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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01147185
• Other study ID #: EMSCI-DR
• Status: Completed
• Phase: N/A
• First received: May 7, 2010
• Last updated: June 28, 2016
• Start date: February 2010
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

Device:
• Locomotor training using a robotic device
50min walking time, 3-5 trainings/week.
• Locomotor training using a robotic device
25min walking time, 3-5 trainings/week.

Locations

Country	Name	City	State
Germany	Berufsgenossenschaftliche Unfallklinik Murnau	Murnau
Spain	Institut Guttmann	Barcelona
Spain	Hospital Nacional de Parapléjicos	Toledo
Switzerland	Balgrist University Hospital	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Countries where clinical trial is conducted

Germany,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Walking Index for Spinal Cord Injury (WISCI)	Classification of walking ability on a rank ordered scale with 21 categories.	at start of training, at weeks 2, 4, 6, 8, 6 and 24	No
Secondary	Spasticity	Muscle tone is rated using the modified Ashworth and the Pess spasm frequency tests	at start of training, at weeks 2, 4, 6, 8, 6 and 24	No
Secondary	Perceived exertion		after every training	Yes
Secondary	Spinal Cord Independence Measure		at start of training, at weeks 2, 4, 6, 8, 6 and 24	No
Secondary	Spinal cord injury classification	Classification according to the standards by the American Spinal Cord Injury Association (ASIA)	at start of training, at weeks 2, 4, 6, 8, 6 and 24	No
Secondary	Patients' Global Impression of Change Scale		At week 8	No