NCT02149186

Brief Summary

This project will build and test the first rehabilitation system employing virtual reality (VR)-based observation, motor imagery and execution to treat lower-limb neuropathic pain and motor dysfunction in participants with an incomplete spinal cord injury or another neurological disorder, eg. stroke: iCTuS-L (Interactive Computer-based Therapy System for legs). Patients using the system will control virtual representations of their legs to engage in entertaining gaming interactions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

October 1, 2009

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 29, 2014

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 7, 2020

Status Verified

December 1, 2019

Enrollment Period

10.2 years

First QC Date

April 24, 2014

Last Update Submit

January 6, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Sensorimotor Assessment

    Questionnaire assessing distinct pain qualities associated with neuropathic pain, structured pain interview, questionnaire for assessing patients diagnosed as depressed and detects depression among the normal population, transcutaneous electrical stimulation of superficial nerves, information about the motor level of the lesion, the sensory levels of the lesion (light touch and pin prick), questionnaire assessing activities of daily life and independence in subjects with spinal cord lesion, walking aids and/or personal assistance, examining gait speed, transcranial magnetic stimulation

    16 weeks

Study Arms (1)

Rehabilitation

EXPERIMENTAL
Device: iCTuS-L

Interventions

iCTuS-LDEVICE
Rehabilitation

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 16 and 80
  • clinically incomplete spinal cord injury (time since injury: chronic \> 1 year; acute \< 3 months)
  • ASI C or D
  • neuropathic pain and/or motor deficits
  • diagnosed neurological disorder, eg. stroke

You may not qualify if:

  • any disease limiting training
  • epilepsy
  • major depression or psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Curt, Armin, MD

Zurich, 8008, Switzerland

Location

Related Publications (1)

  • Villiger M, Liviero J, Awai L, Stoop R, Pyk P, Clijsen R, Curt A, Eng K, Bolliger M. Home-Based Virtual Reality-Augmented Training Improves Lower Limb Muscle Strength, Balance, and Functional Mobility following Chronic Incomplete Spinal Cord Injury. Front Neurol. 2017 Nov 28;8:635. doi: 10.3389/fneur.2017.00635. eCollection 2017.

MeSH Terms

Conditions

Spinal Cord InjuriesStroke

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesCerebrovascular DisordersBrain DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2014

First Posted

May 29, 2014

Study Start

October 1, 2009

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

January 7, 2020

Record last verified: 2019-12

Locations