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Effects of Whole Body Vibration in Parkinson's Disease Symptoms

Primary Purpose

Parkinson Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Whole body Vibration
Habitual Therapy
Placebo whole body vibration
Sponsored by
University of Seville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring parkinson disease,, whole body vibration, rigidity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Asociación de Enfermos de Parkinson de Sevilla

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PDExperimental

PDControl

Arm Description

This group will receive usual care (physical therapy) and whole body vibration sessions.

This group will receive usual care (physical therapy) and placebo whole body vibration session.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
November 3, 2022
Last Updated
November 11, 2022
Sponsor
University of Seville
Collaborators
Asociación de Enfermos de Parkinson de Sevilla
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1. Study Identification

Unique Protocol Identification Number
NCT05621031
Brief Title
Effects of Whole Body Vibration in Parkinson's Disease Symptoms
Official Title
Effects of Whole Body Vibration in Parkinson's Disease Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Seville
Collaborators
Asociación de Enfermos de Parkinson de Sevilla

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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 (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
parkinson disease,, whole body vibration, rigidity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PDExperimental
Arm Type
Experimental
Arm Description
This group will receive usual care (physical therapy) and whole body vibration sessions.
Arm Title
PDControl
Arm Type
Active Comparator
Arm Description
This group will receive usual care (physical therapy) and placebo whole body vibration session.
Intervention Type
Device
Intervention Name(s)
Whole body Vibration
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Habitual Therapy
Intervention Description
Physical therapy will be administered to all study subjects. Experimental group will perform their session the same day that the experimental intervention.
Intervention Type
Device
Intervention Name(s)
Placebo whole body vibration
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change from baseline muscle tone at 9 weeks
Description
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.
Time Frame
Week 9
Title
Change from baseline muscle stiffness at 9 weeks
Description
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.
Time Frame
Week 9
Title
Change from baseline muscle elasticity at 9 weeks
Description
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.
Time Frame
Week 9
Title
Change from week 9 muscle tone at 22 weeks (follow up period)
Description
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.
Time Frame
Week 22
Title
Change from week 9 muscle stiffness at 22 weeks (follow up period)
Description
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.
Time Frame
Week 22
Title
Change from week 9 muscle elasticity at 22 weeks (follow up period)
Description
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.
Time Frame
Week 22
Title
Changes from baseline gait functionality at 9 weeks
Description
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.
Time Frame
Week 9
Title
Changes from week 9 gait functionality at 22 weeks (follow up period)
Description
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.
Time Frame
Week 22
Secondary Outcome Measure Information:
Title
Changes from baseline thoracic kyphosis at 9 weeks
Description
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.
Time Frame
Week 9
Title
Changes from week 9 thoracic kyphosis at 22 weeks (follow up period)
Description
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.
Time Frame
Week 22
Title
Changes from baseline aspects of quality of life at 9 weeks
Description
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.
Time Frame
Week 9
Title
Changes from week 9 aspects of quality of life at 22 weeks (follow up period)
Description
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.
Time Frame
Week 22
Title
Changes from baseline freezing of gait at 9 weeks
Description
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.
Time Frame
Week 9
Title
Changes from week 9 freezing of gait at 22 weeks (follow up period)
Description
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.
Time Frame
Week 22
Title
Changes from baseline reactive balance at 9 weeks
Description
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.
Time Frame
Week 9
Title
Changes from week 9 reactive balance at 22 weeks
Description
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.
Time Frame
Week 22
Other Pre-specified Outcome Measures:
Title
Age
Description
Years
Time Frame
Baseline
Title
Height
Description
Cm
Time Frame
Baseline
Title
Weight
Description
Kg
Time Frame
Baseline
Title
Time since Parkinson disease diagnosis
Description
Years and months
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paula González García
Phone
954486516
Email
pgonzalez@us.es
First Name & Middle Initial & Last Name or Official Title & Degree
Alfonso Garrido Bueno
Email
alfgarbuen@gmail.com
Facility Information:
Facility Name
Asociación de Enfermos de Parkinson de Sevilla
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oscar García Sánchez
Email
fisioterapia@parkinsonsevilla.org

12. IPD Sharing Statement

Learn more about this trial

Effects of Whole Body Vibration in Parkinson's Disease Symptoms

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