Spinal Cord InjuriesNCT01147185
Effectiveness of Automated Locomotor Training in Patients With Acute Incomplete Spinal Cord Injury: A Multicenter Trial
A study testing Locomotor training using a robotic device in people with Spinal Cord Injuries, run by University of Zurich at 4 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Locomotor training using a robotic device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Feb 2010to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Spain2 sites
Institut Guttmann
Barcelona
Hospital Nacional de Parapléjicos
Toledo
Germany1 site
Berufsgenossenschaftliche Unfallklinik Murnau
Murnau am Staffelsee, 82418
About this study
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.
Read the 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
- Being tested
- Locomotor training using a robotic device
- Keywords
- Spinal Cord Injuries, Locomotor training, Dose-Response
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Locomotor training using a robotic deviceDevice
Also called Lokomat, Hocoma AG, Volketswil/Switzerland
50min walking time, 3-5 trainings/week.
Locomotor training using a robotic deviceDevice
Also called Lokomat, Hocoma AG, Volketswil/Switzerland
25min walking time, 3-5 trainings/week.
| Study group | Role | What they receive |
|---|---|---|
| Intensive training | Other | Locomotor training using a robotic device of at least 50 minutes Receives: Device: Locomotor training using a robotic device |
| Standard training | Active comparator | Locomotor training using a robotic device of maximally 25 minutes Receives: Device: Locomotor training using a robotic device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ten meter walking test
Self selected walking speed over a distance of 10m
Measured: at start of training, at weeks 2, 4, 6, 8, 6 and 24
Secondary outcomes (6)
Walking Index for Spinal Cord Injury (WISCI)
Classification of walking ability on a rank ordered scale with 21 categories.
Measured: at start of training, at weeks 2, 4, 6, 8, 6 and 24
Spasticity
Muscle tone is rated using the modified Ashworth and the Pess spasm frequency tests
Measured: at start of training, at weeks 2, 4, 6, 8, 6 and 24
Perceived exertion
Measured: after every training
Spinal Cord Independence Measure
Measured: at start of training, at weeks 2, 4, 6, 8, 6 and 24
Spinal cord injury classification
Classification according to the standards by the American Spinal Cord Injury Association (ASIA)
Measured: at start of training, at weeks 2, 4, 6, 8, 6 and 24
Patients' Global Impression of Change Scale
Measured: At week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startFeb 2010
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Markus Wirz, PT PhD, Principal investigator, Zurich University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01147185
- Sponsor's protocol ID
- EMSCI-DR
- Status last verified
- Jun 2016
- First submitted
- 7 May 2010
- Last updated
- 29 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21619574
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Automated Locomotor Training in Patients With Acute Incomplete Spinal Cord Injury: A Multicenter Trial
- ClinicalTrials.gov ID
- NCT01147185
- Acronym / sponsor ID
- EMSCI-DR
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal Cord Injuries, Locomotor training, Dose-Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 22 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive training | Other | Device: Locomotor training using a robotic deviceLocomotor training using a robotic device of at least 50 minutes |
| Standard training | Active comparator | Device: Locomotor training using a robotic deviceLocomotor training using a robotic device of maximally 25 minutes |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Locomotor training using a robotic deviceAlso: Lokomat, Hocoma AG, Volketswil/Switzerland50min walking time, 3-5 trainings/week. | Device | Intensive training |
| Locomotor training using a robotic deviceAlso: Lokomat, Hocoma AG, Volketswil/Switzerland25min walking time, 3-5 trainings/week. | Device | Standard training |
Primary outcome
Ten meter walking test
Time frame: at start of training, at weeks 2, 4, 6, 8, 6 and 24
Self selected walking speed over a distance of 10m
6 secondary outcomes
Walking Index for Spinal Cord Injury (WISCI)
Time frame: at start of training, at weeks 2, 4, 6, 8, 6 and 24
Spasticity
Time frame: at start of training, at weeks 2, 4, 6, 8, 6 and 24
Perceived exertion
Time frame: after every training
Spinal Cord Independence Measure
Time frame: at start of training, at weeks 2, 4, 6, 8, 6 and 24
Spinal cord injury classification
Time frame: at start of training, at weeks 2, 4, 6, 8, 6 and 24
Patients' Global Impression of Change Scale
Time frame: At week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2016.
- Derived from this study: PubMed 21619574Wirz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Wirz, PT PhD principal investigator
Zurich University of Applied Sciences
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Locomotor training using a robotic device in people with Spinal Cord Injuries, run by University of Zurich at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain, Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ten meter walking test (time frame: at start of training, at weeks 2, 4, 6, 8, 6 and 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01147185, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2016.