Trial Outcomes & Findings for Playware Technology for Balance Training (NCT NCT02496702)
NCT ID: NCT02496702
Last Updated: 2018-07-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
Baseline and at week 14
Results posted on
2018-07-13
Participant Flow
Participant milestones
| Measure |
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).
Training on Interactive Modulare Tiles: Training with the Interactive Modulare Tiles
|
Control
No training.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
Received Allocated Intervention
|
21
|
0
|
|
Overall Study
Did Not Receive Allocated Intervention
|
9
|
0
|
|
Overall Study
COMPLETED
|
22
|
22
|
|
Overall Study
NOT COMPLETED
|
8
|
8
|
Reasons for withdrawal
| Measure |
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).
Training on Interactive Modulare Tiles: Training with the Interactive Modulare Tiles
|
Control
No training.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
6
|
|
Overall Study
Only partially tested
|
0
|
2
|
Baseline Characteristics
Playware Technology for Balance Training
Baseline characteristics by cohort
| Measure |
Training
n=30 Participants
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).
Training on Interactive Modulare Tiles: Training with the Interactive Modulare Tiles
|
Control
n=30 Participants
No training.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
83.14 years
STANDARD_DEVIATION 6.69 • n=5 Participants
|
82.37 years
STANDARD_DEVIATION 6.61 • n=7 Participants
|
82.73 years
STANDARD_DEVIATION 6.57 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Timed Up and Go
|
12.24 Seconds
STANDARD_DEVIATION 5.13 • n=5 Participants
|
13.35 Seconds
STANDARD_DEVIATION 10.10 • n=7 Participants
|
12.80 Seconds
STANDARD_DEVIATION 7.96 • n=5 Participants
|
|
Chair Stand
|
9.23 Chair stands per 30 seconds
STANDARD_DEVIATION 4.47 • n=5 Participants
|
8.77 Chair stands per 30 seconds
STANDARD_DEVIATION 3.91 • n=7 Participants
|
9 Chair stands per 30 seconds
STANDARD_DEVIATION 4.17 • n=5 Participants
|
|
6 Minute Walking Test
|
240.28 Meters
STANDARD_DEVIATION 71.21 • n=5 Participants
|
237.18 Meters
STANDARD_DEVIATION 94.77 • n=7 Participants
|
238.73 Meters
STANDARD_DEVIATION 83.12 • n=5 Participants
|
|
Line Walk
|
2.37 Steps
STANDARD_DEVIATION 4.36 • n=5 Participants
|
3.50 Steps
STANDARD_DEVIATION 2.49 • n=7 Participants
|
2.93 Steps
STANDARD_DEVIATION 3.56 • n=5 Participants
|
|
Height
|
1.62 cm
n=5 Participants
|
1.65 cm
n=7 Participants
|
1.63 cm
n=5 Participants
|
|
Weight
|
68.33 kg
STANDARD_DEVIATION 13.22 • n=5 Participants
|
71.13 kg
STANDARD_DEVIATION 13.34 • n=7 Participants
|
69.73 kg
STANDARD_DEVIATION 13.25 • n=5 Participants
|
|
BMI
|
26.17 kg/m^2
STANDARD_DEVIATION 5.21 • n=5 Participants
|
26.16 kg/m^2
STANDARD_DEVIATION 4.45 • n=7 Participants
|
26.16 kg/m^2
STANDARD_DEVIATION 4.80 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and at week 14Numbers 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.
Outcome measures
| Measure |
Training
n=22 Participants
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).
Training on Interactive Modulare Tiles: Training with the Interactive Modulare Tiles
|
Control
n=22 Participants
No training.
|
|---|---|---|
|
Change From Baseline in Test Score of 6 Minute Walking Test at Week 14.
|
1.07 m
Interval -13.6 to 15.7
|
0.568 m
Interval -18.2 to 19.3
|
PRIMARY outcome
Timeframe: Baseline and at week 14Number of full stands that can be completed in 30 seconds with arms folded across chest. Baseline score compared to score at week 14.
Outcome measures
| Measure |
Training
n=22 Participants
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).
Training on Interactive Modulare Tiles: Training with the Interactive Modulare Tiles
|
Control
n=22 Participants
No training.
|
|---|---|---|
|
Change From Baseline in Test Score of 30-second Chair Stand at Week 14.
|
2.05 Full chair stands per 30 seconds
Interval 0.513 to 3.58
|
0.455 Full chair stands per 30 seconds
Interval -0.375 to 1.28
|
PRIMARY outcome
Timeframe: Baseline and at week 14Number 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.
Outcome measures
| Measure |
Training
n=22 Participants
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).
Training on Interactive Modulare Tiles: Training with the Interactive Modulare Tiles
|
Control
n=22 Participants
No training.
|
|---|---|---|
|
Change From Baseline in Test Score of 8-Foot Up-and-Go at Week 14.
|
-1.38 seconds
Interval -2.77 to 0.0207
|
-0.0473 seconds
Interval -0.837 to 0.742
|
SECONDARY outcome
Timeframe: Baseline and at week 14Number 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.
Outcome measures
| Measure |
Training
n=22 Participants
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).
Training on Interactive Modulare Tiles: Training with the Interactive Modulare Tiles
|
Control
n=22 Participants
No training.
|
|---|---|---|
|
Change From Baseline in Test Score of Line Walk at Week 14.
|
2.23 Steps
Interval 0.88 to 3.57
|
1.09 Steps
Interval -0.539 to 2.72
|
SECONDARY outcome
Timeframe: Baseline and at week 14Population: Data were not collected.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At week 14Adherence to the training will be measured by registering the number of times the participants participate and how much they participate at each session.
Outcome measures
| Measure |
Training
n=22 Participants
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).
Training on Interactive Modulare Tiles: Training with the Interactive Modulare Tiles
|
Control
No training.
|
|---|---|---|
|
Adherence to Training, Composite Outcome Measure.
|
90.6 percentage of sessions
Interval 85.6 to 95.6
|
—
|
SECONDARY outcome
Timeframe: At week 14.Semi-structured interviews will be done with the participant after the intervention to investigate the motivation of the IMT.
Outcome measures
| Measure |
Training
n=20 Participants
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).
Training on Interactive Modulare Tiles: Training with the Interactive Modulare Tiles
|
Control
No training.
|
|---|---|---|
|
Motivation for Training
|
85 percentage of wanting to continue
|
—
|
SECONDARY outcome
Timeframe: At week 14.Semi-structured interviews will be done with the participant after the intervention to investigate the acceptability of the IMT
Outcome measures
| Measure |
Training
n=20 Participants
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).
Training on Interactive Modulare Tiles: Training with the Interactive Modulare Tiles
|
Control
No training.
|
|---|---|---|
|
Acceptability of IMT
|
90 percentage of happy to train on IMT
|
—
|
Adverse Events
Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jari Due Jessen
Technical University of Denmark, Center for Playware
Phone: +45 45 25 39 29
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place