PARKINSON DISEASE (Disorder)NCT07472946
Whole-Body Vibration Exercise in Patients With Parkinson's Disease
A study testing Whole-Body Vibration Plus Home Exercise and Home Exercise Only in people with PARKINSON DISEASE (Disorder), run by Istanbul University.
Trial summary
This study is a prospective, single-blind, randomized controlled trial designed to investigate the effects of whole-body vibration (WBV) exercise on balance, mobility, fall risk, and proprioception in patients with Parkinson's disease. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- PARKINSON DISEASE (Disorder)
- What is being tested?
- Whole-Body Vibration Plus Home Exercise and Home Exercise Only
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Age between 50 and 75 years
- Clinical diagnosis of Parkinson's disease
- Hoehn and Yahr stage 1-3
- MDS-UPDRS stage 2-3
- Clinically stable (no change in antiparkinsonian medication or treatment plan within the last 3 months)
- Ability to stand independently and participate in exercise sessions
- Provided written informed consent
Who cannot join
- • Participation in an inpatient or outpatient rehabilitation program within the last 3 months
- Diagnosis of dementia or significant cognitive/communication impairment
- Contraindications to whole-body vibration (e.g., severe peripheral neuropathy affecting vibration perception, epilepsy, pregnancy, metal implants or joint prostheses in the lower extremities, cardiac or brain pacemaker, uncontrolled hypertension, history of acute thrombosis)
- Presence of additional neurological disorders affecting balance or neuromuscular performance
- Functional Ambulation Classification (FAC) level 0-2
- Musculoskeletal conditions preventing safe standing on the vibration platform (e.g., fracture, ulcer, acute injury)
About this study
Official title: The Effect of Whole-Body Vibration Exercise on Balance, Mobility, Fall Risk, and Proprioception in Patients With Parkinson's Disease: A Single-Blind Randomized Controlled Trial
This study is a prospective, single-blind, randomized controlled trial designed to investigate the effects of whole-body vibration (WBV) exercise on balance, mobility, fall risk, and proprioception in patients with Parkinson's disease.
A total of 68 patients diagnosed with Parkinson's disease, aged between 50 and 75 years, will be recruited from the outpatient clinic of the Department of Physical Medicine and Rehabilitation at Istanbul University, Istanbul Faculty of Medicine. Eligible participants will be clinically stable (no medication changes within the last 3 months), classified as Hoehn and Yahr stage 1-3, and MDS-UPDRS stage 2-3. Written informed consent will be obtained from all participants before enrollment.
Read more
Participants will be randomly assigned in a 1:1 ratio to either the intervention group (n=34) or the control group (n=34). Randomization will be performed using a computer-generated random allocation sequence. Outcome assessments will be conducted by a blinded assessor.
The intervention group will receive whole-body vibration (WBV) training in addition to a standardized home exercise program. WBV sessions will be performed using the Power Plate pro5 vibration platform (Performance Health Systems, LLC, Northbrook, IL, USA). Training will be conducted three times per week for 8 weeks (24 sessions total). Each session will include 5 sets of vibration exposure, consisting of 1 minute of vibration followed by 1 minute of rest. Exercises will be performed in semi-squat and lunge positions. Vibration parameters will be set at 6 Hz frequency with 2-4 mm amplitude. Sessions will be scheduled during the "on" phase of dopaminergic medication. Each session will include a 10-minute warm-up and a 5-minute cool-down period.
The control group will perform only the standardized home exercise program. Both groups will receive initial in-clinic instruction for the home exercise program, which includes posture exercises, breathing and relaxation exercises, lower extremity active range-of-motion exercises, stretching, quadriceps strengthening, terminal knee extension exercises, rhythmic gait training, and balance/coordination/proprioceptive exercises. Home exercises will be performed three times per week for 8 weeks, lasting 30-45 minutes per session. Participants will be contacted weekly to monitor adherence.
Outcome assessments will be conducted at baseline, at 8 weeks (post-intervention), and at 16 weeks (follow-up).
The primary outcome measure is the Berg Balance Scale (BBS).
Secondary outcome measures include:
- Timed Up and Go (TUG) test
- Six-Minute Walk Test (6MWT)
- Fall Risk Index measured by computerized static posturography (TETRAX®)
- Knee joint position sense measured using an isokinetic dynamometer (Biodex System 3 Pro), calculated as absolute angular error
The primary analysis will evaluate changes in BBS scores between groups across time points using repeated measures analysis of variance. Secondary outcomes will be analyzed using similar statistical methods. Statistical significance will be set at p < 0.05.
The study aims to determine whether WBV combined with a home exercise program provides superior improvements in balance, mobility, fall risk, and proprioception compared with a home exercise program alone in individuals with Parkinson's disease.
- Conditions
- PARKINSON DISEASE (Disorder)
- Being tested
- Whole-Body Vibration Plus Home Exercise, Home Exercise Only
- Keywords
- parkinson's disease, whole body vibration exercise, balance, mobility, gait, proprioception
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-Body Vibration Plus Home ExerciseDevice
Participants in this arm will receive whole-body vibration (WBV) training in addition to a standardized home exercise program. WBV will be performed using the Power Plate pro5 platform, three times per week for 8 weeks (24 sessions). Each session will include 5 sets of 1-minute vibration with 1-minute rest intervals in semi-squat and lunge positions (6 Hz, 2-4 mm amplitude). Sessions will include a short warm-up and cool-down period.
The home exercise program will consist of posture, breathing, stretching, strengthening, gait training, and balance/proprioceptive exercises, performed three times weekly for 8 weeks (30-45 minutes per session).
Home Exercise OnlyOther
Participants in this arm will receive a standardized home exercise program only. The program will include posture training, breathing and relaxation exercises, lower extremity active range-of-motion and stretching exercises, quadriceps strengthening, terminal knee extension exercises, rhythmic gait training, and balance/coordination/proprioceptive exercises. Participants will receive initial in-clinic instruction and written guidance. Exercises will be performed three times per week for 8 weeks, with each session lasting approximately 30-45 minutes. Participants will be contacted weekly to monitor adherence.
| Study group | Role | What they receive |
|---|---|---|
| Whole-Body Vibration Plus Home Exercise | Experimental | Not described Receives: Device: Whole-Body Vibration Plus Home Exercise |
| Home Exercise Program Only | Active comparator | Not described Receives: Other: Home Exercise Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance assessed by Berg Balance Scale (BBS)
Balance will be assessed using the Berg Balance Scale (BBS), a 14-item clinical scale that evaluates static and dynamic balance abilities. Each item is scored from 0 to 4, yielding a total score ranging from 0 to 56. Higher scores indicate better balance performance.
Measured: From baseline to 8 weeks (end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PARKINSON DISEASE (Disorder)Studies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Topsakal, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472946
- Sponsor's protocol ID
- E-87986082-010.99-3074420
- Status last verified
- Mar 2026
- First submitted
- 22 Feb 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Whole-Body Vibration Exercise on Balance, Mobility, Fall Risk, and Proprioception in Patients With Parkinson's Disease: A Single-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07472946
- Acronym / sponsor ID
- E-87986082-010.99-3074420
- Conditions
- PARKINSON DISEASE (Disorder)
- Keywords
- parkinson's disease, whole body vibration exercise, balance, mobility, gait, proprioception
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective, single-blind, randomized controlled trial designed to investigate the effects of whole-body vibration (WBV) exercise on balance, mobility, fall risk, and proprioception in patients with Parkinson's disease.
A total of 68 patients diagnosed with Parkinson's disease, aged between 50 and 75 years, will be recruited from the outpatient clinic of the Department of Physical Medicine and Rehabilitation at Istanbul University, Istanbul Faculty of Medicine. Eligible participants will be clinically stable (no medication changes within the last 3 months), classified as Hoehn and Yahr stage 1-3, and MDS-UPDRS stage 2-3. Written informed consent will be obtained from all participants before enrollment.
Participants will be randomly assigned in a 1:1 ratio to either the intervention group (n=34) or the control group (n=34). Randomization will be performed using a computer-generated random allocation sequence. Outcome assessments will be conducted by a blinded assessor.
The intervention group will receive whole-body vibration (WBV) training in addition to a standardized home exercise program. WBV sessions will be performed using the Power Plate pro5 vibration platform (Performance Health Systems, LLC, Northbrook, IL, USA). Training will be conducted three times per week for 8 weeks (24 sessions total). Each session will include 5 sets of vibration exposure, consisting of 1 minute of vibration followed by 1 minute of rest. Exercises will be performed in semi-squat and lunge positions. Vibration parameters will be set at 6 Hz frequency with 2-4 mm amplitude. Sessions will be scheduled during the "on" phase of dopaminergic medication. Each session will include a 10-minute warm-up and a 5-minute cool-down period.
The control group will perform only the standardized home exercise program. Both groups will receive initial in-clinic instruction for the home exercise program, which includes posture exercises, breathing and relaxation exercises, lower extremity active range-of-motion exercises, stretching, quadriceps strengthening, terminal knee extension exercises, rhythmic gait training, and balance/coordination/proprioceptive exercises. Home exercises will be performed three times per week for 8 weeks, lasting 30-45 minutes per session. Participants will be contacted weekly to monitor adherence.
Outcome assessments will be conducted at baseline, at 8 weeks (post-intervention), and at 16 weeks (follow-up).
The primary outcome measure is the Berg Balance Scale (BBS).
Secondary outcome measures include:
- Timed Up and Go (TUG) test
- Six-Minute Walk Test (6MWT)
- Fall Risk Index measured by computerized static posturography (TETRAX®)
- Knee joint position sense measured using an isokinetic dynamometer (Biodex System 3 Pro), calculated as absolute angular error
The primary analysis will evaluate changes in BBS scores between groups across time points using repeated measures analysis of variance. Secondary outcomes will be analyzed using similar statistical methods. Statistical significance will be set at p < 0.05.
The study aims to determine whether WBV combined with a home exercise program provides superior improvements in balance, mobility, fall risk, and proprioception compared with a home exercise program alone in individuals with Parkinson's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole-Body Vibration Plus Home Exercise | Experimental | Device: Whole-Body Vibration Plus Home Exercise |
| Home Exercise Program Only | Active comparator | Other: Home Exercise Only |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- • Age between 50 and 75 years
Key exclusion criteria (6 listed)
- • Participation in an inpatient or outpatient rehabilitation program within the last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole-Body Vibration Plus Home ExerciseParticipants in this arm will receive whole-body vibration (WBV) training in addition to a standardized home exercise program. WBV will be performed using the Power Plate pro5 platform, three times per week for 8 weeks (24 sessions). Each session will include 5 sets of 1-minute vibration with 1-minute rest intervals in semi-squat and lunge positions (6 Hz, 2-4 mm amplitude). Sessions will include a short warm-up and cool-down period. The home exercise program will consist of posture, breathing, stretching, strengthening, gait training, and balance/proprioceptive exercises, performed three times weekly for 8 weeks (30-45 minutes per session). | Device | Whole-Body Vibration Plus Home Exercise |
| Home Exercise OnlyParticipants in this arm will receive a standardized home exercise program only. The program will include posture training, breathing and relaxation exercises, lower extremity active range-of-motion and stretching exercises, quadriceps strengthening, terminal knee extension exercises, rhythmic gait training, and balance/coordination/proprioceptive exercises. Participants will receive initial in-clinic instruction and written guidance. Exercises will be performed three times per week for 8 weeks, with each session lasting approximately 30-45 minutes. Participants will be contacted weekly to monitor adherence. | Other | Home Exercise Program Only |
Primary outcome
Balance assessed by Berg Balance Scale (BBS)
Time frame: From baseline to 8 weeks (end of intervention)
Balance will be assessed using the Berg Balance Scale (BBS), a 14-item clinical scale that evaluates static and dynamic balance abilities. Each item is scored from 0 to 4, yielding a total score ranging from 0 to 56. Higher scores indicate better balance performance.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Whole-Body Vibration Plus Home Exercise and Home Exercise Only in people with PARKINSON DISEASE (Disorder), run by Istanbul University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance assessed by Berg Balance Scale (BBS) (time frame: From baseline to 8 weeks (end of intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.