Back to resultsVideo Game-based Exercise for Persons With Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
interactive video game-based exercise
no intervention
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
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.
Sites / Locations
- Taipei Medical university Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A
Group B
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change of Berg Balance Scale (BBS)
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.
Secondary Outcome Measures
Change of 36-Item Short-Form Health Survey (SF-36)
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)
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)
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
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.
Full Information
NCT ID
NCT03689764
First Posted
September 24, 2018
Last Updated
October 17, 2019
Sponsor
Taipei Medical University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03689764
Brief Title
Video Game-based Exercise for Persons With Parkinson's Disease
Official Title
Effects of Interactive Video Game-based Exercise on Balance of Persons With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
June 2014 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
January 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
interactive video game-based exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
no intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Berg Balance Scale (BBS)
Description
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.
Time Frame
15 minutes/session; measured at weeks 0, 6, and 12 of the experiment
Secondary Outcome Measure Information:
Title
Change of 36-Item Short-Form Health Survey (SF-36)
Description
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 .
Time Frame
15 minutes/session; measured at weeks 0, 6, and 12 of the experiment
Title
Change of Modified Falls Efficacy Scale (MFES)
Description
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.
Time Frame
10 minutes/session; measured at weeks 0, 6, and 12 of the experiment
Title
Change of Multidirectional Reach Test (MDRT)
Description
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.
Time Frame
10 minutes/session; measured at weeks 0, 6, and 12 of the experiment
Title
Change of Maximum Step Length (MSL) test
Description
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.
Time Frame
10 minutes/session; measured at weeks 0, 6, and 12 of the experiment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chien-Hung Lai, MD PhD
Organizational Affiliation
Taipei Medical University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Medical university Hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32660512
Citation
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.
Results Reference
derived
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Video Game-based Exercise for Persons With Parkinson's Disease
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