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

NCT ID: NCT03774225

Last Updated: 2019-02-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2019-07-20

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Manual and verbal guidance (MVG)

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®

Group Type: EXPERIMENTAL

Virtual Reality with Manual and Verbal Guidance

Intervention Type: OTHER

Participants will perform 4 balance games during 8 sessions with a manually and verbally assisted by a experient physiotherapist.

Virtual Reality with No Manual and Verbal Guidance

Intervention Type: OTHER

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.

Physical Therapy

Intervention Type: OTHER

Patients of the control group will be trained with balance exercises by a experient physiotherapist.

No manual and verbal guidance (NMVG)

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.

Group Type: EXPERIMENTAL

Virtual Reality with Manual and Verbal Guidance

Intervention Type: OTHER

Participants will perform 4 balance games during 8 sessions with a manually and verbally assisted by a experient physiotherapist.

Virtual Reality with No Manual and Verbal Guidance

Intervention Type: OTHER

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.

Physical Therapy

Intervention Type: OTHER

Patients of the control group will be trained with balance exercises by a experient physiotherapist.

Physical Therapy

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

Group Type: ACTIVE_COMPARATOR

Virtual Reality with Manual and Verbal Guidance

Intervention Type: OTHER

Participants will perform 4 balance games during 8 sessions with a manually and verbally assisted by a experient physiotherapist.

Virtual Reality with No Manual and Verbal Guidance

Intervention Type: OTHER

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.

Physical Therapy

Intervention Type: OTHER

Patients of the control group will be trained with balance exercises by a experient physiotherapist.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Physical Therapy

Patients of the control group will be trained with balance exercises by a experient physiotherapist.

Intervention Type: OTHER

Other Intervention Names

Experimental Group with Manual and Verbal Guidance (MVG); Experimental Group with No Manual and Verbal Guidance (NMVG); Control Group

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Elisa P Piemonte

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

Brazil Parkinson Association

São Paulo, , Brazil

Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy, School of Medicine, University of São Paulo

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

Pâmela e Amarílis

Identifier Type: -

Identifier Source: org_study_id