NCT02699398

Brief Summary

The purpose of this study is to determine whether domiciliary VR-based telerehabilitation is superior than domiciliary occupational therapy for inducing functional gains, enhancing corticospinal excitability, and cortical reorganization.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2011

Status
completed

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

Study Start

First participant enrolled

November 1, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 4, 2016

Completed
Last Updated

March 4, 2016

Status Verified

February 1, 2016

Enrollment Period

1.7 years

First QC Date

February 25, 2016

Last Update Submit

February 29, 2016

Conditions

HemiparesisFunctional IndependenceMovement DisorderStroke

Outcome Measures

Primary Outcomes (1)

  • Change in motor function for activities of daily living as measured by Chedoke Arm Hand Inventory clinical

    At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.

Secondary Outcomes (7)

  • Change in depression as measured by the Hamilton scale

    At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.

  • Change in motor function as measured by the Medical Research Council scale

    At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.

  • Change in spasticity for the upper arms as measured by the Ashworth scale

    At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.

  • Change in cognitive function as measured by the Mini-mental State Evaluation test

    At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.

  • Change in Grip Force as measured by a grip dynamometer

    At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.

  • +2 more secondary outcomes

Study Arms (2)

VR-based therapy

EXPERIMENTAL

3 weeks of home-based treatment for motor training using a virtual reality rehabilitation setup.

Behavioral: Domiciliary VR-based motor rehabilitation

Control

ACTIVE COMPARATOR

3 weeks of home-based occupational therapy for motor training.

Behavioral: Domiciliary occupational therapy for motor rehabilitation

Interventions

Domiciliary VR-based motor rehabilitationBEHAVIORAL

3 weeks, 1 to 3 sessions a day, 20min per sessions, of physical therapy using a VR gaming system.

VR-based therapy
Domiciliary occupational therapy for motor rehabilitationBEHAVIORAL

3 weeks, 1 to 3 sessions a day, 20min per sessions, of physical therapy using a VR gaming system.

Control

Eligibility Criteria

Age45 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of Hemorrhagic or ischemic stroke
  • Subject had the stroke more than 12 months ago.
  • Subject presents mild-to-moderate upper-limbs hemiparesis (Proximal Medial Research Council Scale\>2) secondary to a first-ever stroke.
  • Age between 45 and 85 years old.
  • Subject has previous experience using the RGS system in the clinic.

You may not qualify if:

  • Subject presents a major cognitive impairment (Mini-Mental State Evaluation\> 22).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ballester BR, Nirme J, Camacho I, Duarte E, Rodriguez S, Cuxart A, Duff A, Verschure PFMJ. Domiciliary VR-Based Therapy for Functional Recovery and Cortical Reorganization: Randomized Controlled Trial in Participants at the Chronic Stage Post Stroke. JMIR Serious Games. 2017 Aug 7;5(3):e15. doi: 10.2196/games.6773.

    PMID: 28784593DERIVED

MeSH Terms

Conditions

ParesisMovement DisordersStroke

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCentral Nervous System DiseasesCerebrovascular DisordersBrain DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Paul Verschure, PhD

    Synthetic Perceptive, Emotive and Cognitive Systems group, Department of Information and Communication Technologies at the Universitat Pompeu Fabra (UPF).

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

February 25, 2016

First Posted

March 4, 2016

Study Start

November 1, 2011

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

March 4, 2016

Record last verified: 2016-02