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Title: Effectiveness of Mixed Reality Combined with Occupational Therapy to Reduce Fall Risk in Patients with Hemiparesis After Acquired Brain Injury Study Purpose: This study aims to test whether adding Nintendo Switch video game exercises to regular occupational therapy helps adults with hemipareasia after brain injury. The main goals are to reduce fall risk, improve balance, and enhace quality of life and motivation during rehabilitation.
Study Design: This is a pilot randomized controlled trial. The study will run for 5 months at Polibea Norte Rehabilitation Center for Brain Injury in Madrid, Spain.
Participants: Adults over 18 years old with hemiparesia from stroke or brain injury who can walk and have mild to moderate balance problems.
Groups: Participants will be randomly assigned to one of two groups:
Control Group: Receives usual occupational therapy (2 sessions per week, 1 hour each) Experimental Group: Receives 30 minutes of occupational therapy plus 30 minutes of Nintendo Switch exercises (2 sessions per week, 1 hour total) for 8 weeks The Nintendo Switch sessions use Ring Fit Adventure and Nintendo Switch Sports games that require standing, balancing, reaching, and moving different body parts. A therapist supervises all sessions.
Before and after the 8-week intervention, all participants will be assessed on:
Fall risk and balance: Using standardized tests including the Tinetti Scale, Timed Up and Go test, and Functional Reach Test Functional independence: Using the Functional Independence Measure (FIM) Quality of life: Using the WHOQOL-BREF questionnaire Satisfaction with treatment: Using the Client Satisfaction Questionnaire (CSQ-8) This study will provide preliminary information about whether Nintendo Switch can be a useful tool for rehabilitation of adults with hemiparesia after brain injury. If the intervention proves feasible and shows positive effects, it could be developed into a larger study and potentially used in clinical practice as a complement to traditional therapy. The engaging nature of video games might improve motivation and adherence to rehabilitation, which are important factors for recovery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | The control grpup receives conventional occupational therapy only |
|
| Experimental Group | Experimental | The experimental group recceives treatment with Nintendo Switch plus conventional occupational therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nintendo Switch Exergaming Combined With Occupational Therapy | Other | This study tests a novel rehabilitation approach combining Nintendo Switch active video gaming (exergaming) with conventional occupational therapy for adults with hemiparesia following stroke or acquired brain injury. The intervention uses commercially available Nintendo Switch console and games requiring full-body movement to target balance, postural control, strength, and coordination. The intervention is 30 minutes Nintendo Switch + 30 minutes conventional occupational therapy per session, twice weekly. This differs from: Pure exergame interventions where gaming replaces traditional therapy Technology-only approaches without conventional therapy Home-based unsupervised programs without therapist supervision Sessions are supervised by licensed occupational therapists who adjust difficulty, provide cues and assistance, ensure safety and proper movement patterns, and integrate gaming with conventional therapy goals. |
| Measure | Description | Time Frame |
|---|---|---|
| Fall Risk (Tinetti Scale) | The Tinetti Scale assesses balance and gait to estimate fall risk. Includes two sections: balance (maximum 16 points) and gait (maximum 12 points), totaling 28 points. Higher score indicates lower fall risk. Administered through direct observation. | Baseline (pre-intervention) and after 8 weeks (post-intervention, up to 1 week) |
| Measure | Description | Time Frame |
|---|---|---|
| Gait Speed and Balance (Timed Up and Go Test - TUG) | Measures time to stand from chair, walk 3 meters, turn, return, and sit down. Assesses balance and gait speed. Recorded in seconds. Lower time indicates better performance. | Baseline (pre-intervention) and post-intervention (up to 1 week) |
| Dynamic Balance (Functional Reach Test - FRT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Polibea Norte | Madrid | Madrid | Spain |
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|
| Conventional | Other | Participants receive standard occupational therapy sesions |
|
Measures maximum distance individual can move center of gravity toward limits of base of support while standing. Participant flexes shoulders to 90 degrees with extended hand and moves forward as far as possible while maintaining balance. Recorded in centimeters. Greater distance indicates better dynamic balance. |
| Baseline (pre-intervention) and post-intervention (up to 1 week) |
| Functional Independence (Functional Independence Measure - FIM) | Instrument measuring level of functional independence in activities of daily living through 18 items covering motor and cognitive performance. Score ranges 1-7 per item, with higher score indicating greater independence. Administered through observation and interview. | Baseline (pre-intervention) and post-intervention (up to 1 week) |
| Quality of Life (WHOQOL-BREF) | Self-administered questionnaire evaluating general perception of quality of life and global health status. Contains four domains: physical health, psychological health, social relationships, and environment. Higher score indicates better quality of life. | Baseline (pre-intervention) and post-intervention (up to 1 week) |
| Treatment Satisfaction (Client Satisfaction Questionnaire - CSQ-8) | Self-administered questionnaire with 8 questions evaluating satisfaction level with care and quality of service received, plus fulfillment of patient expectations prior to intervention. Responses coded 1-4, total score 32 points. Higher score indicates greater satisfaction with treatment. | Post-intervention (up to 1 week)] |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D009788 | Occupational Therapy |
| D003226 | Congresses as Topic |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
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