NCT03482414

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 7, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

3 months

First QC Date

February 1, 2018

Last Update Submit

March 22, 2018

Conditions

Keywords

strokeupper limb rehabilitationneuro-rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Change from baseline motivation at 12 weeks

    Intrinsic Motivation Inventory (IMI) - psychological measurement of motivation questionnaire

    week 1, week 12

Secondary Outcomes (3)

  • Change from baseline function of manual dexterity at 12 weeks

    week 1, week 12

  • Change from baseline function of finger dexterity at 12 weeks

    week 1, week 12

  • Exercise duration

    week 1 to week 12

Study Arms (3)

traditional wooden checkerboard

ACTIVE COMPARATOR

upper limb training with traditional wooden checkerboard

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

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

Other: gaming board with two-player games

Interventions

upper limb training with traditional wooden checkerboard

Also known as: checkerboard for upper limb training
traditional wooden checkerboard

upper limb training with a LED-based interactive gaming board equipped with single-player games

Also known as: interactive gaming board with single-player games
gaming board with single-player games

upper limb training with two LED-based interactive gaming boards equipped with two-player competitive games

Also known as: interactive gaming board with two-player competitive games
gaming board with two-player games

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wang Pan

Singapore, Singapore - No State, 119613, Singapore

Location

Related Publications (5)

  • McDonnell M. Action research arm test. Aust J Physiother. 2008;54(3):220. doi: 10.1016/s0004-9514(08)70034-5. No abstract available.

    PMID: 18833688BACKGROUND
  • 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.

    PMID: 2489825BACKGROUND
  • 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.

    PMID: 3160243BACKGROUND
  • 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.

    PMID: 14527120BACKGROUND
  • 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.

    PMID: 24991557BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Pan Wang

    National University of Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 3-arm randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 1, 2018

First Posted

March 29, 2018

Study Start

August 7, 2017

Primary Completion

October 30, 2017

Study Completion

October 30, 2017

Last Updated

March 29, 2018

Record last verified: 2018-03

Locations