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Completed

NCT Number: NCT02496702

Playware Technology for Balance Training

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.

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Key information

Conditions

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Technical University of Denmark

Kongens Lyngby, 2800, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Training on Interactive Modulare Tiles

Device

Training with the Interactive Modulare Tiles

Primary outcomes

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

    Time frame: Baseline and 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.

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

    Time frame: Baseline and 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.

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

    Time frame: Baseline and 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.

Secondary outcomes

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

    Time frame: Baseline and at week 14

    Number of steps a person can do on a line directly after the foot without touching outside the line. Baseline score compared to score at week 14.

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

    Time frame: Baseline and at week 14

    Static Balance will be measured using Wii Balance Board, which have proven to be a valid measure of balance (Sgró 2014). This measure will be done using an application developed by Francesco Sgró and colleagues (Sgró 2014). Baseline score compared to score at week 14.

  3. Adherence to Training, Composite Outcome Measure.

    Time frame: At week 14

    Adherence to the training will be measured by registering the number of times the participants participate and how much they participate at each session.

  4. Motivation for Training

    Time frame: At week 14.

    Semi-structured interviews will be done with the participant after the intervention to investigate the motivation of the IMT.

  5. Acceptability of IMT

    Time frame: At week 14.

    Semi-structured interviews will be done with the participant after the intervention to investigate the acceptability of the IMT

Sponsors and collaborators

Lead sponsor

Technical University of Denmark

Other

Registry information

Official study title

Efficacy of Interactive Modular Tiles Training Versus "Usual Care" on Physical Attributes Among Elder Adults 70+. A Randomized Controlled Trial

Acronym: IMT

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 14, 2015
Registry last updated
Jul 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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