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

NCT04507490 | Unknown

• 1 other identifier: Whole_body_vibration_PD
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Parkinson Disease; Balance; Function Mobility; Whole body vibration

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Change in Cadence of gait

  Before (T0) and immediate after vibration (T1)

• Change in support phase of gait

  Before (T0) and immediate after vibration (T1)

• Change in swing phase of gait

  Before (T0) and immediate after vibration (T1)

• Change in Risk of falls

  Before (T0) and immediate after vibration (T1)

• Change in Functionality assessment

  Before (T0) and immediate after vibration (T1)

Study Arms (3)

Whole body vibration 6 Hz

EXPERIMENTAL

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

Whole body vibration 25 Hz

EXPERIMENTAL

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

Whole body vibration sham

SHAM COMPARATOR

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

Interventions

Whole body vibration DEVICE

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

Whole body vibration 25 Hz; Whole body vibration 6 Hz; Whole body vibration sham

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• · 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.

You may not qualify if:

• · 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

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

Luis Mendes

Paulista, Pernambuco, 53433-665, Brazil

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maria das Graças Rodrigues de Araújo

Model Details: 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

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: August 11, 2020
• Study Start: August 15, 2020
• Primary Completion: October 15, 2020
• Study Completion: November 15, 2020
• Last Updated: August 11, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)