Accidental FallsIMTNCT02496702

Playware Technology for Balance Training

A study testing Training on Interactive Modulare Tiles in people with Accidental Falls, run by Technical University of Denmark at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 70 years and olderHealthy volunteers can take part
Conditions the study is for: Accidental Falls
What is being tested?: Training on Interactive Modulare Tiles
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteDenmark
Study dates: Jul 2015to May 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 70 years and older
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

Community-dwelling
70+ years

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Technical University of Denmark
Kongens Lyngby, 2800

Other trials in Denmark

About this study

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

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.

Read the 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
Being tested: Training on Interactive Modulare Tiles
Keywords: exergaming, Senior Fitness Test

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Training on Interactive Modulare TilesDevice
Training with the Interactive Modulare Tiles

Study groups in NCT02496702
Study group	Role	What they receive
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). Receives: Device: Training on Interactive Modulare Tiles
Control	No intervention	No training.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: Baseline and at week 14

Secondary outcomes (5)

Change From Baseline in Test Score of Line Walk 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.
Measured: Baseline and at week 14
Change From Baseline in Test Score of Static Balance 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.
Measured: Baseline and at week 14
Adherence to Training, Composite Outcome Measure.
Adherence to the training will be measured by registering the number of times the participants participate and how much they participate at each session.
Measured: At week 14
Motivation for Training
Semi-structured interviews will be done with the participant after the intervention to investigate the motivation of the IMT.
Measured: At week 14.
Acceptability of IMT
Semi-structured interviews will be done with the participant after the intervention to investigate the acceptability of the IMT
Measured: At week 14.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2015May 2016

First posted14 Jul 2015 (estimated)
Study startJul 2015
Primary completionApr 2016
Study completionMay 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Accidental FallsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02496702
Sponsor's protocol ID: H-15006703
Acronym: IMT
Status last verified: Oct 2017
First submitted: 7 Jul 2015
Last updated: 13 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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. doi: 10.1089/g4h.2014.0028.
PubMed 25276497
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.
PubMed 28103811

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Accidental Falls trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Interactive Modular Tiles Training Versus "Usual Care" on Physical Attributes Among Elder Adults 70+. A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT02496702
Acronym / sponsor ID: IMT / H-15006703
Conditions: Accidental Falls
Keywords: exergaming, Senior Fitness Test
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Technical University of DenmarkUniversity, hospital or other
Study start: Jul 2015
Primary completion: Apr 2016 (actual)
Study completion: May 2016 (actual)
First posted: 14 Jul 2015 (estimated)
Results: Posted 13 Jul 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

The control group will not train.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Training	Experimental	Device: Training on Interactive Modulare TilesThe 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).
Control	No intervention	–No training.

Who may qualify

Ages: 70 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (2 listed)

Community-dwelling
70+ years

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Training on Interactive Modulare TilesTraining with the Interactive Modulare Tiles	Device	Training

Primary outcome

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.
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.
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.

5 secondary outcomes

Change From Baseline in Test Score of Line Walk at Week 14.
Time frame: Baseline and at week 14
Change From Baseline in Test Score of Static Balance at Week 14.
Time frame: Baseline and at week 14
Adherence to Training, Composite Outcome Measure.
Time frame: At week 14
Motivation for Training
Time frame: At week 14.
Acceptability of IMT
Time frame: At week 14.

Results and safety

Results posted to the registry on 13 Jul 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Training	30	22
Control	30	22

Primary outcome: Change From Baseline in Test Score of 6 Minute Walking Test at Week 14.

Time frame: Baseline and at week 14. Mean (95% Confidence Interval). Unit: m

Measure	Training n = 22	Control n = 22
Value	1.07 (-13.6 to 15.7)	0.568 (-18.2 to 19.3)

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

Time frame: Baseline and at week 14. Mean (95% Confidence Interval). Unit: Full chair stands per 30 seconds

Measure	Training n = 22	Control n = 22
Value	2.05 (0.513 to 3.58)	0.455 (-0.375 to 1.28)

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

Time frame: Baseline and at week 14. Mean (95% Confidence Interval). Unit: seconds

Measure	Training n = 22	Control n = 22
Value	-1.38 (-2.77 to 0.0207)	-0.0473 (-0.837 to 0.742)

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Training	0 of 30 (0%)	0 of 30 (0%)	Not reported
Control	0 of 30 (0%)	0 of 30 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25276497Lund 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.
Derived from this study: PubMed 28103811Jessen 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Training on Interactive Modulare Tiles in people with Accidental Falls, run by Technical University of Denmark at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Test Score of 6 Minute Walking Test at Week 14. (time frame: Baseline and at week 14). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02496702, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2018.