Clinical trial NCT03774225: The Influence of Manual and Verbal Guidance for Therapeutic Results in People With Parkinson's Disease
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: Virtual Reality
International Classification of Functioning
Disability and Health
Rehabilitation
Gait
Balance
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2018-12-12
Enrollment: 49
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, single-blind, parallel-group, randomised trial
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Functional balance and gait with Best Test
timeFrame: 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)
measure: Change in Gait with 6 minut walk test
timeFrame: 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)
measure: Change in Functional balance with Rapid turn test
timeFrame: 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 outcomes:
measure: Specific motor and non-motor aspects of Parkinson's disease with UPDRS scale
timeFrame: 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)
measure: Risk of falls with FES-I scale
timeFrame: 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)
measure: Endurance with 6 minut walk test
timeFrame: 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)
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Brazil Parkinson Association
city: São Paulo
country: Brazil
facility: Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy, School of Medicine, University of São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Maria Elisa P Piemonte
role: PRINCIPAL_INVESTIGATOR
References: