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

Video Game-based Exercise for Persons With Parkinson's Disease

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: NCT03689764
Recruitment Status : Completed
First Posted : September 28, 2018
Last Update Posted : October 18, 2019
Sponsor:
Information provided by (Responsible Party):
Lai chien hung, Taipei Medical University Hospital

Tracking Information
First Submitted Date  ICMJE September 24, 2018
First Posted Date  ICMJE September 28, 2018
Last Update Posted Date October 18, 2019
Actual Study Start Date  ICMJE June 2014
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2018)
Change of Berg Balance Scale (BBS) [ Time Frame: 15 minutes/session; measured at weeks 0, 6, and 12 of the experiment ]
Participants perform a series of 14 functional balance tasks, such as maintaining a quiet stance, sitting-to-stand, shifting weight and reaching, turning in place, standing on one leg, and maintaining a tandem stance. The performance of each task is scored on a 5-point ordinal scale (from 0 to 4). A score of 0 denotes the inability of the participant to perform the task, and a score of 4 denotes that the participant can complete the task based on a preset criterion. The highest possible score is 56 . Previous studies have shown that inter-rater and intra-rater reliability of BBS is high in elderly people and stroke patients.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2018)
  • Change of 36-Item Short-Form Health Survey (SF-36) [ Time Frame: 15 minutes/session; measured at weeks 0, 6, and 12 of the experiment ]
    The 8 scales in SF 36 including Physical function (PF), Role-physical (RP), Bodily pain (BP), General health (GH), Vitality (VT), Social Function (SF), Role-Emotional (RE), Mental Health (MH) . Neuromuscular condition is one of the most frequently studied disease with use of SF-36 .
  • Change of Modified Falls Efficacy Scale (MFES) [ Time Frame: 10 minutes/session; measured at weeks 0, 6, and 12 of the experiment ]
    The MFES is a 14-item rating scale questionnaire that contains the original 10-activity Falls Efficacy Scale and 4 additional activities. Items are rated from 0 (not confident at all) to 10 (completely confident), and the highest possible score is 140.
  • Change of Multidirectional Reach Test (MDRT) [ Time Frame: 10 minutes/session; measured at weeks 0, 6, and 12 of the experiment ]
    The participants were required to reach in the forward, left and right directions. For the forward-reaching direction, the participants began by raising both arms to the shoulder level. They were then instructed to reach forward as far as they could without moving their feet, while maintaining the end-range position for 3 seconds. A soft measuring tape fixed to the wall was used to measure the start and end positions of the middle finger to measure the reaching distance. The same instructions were provided for the lateral reaching tests, except that the participants lifted only their right or left arm when reaching in the right or left directions, respectively. Three trials were performed in each direction, and the reaching distance was normalized according to the measured foot length.
  • Change of Maximum Step Length (MSL) test [ Time Frame: 10 minutes/session; measured at weeks 0, 6, and 12 of the experiment ]
    The participants performed the MSL test in the forward, lateral and backward directions. For the forward direction test, the participants assumed the starting position by crossing their arms over their chest. They were then instructed to take a maximum step forward with one leg without moving the other, and then to return to the starting position with a single step.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Video Game-based Exercise for Persons With Parkinson's Disease
Official Title  ICMJE Effects of Interactive Video Game-based Exercise on Balance of Persons With Parkinson's Disease
Brief Summary This study assessed the effects of interactive video game-based exercise (IVGB) on balance in persons with Parkinson's disease . Twenty-four patients were randomly allocated to two groups (12 participants per group). Group A underwent IVGB training for the first 6 weeks, with no exercise in the subsequent 6 weeks. Group B had no exercise for the first 6 weeks and then received IVGB training in the subsequent 6 weeks. Both subjective and objective measures were used to determine whether IVGB exercise improves balance function.
Detailed Description The experiments were conducted as a prospective, randomized, single blinded, crossover, 12-week trial. The group A undergoes the IVGB training in the initial 6 weeks (intervention phase), follows by suspended from exercise in the subsequent 6 weeks (control phase). The group B does not received treatment in the first 6 weeks (control phase), and then performs IVGB training in the following 6 weeks (intervention phase). For all participants, The 36-Item Short-Form Health Survey (SF-36), Modified Falls Efficacy Scale (MFES), Berg Balance Scale (BBS), Multidirectional reach test (MDRT) and Maximum step length (MSL) test were assessed at weeks 0, 6, and 12 of the experiment.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Parkinson Disease
Intervention  ICMJE
  • Other: interactive video game-based exercise
    Twenty-four patients were randomly allocated to two groups (12 participants per group). Group A received interactive video game-based exercise training for the first 6 weeks, with no intervention in the subsequent 6 weeks. Group B had no intervention for the first 6 weeks and then underwent interactive video game-based exercise training in the subsequent 6 weeks.
  • Other: no intervention
    Twenty-four patients were randomly assigned to two groups (12 participants per group). Group A received interactive video game-based exercise training for the first 6 weeks, with no intervention in the subsequent 6 weeks. Group B had no intervention for the first 6 weeks and then underwent interactive video game-based exercise training in the subsequent 6 weeks.
Study Arms  ICMJE
  • Experimental: Group A
    Group A underwent interactive video game-based exercise for the initial 6 weeks, with no treatment in the subsequent 6 weeks. The exercise program consisted of 30-minute sessions 3 times per week for 6 weeks. Outcomes were measured at weeks 0, 6, and 12.
    Interventions:
    • Other: interactive video game-based exercise
    • Other: no intervention
  • Experimental: Group B
    Group B had no intervention in the first 6 weeks and then received interactive video game-based exercise in the subsequent 6 weeks. The exercise program consisted of 30-minute sessions 3 times per week for 6 weeks. Outcomes were measured at weeks 0, 6, and 12.
    Interventions:
    • Other: interactive video game-based exercise
    • Other: no intervention
Publications * Yuan RY, Chen SC, Peng CW, Lin YN, Chang YT, Lai CH. Effects of interactive video-game-based exercise on balance in older adults with mild-to-moderate Parkinson's disease. J Neuroeng Rehabil. 2020 Jul 13;17(1):91. doi: 10.1186/s12984-020-00725-y.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 27, 2018)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 15, 2019
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • medical diagnosis of idiopathic Parkinson's Disease
  • independent community ambulatory individuals
  • capable of giving informed and written consent (Mini-Mental Status Examination (MMSE)>23)

Exclusion Criteria:

  • the other neurological conditions such as dementia, and stroke, or if they have arthritis, vision impairment,
  • cardiovascular disease that impair walking, or diabetic and uremic individuals, or if they were unable to walk without assistance.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03689764
Other Study ID Numbers  ICMJE 201311032
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Lai chien hung, Taipei Medical University Hospital
Study Sponsor  ICMJE Taipei Medical University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chien-Hung Lai, MD PhD Taipei Medical University Hospital
PRS Account Taipei Medical University Hospital
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP