Clinical trial NCT04144556: Nintendo Wii® and Physical Therapy in Stroke Patients (NW-SP)
Official title: The Effects of Nintendo Wii® and Conventional Physical Therapy in Functional Capability and Daily Living Activities in Stroke Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
virtual reality
physical therapy
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2019-10-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Brief Summary: In the present study a program which combines virtual rehabilitation through Nintendo Wii and conventional physical therapy is applied in stroke patients, evaluating functional capability (TUG), gait and balance (POMA and BBS), motor impairment (FMA), daily living activities (Barthel) and complex activities (FAI).

The hypothesis is that a virtual rehabilitation, through the use of Nintendo Wii®, could be used to improve functionality, gait, balance and living activities of people with chronic physical disabilities in addition to a conventional physical intervention program.

Methods: randomized and controlled clinical study of functional and motor parameters of stroke patients. The subjects will be divided into 2 groups: 1) Nintendo Wii and conventional physical therapy 2) control group which will have conventional physical therapy applied. There will be 2 treatment sessions during 4 weeks, with evaluations before the study and after 4 weeks, which include: functional capability (Timed up and go test), gait and balance performance (Tinetti performance-oriented mobility assessment and Berg balance scale), motor impairment (Fugl-Meyer assessment), daily living activities (Barthel Index) and complex activities (Frenchay activity index).

Detailed description: Introduction. Stroke is one of the most common causes of acquired adult disability. Much of the focus of stroke rehabilitation, in particular, the work of physiotherapists, is focused on recovery of physical independence and functional ability during activities of daily living. Physiotherapy based on conventional therapy has been shown to produce good results in recovery progress after stroke. However, patients tend to find the movements involved in this treatment as difficult and monotonous over time. Virtual rehabilitation is a novel therapeutic intervention based on simulation exercises using virtual reality technology.

Objective. The main objective of the present study was to assess whether a virtual rehabilitation program added to a conventional physical therapy intervention results in greater improvements in functional capability, gait, balance and daily activities compared to conventional physical therapy intervention on its own.

Material and Methods Sample: men and women aged 18 to 80 years having had a first simple stroke Study design. Randomized clinical trial with 2 groups: Group 1. 1) Nintendo Wii and conventional physical therapy 2) control group which will have conventional physical therapy applied.

Evaluations. Clinical interview with anthropometric data. There will be 2 evaluations: at the beginning of the study and at the end of the intervention (at 4 weeks).

In addition, it includes the following evaluation instruments:

* Functional capability: Timed up and go test (TUG)
* Gait and balance performance: Tinetti performance-oriented mobility assessment (POMA) and Berg balance scale (BBS)
* Motor impairment: Fugl-Meyer assessment (FMA)
* Daily living activities: Barthel Index.
* Complex activities: Frenchay activity index (FAI)

Eligibility criteria: Inclusion Criteria:

* men and women aged 18 to 80 years
* having had a first simple stroke (ischemic or hemorrhagic) in one cerebral hemisphere
* onset of stroke at least 6 months prior to study inclusion
* have physical limitation in the upper limb and/or lower limb function.

Exclusion Criteria:

* have other morbid neurological conditions
* have hand anesthesia
* show severe cognitive impairment that prevents speaking or understanding both questions and simple instructions.

Primary outcomes:
measure: Functional capability: Timed up and go test (TUG)
timeFrame: 4 weeks
measure: Gait and balance performance
timeFrame: 4 weeks
measure: The Berg Balance Scale (BBS)
timeFrame: 4 weeks
Secondary outcomes:
measure: Motor impairment: Fugl-Meyer assessment (FMA)
timeFrame: 4 weeks
measure: Daily living activities: Barthel Index.
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Gemma V Espí López
Study officials:
References:
citation: Marques-Sule E, Arnal-Gomez A, Buitrago-Jimenez G, Suso-Marti L, Cuenca-Martinez F, Espi-Lopez GV. Effectiveness of Nintendo Wii and Physical Therapy in Functionality, Balance, and Daily Activities in Chronic Stroke Patients. J Am Med Dir Assoc. 2021 May;22(5):1073-1080. doi: 10.1016/j.jamda.2021.01.076. Epub 2021 Feb 24.