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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06129630
Other study ID # 2702202309423
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2023
Est. completion date December 28, 2023

Study information

Verified date May 2024
Source Universidad Rey Juan Carlos
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Purpose: Healthy aging is the process of optimizing opportunities for health, participation and safety in order to improve quality of life as people age. This study aimed to provide healthy aging for people with cognitive impairment through the use of the Nintendo Switch combined with Occupational Therapy sessions. Material and methods: a randomized clinical trial was conducted. The sample was randomized using a software program, OxMar, which allowed the separation of the sample into a control group (CG), which received their usual sessions of conventional occupational therapy, and an experimental group (EG), which received therapy with Nintendo Switch, plus their conventional occupational therapy sessions. An 8-week intervention was conducted with Nintendo Switch. Measures: Nine Hole Peg Test, Box and Block Test, Barthel Index, WHOQOL-BREF, CSQ-8.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date December 28, 2023
Est. primary completion date December 15, 2023
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Adult men or women, aged 65 years or older, cohabitating in the nursing home. - Not presenting moderate or severe cognitive impairment measured through the MEC- Lobo test (score = 24-35) (20). - Agree to participate voluntarily, having read the project information sheet and signed the informed consent. Exclusion Criteria: - Presence of neurodegenerative pathology. - Presence of physical pathology that compromised the person's safety. - Severe cognitive impairment.

Study Design


Intervention

Procedure:
Conventional occupational therapy sessions.
Occupational therapy sessions are based on cognitive stimulation, manipulative dexterity training and psychomotor skills.
Conventional occupational therapy sessions + Nintendo Switch
Occupational therapy sessions are based on cognitive stimulation, manipulative skill training and psychomotor skills. In addition, 2 sessions per week are conducted with two Nintendo Switch games.

Locations

Country Name City State
Spain Physiocare Madrid Clinic Madrid

Sponsors (1)

Lead Sponsor Collaborator
Universidad Rey Juan Carlos

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Nine Hole Peg Test This test measures fine manual dexterity. This is considered a "gold standard" to evaluate fine manual dexterity (21). It consists of placing a number of pins on a board with 9 holes and removing them as quickly as possible. This test records the time the person uses with each upper limb. Pre-intervention and post-intervention (up to 1 week)
Primary Box and Block Test Test that measures the gross motor skills of the upper limbs. It consists of a wooden box that is divided into two halves by an axis, and consists of passing from one half to the other as many wooden blocks as possible with each upper limb, for 1 minute. In this test, the number of blocks that the person is able to pass in one minute with each upper limb is recorded. Pre-intervention and post-intervention (up to 1 week)
Primary Barthel Index This scale is used to assess the level of functional independence in the basic activities of daily living that a person presents. In this test, the higher the score, the higher the level of functional independence of the person. Pre-intervention and post-intervention (up to 1 week)
Primary World Health Organization WHOQOL-BREF self-administered questionnaire, assesses the general perception of quality of life and general perception of health. It is composed of four domains: physical health, psychological health, social relationships and environment. A higher score on this scale indicates a higher quality of life. Potential scores for all domain scores, therefore, range from 4-20. Pre-intervention and post-intervention (up to 1 week)
Secondary The Client Satisfaction Questionnaire-8, CSQ-8 Self-administered questionnaire used to evaluate satisfaction with the care services received, it consists of 8 questions. Items are scored on a Likert scale from 1 (low satisfaction) to 4 (high satisfaction). Total scores range from 8 to 32, with higher scores indicating greater satisfaction. Post-intervention (up to 1 week)
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