NCT02938754

Brief Summary

In this study the investigators evaluate the effectivity of Virtual Reality-based rehabilitation protocols for preventing motor deterioration in patients with cerebral palsy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

June 22, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 19, 2016

Completed
13 days until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

November 5, 2018

Status Verified

November 1, 2018

Enrollment Period

1.5 years

First QC Date

June 22, 2016

Last Update Submit

November 1, 2018

Conditions

Cerebral PalsyMovement Disorder

Keywords

HemiparesisFunctional independenceVirtual Rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Change in motor function of the affected extremity as measured by MACS clinical scale

    Change from Baseline to week 5 (End of Treatment)

Secondary Outcomes (3)

  • Change in attention and visuo-perceptive and visuo-constructional apraxia as measured by the WAIS-III scale

    Change from Baseline to week 5 (End of Treatment)

  • Change in motor function of the affected extremity as measured by the Box and Blocks clinical scale

    Change from Baseline to week 5 (End of Treatment)

  • Change in the amount of use of the affected arm during training as measured by the Virtual Reality system

    Change from Baseline to week 5 (End of Treatment)

Study Arms (2)

VR-based motor training

EXPERIMENTAL

Subjects will perform 3 different training protocols in Virtual Reality that imply performing tasks of vertical and planar reaching and hitting spheres, or hockey pucks, spaced at different time, speed and color.

Behavioral: VR-based motor training

Conventional Therapy

ACTIVE COMPARATOR

Subjects will perform conventional rehabilitation tasks for the upper-extremities that imply vertical and planar reaching movements.

Behavioral: Conventional Therapy

Interventions

VR-based motor trainingBEHAVIORAL

Subjects will perform 3 different training protocols in Virtual Reality that imply performing tasks of vertical and planar reaching and hitting spheres, or hockey pucks, spaced at different time, speed and color.

VR-based motor training
Conventional TherapyBEHAVIORAL

Subjects will perform conventional rehabilitation tasks for the upper-extremities that imply vertical and planar reaching movements.

Conventional Therapy

Eligibility Criteria

Age12 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children and Adult patients between 12- 50 years old diagnosed with CP according to Gross Motor Function Classification System (GMFCS). Level of disability between I and IV.
  • Ashworth modified clinical scale \< 3 (Ashworth, 1964, Bohannon Bohannon and Smith, 1987).

You may not qualify if:

  • Severe visual impairment.
  • Severe cognitive impairment such as mental retardation which impedes the understanding of the task.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitat Pompeu Fabra

Barcelona, 08002, Spain

Location

Related Publications (2)

  • Cameirao MS, Badia SB, Duarte E, Frisoli A, Verschure PF. The combined impact of virtual reality neurorehabilitation and its interfaces on upper extremity functional recovery in patients with chronic stroke. Stroke. 2012 Oct;43(10):2720-8. doi: 10.1161/STROKEAHA.112.653196. Epub 2012 Aug 7.

    PMID: 22871683BACKGROUND

  • Wittenberg GF. Neural plasticity and treatment across the lifespan for motor deficits in cerebral palsy. Dev Med Child Neurol. 2009 Oct;51 Suppl 4:130-3. doi: 10.1111/j.1469-8749.2009.03425.x.

    PMID: 19740220BACKGROUND

MeSH Terms

Conditions

Cerebral PalsyMovement DisordersParesis

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Paul FMJ Verschure, PhD

    Center of Autonomous Systems and Neurorobotics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 22, 2016

First Posted

October 19, 2016

Study Start

November 1, 2016

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

November 5, 2018

Record last verified: 2018-11

Locations

ES(1)