CClinicalTrials.gg
CompletedNCT03375346Updated Dec 20, 2017

Effects of Whole-body Vibration Exercise on Stroke Patients

An interventional study of Whole body vibration and Exercise in Stroke and Hemiplegia, sponsored by Samsung Medical Center. Completed. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-12-20.

Sponsored by Samsung Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
29
Allocation
Randomized
Ages
19 Years to 80 Years
Sex
All
01

Study summary

The purpose of this study is to investigate the effect of the whole body vibration exercise on cortical activity and gait function in patients with chronic stroke.

Read the detailed description

Whole body vibration exercise can provide proper somatosensory stimulation and improve muscle strength and postural control in stroke patients. However, there has not yet been a report on the cortical activity changes induced by whole body vibration exercise.

Patients will be randomly assigned to one of the two groups. One group will go through whole body vibration with exercise and the other will only perform exercise. The primary outcome measurement of this study was cerebral cortex activity based on changes in oxygenated hemoglobin concentration using functional near-infrared spectroscopy. Behavioral assessments were performed before and after the intervention session using the 10-meter walk test, timed up and go test, Fugl-Meyer Assessment, and Tinetti Performance Oriented Mobility Assessment.

02

Conditions studied

  • Stroke
  • Hemiplegia

Keywords

  • Whole body vibration exercise
03

Who can participate

Ages eligible
19 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Unilateral stroke with hemiplegia
  • 3 months after stroke onset
  • Able to walk at least 10 meters without assistive devices

Exclusion criteria

Exclusion Criteria:

  • Subjects under 18 years and above 80 years old,
  • Unable to perform a half squat on a vibrator (eg. visual field defects, fracture, and severe muscle paralysis)
  • Musculoskeletal disorders
  • Risk of falling due to dizziness
  • Pregnant women
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
29 participants (actual)

Study arms

  • Experimental
    Whole body vibration group

    Whole body vibration group performed a single session of whole body vibration exercise via a vibrating platform (Galileo® Advanced Plus, Novotec Medical, Pforzheim, Germany) with a magnitude of 20 Hz and an amplitude of 4 mm.

    Device: Whole body vibration · Other: Exercise

  • Active comparator
    Exercise only group

    The control group performed the same session without vibration.

    Other: Exercise

Interventions

  • DeviceWhole body vibration

    whole body vibration exercise is a stimulus that uses vibrations generated on a machine with oscillatory movement determined by the amplitude and frequency of the vibration.

  • OtherExercise

    maintain a half-squat position (knee joint angle at 160 degrees) on the tilt table with an incline of 60 degrees

05

What researchers measure

Primary outcomes

  1. Cerebral cortex activity

    cerebral cortex activity was measured based on changes in oxygenated hemoglobin concentration using fNIRS

    Time frame: check before, during and directly after intervention(for approximately 14 minutes)

Secondary outcomes

  1. 10 meter walk test

    performance measure used to assess walking speed in metres per second over a short distance. It can be Blender3D NormalWalkCycle.gifemployed to determine functional mobility, gait, and vestibular function.

    Time frame: before and after intervention(Approximately 14 minutes)

  2. Timed up and go test

    test for gait speed and gait balance

    Time frame: before and after intervention(Approximately 14 minutes)

  3. Fugl-Meyer Assessment

    a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.

    Time frame: before and after intervention(Approximately 14 minutes)

  4. Tinetti Performance Oriented Mobility Assessment

    Task-oriented outcome measure that assesses gait and balance ability; is composed of a 9-item gait portion (POMA-G) and 7-item balance portion (POMA-B)

    Time frame: before and after intervention(Approximately 14 minutes)

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03375346
Lead sponsor
Samsung Medical Center
Responsible party
Sponsor
First posted
Dec 18, 2017
Start date
Aug 4, 2015
Primary completion
Aug 3, 2017
Completion
Aug 3, 2017
Last update
Dec 20, 2017

Study contacts

Yun-Hee Kim, MD, PhD
principal investigator · Samsung Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion