Clinical trial NCT02496702: Playware Technology for Balance Training
Official title: Efficacy of Interactive Modular Tiles Training Versus "Usual Care" on Physical Attributes Among Elder Adults 70+. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accidental Falls
Keywords: exergaming
Senior Fitness Test
Lead sponsor: Technical University of Denmark
Sponsor class: OTHER
First posted: 2015-07-14
Enrollment: 60
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Change From Baseline in Test Score of 6 Minute Walking Test at Week 14.
timeFrame: Baseline and at week 14
measure: Change From Baseline in Test Score of 30-second Chair Stand at Week 14.
timeFrame: Baseline and at week 14
measure: Change From Baseline in Test Score of 8-Foot Up-and-Go at Week 14.
timeFrame: Baseline and at week 14
Secondary outcomes:
measure: Change From Baseline in Test Score of Line Walk at Week 14.
timeFrame: Baseline and at week 14
measure: Change From Baseline in Test Score of Static Balance at Week 14.
timeFrame: Baseline and at week 14
measure: Adherence to Training, Composite Outcome Measure.
timeFrame: At week 14
measure: Motivation for Training
timeFrame: At week 14.
measure: Acceptability of IMT
timeFrame: At week 14.
Other outcomes:
Locations:
city: Kgs. Lyngby
country: Denmark
facility: Technical University of Denmark
Study officials:
References:
citation: 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.
citation: 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.