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

NCT ID: NCT04507490

Last Updated: 2020-08-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-15
• Study Completion Date: 2020-11-15

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Whole body vibration

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Whole body vibration

Intervention Type: 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 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.

Group Type: SHAM_COMPARATOR

Whole body vibration

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal de Pernambuco

OTHER

Sponsor Role: lead

Responsible Party

Maria das Graças Rodrigues de Araújo

Maria das Graças Rodrigues de Araújo

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Luis Mendes

Paulista, Pernambuco, Brazil

Site Status: RECRUITING

Countries

Brazil

Facility Contacts

Luis Mendes

Role: primary

luuismendess@gmail.com

81995082891

Other Identifiers

Whole_body_vibration_PD

Identifier Type: -

Identifier Source: org_study_id