Active Aging With Technological Devices

Effects of Technological Devices in Older Adults

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

Study Overview

• Status: Recruiting
• Conditions: Older Adults Institutionalized in Residential Homes
• Intervention / Treatment: Other: Technological devices intervention (use of tablet and big screen with games oriented to training physical and cognitive function)

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ELISA MARIA GARRIDO-ARDILA, PhD; Phone Number: 21500 0034 927 257450; Email: egarridoa@unex.es
• Study Contact Backup: Name: Maria Trinidad Rodríguez-Dominguez, PhD; Email: trdomin@unex.es

Study Locations

• Spain
  • Extremadura
    • Cáceres, Extremadura, Spain, 10003
      • Recruiting
      • University of Extremadura
      • Contact: Maria Trinidad Rodriguez-Domínguez, Phd; Phone Number: 0034 927 257450; Email: trdomin@unex.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)
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.	It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)
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.	It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)
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.	It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)
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	It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)
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	It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)
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	It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)

Collaborators and Investigators

• Sponsor: University of Extremadura

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): September 1, 2023
• Study Completion (Estimated): November 1, 2023

Study Registration Dates

• First Submitted: May 15, 2023
• First Submitted That Met QC Criteria: May 26, 2023
• First Posted (Actual): June 7, 2023

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: May 26, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: older adults,
• Other Study ID Numbers: 03/2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No