Effects of Kinesthetic Stimuli During XBOX Kinect Training on People With Parkinson's Disease

NCT ID: NCT04717271

Last Updated: 2023-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-30
• Study Completion Date: 2021-12-16

Brief Summary

A single-blind, parallel-group, randomised trial will be conducted in Sao Paulo, Brazil. People with Parkinson's Disease (PD) will be recruited at "Brazil Parkinson Association" (BPA), a non-governmental association of PD care, and randomly allocated in two groups: the Movement Guidance Group (MVG) and NO-MVG Group. Both groups will perform XBOX Kinect training for balance and gait. However, the MVG will receive kinesthetic stimuli manually by the physiotherapist (PT) to improve the participant movements while the NO-MVG Group will not, the presence of the PT will be restrict to only guarantee the participant safety.

Detailed Description

BACKGROUND: Despite evidences indicate the benefit of motor interventions based on video games in people with Parkinson's Disease (PD), practice guidelines for the therapeutic use in physiotherapy were still not established. Although visual and auditory stimuli provided by video games are pointed as one of the main advantages for their therapeutic use, the effects of kinesthetic stimuli offered through physical therapist manual intervention during this type of training in people with PD have not been investigated yet. The answer to this question is relevant to guide the physical therapist (PT) conduct during this kind of intervention.

PURPOSE: To compare the effects of motor training using video games with and without kinesthetic stimuli offered by physical therapist manual guidance during intervention on the functionality of people with PD.

METHODS: A blind randomized clinical trial in people with idiopathic PD, staging of 1 to 3 according to disability scale of Hoehn and Yahr, will be performed. Participants will be randomized into two groups: the Movement Guidance Group (MVG) and NO-MVG Group. Both groups will receive 8 individual sessions, twice a week, for 4 weeks. Each session consist of 10 minutes of warm-up and 40 minutes of XBOX Kinect training for balance and gait. In the MVG Group, the PT will provide kinesthetic stimuli by assisting manually the participant movements. In the NO-MVG Group, the involvement of the PT will be restricted to ensure participant safety. The two groups will be evaluated before (BT) and after (AT) training and after 60 days (follow-up). A blind physiotherapist will conduct the assessments. Measurements are categorized according to the International Functioning Classification (ICF), those associated with the activity level were established as primary measures: Balance Evaluation Systems Test (BESTest); International Falls Effectiveness Scale (FES-I); 30-second Gait Test; Six Minute Walk Distance (6MWD); Five Times Sit to Stand Test (FTSTS) and Unified Parkinson's Disease Rate Scale (UPDRS) session II. Secondary measures were the evaluation of function using UPDRS session III; Rapid Turns Test (RTT); Montreal Cognitive Assessment (MOCA); Geriatric Depression Scale (GDS-15), and participation using the Parkinson's Disease Quality of Life Questionnaire (PDQ-39).

STATISTICAL ANALYSIS: An ANOVA to repeated measures will be use, having as factors: group (MVG Group and NO-MVG Group) and evaluations (BT, AT and FU). Followed by post hoc Tukey Test to the significance factors. A significance of 5% will be considered.

Conditions

Parkinson Disease

Study Design

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

Study Groups

Movement Guidance Group (MVG)

In the MVG Group, the physiotherapist will provide kinesthetic stimuli by assisting manually the participant movements.

Group Type: EXPERIMENTAL

Movement Guidance Group

Intervention Type: OTHER

Participants of the MVG will received kinesthetic stimuli by manual assistance of the physiotherapist, which has the intention of guiding and improving the quality of movement during XBOX Kinect training for balance and gait.

Each session consisted of 10 minutes of warm-up and 40 minutes of XBOX Kinect training, using 4 different exergames.

No Movement Guidance Group (NO-MVG)

In the NO-MVG, the involvement of the physiotherapist will be restricted to guarantee the safety of the participant.

Group Type: EXPERIMENTAL

No Movement Guidance Group

Intervention Type: OTHER

Participants of the NO-MVG will not received kinesthetic stimuli by manual assistance of the physiotherapist during XBOX Kinect training for balance and gait.

They will perform the exercises without any manual correction. Although, the physiotherapist will be present during all session to ensure their safety.

Each session consisted of 10 minutes of warm-up and 40 minutes of XBOX Kinect training, using 4 different exergames.

Interventions

Movement Guidance Group

Participants of the MVG will received kinesthetic stimuli by manual assistance of the physiotherapist, which has the intention of guiding and improving the quality of movement during XBOX Kinect training for balance and gait.

Each session consisted of 10 minutes of warm-up and 40 minutes of XBOX Kinect training, using 4 different exergames.

Intervention Type: OTHER

No Movement Guidance Group

Participants of the NO-MVG will not received kinesthetic stimuli by manual assistance of the physiotherapist during XBOX Kinect training for balance and gait.

They will perform the exercises without any manual correction. Although, the physiotherapist will be present during all session to ensure their safety.

Each session consisted of 10 minutes of warm-up and 40 minutes of XBOX Kinect training, using 4 different exergames.

Intervention Type: OTHER

Other Intervention Names

MVG; NO-MVG

Eligibility Criteria

Inclusion Criteria

• Idiopathic Parkinson's disease diagnosis according to Parkinson's Disease Society Brain Bank of London criteria
• Active treatment with levodopa
• Stages 1, 2, and 3 according to Hoehn and Yahr Classification

Exclusion Criteria

• Severe cognitive impairment defined as ≤ 20 in Montreal Cognitive Assessment
• Score greater than or equal to 6 on the geriatric depression scale
• Severe respiratory and / or cardiovascular conditions
• Visual and / or auditory deficit that cannot be corrected with glasses or a hearing aid;
• 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
• And being in rehabilitation in another location concomitant to this 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, PT, PhD

Role: STUDY_DIRECTOR

University of Sao Paulo

Pâmela Y Igarasi Barbosa, PT

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Amarilis Falconi, PT

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

Pâmela

Identifier Type: -

Identifier Source: org_study_id