Parkinson Disease Clinical Trial
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
Verified date | August 2020 |
Source | Universidade Federal de Pernambuco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 12 |
Est. completion date | November 15, 2020 |
Est. primary completion date | October 15, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Luis Mendes | Paulista | Pernambuco |
Lead Sponsor | Collaborator |
---|---|
Universidade Federal de Pernambuco |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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 | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) |
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