- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06129630
Effects of Nintendo Switch on Rehabilitation Programs for Elderly People With Cognitive Impairment
Effects of Nintendo Switch on Rehabilitation Programs for Elderly People With Cognitive Impairment: A Randomized Clinical Trial
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.
Study Overview
Status
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Madrid, Spain, 28026
- Physiocare Madrid Clinic
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control Group (CG)
Control Group (CG), which received their usual sessions of conventional occupational therapy.
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Occupational therapy sessions are based on cognitive stimulation, manipulative dexterity training and psychomotor skills.
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Experimental: Experimental Group (EG)
Experimental Group (EG), which received therapy with Nintendo Switch, plus their conventional occupational therapy sessions.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nine Hole Peg Test
Time Frame: 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.
|
Pre-intervention and post-intervention (up to 1 week)
|
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Box and Block Test
Time Frame: 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.
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Pre-intervention and post-intervention (up to 1 week)
|
|
Barthel Index
Time Frame: 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.
|
Pre-intervention and post-intervention (up to 1 week)
|
|
World Health Organization WHOQOL-BREF
Time Frame: 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.
|
Pre-intervention and post-intervention (up to 1 week)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Client Satisfaction Questionnaire-8, CSQ-8
Time Frame: Post-intervention (up to 1 week)
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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.
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Post-intervention (up to 1 week)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2702202309423
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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