Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03891069
Recruitment Status : Completed
First Posted : March 26, 2019
Last Update Posted : March 26, 2019
Sponsor:
Collaborator:
University of Lisbon
Information provided by (Responsible Party):
Campus Neurológico Sénior

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).


Condition or disease Intervention/treatment Phase
Parkinson Disease Device: AHA Exergame System Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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).
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Feasibility and Safety of the AHA Exergame System in Parkinson's Disease Patients: a Mixed Methods Study
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : September 30, 2018
Actual Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Interventional arm
Participants will be invited to play the five different Exergames, for a total of 5 minutes.
Device: AHA Exergame System
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.




Primary Outcome Measures :
  1. Patients' satisfaction with the games [ Time Frame: End of each game and at the end of the intervention, up to 5 hours after baseline assessment ]
    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)


Secondary Outcome Measures :
  1. Level of difficulty [ Time Frame: End of each game and at the end of the intervention, up to 5 hours after baseline assessment ]
    Patients level of difficulty with the game measures through a 7-point Likert scale

  2. Level of perceived exertion [ Time Frame: End of each game and at the end of the intervention, up to 5 hours after baseline assessment ]
    Changes in the level of perceived exertion measure at the end of each game and from baseline to end of all games with the modified Borg scale

  3. Number of adverse events [ Time Frame: Up to 2 days after baseline assessment ]
    Frequency of adverse events during study period

  4. Efficacy on functional mobility [ Time Frame: Baseline and end of the intervention, up to 5 hours after baseline assessment ]
    Changes in TUG test result from baseline to end of the intervention



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03891069


Locations
Layout table for location information
Portugal
Campus Neurológico Sénior
Torres Vedras, Portugal, 2560-280
Sponsors and Collaborators
Campus Neurológico Sénior
University of Lisbon
Investigators
Layout table for investigator information
Principal Investigator: Joaquim Ferreira, MD, PhD Campus Neurológico Sénior
Layout table for additonal information
Responsible Party: Campus Neurológico Sénior
ClinicalTrials.gov Identifier: NCT03891069    
Other Study ID Numbers: CNS2019-01
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Campus Neurológico Sénior:
Parkinson's disease
Exergames
Virtual reality
Exercise
Feasibility study
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases