Improving Patient Motivation and Participation in Rehabilitation Program Through Social Games
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
traditional wooden checkerboard
gaming board with single-player games
gaming board with two-player games
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, upper limb rehabilitation, neuro-rehabilitation
Eligibility Criteria
Inclusion Criteria:
- Age≥65 years
- Has neurological disorders (e.g. cerebrovascular accident) with the need of upper limb rehabilitation;
- Able to stand or sit unsupported for 10 minutes;
- Discharged from hospital and living in community;
- Able to communicate either in English or Mandarin; and
- Able to provide informed written consent.
Exclusion Criteria:
- Has severe cognitive impairments (Mini-Mental State Examination (MMSE) score <10),
- With serious cardiorespiratory conditions,
- With capacity but do not wish to sign the consent form.
Sites / Locations
- Wang Pan
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
traditional wooden checkerboard
gaming board with single-player games
gaming board with two-player games
Arm Description
upper limb training with traditional wooden checkerboard
upper limb training with a LED-based interactive gaming board equipped with single-player games
upper limb training with two LED-based interactive gaming boards equipped with two-player competitive games
Outcomes
Primary Outcome Measures
Change from baseline motivation at 12 weeks
Intrinsic Motivation Inventory (IMI) - psychological measurement of motivation questionnaire
Secondary Outcome Measures
Change from baseline function of manual dexterity at 12 weeks
Measuring gross manual dexterity Block and Box Test (BBT)
Change from baseline function of finger dexterity at 12 weeks
Measuring finger dexterity with Nine-Hole Peg Test (NHPT)
Exercise duration
Overall exercise duration over12 weeks
Full Information
NCT ID
NCT03482414
First Posted
February 1, 2018
Last Updated
March 22, 2018
Sponsor
National University of Singapore
Collaborators
AWWA Rehab and Day Care Centre
1. Study Identification
Unique Protocol Identification Number
NCT03482414
Brief Title
Improving Patient Motivation and Participation in Rehabilitation Program Through Social Games
Official Title
Improving Patient Motivation and Participation in Rehabilitation Program Through Social Games: A 3-arm Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
August 7, 2017 (Actual)
Primary Completion Date
October 30, 2017 (Actual)
Study Completion Date
October 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Singapore
Collaborators
AWWA Rehab and Day Care Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This 12-week randomized controlled trial involves two intervention groups (i.e., single-player game group, competition game group) and one control group (i.e., conventional checkerboard group). The main objective of this study is to examine the effects of game-based training on patient motivation, exercise duration, and functional outcomes in comparison with the control group.
Detailed Description
A 12-week three-arm randomized controlled trial was conducted to compare the effects between the single-player game, competitive game and a control group (i.e. conventional training) on the motivation, exercise duration and functional improvement in a rehabilitation program. A mix of quantitative method (i.e., questionnaire) and qualitative methods (i.e., interview and observation) were used. The outcome measurements were: (1) motivation: Intrinsic Motivation Inventory (IMI), (2) participation: exercise duration, (3) functional improvement: nine-hole peg test (NHPT) and box and block test (BBT), and (4) user feedback.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, upper limb rehabilitation, neuro-rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
3-arm randomized controlled trial
Masking
Participant
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
traditional wooden checkerboard
Arm Type
Active Comparator
Arm Description
upper limb training with traditional wooden checkerboard
Arm Title
gaming board with single-player games
Arm Type
Experimental
Arm Description
upper limb training with a LED-based interactive gaming board equipped with single-player games
Arm Title
gaming board with two-player games
Arm Type
Experimental
Arm Description
upper limb training with two LED-based interactive gaming boards equipped with two-player competitive games
Intervention Type
Other
Intervention Name(s)
traditional wooden checkerboard
Other Intervention Name(s)
checkerboard for upper limb training
Intervention Description
upper limb training with traditional wooden checkerboard
Intervention Type
Other
Intervention Name(s)
gaming board with single-player games
Other Intervention Name(s)
interactive gaming board with single-player games
Intervention Description
upper limb training with a LED-based interactive gaming board equipped with single-player games
Intervention Type
Other
Intervention Name(s)
gaming board with two-player games
Other Intervention Name(s)
interactive gaming board with two-player competitive games
Intervention Description
upper limb training with two LED-based interactive gaming boards equipped with two-player competitive games
Primary Outcome Measure Information:
Title
Change from baseline motivation at 12 weeks
Description
Intrinsic Motivation Inventory (IMI) - psychological measurement of motivation questionnaire
Time Frame
week 1, week 12
Secondary Outcome Measure Information:
Title
Change from baseline function of manual dexterity at 12 weeks
Description
Measuring gross manual dexterity Block and Box Test (BBT)
Time Frame
week 1, week 12
Title
Change from baseline function of finger dexterity at 12 weeks
Description
Measuring finger dexterity with Nine-Hole Peg Test (NHPT)
Time Frame
week 1, week 12
Title
Exercise duration
Description
Overall exercise duration over12 weeks
Time Frame
week 1 to week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age≥65 years
Has neurological disorders (e.g. cerebrovascular accident) with the need of upper limb rehabilitation;
Able to stand or sit unsupported for 10 minutes;
Discharged from hospital and living in community;
Able to communicate either in English or Mandarin; and
Able to provide informed written consent.
Exclusion Criteria:
Has severe cognitive impairments (Mini-Mental State Examination (MMSE) score <10),
With serious cardiorespiratory conditions,
With capacity but do not wish to sign the consent form.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pan Wang
Organizational Affiliation
National University of Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wang Pan
City
Singapore
State/Province
Singapore - No State
ZIP/Postal Code
119613
Country
Singapore
12. IPD Sharing Statement
Citations:
PubMed Identifier
18833688
Citation
McDonnell M. Action research arm test. Aust J Physiother. 2008;54(3):220. doi: 10.1016/s0004-9514(08)70034-5. No abstract available.
Results Reference
background
PubMed Identifier
2489825
Citation
McAuley E, Duncan T, Tammen VV. Psychometric properties of the Intrinsic Motivation Inventory in a competitive sport setting: a confirmatory factor analysis. Res Q Exerc Sport. 1989 Mar;60(1):48-58. doi: 10.1080/02701367.1989.10607413.
Results Reference
background
PubMed Identifier
3160243
Citation
Mathiowetz V, Volland G, Kashman N, Weber K. Adult norms for the Box and Block Test of manual dexterity. Am J Occup Ther. 1985 Jun;39(6):386-91. doi: 10.5014/ajot.39.6.386.
Results Reference
background
PubMed Identifier
14527120
Citation
Oxford Grice K, Vogel KA, Le V, Mitchell A, Muniz S, Vollmer MA. Adult norms for a commercially available Nine Hole Peg Test for finger dexterity. Am J Occup Ther. 2003 Sep-Oct;57(5):570-3. doi: 10.5014/ajot.57.5.570.
Results Reference
background
PubMed Identifier
24991557
Citation
Popovic MD, Kostic MD, Rodic SZ, Konstantinovic LM. Feedback-mediated upper extremities exercise: increasing patient motivation in poststroke rehabilitation. Biomed Res Int. 2014;2014:520374. doi: 10.1155/2014/520374. Epub 2014 Jun 2.
Results Reference
background
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