Whole-Body Vibration in Parkinson Disease

NCT07678983 | Active Not Recruiting

• 2 other identifiers: 2593TEZ.2025.009
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the effects of different frequencies of Whole Body Vibration (WBV) application on balance, gait, cognitive functions, and dual-task performance in patients with Parkinson's disease. Study Hypotheses: H0.1 - There is no effect of different frequencies of WBV application on balance performance in patients with Parkinson's disease. H1.1 - There is an effect of different frequencies of WBV application on balance performance in patients with Parkinson's disease. H0.2 - There is no effect of different frequencies of WBV application on gait performance in patients with Parkinson's disease. H1.2 - There is an effect of different frequencies of WBV application on gait performance in patients with Parkinson's disease. H0.3 - There is no effect of different frequencies of WBV application on cognitive functions in patients with Parkinson's disease. H1.3 - There is an effect of different frequencies of WBV application on cognitive functions in patients with Parkinson's disease. H0.4 - There is no effect of different frequencies of WBV application on dual-task performance in patients with Parkinson's disease. H1.4 - There is an effect of different frequencies of WBV application on dual-task performance in patients with Parkinson's disease. H0.5 - There is no effect of different frequencies of WBV application on reaction time in patients with Parkinson's disease. H1.5 - There is an effect of different frequencies of WBV application on reaction time in patients with Parkinson's disease. H0.6 - There is no significant difference between medium-frequency and low-frequency WBV in terms of balance performance in patients with Parkinson's disease. H1.6 - There is a significant difference between medium-frequency and low-frequency WBV in terms of balance performance in patients with Parkinson's disease. H0.7 - There is no significant difference between medium-frequency and low-frequency WBV in terms of gait performance in patients with Parkinson's disease. H1.7 - There is a significant difference between medium-frequency and low-frequency WBV in terms of gait performance in patients with Parkinson's disease. H0.8 - There is no significant difference between medium-frequency and low-frequency WBV in terms of cognitive functions in patients with Parkinson's disease. H1.8 - There is a significant difference between medium-frequency and low-frequency WBV in terms of cognitive functions in patients with Parkinson's disease. H0.9 - There is no significant difference between medium-frequency and low-frequency WBV in terms of dual-task performance in patients with Parkinson's disease. H1.9 - There is a significant difference between medium-frequency and low-frequency WBV in terms of dual-task performance in patients with Parkinson's disease. H0.10 - There is no significant difference between medium-frequency and low-frequency WBV in terms of reaction time in patients with Parkinson's disease. H1.10 - There is a significant difference between medium-frequency and low-frequency WBV in terms of reaction time in patients with Parkinson's disease.

Conditions

Parkinson's Disease; Balance; Gait; Cognitive Function; Dual-Task Performance; Reaction Time

Keywords

Parkinson's Disease; Whole Body Vibration (WBV); Balance; Gait; Cognitive Function; Dual-Task Performance; Reaction Time; Postural Control; Rehabilitation; Neuromuscular Coordination; Neurology

Outcome Measures

Primary Outcomes (2)

• Mini Balance Evaluation Systems Test (Mini-BESTest)

  Participants will be assessed while standing on a flat and firm surface. During the test, appropriate safety precautions will be taken if necessary to ensure participant safety. The assessment includes 4 subcomponents and 14 items: anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. Each subcomponent represents different aspects of balance control and evaluates specific components of the postural control system. In each section of the assessment, participants will be asked to perform various functional tasks, and their performance will be observed during these tasks. The tasks include sit-to-stand and stand-to-sit transitions, standing balance, forward reach, backward stepping, standing with eyes closed, and turning while walking. Each item is scored on a 0-2 scale (0 = Severe İmpairment, 1 = Moderate İmpairment, 2 = Normal/No İmpairment), with a total score ranging from 0 to 28.

  Baseline and 8 weeks

• 10 Meter Walk Test (10MWT)

  Participants will be assessed while standing on a flat, firm, and non-slip surface. Participants will be asked to walk a 14 meter walkway, with the central 10 meter section used for timing. Walking speed will be recorded over this 10 meter distance. The test will be performed under two conditions: comfortable walking speed and maximum walking speed, with two trials for each condition. Completion time will be measured using a stopwatch, and walking speed will be calculated and expressed as meters per second (m/s) based on the average of the trials.

  Baseline and 8 weeks

Secondary Outcomes (7)

• Verbal Fluency Test

  Baseline and 8 weeks

• Forward-Backward Digit Span Test

  Baseline and 8 weeks

• Trail Making Test (TMT)

  Baseline and 8 weeks

• Stroop Color and Word Test

  Baseline and 8 weeks

• Dual-Task Gait Test

  Baseline and 8 weeks

Study Arms (3)

Control Group

ACTIVE COMPARATOR

Participants, will receive a functional exercise based physiotherapy program in a hospital setting. The program will be supervised and conducted twice per week for 8 weeks.

Behavioral: Functional Exercise Based Physiotherapy

Low Frequency Whole Body Vibration (WBV) Group

EXPERIMENTAL

Participants will receive a functional exercise based physiotherapy program in a hospital setting, conducted twice per week for 8 weeks. In addition, Whole Body Vibration (WBV) will be applied for 20 minutes per session at a low frequency range (3-10 Hz).

Behavioral: Functional Exercise Based Physiotherapy; Device: Low-Frequency Whole-Body Vibration Therapy

Medium Frequency Whole Body Vibration (WBV) Group

EXPERIMENTAL

Participants will receive a functional exercise based physiotherapy program in a hospital setting, conducted twice per week for 8 weeks. In addition, Whole Body Vibration (WBV) will be applied for 20 minutes per session at a medium frequency range (12-20 Hz).

Behavioral: Functional Exercise Based Physiotherapy; Device: Medium-Frequency Whole-Body Vibration Therapy

Interventions

Functional Exercise Based Physiotherapy BEHAVIORAL

A supervised functional exercise-based physiotherapy program will be conducted in a hospital setting twice per week for 8 weeks.

Control Group; Low Frequency Whole Body Vibration (WBV) Group; Medium Frequency Whole Body Vibration (WBV) Group

Low-Frequency Whole-Body Vibration Therapy DEVICE

Whole-Body Vibration (WBV) will be applied as an adjunct to the functional exercise-based physiotherapy program. The intervention will be conducted in a hospital setting twice weekly for 8 weeks, with each session lasting 20 minutes. WBV will be applied to the low-frequency group at a frequency range of 3-10 Hz.

Low Frequency Whole Body Vibration (WBV) Group

Medium-Frequency Whole-Body Vibration Therapy DEVICE

Whole-Body Vibration (WBV) will be applied as an adjunct to the functional exercise-based physiotherapy program. The intervention will be conducted in a hospital setting twice weekly for 8 weeks, with each session lasting 20 minutes. WBV will be applied to the medium-frequency group at a frequency range of 12-20 Hz.

Medium Frequency Whole Body Vibration (WBV) Group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals aged 30-80 years with a clinical diagnosis of Parkinson's disease. Hoehn and Yahr stages 1-3.
• Stable medical treatment (no changes in medication for the past 4 weeks).
• Willingness to participate and provision of written informed consent.
• Score of 24 or higher on the Standardized Mini Mental State Examination (SMMSE).

You may not qualify if:

• Advanced stage Parkinson's disease (Hoehn and Yahr stage \>3) or presence of severe motor complications.
• History of surgical interventions or other neurological/vestibular disorders that may affect balance and gait (E.G., stroke, epilepsy, peripheral neuropathy).
• Presence of severe cardiovascular or respiratory conditions that may affect stability (E.G., heart failure, uncontrolled hypertension, advanced COPD).
• Conditions contraindicating whole-body vibration (WBV) application (E.G., severe osteoporosis, active thrombosis).
• Psychiatric disorders or major depression that may interfere with treatment participation.
• Significant communication or language impairments affecting participation.
• Withdrawal Criteria
• Voluntary withdrawal from the study.
• Development of health problems during the intervention that prevent completion of the study (E.G., unexpected acute illness or temporary medical condition).
• Changes in medication or medical status during the study that may affect participation or performance.
• Non-adherence to the protocol (attendance rate below 80% of sessions).

Sponsors & Collaborators

• Izmir Bakircay University: lead

Study Sites (1)

Izmir Bakircay University Cigli Training and Research Hospital

Izmir, 35610, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Gülbin Ergin, Prof. Dr

  Izmir Bakircay University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr

Model Details: Participants will be randomly assigned using a stratified randomization method to three groups with homogeneous demographic and clinical characteristics: a control group, a low frequency whole body vibration group (3-10 Hz), and a moderate frequency whole body vibration group (12-20 Hz). All interventions will be performed twice weekly for a total of 8 weeks in a hospital setting under appropriate safety precautions. Participants in all groups will receive the same functional exercise based physiotherapy program with identical duration and intensity. In addition, participants in the low- and moderate frequency whole body vibration groups will receive a 20 minute whole body vibration intervention integrated into the exercise program according to their assigned frequency range. The control group will receive only the functional exercise-based physiotherapy program.

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 1, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 14, 2026

Record last verified: 2026-06

Locations

TU (1)