Nintendo Wii® and Physical Therapy in Stroke Patients (NW-SP)

NCT ID: NCT04144556

Last Updated: 2020-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-02
• Study Completion Date: 2019-12-30

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)

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Nintendo Wii and conventional physical therapy

This group of patients will receive, in addition to the exercise program described below, a virtual rehabilitation program through Nintendo Wii. This program will include upper limb training and lower limb balance training. Participants will choose the games they want to perform the session with. "Wii Fit" (balance games) will be used for the treatment of the lower limbs, and "Wii Sports" (bowling, golf and tennis games) will be used for the treatment of the upper limbs.

Group Type: EXPERIMENTAL

Nintendo Wii and conventional physical therapy

Intervention Type: OTHER

This group of patients will receive, in addition to the exercise program described below, a virtual rehabilitation program through Nintendo Wii. This program will include upper limb training and lower limb balance training. Participants will choose the games they want to perform the session with. "Wii Fit" (balance games) will be used for the treatment of the lower limbs, and "Wii Sports" (bowling, golf and tennis games) will be used for the treatment of the upper limbs.

Conventional Physical therapy

A warm-up period using a stationary bicycle, mobility exercises in supine position, active-assisted/passive kinesiotherapy of the lower and upper limbs, strengthening exercises in sitting position, balance, stability and coordination exercises and walking re-education exercises.

Group Type: ACTIVE_COMPARATOR

Conventional Physical therapy

Intervention Type: OTHER

A warm-up period using a stationary bicycle, mobility exercises in supine position, active-assisted/passive kinesiotherapy of the lower and upper limbs, strengthening exercises in sitting position, balance, stability and coordination exercises and walking re-education exercises.

Interventions

Nintendo Wii and conventional physical therapy

This group of patients will receive, in addition to the exercise program described below, a virtual rehabilitation program through Nintendo Wii. This program will include upper limb training and lower limb balance training. Participants will choose the games they want to perform the session with. "Wii Fit" (balance games) will be used for the treatment of the lower limbs, and "Wii Sports" (bowling, golf and tennis games) will be used for the treatment of the upper limbs.

Intervention Type: OTHER

Conventional Physical therapy

A warm-up period using a stationary bicycle, mobility exercises in supine position, active-assisted/passive kinesiotherapy of the lower and upper limbs, strengthening exercises in sitting position, balance, stability and coordination exercises and walking re-education exercises.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Valencia

OTHER

Sponsor Role: lead

Responsible Party

GEMMA V ESPÍ LÓPEZ, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gemma V Espí López

Valencia, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 33639116 (View on PubMed)

Other Identifiers

ID0026

Identifier Type: -

Identifier Source: org_study_id