Playware Technology for Balance Training (IMT)

• ClinicalTrials.gov Identifier: NCT02496702
• Recruitment Status: Completed
• First Posted: July 14, 2015
• Results First Posted: July 13, 2018
• Last Update Posted: July 13, 2018
• Sponsor: Technical University of Denmark
• Information provided by (Responsible Party): Jari Due Jessen, Technical University of Denmark

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Accidental Falls	Device: Training on Interactive Modulare Tiles	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Efficacy of Interactive Modular Tiles Training Versus "Usual Care" on Physical Attributes Among Elder Adults 70+. A Randomized Controlled Trial
• Study Start Date: July 2015
• Actual Primary Completion Date: April 2016
• Actual Study Completion Date: May 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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).	Device: Training on Interactive Modulare Tiles; Training with the Interactive Modulare Tiles
No Intervention: Control; No training.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 70 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Denmark

Technical University of Denmark

Kgs. Lyngby, Denmark, 2800

Sponsors and Collaborators

Technical University of Denmark

More Information

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Jari Due Jessen, PhD Student, Technical University of Denmark
• ClinicalTrials.gov Identifier: NCT02496702
• Other Study ID Numbers: H-15006703
• First Posted: July 14, 2015
• Results First Posted: July 13, 2018
• Last Update Posted: July 13, 2018
• Last Verified: October 2017

Keywords provided by Jari Due Jessen, Technical University of Denmark:

exergaming; Senior Fitness Test