Effects of Whole Body Vibration in Parkinson's Disease Symptoms

Parkinson Disease Clinical Trial

Official title:

Effects of Whole Body Vibration in Parkinson's Disease Symptoms

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05621031
• Other study ID #: USFISIOTERAPIAPGG01
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: November 30, 2023

Study information

• Verified date: November 2022
• Source: University of Seville
• Contact: Paula González García
• Phone: 954486516
• Email: pgonzalez[@]us.es
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 (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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: November 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.

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).

Locations

Country	Name	City	State
Spain	Asociación de Enfermos de Parkinson de Sevilla	Sevilla

Sponsors (2)

Lead Sponsor	Collaborator
University of Seville	Asociación de Enfermos de Parkinson de Sevilla

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Age	Years	Baseline
Other	Height	Cm	Baseline
Other	Weight	Kg	Baseline
Other	Time since Parkinson disease diagnosis	Years and months	Baseline
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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