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RecruitingNCT05891912Updated Jun 7, 2023

Active Aging With Technological Devices

An interventional study of Technological devices intervention (use of tablet and big screen with games oriented to training physical and cognitive function) in Older Adults Institutionalized in Residential Homes, sponsored by University of Extremadura. Recruiting at 1 site in Spain. Open to participants aged 50 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-07.

Sponsored by University of Extremadura · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Sep 2023, 3 years 2 months ago, but the record still lists the study as recruiting.
  • Started Apr 2023; still recruiting 3 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Ages
50 Years to 100 Years
Sex
All
01

Study summary

Clinical trial with users of health care centres and nursing homes in Extremadura (Spain). Inclusion criteria are: women and men over 55 years of age with a Minimental State Examination (MMSE) equal or higher than 21 (no cognitive impairment or mild to moderate cognitive impairment) who are able to walk independently. Exclusion criteria are: patients with severe cognitive impairment or language impairment that prevents the use of verbal communication, non-autonomous gait and severe limitation of mobility at the level of the upper limb.

Treatment schedule: 30 min sessions, twice a week during 12 weeks

  • 1 session per week: 15min small TABLET and 15min LIGHTS game.
  • 1 session per week: 15min TABLE TABLET and 15min game of grape harvesting.

The intervention will be carried out by occupational therapists or physiotherapists.

The intervention period and evaluations will be performed as follows:

  • Training of Occupational therapists/physiotherapists: 1 week prior to the start of the intervention for.
  • Week 0- Initial measurements
  • Week 1-12: device interventions
  • Week 13: Final measurements
  • Week 17: First follow-up measurement
  • Week 21: Second follow-up measurement
02

Conditions studied

  • Older Adults Institutionalized in Residential Homes

Keywords

  • older adults,
03

In context

Lead sponsor

University of Extremadura is the lead sponsor of 48 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • women and men over 50 years of age
  • Minimental State Examination () equal or higher than 21 (no cognitive impairment or mild to moderate cognitive impairment)
  • Independent gait

Exclusion criteria

Exclusion Criteria:

  • patients with severe cognitive impairment or language impairment that prevents the use of verbal communication
  • No independent gait
  • Severe limitation of upper limb range of movement.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Technological devices intervention

    The intervention will be in individual sessions with the following technological devices and games: * Vertical screen: game of lights and vintage game. * Horizontal screen: cognitive function and activities of daily living games * Tablets: cognitive function and activities of daily living games

    Other: Technological devices intervention (use of tablet and big screen with games oriented to training physical and cognitive function)

Interventions

  • OtherTechnological devices intervention (use of tablet and big screen with games oriented to training physical and cognitive function)

    The treatment will be performed in 30 min sessions, twice a week during 12 weeks. the weekly sessions will include the following games: * 1 session per week: 15min small TABLET and 15min LIGHTS game. * 1 session per week: 15min TABLE TABLET and 15min game of VINTAGE.

06

What researchers measure

Primary outcomes

  1. Change from the cognitive impairment measured with the Minimental State Examination at 13 weeks , 17 weeks and 21 weeks

    The Mini-Mental State Examination (MMSE) is a set of 11 questions that doctors and other healthcare professionals commonly use to check for cognitive impairment. Any score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment.

    Time frame: It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)

  2. Change from the Activities of daily living performance measured with the Barthel Index at 13 weeks , 17 weeks and 21 weeks

    The Barthel Scale/Index is an ordinal scale used to measure performance in activities of daily living (ADL). Ten variables describing ADL and mobility are scored, a higher number being a reflection of greater ability to function independently following hospital discharge. Each item is rated in terms of whether the patient can perform the task independently, with some assistance, or is dependent on help based on observation (0=unable, 1=needs help, 2=independent). The final score is x 5 to get a number on a 100 point score. Proposed guidelines for interpreting Barthel scores are that scores of 0-20 indicate "total" dependency, 21-60 indicate "severe" dependency, 61-90 indicate "moderate" dependency, and 91-99 indicates "slight" dependency.2 Most studies apply the 60/61 cutting point.

    Time frame: It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)

  3. Change from the Depression level measured with the Yesavage Geriatric Depression Scale (GDS) at 13 weeks , 17 weeks and 21 weeks

    The The Yesavage Geriatric Depression Scale (GDS) is an assessment tool for diagnosing depression in older adults and expresses the degree of satisfaction, quality of life and feelings. (GDS) is an assessment tool for diagnosing depression in older adults and expresses the degree of satisfaction, quality of life and feelings. Scores of 0-4 are considered normal, depending on age, education, and complaints; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.

    Time frame: It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)

  4. Change from Instrumental Activities of Daily Living performance measured with The Lawton Instrumental Activities of Daily Living (IADL) Scale at 13 weeks , 17 weeks and 21 weeks

    The Lawton Instrumental Activities of Daily Living Scale (IADL) is an appropriate instrument to assess independent living skills. These skills are considered more complex than the basic activities of daily living as measured by the Katz Index of ADLs (See Try this: Katz Index of ADLs). The instrument is most useful for identifying how a person is functioning at the present time, and to identify improvement or deterioration over time. There are eight domains of function measured with the Lawton IADL scale. Scores range from 0 (low function, dependent) to 8 (high function, independent) for women, and 0 through 5 for men.

    Time frame: It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)

Secondary outcomes

  1. Change from the balance and gait performance measured with the Tinetti test at 13 weeks , 17 weeks and 21 weeks

    The Tinetti-test, also called Performance-Oriented Mobility Assessment (POMA) assesses a person's perception of balance and stability during activities of daily living and their fear of falling. It is a very good indicator of the fall risk of an individual. The test comprises two short sections that contain one examining static balance abilities in a chair and then standing, and the other gait It has better test-retest, discriminative and predictive validities concerning fall risk than other tests including Timed Up and Go test (TUG), one-leg stand and functional reach test. The Tinetti test has a gait score and a balance score. It uses a 3-point ordinal scale of 0, 1 and 2. Gait is scored over 12 and balance is scored over 16 totalling 28. The lower the score on the Tinetti test, the higher the risk of falling. Tineti tool score: Risk of fall: ≤ 18 High, 19-23 Moderate, ≥ 24 Low

    Time frame: It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)

  2. Change from the upper limb range of movement at 13 weeks , 17 weeks and 21 weeks

    The range of movement of the wrist, elbow and shoulder will be measured with the goniometer

    Time frame: It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)

  3. Change from the Reaction speed or number of attempts during the sessions at 13 weeks , 17 weeks and 21 weeks

    The data related to the reaction speed or number of attempts during the sessions and each game performed will be measured and registered by the technological devices

    Time frame: It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)

  4. Change from the Number of correct tries in each game at 13 weeks , 17 weeks and 21 weeks

    The data related to the number of correct tries in each game performed will be measured and registered by the technological devices

    Time frame: It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05891912
Lead sponsor
University of Extremadura
Responsible party
Elisa María Garrido Ardila (Professor, University of Extremadura) — Principal investigator
First posted
Jun 7, 2023
Start date
Apr 1, 2023
Primary completion
Sep 1, 2023 (estimated)
Completion
Nov 1, 2023 (estimated)
Last update
Jun 7, 2023

Study contacts

ELISA MARIA GARRIDO-ARDILA, PhD
Contact
egarridoa@unex.es
0034 927 257450 ext. 21500
Maria Trinidad Rodríguez-Dominguez, PhD
Contact
trdomin@unex.es

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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