Virtual Reality Rehabilitation in Patients With Acquired Brain Injury

Acquired Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03402360
• Other study ID #: VR-ABI
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: April 30, 2022

Study information

• Verified date: June 2019
• Source: IRCCS San Raffaele
• Contact: Sandro Iannaccone
• Phone: 0226435734
• Email: iannaccone.sandro[@]hsr.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Wounds and Injuries

Intervention

Other:
• Virtual 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
• Control 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

Locations

Country	Name	City	State
Italy	IRCSS Ospedale San Raffaele	Milan	MI

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Resting state functional MRI (fMRI)		From Baseline (T0) to 3 weeks of rehabilitation (T1)
Primary	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	From Baseline (T0) to 3 weeks of rehabilitation (T1)
Secondary	Change in Action Research Arm Test (ARAT)		From Baseline (T0) to 3 weeks of rehabilitation (T1)
Secondary	Change in Functional Independence Measures (FIM)		From Baseline (T0) to 3 weeks of rehabilitation (T1)
Secondary	Change in Mini Mental State Examination (MMSE)		From Baseline (T0) to 3 weeks of rehabilitation (T1)
Secondary	Change in Montreal Cognitive Assessment (MoCA)		From Baseline (T0) to 3 weeks of rehabilitation (T1)
Secondary	Change in Beck Depression Inventory (BDI)		From Baseline (T0) to 3 weeks of rehabilitation (T1)
Secondary	Change in 36-Item Short Form Survey (SF-36)		From Baseline (T0) to 3 weeks of rehabilitation (T1)