Effects of Whole Body Vibration in Parkinson's Disease Symptoms

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 Overview

• Status: Not yet recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Device: Whole body Vibration; Other: Habitual Therapy; Device: Placebo whole body vibration

• Study Type: Interventional
• Enrollment (Anticipated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paula González García; Phone Number: 954486516; Email: pgonzalez@us.es
• Study Contact Backup: Name: Alfonso Garrido Bueno; Email: alfgarbuen@gmail.com

Study Locations

• Spain
  • Sevilla, Spain, 41009
    • Asociación de Enfermos de Parkinson de Sevilla
    • Contact: Oscar García Sánchez; Email: fisioterapia@parkinsonsevilla.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PDExperimental; This group will receive usual care (physical therapy) and whole body vibration sessions.	Device: Whole body Vibration; 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).; Other: Habitual Therapy; Physical therapy will be administered to all study subjects. Experimental group will perform their session the same day that the experimental intervention.
Active Comparator: PDControl; This group will receive usual care (physical therapy) and placebo whole body vibration session.	Other: Habitual Therapy; Physical therapy will be administered to all study subjects. Experimental group will perform their session the same day that the experimental intervention.; Device: Placebo whole body vibration; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	Week 22

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	Week 22

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	Years	Baseline
Height	Cm	Baseline
Weight	Kg	Baseline
Time since Parkinson disease diagnosis	Years and months	Baseline

Collaborators and Investigators

• Sponsor: University of Seville
• Collaborators: Asociación de Enfermos de Parkinson de Sevilla

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): September 30, 2023
• Study Completion (Anticipated): November 30, 2023

Study Registration Dates

• First Submitted: November 3, 2022
• First Submitted That Met QC Criteria: November 11, 2022
• First Posted (Actual): November 17, 2022

Study Record Updates

• Last Update Posted (Actual): November 17, 2022
• Last Update Submitted That Met QC Criteria: November 11, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: whole body vibration; rigidity; parkinson disease,
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: USFISIOTERAPIAPGG01

Drug and device information, study documents

• 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