NCT03402360

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 18, 2018

Completed
1.8 years until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

June 17, 2019

Status Verified

June 1, 2019

Enrollment Period

2.5 years

First QC Date

January 9, 2018

Last Update Submit

June 14, 2019

Conditions

Acquired Brain Injury

Keywords

Virtual RealityRehabilitationAcquired Brain Injury

Outcome Measures

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

    From Baseline (T0) to 3 weeks of rehabilitation (T1)

Secondary Outcomes (6)

  • 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 Montreal Cognitive Assessment (MoCA)

    From Baseline (T0) to 3 weeks of rehabilitation (T1)

  • Change in Beck Depression Inventory (BDI)

    From Baseline (T0) to 3 weeks of rehabilitation (T1)

  • +1 more secondary outcomes

Other Outcomes (1)

  • Change in Resting state functional MRI (fMRI)

    From Baseline (T0) to 3 weeks of rehabilitation (T1)

Study Arms (2)

Virtual Reality rehabilitation group

EXPERIMENTAL

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

Other: Virtual Reality rehabilitation group

Control group

ACTIVE COMPARATOR

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

Other: Control group rehabilitation

Interventions

Virtual Reality rehabilitation groupOTHER

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

Virtual Reality rehabilitation group
Control group rehabilitationOTHER

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

Control group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCSS Ospedale San Raffaele

Milan, MI, 20132, Italy

Location

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Central Study Contacts

Sandro Iannaccone

CONTACT

0226435734iannaccone.sandro@hsr.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Neuro Rehabilitation Unit, Principal Investigator

Study Record Dates

First Submitted

January 9, 2018

First Posted

January 18, 2018

Study Start

November 1, 2019

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

June 17, 2019

Record last verified: 2019-06

Locations

IT(1)