Parkinson Disease Clinical Trial
Official title:
Effects Of Physiotherapy Intervention In A Motor Training With Virtual Reality On Motor, Cognitive, Balance And Gait Of Patients With Parkinson Disease: A Randomized Clinical Trial
Verified date | July 2018 |
Source | University of Sao Paulo General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A prospective, single-blind, parallel-group, randomised trial was conducted in Sao Paulo, Brazil. Thrid eight People with Parkinson's Disease were recruited and randomly allocated in two groups: Experimental Group (EG), that performed the balance and gait training based on games from Microsoft Xbox Kinect System ® (MXKS) supported by manual and verbal guidance (MVG) provided by a PT and a control group (CG) that performed an identical training with no MVG during the training.
Status | Active, not recruiting |
Enrollment | 49 |
Est. completion date | July 20, 2019 |
Est. primary completion date | April 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Parkinson's disease diagnosis according to Parkinson's Disease Society Brain Bank of London criteria - Active treatment with levodopa - Classification in stages 1, 2 and 3 according to Hoehn and Yahr Classification Exclusion Criteria: - Severe cognitive impairment defined as = 20 in Montreal Cognitive Assessment - Severe respiratory and / or cardiovascular conditions - Visual and / or auditory deficit that can not be corrected with orthotics; - Other previously detected orthopedic or neurological diseases, other than Parkinson's Disease, that may interfere with the individual's performance; - Previous experience with Microsoft XBOX Kinect® games; - Be in rehab at another location concomitant with study training. |
Country | Name | City | State |
---|---|---|---|
Brazil | Brazil Parkinson Association | São Paulo | |
Brazil | Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy, School of Medicine, University of São Paulo | São Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo General Hospital |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Functional balance and gait with Best Test | A scale consisting of 36 items, the score having a variation in four levels, 0 being the worst performance and 3 the best, with a total score of 108. This scale evaluates the balance under six different domains: biomechanical changes, stability / verticality limits, anticipatory postural adjustments, postural responses, sensory orientation and gait stability | 1 week before beginning the training; after 1 week of the end of training; and after 8 weeks of the ending the training (follow up) | |
Primary | Change in Gait with 6 minut walk test | a gait assessment method that measures the maximum distance a person can walk and measures maximal cardiorespiratory functions | 1 week before beginning the training; after 1 week of the end of training; and after 8 weeks of the ending the training (follow up) | |
Primary | Change in Functional balance with Rapid turn test | Is a mesure of dynamic balance. The subject tested turns in a complete circle (360 degrees) as faster as it could while time to finshed the turn is recorded. The test is done for both sides (right and left). | 1 week before beginning the training; after 1 week of the end of training; and after 8 weeks of the ending the training (follow up) | |
Secondary | Specific motor and non-motor aspects of Parkinson's disease with UPDRS scale | It's a scale composed of four parts: Part I (non-motor aspects of daily life), Part II (motor aspects of daily life), Part III (motor evaluation) and Part IV (motor complications) | 1 week before beginning the training; after 1 week of the end of training; and after 8 weeks of the ending the training (follow up) | |
Secondary | Risk of falls with FES-I scale | presents questions about the concern with the possibility of falling when performing 16 activities, with respective scores from one to four. The total score can range from 16 (no concern) to 64 (extreme worry) | 1 week before beginning the training; after 1 week of the end of training; and after 8 weeks of the ending the training (follow up) | |
Secondary | Endurance with 6 minut walk test | a gait assessment method that measures the maximum distance a person can walk and measures maximal cardiorespiratory functions | 1 week before beginning the training; after 1 week of the end of training; and after 8 weeks of the ending the training (follow up) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05415774 -
Combined Deep Brain Stimulation in Parkinson's Disease
|
N/A | |
Recruiting |
NCT04691661 -
Safety, Tolerability, Pharmacokinetics and Efficacy Study of Radotinib in Parkinson's Disease
|
Phase 2 | |
Active, not recruiting |
NCT05754086 -
A Multidimensional Study on Articulation Deficits in Parkinsons Disease
|
||
Completed |
NCT04045925 -
Feasibility Study of the Taïso Practice in Parkinson's Disease
|
N/A | |
Recruiting |
NCT04194762 -
PARK-FIT. Treadmill vs Cycling in Parkinson´s Disease. Definition of the Most Effective Model in Gait Reeducation
|
N/A | |
Completed |
NCT02705755 -
TD-9855 Phase 2 in Neurogenic Orthostatic Hypotension (nOH)
|
Phase 2 | |
Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
Recruiting |
NCT05830253 -
Free-living Monitoring of Parkinson's Disease Using Smart Objects
|
||
Recruiting |
NCT03272230 -
Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System
|
N/A | |
Recruiting |
NCT06139965 -
Validity and Reliability of the Turkish Version of the Comprehensive Coordination Scale in Parkinson's Patients
|
||
Completed |
NCT04580849 -
Telerehabilitation Using a Dance Intervention in People With Parkinson's Disease
|
N/A | |
Completed |
NCT03980418 -
Evaluation of a Semiconductor Camera for the DaTSCAN™ Exam
|
N/A | |
Completed |
NCT04477161 -
Effect of Ketone Esters in Parkinson's Disease
|
N/A | |
Recruiting |
NCT04788693 -
Effects of Gait Rehabilitation With Motor Imagery in People With Parkinson's Disease
|
N/A | |
Completed |
NCT04942392 -
Digital Dance for People With Parkinson's Disease During the COVID-19 Pandemic
|
N/A | |
Terminated |
NCT03446833 -
LFP Beta aDBS Feasibility Study
|
N/A | |
Completed |
NCT03497884 -
Individualized Precise Localization of rTMS on Primary Motor Area
|
N/A | |
Completed |
NCT05538455 -
Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases
|
N/A | |
Recruiting |
NCT04997642 -
Parkinson's Disease and Movement Disorders Clinical Database
|
||
Completed |
NCT04117737 -
A Pilot Study of Virtual Reality and Antigravity Treadmill for Gait Improvement in Parkinson
|
N/A |