An interventional study of Virtual Reality with Manual and Verbal Guidance and Virtual Reality with No Manual and Verbal Guidance in Parkinson Disease, sponsored by University of Sao Paulo General Hospital. Status unknown at 2 sites in Brazil. Open to participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-02-18.
Sponsored by University of Sao Paulo General Hospital · Not applicable, Interventional, and Treatment
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.
It were recruited PPD in the "Brazil Parkinson Association" (BPA), a no-government association of PD care, where the assessments and intervention were performed from December 2017 to June 2018. The PPD were recruited by randomization from the BPA list of active patients and waiting list for PT intervention.
Outcome measures were obtained at up to three time points: before intervention, after 1 week and after 8 weeks of the end of intervention, the last time point was considered as a follow-up assessment. This study is in agreement with CONSORT guidelines for developing randomised trials . Primary measures was the functional balance evaluation by the Balance Evaluation Systems Test (BESTest) and Rapid Turn Test (RT Test), and gait performance assessed in the six-minute walk test and Gait test in 30 seconds. As secondary measures were used: Unified Parkinson's Disease Rate Scale (UPDRS), 5-Step Standing Passing Test (ST-DP5), International Falls Efficiency Scale (FES-I), Brazilian Version of the Freezing Scale March (FOGQ), Parkinson's Disease Quality of Life Questionnaire (PDQ-39), Geriatric Depression Scale (GDS-15).
All patients performed 8 individual training sessions, under the supervision of a physiotherapist, twice a week for four weeks. Each session had 10 minutes of identical global exercises for both groups, consisting of stretching, muscle strengthening and axial mobility exercises, one serie per session. After these initial 10 minutes, both groups performed an additional 40 minutes of balance training using four XBOX games, four per session, under different conditions for MVG and NMVG.
While the Control Group will be trained by conventional Physical Therapy exercises.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 49 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
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Exclusion Criteria:
The MVG Group will be done by experimental group with the manual and verbal guidance of a physiotherapist using four games of X-Box Kinect system®
Other: Virtual Reality with Manual and Verbal Guidance · Other: Virtual Reality with No Manual and Verbal Guidance · Other: Physical Therapy
The NMVG Group will be done by experimental group using four games of X-Box Kinect system® in the presence of a physiotherapist that will care about the safety of the participants without interfere in their moviment pattern.
Other: Virtual Reality with Manual and Verbal Guidance · Other: Virtual Reality with No Manual and Verbal Guidance · Other: Physical Therapy
The Control Group will be trained by conventional Physical Therapy exercises.
Other: Virtual Reality with Manual and Verbal Guidance · Other: Virtual Reality with No Manual and Verbal Guidance · Other: Physical Therapy
Participants will perform 4 balance games during 8 sessions with a manually and verbally assisted by a experient physiotherapist.
Also known as: Experimental Group with Manual and Verbal Guidance (MVG)
Participants will perform 4 balance games during 8 sessions in the presence of a experient physiotherapist that will ensure patient safety, providing motivational verbal stimuli, and replicating the feedback provided by the game.
Also known as: Experimental Group with No Manual and Verbal Guidance (NMVG)
Patients of the control group will be trained with balance exercises by a experient physiotherapist.
Also known as: Control Group
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
Time frame: 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)
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
Time frame: 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)
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).
Time frame: 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)
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)
Time frame: 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)
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)
Time frame: 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)
Endurance with 6 minut walk test
a gait assessment method that measures the maximum distance a person can walk and measures maximal cardiorespiratory functions
Time frame: 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)
This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo General Hospital