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Status unknownNCT03402360Updated Jun 17, 2019

Virtual Reality Rehabilitation in Patients With Acquired Brain Injury

An interventional study of Virtual Reality rehabilitation group and Control group rehabilitation in Acquired Brain Injury, sponsored by IRCCS San Raffaele. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-06-17.

Sponsored by IRCCS San Raffaele · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Acquired Brain Injury

Keywords

  • Virtual Reality
  • Rehabilitation
  • Acquired Brain Injury
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    Virtual Reality rehabilitation group

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

    Other: Virtual Reality rehabilitation group

  • Active comparator
    Control group

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

    Other: Control group rehabilitation

Interventions

  • OtherVirtual Reality rehabilitation group

    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

  • OtherControl group rehabilitation

    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

05

What researchers measure

Primary outcomes

  1. 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

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

Secondary outcomes

  1. Change in Action Research Arm Test (ARAT)

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

  2. Change in Functional Independence Measures (FIM)

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

  3. Change in Mini Mental State Examination (MMSE)

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

  4. Change in Montreal Cognitive Assessment (MoCA)

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

  5. Change in Beck Depression Inventory (BDI)

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

  6. Change in 36-Item Short Form Survey (SF-36)

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

Other outcomes

  1. Change in Resting state functional MRI (fMRI)

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

06

Study locations

1 site
07

Registry details

Key details

Study ID
NCT03402360
Lead sponsor
IRCCS San Raffaele
Responsible party
Sandro Iannaccone (Head of Neuro Rehabilitation Unit, Principal Investigator, IRCCS San Raffaele) — Principal investigator
First posted
Jan 18, 2018
Start date
Nov 1, 2019 (estimated)
Primary completion
Apr 30, 2022 (estimated)
Completion
Apr 30, 2022 (estimated)
Last update
Jun 17, 2019

Study contacts

Sandro Iannaccone
Contact
iannaccone.sandro@hsr.it
0226435734 ext. 0039

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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