Comparison of Training in Virtual Environment With and Without Physiotherapeutic Intervention in Chronic Stroke Patients

University of Sao Paulo General Hospital

Status: Completed

Conditions: Stroke

Treatments: Other: No Physiotherapeutic Intervention; Other: Physiotherapeutic Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03361241

USPCR001

Details and patient eligibility

About

The aim of this study is to compare the effects of balance training in a virtual environment with and without physiotherapeutic intervention on the motor function, balance and gait in chronic stroke patients.

It is a prospective, single blinded, randomized clinical trial performed at Center of Research of the Department of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University. Forty patients will be randomly assigned in control and experimental group.

Full description

The aim of this study is to compare the effects of a balance training program in a virtual environment (using a gaming system with balance board device) with and without verbal/manual physiotherapeutic intervention, on the motor function, balance and gait in chronic stroke patients.

It is a prospective, single blinded, randomized clinical trial, performed at Center of Research of the Department of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University.

Forty chronic stroke patients will be randomly in control and experimental group, 20 each one. Both groups conduct 14 training sessions, twice a week, for seven weeks. Each session will consist a 30 minute-global-exercise series including stretching, muscle strength and axial mobility exercises. After this, both groups will perform more 30 minutes of balance training using eight Wii Fit games which stimulate motor and cognitive functions.

The main outcome measures will be: the lower limb subscale of the Fugl-Meyer Assessment (FMA-LE); Balance Evaluation Systems Test (BESTest) and 6- minute walk test (6MWT).

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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;
• a Montreal Cognitive Assessment (MoCA) score of ≥ 20;
• the absence of a musculoskeletal condition that could potentially affect the ability to stand or walk safely;
• the absence of serious visual impairment or a hearing disorder;
• muscle strength ≥ 3 in lower limbs;
• ability to understand and follow simple instructions.

Exclusion criteria

• severe dementia or aphasia;
• hemispatial neglect, ataxia or any other cerebellar symptom;
• inability to stand without minimal assist;
• uncontrollable medical complications
• participation in other studies or rehabilitation programs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

No Physiotherapeutic Intervention

Experimental group

Description:

Virtual reality training without physiotherapeutic intervention

Treatment:

Other: No Physiotherapeutic Intervention

Physiotherapeutic Intervention

Active Comparator group

Description:

Virtual reality training with physiotherapeutic intervention

Treatment:

Other: Physiotherapeutic Intervention