Virtual Reality Rehabilitation in Patients With Acquired Brain Injury

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03402360

Enrollment

Registered

2018-01-18

Start date

2019-11-01

Completion date

2022-04-30

Last updated

2019-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired Brain Injury

Keywords

Virtual Reality, Rehabilitation, Acquired Brain Injury

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.

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
Change in Action Research Arm Test (ARAT)	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 Beck Depression Inventory (BDI)	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 Montreal Cognitive Assessment (MoCA)	From Baseline (T0) to 3 weeks of rehabilitation (T1)

Other

Measure	Time frame
Change in Resting state functional MRI (fMRI)	From Baseline (T0) to 3 weeks of rehabilitation (T1)

Countries

Italy

Contacts

Primary ContactSandro Iannaccone

iannaccone.sandro@hsr.it0226435734

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026