Clinical trial NCT01147185: Effectiveness of Automated Locomotor Training in Patients With Acute Incomplete Spinal Cord Injury: A Multicenter Trial
Official title: Effectiveness of Automated Locomotor Training in Patients With Acute Incomplete Spinal Cord Injury: A Multicenter Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Spinal Cord Injuries, Locomotor training, Dose-Response
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2010-06-22
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

* exclusion criteria of the Lokomat:(bodyweight \> 130kg, body height \> 200cm, leg length diff \> 2cm, osteoporosis, instable fracture of lower extremity, restricted range of motion, decubitus ulcer of lower extremity)
* 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

Primary outcomes:
measure: Ten meter walking test
timeFrame: at start of training, at weeks 2, 4, 6, 8, 6 and 24
Secondary outcomes:
measure: Walking Index for Spinal Cord Injury (WISCI)
timeFrame: at start of training, at weeks 2, 4, 6, 8, 6 and 24
measure: Spasticity
timeFrame: at start of training, at weeks 2, 4, 6, 8, 6 and 24
measure: Perceived exertion
timeFrame: after every training
measure: Spinal Cord Independence Measure
timeFrame: at start of training, at weeks 2, 4, 6, 8, 6 and 24
measure: Spinal cord injury classification
timeFrame: at start of training, at weeks 2, 4, 6, 8, 6 and 24
measure: Patients' Global Impression of Change Scale
timeFrame: At week 8
Other outcomes:
Locations:
city: Murnau
country: Germany
facility: Berufsgenossenschaftliche Unfallklinik Murnau
city: Barcelona
country: Spain
facility: Institut Guttmann
city: Toledo
country: Spain
facility: Hospital Nacional de Parapléjicos
city: Zurich
country: Switzerland
facility: Balgrist University Hospital
Study officials:
affiliation: Zurich University of Applied Sciences
name: Markus Wirz, PT PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.