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

Primary Purpose

Parkinson Disease

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Whole body vibration
Sponsored by
Universidade Federal de Pernambuco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson Disease, Balance, Function Mobility, Whole body vibration

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Luis MendesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Whole body vibration 6 Hz

Whole body vibration 25 Hz

Whole body vibration sham

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

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
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
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
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.

Secondary Outcome Measures

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
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
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
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
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

Full Information

First Posted
August 5, 2020
Last Updated
August 7, 2020
Sponsor
Universidade Federal de Pernambuco
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1. Study Identification

Unique Protocol Identification Number
NCT04507490
Brief Title
Analysis of Balance and Mobility for Parkinson Disease After Whole Body Vibration
Official Title
Acute Effect of Whole Body Vibration of Different Frequencies on Balance and Functional Mobility of Patients With Parkinson: Crossover-type Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 15, 2020 (Anticipated)
Primary Completion Date
October 15, 2020 (Anticipated)
Study Completion Date
November 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Pernambuco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson Disease, Balance, Function Mobility, Whole body vibration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model 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. There will be a washout time of at least one week between one intervention and another
Masking
ParticipantInvestigator
Masking Description
Double blind. Only the interventionist will be allowed to access the vibration condition. In this way, the patient and the investigator will be blind for the type of vibration that the patient will receive.
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Whole body vibration 6 Hz
Arm Type
Experimental
Arm Description
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
Arm Title
Whole body vibration 25 Hz
Arm Type
Experimental
Arm Description
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
Arm Title
Whole body vibration sham
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Whole body vibration
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Function mobility
Description
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
Time Frame
Before (T0) and immediate after vibration (T1)
Title
Change in Static and dynamic balance
Description
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
Time Frame
Before (T0) and immediate after vibration (T1)
Title
Change in static balance
Description
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
Time Frame
Before (T0) and immediate after vibration (T1)
Title
Change in foot pressure
Description
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.
Time Frame
Before (T0) and immediate after vibration (T1)
Secondary Outcome Measure Information:
Title
Change in Cadence of gait
Description
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
Time Frame
Before (T0) and immediate after vibration (T1)
Title
Change in support phase of gait
Description
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
Time Frame
Before (T0) and immediate after vibration (T1)
Title
Change in swing phase of gait
Description
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
Time Frame
Before (T0) and immediate after vibration (T1)
Title
Change in Risk of falls
Description
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
Time Frame
Before (T0) and immediate after vibration (T1)
Title
Change in Functionality assessment
Description
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
Time Frame
Before (T0) and immediate after vibration (T1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Luis Mendes
City
Paulista
State/Province
Pernambuco
ZIP/Postal Code
53433-665
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Mendes
Phone
81995082891
Email
luuismendess@gmail.com
First Name & Middle Initial & Last Name & Degree
Adriana Baltar
First Name & Middle Initial & Last Name & Degree
Rodrigo Brito
First Name & Middle Initial & Last Name & Degree
Lavinia Salgado
First Name & Middle Initial & Last Name & Degree
Bianca Maciel

12. IPD Sharing Statement

Plan to Share IPD
No

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

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