Parkison's disease, Neurological Gait Disorders
Conditions
Interventions
For the evaluations, individuals will be on previously booked a session for three-dimensional gait analysis , which will be held at the UNINOVE Gait Laboratory. On the evaluations , subjects will be i
stretcher and ladder for support, foam for balance training
chair. The frequency will be about two times per week, for at least one day interval and a minimum duration of 60 minutes. The session will be divided into four p
Other
H02.010.625
Sponsors
Faculdade de Medicina da Universidade de São Paulo
Universidade Nove de Julho
Eligibility
Age
37 Years to 71 Years
Inclusion criteria
Inclusion criteria: Indication of the implant deep brain stimulation; Over 18 years of age, clinical diagnosis of idiopathic Parkinson's disease according to international criteria, absence of adequate response to treatment with medication or with complications related to prolonged use of L-dopa; Expected to be anesthesia or local anesthesia or general do not incur greater risk than expected in the general population; Ability to understand and sign the consent form; Blood tests, coagulation and normal metabolic; Absence of anatomic abnormalities that preclude access to the implant the electrodes (cranial tumors, intra-cranial and brain cysts), absence of infection or other medical conditions pre-existing non-controlled (diabetes, hypertension, symptomatic pulmonary or cardiac diseases) no use of antiplatelet agents, not being performing concurrent treatment with other experimental drugs; Absence of pregnancy and breastfeeding; conditions psychological, familial, sociological or geographical impossible medical monitoring post-operative Fitness for Motor Training Program, Maintenance of good clinical conditions previously described; Maintenance of all clinics and drug restrictions described; Installation of deep brain stimulation (DBS) for two months at least; DBS working properly at the time of inclusion; Accept and sign the consent form to participate in the training program.
Exclusion criteria
Exclusion criteria: Inability to consent to participate in the study: With uncontrolled infection or other medical conditions pre-existing non-controlled (eg decompensated diabetes, hypertension, pneumonia or symptomatic heart disease), history of primary or secondary myocardial ischemia, congestive heart failure, cardiac arrhythmia, or bundle branch block refractory to treatment, concomitant treatment with other experimental drugs, pregnant or lactating; Conditions psychological, familial, sociological or geographical conditions that preclude medical monitoring post-operative history of orthopedic surgery of lower limbs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increased functional performance of patients with IPD after the gain obtained by deep brain electrical stimulation, assessed by linear and angular movement of the lower limb joints by means of SMART Software System Analyser. The variables of the linear kinematic (spatiotemporal) are: 1. Velocity (cm / sec). 2. Cadence (steps / minute). 3. Stride length (cm). 4. Step width (cm). 5. Path length (cm). 7. Response to load (% of cycle). 9. Single support time (% cycle). 11. Pre-balance (% of cycle). 13. Double-support time (% cycle). 15. Time Balance (% duty cycle). The angular kinematic variables are: 1. Angular position at initial contact (degrees). 2. Peak in the angular position of the support (degrees). 3. Maximum angular position of the balance (degrees). 4. Time of the maximum value of the balance (% duty cycle). 5. Time minimum value of the balance (% duty cycle) 6. Angular position of the swing (degrees). The kinetic analysis of gait measurement of ground reaction forces (GRF) will be performed with 2 AMTI force platforms, model OR6-6-2000 placed in the center lane of travel. It is expected that the ring foot to be tested through the platform while the other remains outside the card during the past, but it is important that the individual makes as a natural event. | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life improvement, measured by quantitative parameters as clinical tests: Time Up and Go Test(TUG) - stand up and walk. The TUG is utilized to determine functional mobility. Individual is oriented to sit in a arm chair and after a verbal cue he has to stand up, walk 3 meters, turn around, walk again and sit down in the chair. It has to be a comfortable and AN usual walking. It's expected less than 13.5 seconds to complete task which indicate low fall risk. Berg Scale is used to evaluate balance and fall risk in elderly people. The scale is composed by 14 itens, ranging between 0 to 4 points, completing 56 points. It's expected scores up to 50 points which its indicate no fall risk. Even if the patients presents good scores in TUG and BERG Scales is expected an improvement of them after a rehabilitation training. | — |
Countries
Brazil
Contacts
Public ContactJúlia;Júlia Greve;Greve
Faculdade de Medicina da Universidade de São Paulo;Faculdade de Medicina da Universidade de São Paulo
Outcome results
None listed