Clinical trial NCT04717271: Effects of Kinesthetic Stimuli During XBOX Kinect Training on People With Parkinson's Disease
Official title: Effects of Kinesthetic Stimuli Provided by the Physiotherapist During XBOX Kinect Training on the Functionality of People With Parkinson's Disease: A Blind Randomized Clinical Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson's Disease
Physical Therapy Specialty
Virtual Reality
International Classification of Functioning
Disability and Health
Rehabilitation
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 40
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: A single-blind, parallel-group and randomized clinical trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Balance Evaluation Systems Test (BESTest)
timeFrame: Change from baseline up to 3 months
measure: International Falls Effectiveness Scale (FES-I)
timeFrame: Change from baseline up to 3 months
measure: 30-second Gait Test
timeFrame: Change from baseline up to 3 months
measure: Six Minute Walk Distance
timeFrame: Change from baseline up to 3 months
measure: Five Times Sit to Stand
timeFrame: Change from baseline up to 3 months
measure: Unified Parkinson Disease Rating Scale - Session II
timeFrame: Change from baseline up to 3 months
Secondary outcomes:
measure: Unified Parkinson Disease Rating Scale - Session III
timeFrame: Change from baseline up to 3 months
measure: Rapid Turns Test
timeFrame: Change from baseline up to 3 months
measure: Geriatric Depression Scale
timeFrame: Change from baseline up to 3 months
measure: Montreal Cognitive Assessment
timeFrame: Change from baseline up to 3 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy, School of Medicine, University of São Paulo
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Maria Elisa P Piemonte, PT, PhD
role: STUDY_DIRECTOR
affiliation: University of Sao Paulo
name: Pâmela Y Igarasi Barbosa, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Amarilis Falconi, PT
role: PRINCIPAL_INVESTIGATOR
References: