong, China

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Marco YC Pang, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 10, 2009

First Posted

July 13, 2009

Study Start

July 1, 2009

Primary Completion

December 1, 2010

Study Completion

July 1, 2011

Last Updated

April 4, 2013

Record last verified: 2013-04

Locations