Clinical trial NCT04507490: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson Disease
Balance
Function Mobility
Whole body vibration
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2020-08-11
Enrollment: 12
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Function mobility
timeFrame: Before (T0) and immediate after vibration (T1)
measure: Change in Static and dynamic balance
timeFrame: Before (T0) and immediate after vibration (T1)
measure: Change in static balance
timeFrame: Before (T0) and immediate after vibration (T1)
measure: Change in foot pressure
timeFrame: Before (T0) and immediate after vibration (T1)
Secondary outcomes:
measure: Change in Cadence of gait
timeFrame: Before (T0) and immediate after vibration (T1)
measure: Change in support phase of gait
timeFrame: Before (T0) and immediate after vibration (T1)
measure: Change in swing phase of gait
timeFrame: Before (T0) and immediate after vibration (T1)
measure: Change in Risk of falls
timeFrame: Before (T0) and immediate after vibration (T1)
measure: Change in Functionality assessment
timeFrame: Before (T0) and immediate after vibration (T1)
Other outcomes:
Locations:
city: Paulista
country: Brazil
facility: Luis Mendes
state: Pernambuco
Study officials:
References: