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

NCT04717271 | Completed

• 1 other identifier: Pâmela
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Parkinson's Disease; Physical Therapy Specialty; Virtual Reality; International Classification of Functioning; Disability and Health; Rehabilitation

Outcome Measures

Primary Outcomes (6)

• Balance Evaluation Systems Test (BESTest)

  Balance Evaluation Systems Test (BESTest) measures balance. It includes 36 items that evaluate performance of 6 balance systems: biomechanical constraints, stability limits/verticality, anticipatory postural adjustments, postural responses, sensory orientation, and stability in gait.

  Change from baseline up to 3 months

• International Falls Effectiveness Scale (FES-I)

  It presents questions about the concern with the possibility of falling when performing 16 activities, with respective scores from one to four. The total score can range from 16 (no concern) to 64 (extreme worry).

  Change from baseline up to 3 months

• 30-second Gait Test

  Functional mobility test that assesses gait performance under the influence of a verbal fluency cognitive task (speaking as many words that start with a certain letter established by the evaluator), in which the individual must walk continuously for 30 seconds and, when multitasking, he or she is instructed to perform both without interruption (command = "perform both tasks at the same time, without stopping talking or walking"). The evaluator measures the distance that the subject was able to travel in a single task and in a double task.

  Change from baseline up to 3 months

• Six Minute Walk Distance

  A gait assessment method that measures the maximum distance a person can walk in six minutes and measures maximal cardiorespiratory functions.

  Change from baseline up to 3 months

• Five Times Sit to Stand

  A measure of functional mobility that assists in the identification of insufficient strength and muscle strength of the lower limbs, assessing balance and identifying people at risk of falls. In this task, the individual is instructed to sit and get up from a chair, without armrests, for 5 times without stopping as quickly as possible. The evaluator measures the time the subject performs this task.

  Change from baseline up to 3 months

• Unified Parkinson Disease Rating Scale - Session II

  It is a gold standard scale used to assess and monitor PD progression. It consists of 42 items and divided into four segments: Part I (non-motor aspects of daily life), Part II (motor aspects of daily life), Part III (motor evaluation) and Part IV (motor complications). a score from 0 to 4 is established, the lower the score the better the individual's condition. In Part II, the questions are conducted by the evaluator and the answers are based on the self-reported report by the evaluated person regarding his motor performance in daily life activities.

  Change from baseline up to 3 months

Secondary Outcomes (4)

• Unified Parkinson Disease Rating Scale - Session III

  Change from baseline up to 3 months

• Rapid Turns Test

  Change from baseline up to 3 months

• Geriatric Depression Scale

  Change from baseline up to 3 months

• Montreal Cognitive Assessment

  Change from baseline up to 3 months

Study Arms (2)

Movement Guidance Group (MVG)

EXPERIMENTAL

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

Other: Movement Guidance Group

No Movement Guidance Group (NO-MVG)

EXPERIMENTAL

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

Other: No Movement Guidance Group

Interventions

Movement Guidance Group 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.

Also known as: MVG

Movement Guidance Group (MVG)

No Movement Guidance Group 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.

Also known as: NO-MVG

No Movement Guidance Group (NO-MVG)

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

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

São Paulo, São Paulo, 05360-160, Brazil

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Maria Elisa P Piemonte, PT, PhD

  University of Sao Paulo

  STUDY DIRECTOR

• Pâmela Y Igarasi Barbosa, PT

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

• Amarilis Falconi, PT

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: A experient physical therapy will be responsible for assessments of all participants without knowing the group allocation of which.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single-blind, parallel-group and randomized clinical trial

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 22, 2021
• Study Start: November 30, 2020
• Primary Completion: August 31, 2021
• Study Completion: December 16, 2021
• Last Updated: January 31, 2023

Record last verified: 2020-11

Locations

BR (1)