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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03940079
Other study ID # 201804055RINC
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2018
Est. completion date June 27, 2018

Study information

Verified date August 2020
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The declination on cognitive and motor functions in older adults increases the difficulty to achieve successful aging. Previous studies had reported that contrast to the traditional cognitive training methods, computer cognitive training (CCT) is comparable or has better effect on the cognitive function improvement with elders.On the other hand, some researchers claimed motor-cognitive dual-task training may possess greater effects than single cognitive training on cognitive functions. However, it is still on debate. Therefore, the research aims to investigate cognitive and motor benefits to healthy older adults over 65s trained by our computer-based cognitive game with high and low level of motor engagements.The research questions include: (1) Is CCT beneficial of cognitive functions? (2) Does CCT with high level of motor engagements (i.e. motor-cognitive dual-task training) have greater effects than single cognitive training on cognitive functions? (3) Can the training effect remain?


Description:

Quasi-experimental design was adapted in our research.There are four time-series assessments during the experiment: baseline, pretest, posttest, and follow-up. After the baseline assessment, participants were randomized to two groups: gross-motor group (GMG) and fine-motor group (FMG). The intervals between baseline and pretest as well as between pretest and posttest were both 4 weeks, while the interval between posttest and follow-up was 8 weeks.

The investigators developed a computer-based cognitive game and compared the efficacy of cognitive and motor functions between computer-based cognitive game combining two different demands on motor control. Investigators hypothesized: All participants who take part in the computer-based cognitive game training don't have learning effects on pretest and are able to improve cognitive functions including short-term memory, divided attention and inhibitory function after intervention; Gross-motor group make more progress than fine-motor group on cognitive and motor functions after intervention. Furthermore, gross-motor group maintained more training effect over cognitive and motor functions at follow-up than fine-motor group.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date June 27, 2018
Est. primary completion date June 27, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria:

1. = 65 years old

2. Montreal Cognitive Assessment (MoCA) score = 18

3. clear eyesight and hearing

4. both upper and lower limbs are functional

5. normal communication

Exclusion Criteria:

1. injury, fracture, and breathing problem

2. surgery during the research

3. severe disease affecting cognitive functions.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
computer-based cognitive game (including 3 training tasks)
First task was short-term memory training. Participants were instructed to memorize different colored circles with ordinal numbers which would disappear later. They triggered correct colored sensor in sequence according to their memory. Second task was divided attention training. Different colored circles with ordinal numbers would not disappear this time.The participants should trigger correct colored sensor according to their sequence. Third task was inhibitory function training. There were red and green lights, just like the traffic light, hung up at the upper left of the scene. Red light represented prohibition of triggering the colored sensor, while green light urged to trigger it. Yellow, red, blue and green circles showed up randomly and moved toward the beige region. When the circle came extremely closer to the beige region, the traffic light was randomized to lighten up red or green.The participants should judge and trigger the correct colored sensor.

Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline Montreal Cognitive Assessment (MoCA) Taiwan Version at the 4th, 8th and 16th weeks overall cognitive function baseline, 4th weeks pretest, 8th weeks posttest, 16th weeks follow-up
Primary Change from Baseline Digit Span Task-forward (DS-forward) at the 4th, 8th and 16th weeks short-term memory baseline, 4th weeks pretest, 8th weeks posttest, 16th weeks follow-up
Primary Change from Baseline Color Trails Test-2 (CTT-2) at the 4th, 8th and 16th weeks divided attention baseline, 4th weeks pretest, 8th weeks posttest, 16th weeks follow-up
Primary Change from Baseline Stroop Color Word Test (SCWT) at the 4th, 8th and 16th weeks inhibitory function baseline, 4th weeks pretest, 8th weeks posttest, 16th weeks follow-up
Primary Change from Baseline Nine Hole Peg Test (NHPT) at the 4th, 8th and 16th weeks motor function of upper limbs baseline, 4th weeks pretest, 8th weeks posttest, 16th weeks follow-up
Primary Change from Baseline Get-Up and Go Test (GUG) at the 4th, 8th and 16th weeks motor function of lower limbs and balance baseline, 4th weeks pretest, 8th weeks posttest, 16th weeks follow-up
Primary Change from Baseline Five-Times-Sit-to-Stand Test (FTSST) at the 4th, 8th and 16th weeks motor function of lower limbs and balance baseline, 4th weeks pretest, 8th weeks posttest, 16th weeks follow-up
Secondary Change from 4th weeks Game1 (first scenario) evaluated the performance of short-term memory at 8th weeks Game assessment was a new way to evaluate cognitive performance of the participant through the score. All participants proceeded all three scenarios but challenged same degree of difficulty. 4th weeks pretest, 8th weeks posttest
Secondary Change from 4th weeks Game2 (second scenario) evaluated divided attention at 8th weeks Game assessment was a new way to evaluate cognitive performance of the participant through the score. All participants proceeded all three scenarios but challenged same degree of difficulty. 4th weeks pretest, 8th weeks posttest
Secondary Change from 4th weeks Game3 (third scenario) evaluated inhibitory function at 8th weeks Game assessment was a new way to evaluate cognitive performance of the participant through the score. All participants proceeded all three scenarios but challenged same degree of difficulty. 4th weeks pretest, 8th weeks posttest
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