Virtual Reality Rehabilitation in Patients With Acquired Brain Injury

Not Applicable

• Conditions: Acquired Brain Injury
• Interventions: Other: Control group rehabilitation; Other: Virtual Reality rehabilitation group

• 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

Arm && Interventions

Group	Intervention	Description
Control group	Control group rehabilitation	The Control group will perform the same motor and neurocognitive rehabilitation but with the virtual reality turned off.
Virtual Reality rehabilitation group	Virtual Reality rehabilitation group	The Virtual Reality group will perform upper extremity motor rehabilitation and neurocognitive rehabilitation based on virtual reality training.

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 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 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)

Trial Locations

Locations (1)

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