Effects of Whole-body Vibration Exercise on Stroke Patients

NCT03375346 | Completed

• 1 other identifier: 2015-07-092
• Study Type: interventional
• Target: 29
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Stroke; Hemiplegia

Keywords

Whole body vibration exercise

Outcome Measures

Primary Outcomes (1)

• Cerebral cortex activity

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

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

Secondary Outcomes (4)

• 10 meter walk test

  before and after intervention(Approximately 14 minutes)

• Timed up and go test

  before and after intervention(Approximately 14 minutes)

• Fugl-Meyer Assessment

  before and after intervention(Approximately 14 minutes)

• Tinetti Performance Oriented Mobility Assessment

  before and after intervention(Approximately 14 minutes)

Study Arms (2)

Whole body vibration group

EXPERIMENTAL

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

Exercise only group

ACTIVE COMPARATOR

The control group performed the same session without vibration.

Other: Exercise

Interventions

Whole body vibration DEVICE

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.

Whole body vibration group

Exercise OTHER

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

Exercise only group; Whole body vibration group

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Related Publications (1)

• Lee A, Kim H, Kim J, Choi DS, Jung JH, Lee J, Kim YH. Modulating Effects of Whole-body Vibration on Cortical Activity and Gait Function in Chronic Stroke Patients. Brain Neurorehabil. 2020 Mar 26;13(2):e12. doi: 10.12786/bn.2020.13.e12. eCollection 2020 Jul.

  PMID: 36744184 DERIVED

MeSH Terms

Conditions

Stroke; Hemiplegia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Yun-Hee Kim, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible patients were randomly assigned to one of the two groups in a 1:1 ratio using an odd or even random numbers table. 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. The control group performed the same session without vibration.

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: December 18, 2017
• Study Start: August 4, 2015
• Primary Completion: August 3, 2017
• Study Completion: August 3, 2017
• Last Updated: December 20, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share