Feasibility of the AHA Exergame System in Parkinson's Disease Patients

NCT03891069 | Completed

• 1 other identifier: CNS2019-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Parkinson's disease (PD) remains a progressive disease associated with a high level of disability. Due to the physical and cognitive impairments, fatigue and apathy, patients frequently experience a decrease in their daily physical activity. Exercise programs have been recommended for symptomatic control, however, its implementation is still challenging in terms of acceptability and adherence. Exergames (i.e. exercise based on video games) have been proposed as a potential, home-based rehabilitation tool to improve PD patients motor skills and to promote a more active lifestyle. Methods: This study aims to evaluate the feasibility and safety of an exergames system design for PD patients' rehabilitation. A mix-methods study, including two focus groups (with patients and physiotherapists) and quantitative feasibility study, will be performed. Physiotherapists and PD patients with a Hoehn Yahr Stage ≤ 2 (MED ON), ability to walk independently without risk of falling and a Mini-mental state score \> 24 will be included. The primary outcome will be patients' satisfaction with the games measured through a 7-point Likert scale. Secondary outcomes will include games difficulty (7-point Likert scale), perceived effort (modified Borg scale), safety (number of adverse events) and functional mobility (Time up and Go test).

Conditions

Parkinson Disease

Keywords

Parkinson's disease; Exergames; Virtual reality; Exercise; Feasibility study

Outcome Measures

Primary Outcomes (1)

• Patients' satisfaction with the games

  Patients' satisfaction with the games, through a 7-point Likert scale, at the end of each game and at the end of the intervention (global perspective)

  End of each game and at the end of the intervention, up to 5 hours after baseline assessment

Secondary Outcomes (4)

• Level of difficulty

  End of each game and at the end of the intervention, up to 5 hours after baseline assessment

• Level of perceived exertion

  End of each game and at the end of the intervention, up to 5 hours after baseline assessment

• Number of adverse events

  Up to 2 days after baseline assessment

• Efficacy on functional mobility

  Baseline and end of the intervention, up to 5 hours after baseline assessment

Study Arms (1)

Interventional arm

EXPERIMENTAL

Participants will be invited to play the five different Exergames, for a total of 5 minutes.

Device: AHA Exergame System

Interventions

AHA Exergame System DEVICE

The AHA Exergame System consists of a mobile computing platform running a set of parameterizable exergames purposely designed for elderly fitness training. The platform is equipped with a 1000 lumens video projector capable of creating a 2.05m by 1.16m floor projection display and a Kinect V2 sensor to serve as game controller. The AHA exercise-based computer games have been designed for and tested with elderly people and were adapted for the functional limitations of PD patients. The system includes five different games that aim to train patients motor ability, cardiorespiratory and muscular strength.

Interventional arm

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with Parkinson's disease according to MDS criteria
• Age ≥ 40 and ≤ 80 years old
• Hoehn and Yahr stages between I, II and III (MED ON)
• MMSE \> 24
• Ability to walk independently without risk of falling
• Ability to communicate with the investigator, to understand and comply with the requirements of the study
• Willing and able to provide written informed consent to participate in the study
• Being interested in participating in this study

You may not qualify if:

• Patients diagnosed with atypical parkinsonian syndromes
• Significant postural instability in ON likely to affect gait and/or have the need to use a walking aid to walk safely
• Presence of severe dyskinesia's
• Having any other neurological/orthopedic disorders likely to affect gait, e.g., history of stroke
• Having significant active psychiatric problems (example: hallucinations, confusion, psychosis) that aggravates patient´s symptoms when dealing with the use of -Exergames
• Inability to correctly respond to the assessment protocol according to the clinician's judgment

Sponsors & Collaborators

• Campus Neurológico Sénior: lead
• University of Lisbon: collaborator

Study Sites (1)

Campus Neurológico Sénior

Torres Vedras, 2560-280, Portugal

Location

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Joaquim Ferreira, MD, PhD

  Campus Neurológico Sénior

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A mix-methods study, including two focus groups (with patients and physiotherapists) and quantitative feasibility study, will performed. Physiotherapists and PD patients with a Hoehn Yahr Stage ≤ 2 (MED ON), ability to walk independently without risk of falling and a Mini-mental state score \> 24 will be included. The primary outcome will be patients' satisfaction with the games measured through a 7-point Likert scale. Secondary outcomes will include: games difficulty (7-point Likert scale), perceived effort (modified Borg scale), safety (number of adverse events) and functional mobility (Time up and Go test).

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: March 26, 2019
• Study Start: June 1, 2018
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: March 26, 2019

Record last verified: 2019-03

Locations

PT (1)