Effects of Nintendo Switch on Rehabilitation Programs for Elderly People With Cognitive Impairment

Sponsor
Universidad Rey Juan Carlos (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06129630
Collaborator
(none)
32
1
2
9.9
3.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Conventional occupational therapy sessions.
  • Procedure: Conventional occupational therapy sessions + Nintendo Switch
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Nintendo Switch on Rehabilitation Programs for Elderly People With Cognitive Impairment: A Randomized Clinical Trial
Actual Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Dec 15, 2023
Anticipated Study Completion Date :
Dec 28, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Control Group (CG)

Control Group (CG), which received their usual sessions of conventional occupational therapy.

Procedure: Conventional occupational therapy sessions.
Occupational therapy sessions are based on cognitive stimulation, manipulative dexterity training and psychomotor skills.

Experimental: Experimental Group (EG)

Experimental Group (EG), which received therapy with Nintendo Switch, plus their conventional occupational therapy sessions.

Procedure: 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.

Outcome Measures

Primary Outcome Measures

  1. Nine Hole Peg Test [Pre-intervention and post-intervention (up to 1 week)]

    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.

  2. Box and Block Test [Pre-intervention and post-intervention (up to 1 week)]

    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.

  3. Barthel Index [Pre-intervention and post-intervention (up to 1 week)]

    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.

  4. World Health Organization WHOQOL-BREF [Pre-intervention and post-intervention (up to 1 week)]

    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.

Secondary Outcome Measures

  1. The Client Satisfaction Questionnaire-8, CSQ-8 [Post-intervention (up to 1 week)]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Physiocare Madrid Clinic Madrid Spain 28026

Sponsors and Collaborators

  • Universidad Rey Juan Carlos

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cristina García-Bravo, PhD, Occupational Therapist, Universidad Rey Juan Carlos
ClinicalTrials.gov Identifier:
NCT06129630
Other Study ID Numbers:
  • 2702202309423
First Posted:
Nov 13, 2023
Last Update Posted:
Nov 13, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 13, 2023