NCT07567599Csak meghívásos
Deep Brain Stimulation in Parkinson's Disease: Motor and Functional Outcomes
Effects of Deep Brain Stimulation Surgery on Motor and Functional Outcomes in Individuals With Parkinson's Disease: An Uncontrolled Clinical Trial
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. júl. 29.
Rövid összefoglaló (regiszter, angolul)
Introduction: Parkinson's Disease (PD) is a progressive neurodegenerative condition characterized by classic motor symptoms, such as bradykinesia, rigidity, resting tremor, and postural instability, which directly compromise the mobility and autonomy of individuals with PD. Furthermore, non-motor manifestations, including autonomic, cognitive, and emotional changes, impact the quality of life of individuals with PD. Deep Brain Stimulation (DBS) surgery is a well-established treatment to assist in improving the primary motor symptoms of PD; however, literature is scarce in describing specific results regarding physiotherapeutic aspects, such as the motor symptoms that determine better quality of life and social participation for individuals with PD. Determining whether factors amenable to improvement prior to surgery-such as bradykinesia, muscle strength, and balance-are related to better motor and functional outcomes in individuals with PD post-DBS is of great importance to ensure a better result from the surgical intervention. Objective: To compare motor outcomes (gait speed, balance, freezing of gait, fear of falling, muscle strength, functional capacity, and physical activity level) of individuals with PD after undergoing DBS, relative to the motor status previously observed in the preoperative period. Methods: This is an uncontrolled clinical trial, with data collection conducted at the Neurovida private multidisciplinary clinic and the Hospital Santa Casa in Belo Horizonte. This study will be registered at www.clinicalTrials.gov and conducted according to the Consolidated Standards of Reporting Trials (CONSORT) recommendations. The present study will be submitted to the Research Ethics Committee of the Federal University of Minas Gerais (COEP) and will only commence after proper approval. All necessary consents for the development of the study have been obtained. The sample consists of individuals with idiopathic PD selected by a clinical neurologist specializing in movement disorders. The inclusion criteria for the present study are: having idiopathic PD diagnosed for more than five years, being under treatment with a neurologist specializing in movement disorders, and having an indication for DBS. Descriptive statistics and normality tests will be performed for all study variables. Selected variables will be compared in terms of mean difference between post- and pre-surgery measurements, considering a 95% CI. In all analyses, a significance level of α=0.05 will be considered, using the SPSS statistical package version 15.0 for Windows.
- Állapot (regiszter)
- Csak meghívásos
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 40 (tervezett)
- Első benyújtás
- 2026. ápr. 28.
- Kezdés
- 2026. jún. 2.
- Elsődleges befejezés
- 2027. febr.
- Fő szponzor
- Federal University of Minas Gerais
- Betegségek
- Parkinson-kór
- NCT-szám
- NCT07567599
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 40
- 2026. jún. 2. és az elsődleges befejezés (2027. febr.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Más betegség
- Individuals who do not wish to undergo surgery; those with severe cardiovascular or orthopedic comorbidities that pose a risk during the surgical procedure; and those presenting with dementia or severe psychiatric disorders that could be exacerbated by the surgery.
Kiket keres a vizsgálat
- Individuals with PD who have been evaluated by a clinical neurologist specializing in movement disorders and have a medical indication for DBS surgical treatment. These individuals will undergo surgical screening, which includes prior neurological, speech-language pathology, neuropsychological, and physical therapy assessments.
Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Clínica NeuroVida | Belo Horizonte | Brazília | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.