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

NCT04144556 | Completed

• 1 other identifier: ID0026
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Stroke

Keywords

Stroke; virtual reality; physical therapy

Outcome Measures

Primary Outcomes (3)

• Functional capability: Timed up and go test (TUG)

  The patient is timed from the moment he/she begins to get up from a chair, walks at a safe and comfortable pace to a line on the floor three meters away, turns and walks towards the chair until he or she sits down again. The subject wears his/her usual footwear and walking aids (cane or walker) if necessary. A faster time indicates better functional performance, indicating a time more than 20 seconds a reduced mobility and, in addition, a score of ≥ 13.5 seconds is used to identify an increased risk of falls.

  4 weeks

• Gait and balance performance

  The Tinetti Scale has been designed to evaluate the balance in different positions. It consists of sixteen situations divided into two blocks that require the active participation of the patient. One block assesses gait, in which the subject walks with the examiner first with his usual step, returning with a fast but safe step (using his usual walking aids) with a maximum possible score of 12 points; and the other block assesses balance (in seating, standing and transferring from one to another) with a maximum of 16 points being obtained. The maximum overall score between the two blocks is 28 points.

  4 weeks

• The Berg Balance Scale (BBS)

  The Berg Balance Scale (BBS) is a 14-item scale that quantitatively evaluates equilibrium (static and dynamic) and fall risk. The items are scored from 0 to 4; (0 = inability to complete the task; 4 = independent completion of the item). The maximum score is 56 points and the risk of falling limit is 45.

  4 weeks

Secondary Outcomes (2)

• Motor impairment: Fugl-Meyer assessment (FMA)

  4 weeks

• Daily living activities: Barthel Index.

  4 weeks

Study Arms (2)

Nintendo Wii and conventional physical therapy

EXPERIMENTAL

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.

Other: Nintendo Wii and conventional physical therapy

Conventional Physical therapy

ACTIVE COMPARATOR

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.

Other: Conventional Physical therapy

Interventions

Nintendo Wii and conventional physical therapy 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.

Nintendo Wii and conventional physical therapy

Conventional Physical therapy 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.

Conventional Physical therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• men and women aged 18 to 80 years
• having had a first simple stroke (ischemic or hemorrhagic) in one cerebral hemisphere
• have physical limitation in the upper limb and/or lower limb function.

You may not qualify if:

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

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Gemma V Espí López

Valencia, 46010, Spain

Location

Related Publications (1)

• 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.

  PMID: 33639116 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 27, 2019
• First Posted: October 30, 2019
• Study Start: November 2, 2019
• Primary Completion: December 15, 2019
• Study Completion: December 30, 2019
• Last Updated: April 3, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)