StrokeNCT03482414
Improving Patient Motivation and Participation in Rehabilitation Program Through Social Games
A study testing traditional wooden checkerboard, gaming board with single-player games and gaming board with two-player games in people with Stroke, run by National University of Singapore at 1 site in Singapore.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- traditional wooden checkerboard, gaming board with single-player games and gaming board with two-player games
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSingapore
- Study dates
- 7 Aug 2017to 30 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Patient Motivation and Participation in Rehabilitation Program Through Social Games: A 3-arm Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- traditional wooden checkerboard, gaming board with single-player games, gaming board with two-player games
- Keywords
- stroke, upper limb rehabilitation, neuro-rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traditional wooden checkerboardOther
Also called checkerboard for upper limb training
upper limb training with traditional wooden checkerboard
gaming board with single-player gamesOther
Also called interactive gaming board with single-player games
upper limb training with a LED-based interactive gaming board equipped with single-player games
gaming board with two-player gamesOther
Also called interactive gaming board with two-player competitive games
upper limb training with two LED-based interactive gaming boards equipped with two-player competitive games
| Study group | Role | What they receive |
|---|---|---|
| traditional wooden checkerboard | Active comparator | upper limb training with traditional wooden checkerboard Receives: Other: traditional wooden checkerboard |
| gaming board with single-player games | Experimental | upper limb training with a LED-based interactive gaming board equipped with single-player games Receives: Other: gaming board with single-player games |
| gaming board with two-player games | Experimental | upper limb training with two LED-based interactive gaming boards equipped with two-player competitive games Receives: Other: gaming board with two-player games |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline motivation at 12 weeks
Intrinsic Motivation Inventory (IMI) - psychological measurement of motivation questionnaire
Measured: week 1, week 12
Secondary outcomes (3)
Change from baseline function of manual dexterity at 12 weeks
Measuring gross manual dexterity Block and Box Test (BBT)
Measured: week 1, week 12
Change from baseline function of finger dexterity at 12 weeks
Measuring finger dexterity with Nine-Hole Peg Test (NHPT)
Measured: week 1, week 12
Exercise duration
Overall exercise duration over12 weeks
Measured: week 1 to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start7 Aug 2017
- Primary completion30 Oct 2017
- Study completion30 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3-arm randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- AWWA Rehab and Day Care Centre
- Responsible party
- Principal investigator, Wang Pan, National University of Singapore
- Investigators
- Pan Wang, Principal investigator, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03482414
- Sponsor's protocol ID
- NUSingapore_WP
- Status last verified
- Mar 2018
- First submitted
- 1 Feb 2018
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
McDonnell M. Action research arm test. Aust J Physiother. 2008;54(3):220. doi: 10.1016/s0004-9514(08)70034-5. No abstract available.
PubMed 18833688McAuley 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.
PubMed 2489825Mathiowetz 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.
PubMed 3160243Oxford 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.
PubMed 14527120Popovic 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.
PubMed 24991557
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Patient Motivation and Participation in Rehabilitation Program Through Social Games: A 3-arm Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03482414
- Acronym / sponsor ID
- NUSingapore_WP
- Conditions
- Stroke
- Keywords
- stroke, upper limb rehabilitation, neuro-rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- AWWA Rehab and Day Care Centre
- Study start
- 7 Aug 2017 (actual)
- Primary completion
- 30 Oct 2017 (actual)
- Study completion
- 30 Oct 2017 (actual)
- First posted
- 29 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- 3-arm randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| traditional wooden checkerboard | Active comparator | Other: traditional wooden checkerboardupper limb training with traditional wooden checkerboard |
| gaming board with single-player games | Experimental | Other: gaming board with single-player gamesupper limb training with a LED-based interactive gaming board equipped with single-player games |
| gaming board with two-player games | Experimental | Other: gaming board with two-player gamesupper limb training with two LED-based interactive gaming boards equipped with two-player competitive games |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| traditional wooden checkerboardAlso: checkerboard for upper limb trainingupper limb training with traditional wooden checkerboard | Other | traditional wooden checkerboard |
| gaming board with single-player gamesAlso: interactive gaming board with single-player gamesupper limb training with a LED-based interactive gaming board equipped with single-player games | Other | gaming board with single-player games |
| gaming board with two-player gamesAlso: interactive gaming board with two-player competitive gamesupper limb training with two LED-based interactive gaming boards equipped with two-player competitive games | Other | gaming board with two-player games |
Primary outcome
Change from baseline motivation at 12 weeks
Time frame: week 1, week 12
Intrinsic Motivation Inventory (IMI) - psychological measurement of motivation questionnaire
3 secondary outcomes
Change from baseline function of manual dexterity at 12 weeks
Time frame: week 1, week 12
Change from baseline function of finger dexterity at 12 weeks
Time frame: week 1, week 12
Exercise duration
Time frame: week 1 to week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Background: PubMed 18833688McDonnell M. Action research arm test. Aust J Physiother. 2008;54(3):220. doi: 10.1016/s0004-9514(08)70034-5. No abstract available.
- Background: PubMed 2489825McAuley 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.
- Background: PubMed 3160243Mathiowetz 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.
- Background: PubMed 14527120Oxford 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.
- Background: PubMed 24991557Popovic 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pan Wang principal investigator
National University of Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing traditional wooden checkerboard, gaming board with single-player games and gaming board with two-player games in people with Stroke, run by National University of Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline motivation at 12 weeks (time frame: week 1, week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03482414, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018.