NCT01147185

Brief Summary

The purpose of this study is to determine whether longer locomotor training results in a mor favorable outcome in patients with incomplete spinal cord injury.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2010

Longer than P75 for not_applicable

Geographic Reach
3 countries

4 active sites

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

February 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 22, 2010

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

June 29, 2016

Status Verified

June 1, 2016

Enrollment Period

6.3 years

First QC Date

May 7, 2010

Last Update Submit

June 28, 2016

Conditions

Spinal Cord Injuries

Keywords

Spinal Cord Injuries, Locomotor training, Dose-Response

Outcome Measures

Primary Outcomes (1)

  • Ten meter walking test

    Self selected walking speed over a distance of 10m

    at start of training, at weeks 2, 4, 6, 8, 6 and 24

Secondary Outcomes (6)

  • Walking Index for Spinal Cord Injury (WISCI)

    at start of training, at weeks 2, 4, 6, 8, 6 and 24

  • Spasticity

    at start of training, at weeks 2, 4, 6, 8, 6 and 24

  • Perceived exertion

    after every training

  • Spinal Cord Independence Measure

    at start of training, at weeks 2, 4, 6, 8, 6 and 24

  • Spinal cord injury classification

    at start of training, at weeks 2, 4, 6, 8, 6 and 24

  • +1 more secondary outcomes

Study Arms (2)

Intensive training

OTHER

Locomotor training using a robotic device of at least 50 minutes

Device: Locomotor training using a robotic device

Standard training

ACTIVE COMPARATOR

Locomotor training using a robotic device of maximally 25 minutes

Device: Locomotor training using a robotic device

Interventions

Locomotor training using a robotic deviceDEVICE

50min walking time, 3-5 trainings/week.

Also known as: Lokomat, Hocoma AG, Volketswil/Switzerland
Intensive training

Eligibility Criteria

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

You may qualify if:

  • patients with spinal cord injury (SCI) categorized according to the standard classification of the American Spinal Injury Association as ASIA B or C within the first two weeks after trauma
  • traumatic etiology of SCI
  • limited walking ability (Walking Index for Spinal Cord Injury ≤5)
  • able to start training or rehab within 60 days after trauma
  • motor level between cervical 4 and thoracic 12
  • signed informed consent

You may not qualify if:

  • concomitant injury limiting walking ability (e.g. lower extremity fractures, instable spine fractures, Joint instability preventing weight-bearing, severe soft tissue lesion)
  • pre-existing medical conditions interfering with unrestricted walking (e.g. total joint replacement, pain, osteoarthritis, polyneuropathy, cardiopulmonary disease)
  • age older than 65 years or younger than 18 years
  • conus medullaris or cauda equina syndrome
  • traumatic brain injury
  • passive range of motion of the hips, knees and ankles not sufficient to allow normal kinematics consistent with upright gait
  • patient participates in other rehabilitation or pharmacological study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Berufsgenossenschaftliche Unfallklinik Murnau

Murnau am Staffelsee, 82418, Germany

Location

Institut Guttmann

Barcelona, Spain

Location

Hospital Nacional de Parapléjicos

Toledo, Spain

Location

Balgrist University Hospital

Zurich, 8008, Switzerland

Location

Related Publications (1)

  • Wirz M, Bastiaenen C, de Bie R, Dietz V. Effectiveness of automated locomotor training in patients with acute incomplete spinal cord injury: a randomized controlled multicenter trial. BMC Neurol. 2011 May 27;11:60. doi: 10.1186/1471-2377-11-60.

    PMID: 21619574DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Markus Wirz, PT PhD

    Zurich University of Applied Sciences

    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
SPONSOR

Study Record Dates

First Submitted

May 7, 2010

First Posted

June 22, 2010

Study Start

February 1, 2010

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

June 29, 2016

Record last verified: 2016-06

Locations

ES(2)CH(1)DE(1)