Parkinson DiseaseNCT05621031
Effects of Whole Body Vibration in Parkinson's Disease Symptoms
A study testing Whole body Vibration and Habitual Therapy in people with Parkinson Disease, run by University of Seville at 1 site in Spain.
Trial summary
The goal of this clinical trial is to know the effects of an intervention in Parkinson's disease symptoms. The main question it aims to answer are: Is whole body vibration able to reduce rigidity in Parkinson's participants? Can whole body vibration modify gait abilities and other Parkinson's symptoms? Participants… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Whole body Vibration and Habitual Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2023to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Parkinson Disease, in phase I and II according to Hoehn \& Yahr phases.
- Able to maintain independently standing position.
- Able to understand instructions and score >24 in Minimental Test.
Who cannot join
- Changes in pharmacological treatment for PD symptoms during the study.
- Recent injuries in the last 12 weeks in lower limbs or trunk.
- Other neurological conditions not related to Parkinsonism.
Trial locations and contacts
1 site in 1 country.
Alfonso Garrido Bueno contact
Spain1 site
Asociación de Enfermos de Parkinson de Sevilla
Seville, 41009
Oscar García Sánchez, fisioterapia@parkinsonsevilla.org
About this study
The goal of this clinical trial is to know the effects of an intervention in Parkinson's disease symptoms. The main question it aims to answer are:
- Is whole body vibration able to reduce rigidity in Parkinson's participants?
- Can whole body vibration modify gait abilities and other Parkinson's symptoms? Participants (subjects with Parkinson's disease) will do habitual therapy treatment. Experimental group will also carry out whole body vibration sessions and control group will do placebo whole body vibration sessions.
- Conditions
- Parkinson Disease
- Being tested
- Whole body Vibration, Habitual Therapy, Placebo whole body vibration
- Keywords
- parkinson disease,, whole body vibration, rigidity
- Medical subject headings
- Parkinson Disease, Muscle Rigidity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole body VibrationDevice
Whole body vibration will be administered with a vibration platform (Power Plate Move). Subjects will do several exercises (squats and steps) whilst on the platform, set at these parameters: frequency 30 Hz; amplitude: 2 mm; 1 min activation; 1 min rest, 5 activations. 15 sessions will be carried out (2/week).
Habitual TherapyOther
Physical therapy will be administered to all study subjects. Experimental group will perform their session the same day that the experimental intervention.
Placebo whole body vibrationDevice
Placebo whole body vibration will be administered with a vibration platform (Power Plate Move). Subjects will do several exercises (squats and steps) whilst on the platform. The platform will only be working for 3 seconds (parameters: frequency 30 Hz; amplitude: 2 mm) and after 3 seconds, the vibration will stop. Same as experimental group, there will be 1 min placebo activation; 1 min rest, 5 activations. 15 sessions will be carried out (2/week).
| Study group | Role | What they receive |
|---|---|---|
| PDExperimental | Experimental | This group will receive usual care (physical therapy) and whole body vibration sessions. Receives: Device: Whole body Vibration; Other: Habitual Therapy |
| PDControl | Active comparator | This group will receive usual care (physical therapy) and placebo whole body vibration session. Receives: Other: Habitual Therapy; Device: Placebo whole body vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline muscle tone at 9 weeks
Muscle tone will be measured using Myoton Pro (Hz) in the following sites: plantar fascia, Achilles tendon, soleus, gastrocnemius, erector spinae (L3-L4, T12-L1, T8-T9,T3-T4 and C7-T1) , transversus abdominus, rectus femoris, infrapatellar tendon and anterior tibialis . Measures will be taken twice bilaterally.
Measured: Week 9
Change from baseline muscle stiffness at 9 weeks
Muscle stiffness will be measured using Myoton Pro (N/m) in the following sites: plantar fascia, Achilles tendon, soleus, gastrocnemius, erector spinae (L3-L4, T12-L1, T8-T9,T3-T4 and C7-T1) , transversus abdominus, rectus femoris, infrapatellar tendon and anterior tibialis . Measures will be taken twice bilaterally.
Measured: Week 9
Change from baseline muscle elasticity at 9 weeks
Muscle elasticity will be measured using Myoton Pro (logarithmic decrement) in the following sites: plantar fascia, Achilles tendon, soleus, gastrocnemius, erector spinae (L3-L4, T12-L1, T8-T9,T3-T4 and C7-T1) , transversus abdominus, rectus femoris, infrapatellar tendon and anterior tibialis . Measures will be taken twice bilaterally.
Measured: Week 9
Change from week 9 muscle tone at 22 weeks (follow up period)
Muscle tone will be measured using Myoton Pro (Hz) in the following sites: plantar fascia, Achilles tendon, soleus, gastrocnemius, erector spinae (L3-L4, T12-L1, T8-T9,T3-T4 and C7-T1) , transversus abdominus, rectus femoris, infrapatellar tendon and anterior tibialis . Measures will be taken twice bilaterally.
Measured: Week 22
Change from week 9 muscle stiffness at 22 weeks (follow up period)
Muscle stiffness will be measured using Myoton Pro (N/m) in the following sites: plantar fascia, Achilles tendon, soleus, gastrocnemius, erector spinae (L3-L4, T12-L1, T8-T9,T3-T4 and C7-T1) , transversus abdominus, rectus femoris, infrapatellar tendon and anterior tibialis . Measures will be taken twice bilaterally.
Measured: Week 22
Change from week 9 muscle elasticity at 22 weeks (follow up period)
Muscle elasticity will be measured using Myoton Pro (logarithmic decrement) in the following sites: plantar fascia, Achilles tendon, soleus, gastrocnemius, erector spinae (L3-L4, T12-L1, T8-T9,T3-T4 and C7-T1) , transversus abdominus, rectus femoris, infrapatellar tendon and anterior tibialis . Measures will be taken twice bilaterally.
Measured: Week 22
Changes from baseline gait functionality at 9 weeks
This outcome will be measured with the Modified Emory Functional Ambulation Profile. This scale assesses functional ambulation in terms of assistance and time under five different environmental conditions. Since time (seconds) if the main measure, there is not top score and the higher the score, the worse is the performance.
Measured: Week 9
Changes from week 9 gait functionality at 22 weeks (follow up period)
This outcome will be measured with the Modified Emory Functional Ambulation Profile. This scale assesses functional ambulation in terms of assistance and time under five different environmental conditions. Since time (seconds) if the main measure, there is not top score and the higher the score, the worse is the performance.
Measured: Week 22
Secondary outcomes (8)
Changes from baseline thoracic kyphosis at 9 weeks
The degree of thoracic kyphosis will be measure with the mobile application Goniometer Pro (degrees). The mobile will the placed at T1 and T12 and will measure the angle between them.
Measured: Week 9
Changes from week 9 thoracic kyphosis at 22 weeks (follow up period)
The degree of thoracic kyphosis will be measure with the mobile application Goniometer Pro (degrees). The mobile will the placed at T1 and T12 and will measure the angle between them.
Measured: Week 22
Changes from baseline aspects of quality of life at 9 weeks
This outcome will be measured with the Parkinson's Disease Questionnaire (PDQ-399). This questionnaire assesses how often people with Parkinson's experience difficulties across 8 dimensions of daily living. The scores ranges between 0 and 800, with a lower score reflecting better quality of life.
Measured: Week 9
Changes from week 9 aspects of quality of life at 22 weeks (follow up period)
This outcome will be measured with the Parkinson's Disease Questionnaire (PDQ-399). This questionnaire assesses how often people with Parkinson's experience difficulties across 8 dimensions of daily living. The scores ranges between 0 and 800, with a lower score reflecting better quality of life.
Measured: Week 22
Changes from baseline freezing of gait at 9 weeks
This outcome will be measured with the Freezing of Gait Questionary. This scale assesses the severity and the frequency of the episodes of freezing during gait. It also considers the relationship of these episodes with other gait and motor aspects.The scores ranges between 0 and 24, with a lower score less freezing episodes.
Measured: Week 9
Changes from week 9 freezing of gait at 22 weeks (follow up period)
This outcome will be measured with the Freezing of Gait Questionary. This scale assesses the severity and the frequency of the episodes of freezing during gait. It also considers the relationship of these episodes with other gait and motor aspects.The scores ranges between 0 and 24, with a lower score less freezing episodes.
Measured: Week 22
Changes from baseline reactive balance at 9 weeks
This outcome will be measure with the section of reactive balance assessment of the Balance Evaluation System Test (BESTest). This section includes 5 items that specifically measures reactive balance and compensatory responses in all directions. The scores ranges between 0 and 18, with a lower score reflecting worse reactive balance.
Measured: Week 9
Changes from week 9 reactive balance at 22 weeks
This outcome will be measure with the section of reactive balance assessment of the Balance Evaluation System Test (BESTest). This section includes 5 items that specifically measures reactive balance and compensatory responses in all directions. The scores ranges between 0 and 18, with a lower score reflecting worse reactive balance.
Measured: Week 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start1 Jan 2023 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Collaborators
- Asociación de Enfermos de Parkinson de Sevilla
- Responsible party
- Principal investigator, Paula González García, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05621031
- Sponsor's protocol ID
- USFISIOTERAPIAPGG01
- Status last verified
- Nov 2022
- First submitted
- 3 Nov 2022
- Last updated
- 17 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Whole Body Vibration in Parkinson's Disease Symptoms
- ClinicalTrials.gov ID
- NCT05621031
- Acronym / sponsor ID
- USFISIOTERAPIAPGG01
- Conditions
- Parkinson Disease
- Keywords
- parkinson disease,, whole body vibration, rigidity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Collaborators
- Asociación de Enfermos de Parkinson de Sevilla
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 17 Nov 2022 (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.
The goal of this clinical trial is to know the effects of an intervention in Parkinson's disease symptoms. The main question it aims to answer are:
- Is whole body vibration able to reduce rigidity in Parkinson's participants?
- Can whole body vibration modify gait abilities and other Parkinson's symptoms? Participants (subjects with Parkinson's disease) will do habitual therapy treatment. Experimental group will also carry out whole body vibration sessions and control group will do placebo whole body vibration sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PDExperimental | Experimental | Device: Whole body Vibration, Other: Habitual TherapyThis group will receive usual care (physical therapy) and whole body vibration sessions. |
| PDControl | Active comparator | Other: Habitual Therapy, Device: Placebo whole body vibrationThis group will receive usual care (physical therapy) and placebo whole body vibration session. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Parkinson Disease, in phase I and II according to Hoehn \& Yahr phases.
- Able to maintain independently standing position.
- Able to understand instructions and score >24 in Minimental Test.
Key exclusion criteria (3 listed)
- Changes in pharmacological treatment for PD symptoms during the study.
- Recent injuries in the last 12 weeks in lower limbs or trunk.
- Other neurological conditions not related to Parkinsonism.
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 VibrationWhole body vibration will be administered with a vibration platform (Power Plate Move). Subjects will do several exercises (squats and steps) whilst on the platform, set at these parameters: frequency 30 Hz; amplitude: 2 mm; 1 min activation; 1 min rest, 5 activations. 15 sessions will be carried out (2/week). | Device | PDExperimental |
| Habitual TherapyPhysical therapy will be administered to all study subjects. Experimental group will perform their session the same day that the experimental intervention. | Other | PDControl, PDExperimental |
| Placebo whole body vibrationPlacebo whole body vibration will be administered with a vibration platform (Power Plate Move). Subjects will do several exercises (squats and steps) whilst on the platform. The platform will only be working for 3 seconds (parameters: frequency 30 Hz; amplitude: 2 mm) and after 3 seconds, the vibration will stop. Same as experimental group, there will be 1 min placebo activation; 1 min rest, 5 activations. 15 sessions will be carried out (2/week). | Device | PDControl |
Primary outcome
Change from baseline muscle tone at 9 weeks
Time frame: Week 9
Muscle tone will be measured using Myoton Pro (Hz) in the following sites: plantar fascia, Achilles tendon, soleus, gastrocnemius, erector spinae (L3-L4, T12-L1, T8-T9,T3-T4 and C7-T1) , transversus abdominus, rectus femoris, infrapatellar tendon and anterior tibialis . Measures will be taken twice bilaterally.
Change from baseline muscle stiffness at 9 weeks
Time frame: Week 9
Muscle stiffness will be measured using Myoton Pro (N/m) in the following sites: plantar fascia, Achilles tendon, soleus, gastrocnemius, erector spinae (L3-L4, T12-L1, T8-T9,T3-T4 and C7-T1) , transversus abdominus, rectus femoris, infrapatellar tendon and anterior tibialis . Measures will be taken twice bilaterally.
Change from baseline muscle elasticity at 9 weeks
Time frame: Week 9
Muscle elasticity will be measured using Myoton Pro (logarithmic decrement) in the following sites: plantar fascia, Achilles tendon, soleus, gastrocnemius, erector spinae (L3-L4, T12-L1, T8-T9,T3-T4 and C7-T1) , transversus abdominus, rectus femoris, infrapatellar tendon and anterior tibialis . Measures will be taken twice bilaterally.
Change from week 9 muscle tone at 22 weeks (follow up period)
Time frame: Week 22
Muscle tone will be measured using Myoton Pro (Hz) in the following sites: plantar fascia, Achilles tendon, soleus, gastrocnemius, erector spinae (L3-L4, T12-L1, T8-T9,T3-T4 and C7-T1) , transversus abdominus, rectus femoris, infrapatellar tendon and anterior tibialis . Measures will be taken twice bilaterally.
Change from week 9 muscle stiffness at 22 weeks (follow up period)
Time frame: Week 22
Muscle stiffness will be measured using Myoton Pro (N/m) in the following sites: plantar fascia, Achilles tendon, soleus, gastrocnemius, erector spinae (L3-L4, T12-L1, T8-T9,T3-T4 and C7-T1) , transversus abdominus, rectus femoris, infrapatellar tendon and anterior tibialis . Measures will be taken twice bilaterally.
Change from week 9 muscle elasticity at 22 weeks (follow up period)
Time frame: Week 22
Muscle elasticity will be measured using Myoton Pro (logarithmic decrement) in the following sites: plantar fascia, Achilles tendon, soleus, gastrocnemius, erector spinae (L3-L4, T12-L1, T8-T9,T3-T4 and C7-T1) , transversus abdominus, rectus femoris, infrapatellar tendon and anterior tibialis . Measures will be taken twice bilaterally.
Changes from baseline gait functionality at 9 weeks
Time frame: Week 9
This outcome will be measured with the Modified Emory Functional Ambulation Profile. This scale assesses functional ambulation in terms of assistance and time under five different environmental conditions. Since time (seconds) if the main measure, there is not top score and the higher the score, the worse is the performance.
Changes from week 9 gait functionality at 22 weeks (follow up period)
Time frame: Week 22
This outcome will be measured with the Modified Emory Functional Ambulation Profile. This scale assesses functional ambulation in terms of assistance and time under five different environmental conditions. Since time (seconds) if the main measure, there is not top score and the higher the score, the worse is the performance.
8 secondary outcomes
Changes from baseline thoracic kyphosis at 9 weeks
Time frame: Week 9
Changes from week 9 thoracic kyphosis at 22 weeks (follow up period)
Time frame: Week 22
Changes from baseline aspects of quality of life at 9 weeks
Time frame: Week 9
Changes from week 9 aspects of quality of life at 22 weeks (follow up period)
Time frame: Week 22
Changes from baseline freezing of gait at 9 weeks
Time frame: Week 9
Changes from week 9 freezing of gait at 22 weeks (follow up period)
Time frame: Week 22
Changes from baseline reactive balance at 9 weeks
Time frame: Week 9
Changes from week 9 reactive balance at 22 weeks
Time frame: Week 22
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
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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. This study is not recruiting at the moment.
Alfonso Garrido Bueno contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole body Vibration and Habitual Therapy in people with Parkinson Disease, run by University of Seville at 1 site in Spain.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paula González García (954486516, pgonzalez@us.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline muscle tone at 9 weeks (time frame: Week 9). The study lists 8 primary outcomes in all. 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 17 Nov 2022.