NCT03774225

The Influence of Manual and Verbal Guidance for Therapeutic Results in People With Parkinson's Disease

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
OTHER	Virtual Reality with Manual and Verbal Guidance	Participants will perform 4 balance games during 8 sessions with a manually and verbally assisted by a experient physiotherapist.
OTHER	Virtual Reality with No Manual and Verbal Guidance	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.
OTHER	Physical Therapy	Patients of the control group will be trained with balance exercises by a experient physiotherapist.

Timeline

• Start date: 2017-12-01
• Primary completion: 2018-04-30
• Completion: 2019-07-20
• First posted: 2018-12-12
• Last updated: 2019-02-18

Locations

2 sites across 1 country: Brazil