Virtual Reality Rehabilitation in Patients With Acquired Brain Injury

Not Applicable

• Conditions: Acquired Brain Injury

• Registration Number: NCT03402360
• Lead Sponsor: IRCCS San Raffaele

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-09
• Study First Submitted QC: 2018-01-17
• Study First Posted: 2018-01-18
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-14
• Last Update Posted: 2019-06-17
• Study Start: 2019-11-01
• Primary Completion: 2022-04-30
• Study Completion: 2022-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Fugl-Meyer Upper Extremity (FMUE)	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 Outcome Measures

Name	Time	Method
Change in Functional Independence Measures (FIM)	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)
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)

Trial Locations

Locations (1)

IRCSS Ospedale San Raffaele; 🇮🇹 Milan, MI, Italy