NCT06129630

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2023

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

10 months

First QC Date

October 30, 2023

Last Update Submit

May 6, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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)

  • 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)

  • 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)

  • 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 Outcomes (1)

  • The Client Satisfaction Questionnaire-8, CSQ-8

    Post-intervention (up to 1 week)

Study Arms (2)

Control Group (CG)

ACTIVE COMPARATOR

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

Procedure: Conventional occupational therapy sessions.

Experimental Group (EG)

EXPERIMENTAL

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

Procedure: Conventional occupational therapy sessions + Nintendo Switch

Interventions

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

Control Group (CG)

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.

Experimental Group (EG)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Presence of neurodegenerative pathology.
  • Presence of physical pathology that compromised the person's safety.
  • Severe cognitive impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physiocare Madrid Clinic

Madrid, 28026, Spain

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Occupational Therapist

Study Record Dates

First Submitted

October 30, 2023

First Posted

November 13, 2023

Study Start

March 1, 2023

Primary Completion

December 15, 2023

Study Completion

December 28, 2023

Last Updated

May 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations