Analysis of Balance and Mobility for Parkinson Disease After Whole Body Vibration

Acute Effect of Whole Body Vibration of Different Frequencies on Balance and Functional Mobility of Patients With Parkinson: Crossover-type Controlled Clinical Trial

Parkinson's disease has innumerous motor symptoms that impacting on the functional level of the patient, such as impairment in functional mobility and balance . Previous studies have already aimed to evaluate the effectiveness of whole body vibration, but without methodological criteria. The use of whole body vibration may be an alternative for the treatment of Parkinson's disease. Therefore, the objective of the study is to verify which frequency of vibration is able to improve the balance and mobility of patients with Parkinson's disease.

Study Overview

• Status: Unknown
• Conditions: Parkinson Disease
• Intervention / Treatment: Device: Whole body vibration

Detailed Description

After confirming the eligibility criteria, patients will be asked to sign the informed consent form. Subsequently, they will be randomly allocated to three groups: (i) group 6 Hz: full body vibration (frequency 6 Hz, amplitude 4 mm, five cycles lasting 1 minutes and interval between cycles of 1 minute) , (ii) 25 Hz group: full body vibration (25 Hz frequency, 4 mm amplitude, five cycles lasting 1 minute and interval between 1 minute cycles) and (iii) sham group: The sham vibration will be performed with the platform disconnected. Additionally, a sound device will be connected producing a noise similar to that of the connected platform for a time equivalent to that of the treatment protocol. The patient will be instructed to position himself standing on the platform, with a semi knee flexion in order that the vibration wave does not propagate to the head. The allocation will be made randomly among individuals, using a random sequence table generated by the website www.randomization.com. There will be a washout time of at least one week between one intervention and another. All evaluations took place inside the laboratory, which has all the equipment for the evaluation. The evaluations will take place immediately before the intervention and immediately after.

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Pernambuco
    • Paulista, Pernambuco, Brazil, 53433-665
      • Recruiting
      • Luis Mendes
      • Contact: Luis Mendes; Phone Number: 81995082891; Email: luuismendess@gmail.com
      • Sub-Investigator: Adriana Baltar
      • Sub-Investigator: Lavinia Salgado
      • Sub-Investigator: Bianca Maciel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• · Minimum score of the Montreal Cognitive Assessment (MoCA) (27 points);

  • Regular antiparkinsonian pharmacological treatment;
  • Staged from I to III on the modified Hoehn & Yahr scale.

Exclusion Criteria:

• · Individuals with other neurological disorders, postural hypotension, vestibular, visual, cardiovascular or musculoskeletal disorders that affect the performance of the proposed tests;

  • other associated neurological disease
  • changes in medication in use for Parkinson's disease for at least sixty days before the start of the study

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Whole body vibration 6 Hz; application of whole body vibration in the following parameters:frequency 6 Hz, amplitude 4 mm, five cycles lasting 1 minutes and interval between cycles of 1 minute	Device: Whole body vibration; 315/5000 application of whole body vibration with pre-established parameters for each group. All patients will participate in all groups, an interval of at least one week. They will be instructed to climb on the platform and to position a semi knee flexion and remain stationary during the vibration
Experimental: Whole body vibration 25 Hz; application of whole body vibration in the following parameters: 25 Hz frequency, 4 mm amplitude, five cycles lasting 1 minute and interval between 1 minute cycles	Device: Whole body vibration; 315/5000 application of whole body vibration with pre-established parameters for each group. All patients will participate in all groups, an interval of at least one week. They will be instructed to climb on the platform and to position a semi knee flexion and remain stationary during the vibration
Sham Comparator: Whole body vibration sham; application of whole body vibration in the following parameters: The sham vibration will be performed with the platform disconnected. A sound device will be connected producing a noise similar to that of the connected platform for a time equivalent to that of the treatment protocol.	Device: Whole body vibration; 315/5000 application of whole body vibration with pre-established parameters for each group. All patients will participate in all groups, an interval of at least one week. They will be instructed to climb on the platform and to position a semi knee flexion and remain stationary during the vibration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Function mobility	The evaluation of the functional mobility of individuals will be performed by the Timed Up and Go test. It will analyze the time spent by the individual to get up from a chair with arms, walk for three meters and return to the chair	Before (T0) and immediate after vibration (T1)
Change in Static and dynamic balance	The assessment of static and dynamic balance using the Biodex Balance System (BBS) tool, capable of evaluating the displacement of the center of mass in the anteroposterior and laterolateral axes on a circular platform that can oscillate up to 20 ° in all directions in the horizontal plane. Static balance was performed using the Postural Stability Test, while dynamic balance was assessed using the Limits of Stability Test. The MiniBest test was performed to assess dynamic balance. The test consists of the application of 14 tasks that measure the patient's dynamic balance in different positions, through 14 items, with scores ranging from zero to two	Before (T0) and immediate after vibration (T1)
Change in static balance	The indirect center of pressure (COP) was acquired by the baropodometric static platform (Sensor Medica). The patient was instructed to position himself on the platform with his arms relaxed along his body, in the usual posture and looking towards the horizon, with a postural adaptation time of 30 seconds. The collection started without being informed to the patient. The averages of the three acquisitions of the following measures were analyzed of center of pressure	Before (T0) and immediate after vibration (T1)
Change in foot pressure	The direct foot pressure was acquired by the baropodometric static platform (Sensor Medica).The patient was instructed to position himself on the platform with his arms relaxed along his body, in the usual posture and looking towards the horizon, with a postural adaptation time of 30 seconds. The collection started without being informed to the patient. The averages of the three acquisitions of the following measures were analyzed: (i) maximum pressure in the forefoot; (ii) maximum pressure in the midfoot and (iii) maximum pressure in the hindfoot.	Before (T0) and immediate after vibration (T1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cadence of gait	The acquisition was made during the timed up and go, using the Wiva® Mob, an inertial sensor connected to the software via Bluetooth. The inertial sensor will be placed on the patient's waist to measure gait cadence during the timed up ando go test	Before (T0) and immediate after vibration (T1)
Change in support phase of gait	The acquisition was made during the timed up and go, using the Wiva® Mob, an inertial sensor connected to the software via Bluetooth. The inertial sensor will be placed on the patient's waist to measure gait support phase during the timed up ando go test	Before (T0) and immediate after vibration (T1)
Change in swing phase of gait	The acquisition was made during the timed up and go, using the Wiva® Mob, an inertial sensor connected to the software via Bluetooth. The inertial sensor will be placed on the patient's waist to measure gait swing phase during the timed up ando go test	Before (T0) and immediate after vibration (T1)
Change in Risk of falls	It was assessed using the "FallRisk" test of the Biodex balance System balance platform. The BBS will show the general stability index (GSI). In addition to the GSI, the BBS will show whether the patient is at risk of falls considering the age group	Before (T0) and immediate after vibration (T1)
Change in Functionality assessment	It was carried out through session III of the UPDRS (Unified parkinson's disease rating scale), the responses vary between 0 and 4 with a total sum of the items of 108, so that higher values indicate a greater degree of dependence, while, lower values, greater degree of functionality	Before (T0) and immediate after vibration (T1)

Collaborators and Investigators

• Sponsor: Universidade Federal de Pernambuco

Study record dates

Study Major Dates

• Study Start (Anticipated): August 15, 2020
• Primary Completion (Anticipated): October 15, 2020
• Study Completion (Anticipated): November 15, 2020

Study Registration Dates

• First Submitted: August 5, 2020
• First Submitted That Met QC Criteria: August 7, 2020
• First Posted (Actual): August 11, 2020

Study Record Updates

• Last Update Posted (Actual): August 11, 2020
• Last Update Submitted That Met QC Criteria: August 7, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Balance; Parkinson Disease; Whole body vibration; Function Mobility
• 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: Whole_body_vibration_PD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No