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Virtual Reality Rehabilitation in Patients With Acquired Brain Injury

Primary Purpose

Acquired Brain Injury

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Virtual Reality rehabilitation group
Control group rehabilitation
Sponsored by
IRCCS San Raffaele
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acquired Brain Injury focused on measuring Virtual Reality, Rehabilitation, Acquired Brain Injury

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • IRCSS Ospedale San Raffaele

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virtual Reality rehabilitation group

Control group

Arm Description

The Virtual Reality group will perform upper extremity motor rehabilitation and neurocognitive rehabilitation based on virtual reality training.

The Control group will perform the same motor and neurocognitive rehabilitation but with the virtual reality turned off.

Outcomes

Primary Outcome Measures

Change in Fugl-Meyer Upper Extremity (FMUE)
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

Change in Action Research Arm Test (ARAT)
Change in Functional Independence Measures (FIM)
Change in Mini Mental State Examination (MMSE)
Change in Montreal Cognitive Assessment (MoCA)
Change in Beck Depression Inventory (BDI)
Change in 36-Item Short Form Survey (SF-36)

Full Information

First Posted
January 9, 2018
Last Updated
June 14, 2019
Sponsor
IRCCS San Raffaele
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1. Study Identification

Unique Protocol Identification Number
NCT03402360
Brief Title
Virtual Reality Rehabilitation in Patients With Acquired Brain Injury
Official Title
Effectiveness of Virtual Environment Rehabilitation in Patients With Acquired Brain Injury: Clinical Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2019 (Anticipated)
Primary Completion Date
April 30, 2022 (Anticipated)
Study Completion Date
April 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS San Raffaele

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Brain Injury
Keywords
Virtual Reality, Rehabilitation, Acquired Brain Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality rehabilitation group
Arm Type
Experimental
Arm Description
The Virtual Reality group will perform upper extremity motor rehabilitation and neurocognitive rehabilitation based on virtual reality training.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
The Control group will perform the same motor and neurocognitive rehabilitation but with the virtual reality turned off.
Intervention Type
Other
Intervention Name(s)
Virtual Reality rehabilitation group
Intervention Description
Three hours rehabilitation sessions every day that will consist in two hours of physiotherapy and one hour of neurocognitive rehabilitation, for 15 consecutive working days (3 weeks). 1 hour: conventional physiotherapy 1 hour: virtual reality upper extremity motor rehabilitation 1 hour: virtual reality neurocognitive training
Intervention Type
Other
Intervention Name(s)
Control group rehabilitation
Intervention Description
Three hours rehabilitation sessions every day that will consist in two hours of physiotherapy and one hour of neurocognitive rehabilitation, for 15 consecutive working days (3 weeks). 1 hour: conventional physiotherapy 1 hour: upper extremity motor rehabilitation 1 hour: neurocognitive training
Primary Outcome Measure Information:
Title
Change in Fugl-Meyer Upper Extremity (FMUE)
Description
Items are scored on a 3-point ordinal scale 0 = cannot perform; 1 = performs partially; 2 = performs fully. Maximum Score = 66 points
Time Frame
From Baseline (T0) to 3 weeks of rehabilitation (T1)
Secondary Outcome Measure Information:
Title
Change in Action Research Arm Test (ARAT)
Time Frame
From Baseline (T0) to 3 weeks of rehabilitation (T1)
Title
Change in Functional Independence Measures (FIM)
Time Frame
From Baseline (T0) to 3 weeks of rehabilitation (T1)
Title
Change in Mini Mental State Examination (MMSE)
Time Frame
From Baseline (T0) to 3 weeks of rehabilitation (T1)
Title
Change in Montreal Cognitive Assessment (MoCA)
Time Frame
From Baseline (T0) to 3 weeks of rehabilitation (T1)
Title
Change in Beck Depression Inventory (BDI)
Time Frame
From Baseline (T0) to 3 weeks of rehabilitation (T1)
Title
Change in 36-Item Short Form Survey (SF-36)
Time Frame
From Baseline (T0) to 3 weeks of rehabilitation (T1)
Other Pre-specified Outcome Measures:
Title
Change in Resting state functional MRI (fMRI)
Time Frame
From Baseline (T0) to 3 weeks of rehabilitation (T1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sandro Iannaccone
Phone
0226435734
Ext
0039
Email
iannaccone.sandro@hsr.it
Facility Information:
Facility Name
IRCSS Ospedale San Raffaele
City
Milan
State/Province
MI
ZIP/Postal Code
20132
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandro Iannaccone
Phone
0226435734
Ext
0039
Email
iannaccone.sandro@hsr.it

12. IPD Sharing Statement

Learn more about this trial

Virtual Reality Rehabilitation in Patients With Acquired Brain Injury

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