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

University of Sao Paulo General Hospital

Status: Unknown

Conditions: Parkinson Disease

Treatments: Other: Virtual Reality with Manual and Verbal Guidance; Other: Virtual Reality with No Manual and Verbal Guidance; Other: Physical Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03774225

Pâmela e Amarílis

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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49 participants in 3 patient groups

Manual and verbal guidance (MVG)

Experimental group

Description:

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®

Treatment:

Other: Physical Therapy

Other: Virtual Reality with No Manual and Verbal Guidance

Other: Virtual Reality with Manual and Verbal Guidance

No manual and verbal guidance (NMVG)

Experimental group

Description:

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.

Treatment:

Other: Physical Therapy

Other: Virtual Reality with No Manual and Verbal Guidance

Other: Virtual Reality with Manual and Verbal Guidance

Physical Therapy

Active Comparator group

Description:

The Control Group will be trained by conventional Physical Therapy exercises.

Treatment:

Other: Physical Therapy

Other: Virtual Reality with No Manual and Verbal Guidance

Other: Virtual Reality with Manual and Verbal Guidance