Effectiveness of Virtual Environment Rehabilitation in Patients With Acquired Brain Injury: Clinical Randomized Controlled Trial

IRCCS San Raffaele1 site in 1 country90 target enrollmentNovember 1, 2019

ConditionsAcquired Brain Injury

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Acquired Brain Injury
Sponsor: IRCCS San Raffaele
Enrollment: 90
Locations: 1
Primary Endpoint: Change in Fugl-Meyer Upper Extremity (FMUE)
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of the study is to investigate the effectiveness of motor and cognitive virtual environment rehabilitation on upper limb function in sub-acute patients after an acquired brain injury.

Registry

clinicaltrials.gov

Start Date

November 1, 2019

End Date

April 30, 2022

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

IRCCS San Raffaele

Responsible Party

Principal Investigator

Sandro Iannaccone

Head of Neuro Rehabilitation Unit, Principal Investigator

IRCCS San Raffaele

Eligibility Criteria

Inclusion Criteria

•Acquired Brain Injury within 1 month before the recruitment;
•Score between 0 and 3 at the Motor Arm subscore of the Italian version of the National Institutes of Health Stroke Scale (it-NIHSS);
•Score between 9 and 15 at the Glasgow Coma Scale for the traumatic brain injury Acquired Brain Injury.

Exclusion Criteria

•Denial of informed consent;
•Visual deficits that interfere with the virtual reality rehabilitation;
•Score under 18 at the Mini Mental State Examination;
•Severe orthopedic deficit;
•Patients with pace maker;
•Patients with contraindication to undergo magnetic resonance;
•Pregnant women.

Outcomes

Primary Outcomes

Change in Fugl-Meyer Upper Extremity (FMUE)

Time Frame: From Baseline (T0) to 3 weeks of rehabilitation (T1)

Items are scored on a 3-point ordinal scale 0 = cannot perform; 1 = performs partially; 2 = performs fully. Maximum Score = 66 points

Secondary Outcomes

Change in Functional Independence Measures (FIM)(From Baseline (T0) to 3 weeks of rehabilitation (T1))
Change in Action Research Arm Test (ARAT)(From Baseline (T0) to 3 weeks of rehabilitation (T1))
Change in Beck Depression Inventory (BDI)(From Baseline (T0) to 3 weeks of rehabilitation (T1))
Change in Mini Mental State Examination (MMSE)(From Baseline (T0) to 3 weeks of rehabilitation (T1))
Change in Montreal Cognitive Assessment (MoCA)(From Baseline (T0) to 3 weeks of rehabilitation (T1))
Change in 36-Item Short Form Survey (SF-36)(From Baseline (T0) to 3 weeks of rehabilitation (T1))