Playware Technology for Balance Training

NCT ID: NCT02496702

Last Updated: 2018-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-05-31

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.

Detailed Description

This study will investigate the use of one form of exergames called IMT how this compared to usual care of elderly people 70+. The trial will consist of two groups, one for training with the IMT and usual care that will receive the care provided to non-patients elderly, which at this moment is no additional treatment other than recommendations.

The study will be single blinded, randomized controlled trial. It will be funded by the patient@home project and Entertainment robotics. Concealed allocation and intention-to-treat analysis will be used. Measurements will be taken at baseline and after intervention. Upon acceptance the protocol will be registered in clinicaltrials.gov.

The trial's results will be reported using domains and categories described in the taxonomy developed by the Prevention of Falls Network Europe, to allow future synthesis of evidence, or study replication.

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 control group will not train.

Conditions

Accidental Falls

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Training

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).

Group Type: EXPERIMENTAL

Training on Interactive Modulare Tiles

Intervention Type: DEVICE

Training with the Interactive Modulare Tiles

Control

No training.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Training on Interactive Modulare Tiles

Training with the Interactive Modulare Tiles

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Community-dwelling
• 70+ years

Exclusion Criteria

• 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.

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Technical University of Denmark

OTHER

Sponsor Role: lead

Responsible Party

Jari Due Jessen

PhD Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Technical University of Denmark

Kongens Lyngby, , Denmark

Countries

Denmark

References

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.

Reference Type: BACKGROUND

PMID: 25276497 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28103811 (View on PubMed)

Other Identifiers

H-15006703

Identifier Type: -

Identifier Source: org_study_id