Using Immersive Virtual Reality for the Upper Limb Rehabilitation of Post-stroke Subjects

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity Hospital of Ferrara

About this trial

Stroke produces brain damages that results in sensory, motor, and cognitive impairments which reduce the patient's quality of life and social participation. Upper limb recovery is a complex process whose goal is to allow the patients to gain, in part or completely, independence in daily living activities, for that it represents one of the most important rehabilitation focus. Virtual reality is a fairly recent approach able to simulate concrete movements and functional tasks in a higher dosage compared to other therapies. It seems that the use of VR could improve limb function, however, the amount of this gain is still unclear because of insufficient evidence. This study aims at quantitatively investigating the effectiveness of an HMD immersive virtual reality system on the upper limb functioning in subacute stroke survivors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

diagnosis of first, ischemic or hemorrhagic, stroke verified by brain imaging within 4 week

upper limb motor impairment defined by an upper extremity score <55 on the Fugl-Meyer Assessment

Disqualifiers

neurological conditions in addition to stroke that may affect motor function

other medical conditions likely to interfere with the ability to safely complete the study protocol

impaired cognitive functioning that influences the ability to give informed consent

severe neuropsychological disorders

Trial design

Design model

Parallel

Treatments tested in this trial

  • Virtual Reality

    Device

    Four tasks, uni and bi-manuals, will be proposed for the treatment of the patient's paretic upper limb in virtual-apartment for improving the relevance and the transferability of the movements requested.

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: VR groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Changes in upper limb impairment

Motor recovery will be assessed through the Fugl Meyer Assessment - Upper Extremity

Time frame
Score changes before (T0) and after (T1) the 4 weeks of treatment and at 6-month follow-up (T2)

Secondary outcomes

1

Change in Spasticity

Spasticity grade at the paretic upper limb will be measured with the Ashworth Scale (0-5), in which higher scores are related to more severe muscle hypertonia

Time frame
Score changes before (T0) and after (T1) the 4 weeks of treatment and at 6-month follow-up (T2)
2

Change in Activities of Daily Living

Patient's independence will be quantified with the Barthel Index

Time frame
Score changes before (T0) and after (T1) the 4 weeks of treatment and at 6-month follow-up (T2)
3

Change in perceived quality of life

Stroke Impact Scale 2.0 will be performed for investigating the perceived quality of life, higher scores indicate better quality of life perceived

Time frame
Score changes before (T0) and after (T1) the 4 weeks of treatment and at 6-month follow-up (T2)
4

Kinematic data

Instrumental data of hand movements registered during the sessions (relevant kinematic indexes will be recorded and offline analyzed such as hand trajectories and peak velocity)

Time frame
Parameters changes (e.g. hand peak velocities) before (T0) and after (T1) the 4 weeks of treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital of Ferrara

Lead sponsor

Ospedale Accreditato Villa Bellombra

Collaborator

Casa di Cura Città di Rovigo

Collaborator

IRCCS Centro Neurolesi Bonino Pulejo

Collaborator