Clinical trial NCT05891912: Active Aging With Technological Devices
Official title: Effects of Technological Devices in Older Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Older Adults Institutionalized in Residential Homes
Keywords: older adults,
Lead sponsor: University of Extremadura
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a pre-test post-test study.
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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.

Primary outcomes:
measure: Change from the cognitive impairment measured with the Minimental State Examination at 13 weeks , 17 weeks and 21 weeks
timeFrame: It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)
measure: Change from the Activities of daily living performance measured with the Barthel Index at 13 weeks , 17 weeks and 21 weeks
timeFrame: It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)
measure: Change from the Depression level measured with the Yesavage Geriatric Depression Scale (GDS) at 13 weeks , 17 weeks and 21 weeks
timeFrame: It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)
measure: 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
timeFrame: It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)
Secondary outcomes:
measure: Change from the balance and gait performance measured with the Tinetti test at 13 weeks , 17 weeks and 21 weeks
timeFrame: It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)
measure: Change from the upper limb range of movement at 13 weeks , 17 weeks and 21 weeks
timeFrame: It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)
measure: Change from the Reaction speed or number of attempts during the sessions at 13 weeks , 17 weeks and 21 weeks
timeFrame: It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)
measure: Change from the Number of correct tries in each game at 13 weeks , 17 weeks and 21 weeks
timeFrame: It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)
Other outcomes:
Locations:
city: Cáceres
country: Spain
facility: University of Extremadura
state: Extremadura
Study officials:
References: