NCT02496702

Brief Summary

This study evaluates the use of Playware technology for balance training. Falling among elder is a costly problem. Research shows that training can help prevent falls. Pilot studies of the use of Interactive Modular Tiles (IMT) show that the participants can highly increase their physical abilities. The interventions group will train using interactive modular tiles. The tiles include preprogrammed games that create playful training for the participants. The control group will receive "usual care", which here refers to normal day activities. The intervention will be done 2 times a week for 12 weeks, each session lasting 1 hour and each participant receiving 13 minutes of training each time.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable

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

July 1, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 14, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

July 13, 2018

Completed
Last Updated

July 13, 2018

Status Verified

October 1, 2017

Enrollment Period

9 months

First QC Date

July 7, 2015

Results QC Date

June 2, 2016

Last Update Submit

October 1, 2017

Conditions

Keywords

exergamingSenior Fitness Test

Outcome Measures

Primary Outcomes (3)

  • Change From Baseline in Test Score of 6 Minute Walking Test at Week 14.

    Numbers of meters that can be walked in 6 minutes around a 50-yard (45.7 meters) course. Baseline score compared to score at week 14.

    Baseline and at week 14

  • Change From Baseline in Test Score of 30-second Chair Stand at Week 14.

    Number of full stands that can be completed in 30 seconds with arms folded across chest. Baseline score compared to score at week 14.

    Baseline and at week 14

  • Change From Baseline in Test Score of 8-Foot Up-and-Go at Week 14.

    Number of seconds required to get up from a seated position, walk 8 feet (2.44 meters), turn, and return to seated position. Baseline score compared to score at week 14.

    Baseline and at week 14

Secondary Outcomes (5)

  • Change From Baseline in Test Score of Line Walk at Week 14.

    Baseline and at week 14

  • Change From Baseline in Test Score of Static Balance at Week 14.

    Baseline and at week 14

  • Adherence to Training, Composite Outcome Measure.

    At week 14

  • Motivation for Training

    At week 14.

  • Acceptability of IMT

    At week 14.

Study Arms (2)

Training

EXPERIMENTAL

The intervention is done in the form of groups of 4-5 participants per set of tiles, with 2-3 set of tiles at a time. As more set can be used it is possible to make groups of more people. The training will consist of 1.5-3 minutes of training (depending on the game) on tiles and the rest while the other 2-3 participants train (4-6 minutes of break). Then the participants will train for 1.5-3 minutes again until each participant have received a total of 13 minutes of training. The intervention will be done 2 times a week for 12 weeks, each session lasting 1 hour and each participant receiving 13 minutes of training each time (see training plan).

Device: Training on Interactive Modulare Tiles

Control

NO INTERVENTION

No training.

Interventions

Training with the Interactive Modulare Tiles

Training

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Community-dwelling
  • + years

You may not qualify if:

  • A previous diagnosis of strong dementia or a cognitive decline that prevents the understanding of simple instructions or guidelines;
  • A previous stroke with a severe neurological impairment, such as loss of strength, and perceptual or language limitations;
  • A severe visual deficiency;
  • Inability to maintain a standing position, even with the use of a walking aid or other device;
  • Participating in rehabilitative training.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Technical University of Denmark

Kongens Lyngby, 2800, Denmark

Location

Related Publications (2)

  • Lund HH, Jessen JD. Effects of Short-Term Training of Community-Dwelling Elderly with Modular Interactive Tiles. Games Health J. 2014 Oct 1;3(5):277-283. doi: 10.1089/g4h.2014.0028.

    PMID: 25276497BACKGROUND
  • Jessen JD, Lund HH. Study protocol: effect of playful training on functional abilities of older adults - a randomized controlled trial. BMC Geriatr. 2017 Jan 19;17(1):27. doi: 10.1186/s12877-017-0416-5.

Results Point of Contact

Title
Jari Due Jessen
Organization
Technical University of Denmark, Center for Playware

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

July 7, 2015

First Posted

July 14, 2015

Study Start

July 1, 2015

Primary Completion

April 1, 2016

Study Completion

May 1, 2016

Last Updated

July 13, 2018

Results First Posted

July 13, 2018

Record last verified: 2017-10

Locations