Effects of Training in a Virtual Environment in Chronic Stroke Patients

NCT01886183 | Completed DMC

• 1 other identifier: USPNEC005
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this work will be compare the effects of two balance training programs, one Nintendo Wii Fit-based and the other traditionally-based without the use of a gaming system, on the (1) motor function, (2) cognition, (3) balance and (4) gait in chronic stroke patients. It is a prospective, single blinded, randomized clinical trial performed at Center of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University. Forty patients will be randomly assigned in control and experimental group, 20 each one.

Conditions

Stroke

Keywords

Postural Balance; Virtual Reality Exposure Therapy; Gait; Stroke

Outcome Measures

Primary Outcomes (1)

• The lower limb subscale of the Fugl-Meyer Assessment (FMA-LE)

  FMA-LE is a subscale measuring lower limb motor recovery. It examines movement and coordination of the hip, knee, and ankle in the supine, sitting, and standing positions. Each item is scored on a 3-point scale (0, cannot perform; 1, partially performs; 2, performs fully). The score range is 0 to 34, with higher scores indicating better lower limb motor performance

  up to 2 months

Secondary Outcomes (4)

• Balance Evaluation Systems Test (BESTest)

  Up 2 months

• 6-minute walk test

  Up to 2 months

• Stroke specific quality of life scale

  Up to 2 months

• Limits of Stability

  Up to 2 months

Study Arms (2)

Virtual Reality Training

EXPERIMENTAL

The virtual reality training will be done by experimental group with ten games of Nintendo Wii Fit.

Other: Virtual Reality Training

Control group: Physical Therapy

ACTIVE COMPARATOR

The Control Group will be trained by conventional Physical Therapy exercises.

Other: Physical Therapy

Interventions

Virtual Reality Training OTHER

The participants of the study will be trained 8 balance games during 14 sessions

Virtual Reality Training

Physical Therapy OTHER

Patients of the control group will be trained with balance exercises.

Also known as: Control group

Control group: Physical Therapy

Eligibility Criteria

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

You may qualify if:

• hemiparetic status resulting from a single stroke at least 6 months earlier;
• the ability to walk 10 m independently with or without an assistive device;
• the absence of a musculoskeletal condition that could potentially affect the ability to walk safely;
• the absence of serious visual impairment or a hearing disorder;
• power of at least grade 3 in the hemiplegic lower extremity;
• able to understand and follow simple instructions.

You may not qualify if:

• a Montreal Cognitive Assessment (MoCA) score of \< 20;
• severe dementia or aphasia;
• hemispatial neglect, ataxia or any other cerebellar symptom;
• inability to stand without minimal assist;
• Impaired vision
• Uncontrollable medical complications
• participation in other studies or rehabilitation programs

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy, School of Medicine, University of São Paulo

São Paulo, 05360-160, Brazil

Location

MeSH Terms

Conditions

Stroke

Interventions

Physical Therapy Modalities; Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Maria Elisa P Piemonte, PT, PhD

  University of Sao Paulo

  STUDY DIRECTOR

• Tatiana P Oliveira, PhD student

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

• Camila S Miranda, Ms Student

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2013
• First Posted: June 25, 2013
• Study Start: February 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: February 1, 2018
• Last Updated: November 2, 2018

Record last verified: 2018-07

Locations

BR (1)