Effects of Whole Body Vibration in Parkinson's Disease Symptoms

NCT05621031 | Unknown FDA Device

• 1 other identifier: USFISIOTERAPIAPGG01
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

parkinson disease,; whole body vibration; rigidity

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (8)

• Changes from baseline thoracic kyphosis at 9 weeks

  Week 9

• Changes from week 9 thoracic kyphosis at 22 weeks (follow up period)

  Week 22

• Changes from baseline aspects of quality of life at 9 weeks

  Week 9

• Changes from week 9 aspects of quality of life at 22 weeks (follow up period)

  Week 22

• Changes from baseline freezing of gait at 9 weeks

  Week 9

Other Outcomes (4)

• Age

  Baseline

• Height

  Baseline

• Weight

  Baseline

Study Arms (2)

PDExperimental

EXPERIMENTAL

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

Device: Whole body Vibration; Other: Habitual Therapy

PDControl

ACTIVE COMPARATOR

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

Other: Habitual Therapy; Device: Placebo whole body vibration

Interventions

Whole body Vibration DEVICE

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).

PDExperimental

Habitual Therapy OTHER

Physical therapy will be administered to all study subjects. Experimental group will perform their session the same day that the experimental intervention.

PDControl; PDExperimental

Placebo whole body vibration DEVICE

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).

PDControl

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Seville: lead
• Asociación de Enfermos de Parkinson de Sevilla: collaborator

Study Sites (1)

Asociación de Enfermos de Parkinson de Sevilla

Seville, 41009, Spain

Location

MeSH Terms

Conditions

Parkinson Disease; Muscle Rigidity

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Paula González García

CONTACT

954486516; pgonzalez@us.es

Alfonso Garrido Bueno

CONTACT

alfgarbuen@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: November 17, 2022
• Study Start: January 1, 2023
• Primary Completion: September 30, 2023
• Study Completion: November 30, 2023
• Last Updated: November 17, 2022

Record last verified: 2022-11

Locations

ES (1)