Cognitive Impairment Clinical Trial
Official title:
Effects of Nintendo Switch on Rehabilitation Programs for Elderly People With Cognitive Impairment: A Randomized Clinical Trial
Verified date | May 2024 |
Source | Universidad Rey Juan Carlos |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Physiocare Madrid Clinic | Madrid |
Lead Sponsor | Collaborator |
---|---|
Universidad Rey Juan Carlos |
Spain,
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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