Effectiveness of Automated Locomotor Training in Patients With Acute Incomplete Spinal Cord Injury: A Multicenter Trial

NCT ID: NCT01147185

Last Updated: 2016-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2016-06-30

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.

Detailed Description

About half of patients who experience a traumatic spinal cord injury (SCI) have still motor and/or sensory function below the level of the lesion. A large proportion of these patients become ambulatory within the first six months after the SCI. In order to optimally train the walking function patients are partially unloaded from their body weight while they walk on a moving treadmill. In severe cases therapists have to assist the leg movements which is an exhaustive work limiting training time. In the last few years robotic devices have been developed which enable longer training time. Studies evaluating the training of patients with hemiparesis showed that longer training time is associated with a better outcome. The present study aims at evaluating the effect of training time within the robotic device on the recovery of ambulatory function. Subject with an acute incomplete SCI will be included. The intervention consist of a walking training which lasts at least 50min, the training of the control group last at maximum 25min. Both groups will undergo 3-5 trainings per week. Group assignment will be performed at random. The study lasts for 8 weeks. The primary outcome will be the self selected walking speed which will be assessed bi-weekly during the training period and 4 months later.

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intensive training

Locomotor training using a robotic device of at least 50 minutes

Group Type: OTHER

Locomotor training using a robotic device

Intervention Type: DEVICE

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

Standard training

Locomotor training using a robotic device of maximally 25 minutes

Group Type: ACTIVE_COMPARATOR

Locomotor training using a robotic device

Intervention Type: DEVICE

25min walking time, 3-5 trainings/week.

Interventions

Locomotor training using a robotic device

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

Intervention Type: DEVICE

Locomotor training using a robotic device

25min walking time, 3-5 trainings/week.

Intervention Type: DEVICE

Other Intervention Names

Lokomat, Hocoma AG, Volketswil/Switzerland; Lokomat, Hocoma AG, Volketswil/Switzerland

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Markus Wirz, PT PhD

Role: PRINCIPAL_INVESTIGATOR

Zurich University of Applied Sciences

Locations

Berufsgenossenschaftliche Unfallklinik Murnau

Murnau am Staffelsee, , Germany

Institut Guttmann

Barcelona, , Spain

Hospital Nacional de Parapléjicos

Toledo, , Spain

Balgrist University Hospital

Zurich, , Switzerland

Countries

Germany; Spain; Switzerland

References

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.

Reference Type: DERIVED

PMID: 21619574 (View on PubMed)

Other Identifiers

EMSCI-DR

Identifier Type: -

Identifier Source: org_study_id