Spinal Cord InjuryNCT03477123
Evaluation of Robotic Exoskeletons Therapy for Gait Rehabilitation in Patients With Incomplete Spinal Cord Injury.
A study testing Walking therapy with Exo-H2 exoskeleton in people with Spinal Cord Injury and Incomplete Spinal Cord Injury, run by Hospital Nacional de Parapléjicos de Toledo at 1 site in Spain.
Trial summary
The objective of the study is to assess the efficacy of the Exo-H2 robotic exoskeleton for walking rehabilitation of people with incomplete spinal cord injury. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Spinal Cord Injury, Incomplete Spinal Cord Injury
- What is being tested?
- Walking therapy with Exo-H2 exoskeleton
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2016to 3 Jul 2020
- 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 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Incomplete Spinal Cord Syndrome, ASIA scale C or D
- enough strength in the upper extremities to handle a walker or crutches (triceps brachial muscle balance ≥ 3)
- Age between 16 and 70 y.o.
- Heigth: 1.6-1.9m
- Weigth less than 120Kg
- Stable medical condition between 6 weeks and 18 months since injury.
- Subjects must tolerate standing and be included in walking rehabilitation program in the center.
- Lower limb spasticity should be lower than 3 as measyred by Ashworth scale.
Who cannot join
- Cardiovascular diseases.
- Upper limb pathology of any kind.
- irreducible flexo or arthrodesis in lower limb joints, 2 or more osteoporotic fractures in the lower limbs in the last 2 years
- Uncontrolled epilepsy.
- Ulcers sores at the contact points with the exoskeleton.
- Refuse to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Robotic Exoskeletons Therapy for Gait Rehabilitation in Patients With Incomplete Spinal Cord Injury
The objective of the study is to assess the efficacy of the Exo-H2 robotic exoskeleton for walking rehabilitation of people with incomplete spinal cord injury.
Read the detailed description
The recovery of walking ability is a primary concern of rehabilitation programs for people who have suffered anincomplete spinal cord injury. Robotic therapy arises from the new concepts of neuroplasticity. One of the most novel contributions in this field is robotic exoskeletons. However, there is still not enough scientific evidence to support the clinical use of this technology.
The aim of this proposal is to assess the efficacy of a new model of robotic exoskeleton (Exo H2) developed by the CSIC with HNP involvement in the context of HYPER project (Consolider 2009 call) in gait rehabilitation for people with incomplete spinal cord injury. A multicenter study is proposed here, involving the National Hospital of Paraplegics and the Institut Guttmann. Two randomized groups of patients with subacute incomplete spinal cord injury will be defined. In one group, protocol gait rehabilitation based on the Exo H2 will be established and traditional gait therapy will be adapted for control group. Both groups of patients were assessed performing a physical exam including functional gait scales (10 MWT, 6MWT, WISCI II score, SCIM) and a biomechanical gait analysis with kinetic and kinematic techniques. Functional assessment will be carried out before intervention, at the end of the intervention and a follow up six weeks later.
- Conditions
- Spinal Cord Injury, Incomplete Spinal Cord Injury
- Being tested
- Walking therapy with Exo-H2 exoskeleton
- Keywords
- Incomplete spinal cord injury, Walking, Rehabilitation, Robotic exoskeleton
- 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.
Walking therapy with Exo-H2 exoskeletonDevice
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Walking therapy with Exo-H2 exoskeleton Receives: Device: Walking therapy with Exo-H2 exoskeleton |
| Control | No intervention | Group receiving conventional walking therapy without robotic exoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower extremity motor score
This scale evaluate the ability and force of the patient when attepmting to contract five key lower limb muscles. It is manually measured by the therapist. Range from 0 (no contraction) to 5 (healthy function). The total score summs up the scores of all muscles. In healthy conditions is 50 points.
Measured: Change from Baseline Lower Extremity Motor Score at 2 months
Spasticity measured by Ashworth scale
Manual testing of muscle tone in response to manual mobilization of joints. Range from 0 (healthy response) to 4 (maximum muscle tone).
Measured: Change from Baseline Ashworth Scale at 2 months
Ten meters walking test
This test measure walking velocity on covering ten meters walking in flat, straigth line.
Measured: Change from Baseline Ten Meters Walking Test at 2 months
Six minutes walking test
This test measure walking endurance by measuring the distance covered in six minutes of walking in flat, straigth line.
Measured: Change from Baseline Six Minutes Walking Test at 2 months
Time Up-and-Go Test (TUG)
This test measures the time to complete stand to sit, walk 3 meters and sitting back again.
Measured: Change from Baseline TUG Test at 2 months
Walking Index for Spinal Cord Injury II (WISCI II)
WISCI II assess the amount of physical assistance needed, as well as devices required, for walking following paralysis that results from Spinal Cord Injury.
The subject is observed by the trained personnel and the WISCI level is recorded on the scale of 0 to 20 at baseline (Baseline WISCI). The subject is observed again at the defined interval (Interval WISCI). The change in score is calculated by subtracting the baseline WISCI from the Interval WISCI, which equals the change in WISCI (Changed WISCI). If a group of subjects are enrolled, medians and means may be calculated.
Measured: Change from Baseline WISCI II Scale at 2 months
Questionnaire: Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)
The purpose of the QUEST questionnaire is to evaluate how satisfied you are with your assistive device and the related services you experienced. The questionnaire consists of 12 satisfaction items. For each of the 12 items, rate your satisfaction with your assistive device and the related services you experienced by using the following scale of 1 to 5.
Measured: Through study completion
Secondary outcomes (1)
Spinal Cord Independence Measure III (SCIM III)
The SCIM is composed of 19 items that assess 3 domains.1) Self-care, 2) Respiration and sphincter management, 3) Mobility (9 items, scores range from 0-40). The total SCIM scores range from 0 to 100.
Measured: Change from Baseline SCIM III scale at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start1 Jan 2016
- Primary completion31 Mar 2020
- Study completion3 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- 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
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Nacional de Parapléjicos de Toledo
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Guttmann
- Responsible party
- Principal investigator, Angel Gil-Agudo, Hospital Nacional de Parapléjicos de Toledo
- Investigators
- Angel Gil-Agudo, PhD, MD, Study chair, Head of Rehabilitation Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03477123
- Sponsor's protocol ID
- PI15/01437
- Status last verified
- Jul 2020
- First submitted
- 28 Feb 2018
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ditunno PL, Patrick M, Stineman M, Ditunno JF. Who wants to walk? Preferences for recovery after SCI: a longitudinal and cross-sectional study. Spinal Cord. 2008 Jul;46(7):500-6. doi: 10.1038/sj.sc.3102172. Epub 2008 Jan 22.
PubMed 18209742Esquenazi A, Packel A. Robotic-assisted gait training and restoration. Am J Phys Med Rehabil. 2012 Nov;91(11 Suppl 3):S217-27; quiz S228-31. doi: 10.1097/PHM.0b013e31826bce18.
PubMed 23080038Kwakkel G, Kollen B, Lindeman E. Understanding the pattern of functional recovery after stroke: facts and theories. Restor Neurol Neurosci. 2004;22(3-5):281-99.
PubMed 15502272Chen G, Patten C. Treadmill training with harness support: selection of parameters for individuals with poststroke hemiparesis. J Rehabil Res Dev. 2006 Jul-Aug;43(4):485-98. doi: 10.1682/jrrd.2005.04.0063.
PubMed 17123188Colombo G, Joerg M, Schreier R, Dietz V. Treadmill training of paraplegic patients using a robotic orthosis. J Rehabil Res Dev. 2000 Nov-Dec;37(6):693-700.
PubMed 11321005Mantone J. Getting a leg up? Rehab patients get an assist from devices such as HealthSouth's AutoAmbulator, but the robots' clinical benefits are still in doubt. Mod Healthc. 2006 Feb 13;36(7):58-60. No abstract available.
PubMed 16515076Veneman JF, Kruidhof R, Hekman EE, Ekkelenkamp R, Van Asseldonk EH, van der Kooij H. Design and evaluation of the LOPES exoskeleton robot for interactive gait rehabilitation. IEEE Trans Neural Syst Rehabil Eng. 2007 Sep;15(3):379-86. doi: 10.1109/tnsre.2007.903919.
PubMed 17894270Tefertiller C, Pharo B, Evans N, Winchester P. Efficacy of rehabilitation robotics for walking training in neurological disorders: a review. J Rehabil Res Dev. 2011;48(4):387-416. doi: 10.1682/jrrd.2010.04.0055.
PubMed 21674390Zeilig G, Weingarden H, Zwecker M, Dudkiewicz I, Bloch A, Esquenazi A. Safety and tolerance of the ReWalk exoskeleton suit for ambulation by people with complete spinal cord injury: a pilot study. J Spinal Cord Med. 2012 Mar;35(2):96-101. doi: 10.1179/2045772312Y.0000000003. Epub 2012 Feb 7.
PubMed 22333043Aach M, Cruciger O, Sczesny-Kaiser M, Hoffken O, Meindl RCh, Tegenthoff M, Schwenkreis P, Sankai Y, Schildhauer TA. Voluntary driven exoskeleton as a new tool for rehabilitation in chronic spinal cord injury: a pilot study. Spine J. 2014 Dec 1;14(12):2847-53. doi: 10.1016/j.spinee.2014.03.042. Epub 2014 Apr 4.
PubMed 24704677Jackson AB, Carnel CT, Ditunno JF, Read MS, Boninger ML, Schmeler MR, Williams SR, Donovan WH; Gait and Ambulation Subcommittee. Outcome measures for gait and ambulation in the spinal cord injury population. J Spinal Cord Med. 2008;31(5):487-99. doi: 10.1080/10790268.2008.11753644.
PubMed 19086706Ditunno J, Scivoletto G. Clinical relevance of gait research applied to clinical trials in spinal cord injury. Brain Res Bull. 2009 Jan 15;78(1):35-42. doi: 10.1016/j.brainresbull.2008.09.003. Epub 2008 Oct 9.
PubMed 18848865
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Robotic Exoskeletons Therapy for Gait Rehabilitation in Patients With Incomplete Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT03477123
- Acronym / sponsor ID
- PI15/01437
- Conditions
- Spinal Cord Injury, Incomplete Spinal Cord Injury
- Keywords
- Incomplete spinal cord injury, Walking, Rehabilitation, Robotic exoskeleton
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospital Nacional de Parapléjicos de ToledoUniversity, hospital or other
- Collaborators
- Institut Guttmann
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 3 Jul 2020 (actual)
- First posted
- 26 Mar 2018 (actual)
- 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 objective of the study is to assess the efficacy of the Exo-H2 robotic exoskeleton for walking rehabilitation of people with incomplete spinal cord injury.
Detailed description
The recovery of walking ability is a primary concern of rehabilitation programs for people who have suffered anincomplete spinal cord injury. Robotic therapy arises from the new concepts of neuroplasticity. One of the most novel contributions in this field is robotic exoskeletons. However, there is still not enough scientific evidence to support the clinical use of this technology.
The aim of this proposal is to assess the efficacy of a new model of robotic exoskeleton (Exo H2) developed by the CSIC with HNP involvement in the context of HYPER project (Consolider 2009 call) in gait rehabilitation for people with incomplete spinal cord injury. A multicenter study is proposed here, involving the National Hospital of Paraplegics and the Institut Guttmann. Two randomized groups of patients with subacute incomplete spinal cord injury will be defined. In one group, protocol gait rehabilitation based on the Exo H2 will be established and traditional gait therapy will be adapted for control group. Both groups of patients were assessed performing a physical exam including functional gait scales (10 MWT, 6MWT, WISCI II score, SCIM) and a biomechanical gait analysis with kinetic and kinematic techniques. Functional assessment will be carried out before intervention, at the end of the intervention and a follow up six weeks later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Walking therapy with Exo-H2 exoskeletonWalking therapy with Exo-H2 exoskeleton |
| Control | No intervention | –Group receiving conventional walking therapy without robotic exoskeleton |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Incomplete Spinal Cord Syndrome, ASIA scale C or D
- enough strength in the upper extremities to handle a walker or crutches (triceps brachial muscle balance ≥ 3)
- Age between 16 and 70 y.o.
- Heigth: 1.6-1.9m
- Weigth less than 120Kg
Key exclusion criteria (6 listed)
- Cardiovascular diseases.
- Upper limb pathology of any kind.
- irreducible flexo or arthrodesis in lower limb joints, 2 or more osteoporotic fractures in the lower limbs in the last 2 years
- Uncontrolled epilepsy.
- Ulcers sores at the contact points with the exoskeleton.
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 |
|---|---|---|
| Walking therapy with Exo-H2 exoskeleton | Device | Intervention |
Primary outcome
Lower extremity motor score
Time frame: Change from Baseline Lower Extremity Motor Score at 2 months
This scale evaluate the ability and force of the patient when attepmting to contract five key lower limb muscles. It is manually measured by the therapist. Range from 0 (no contraction) to 5 (healthy function). The total score summs up the scores of all muscles. In healthy conditions is 50 points.
Spasticity measured by Ashworth scale
Time frame: Change from Baseline Ashworth Scale at 2 months
Manual testing of muscle tone in response to manual mobilization of joints. Range from 0 (healthy response) to 4 (maximum muscle tone).
Ten meters walking test
Time frame: Change from Baseline Ten Meters Walking Test at 2 months
This test measure walking velocity on covering ten meters walking in flat, straigth line.
Six minutes walking test
Time frame: Change from Baseline Six Minutes Walking Test at 2 months
This test measure walking endurance by measuring the distance covered in six minutes of walking in flat, straigth line.
Time Up-and-Go Test (TUG)
Time frame: Change from Baseline TUG Test at 2 months
This test measures the time to complete stand to sit, walk 3 meters and sitting back again.
Walking Index for Spinal Cord Injury II (WISCI II)
Time frame: Change from Baseline WISCI II Scale at 2 months
WISCI II assess the amount of physical assistance needed, as well as devices required, for walking following paralysis that results from Spinal Cord Injury. The subject is observed by the trained personnel and the WISCI level is recorded on the scale of 0 to 20 at baseline (Baseline WISCI). The subject is observed again at the defined interval (Interval WISCI). The change in score is calculated by subtracting the baseline WISCI from the Interval WISCI, which equals the change in WISCI (Changed WISCI). If a group of subjects are enrolled, medians and means may be calculated.
Questionnaire: Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)
Time frame: Through study completion
The purpose of the QUEST questionnaire is to evaluate how satisfied you are with your assistive device and the related services you experienced. The questionnaire consists of 12 satisfaction items. For each of the 12 items, rate your satisfaction with your assistive device and the related services you experienced by using the following scale of 1 to 5.
1 secondary outcome
Spinal Cord Independence Measure III (SCIM III)
Time frame: Change from Baseline SCIM III scale at 2 months
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 7 Jul 2020.
- Background: PubMed 18209742Ditunno PL, Patrick M, Stineman M, Ditunno JF. Who wants to walk? Preferences for recovery after SCI: a longitudinal and cross-sectional study. Spinal Cord. 2008 Jul;46(7):500-6. doi: 10.1038/sj.sc.3102172. Epub 2008 Jan 22.
- Background: PubMed 23080038Esquenazi A, Packel A. Robotic-assisted gait training and restoration. Am J Phys Med Rehabil. 2012 Nov;91(11 Suppl 3):S217-27; quiz S228-31. doi: 10.1097/PHM.0b013e31826bce18.
- Background: PubMed 15502272Kwakkel G, Kollen B, Lindeman E. Understanding the pattern of functional recovery after stroke: facts and theories. Restor Neurol Neurosci. 2004;22(3-5):281-99.
- Background: PubMed 17123188Chen G, Patten C. Treadmill training with harness support: selection of parameters for individuals with poststroke hemiparesis. J Rehabil Res Dev. 2006 Jul-Aug;43(4):485-98. doi: 10.1682/jrrd.2005.04.0063.
- Background: PubMed 11321005Colombo G, Joerg M, Schreier R, Dietz V. Treadmill training of paraplegic patients using a robotic orthosis. J Rehabil Res Dev. 2000 Nov-Dec;37(6):693-700.
- Background: PubMed 16515076Mantone J. Getting a leg up? Rehab patients get an assist from devices such as HealthSouth's AutoAmbulator, but the robots' clinical benefits are still in doubt. Mod Healthc. 2006 Feb 13;36(7):58-60. No abstract available.
- Background: PubMed 17894270Veneman JF, Kruidhof R, Hekman EE, Ekkelenkamp R, Van Asseldonk EH, van der Kooij H. Design and evaluation of the LOPES exoskeleton robot for interactive gait rehabilitation. IEEE Trans Neural Syst Rehabil Eng. 2007 Sep;15(3):379-86. doi: 10.1109/tnsre.2007.903919.
- Background: PubMed 21674390Tefertiller C, Pharo B, Evans N, Winchester P. Efficacy of rehabilitation robotics for walking training in neurological disorders: a review. J Rehabil Res Dev. 2011;48(4):387-416. doi: 10.1682/jrrd.2010.04.0055.
- Background: PubMed 22333043Zeilig G, Weingarden H, Zwecker M, Dudkiewicz I, Bloch A, Esquenazi A. Safety and tolerance of the ReWalk exoskeleton suit for ambulation by people with complete spinal cord injury: a pilot study. J Spinal Cord Med. 2012 Mar;35(2):96-101. doi: 10.1179/2045772312Y.0000000003. Epub 2012 Feb 7.
- Background: PubMed 24704677Aach M, Cruciger O, Sczesny-Kaiser M, Hoffken O, Meindl RCh, Tegenthoff M, Schwenkreis P, Sankai Y, Schildhauer TA. Voluntary driven exoskeleton as a new tool for rehabilitation in chronic spinal cord injury: a pilot study. Spine J. 2014 Dec 1;14(12):2847-53. doi: 10.1016/j.spinee.2014.03.042. Epub 2014 Apr 4.
- Background: PubMed 19086706Jackson AB, Carnel CT, Ditunno JF, Read MS, Boninger ML, Schmeler MR, Williams SR, Donovan WH; Gait and Ambulation Subcommittee. Outcome measures for gait and ambulation in the spinal cord injury population. J Spinal Cord Med. 2008;31(5):487-99. doi: 10.1080/10790268.2008.11753644.
- Background: PubMed 18848865Ditunno J, Scivoletto G. Clinical relevance of gait research applied to clinical trials in spinal cord injury. Brain Res Bull. 2009 Jan 15;78(1):35-42. doi: 10.1016/j.brainresbull.2008.09.003. Epub 2008 Oct 9.
- Individual participant dataSharing planned: No
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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.
Angel Gil-Agudo, PhD, MD study chair
Head of Rehabilitation Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking therapy with Exo-H2 exoskeleton in people with Spinal Cord Injury and Incomplete Spinal Cord Injury, run by Hospital Nacional de Parapléjicos de Toledo at 1 site in Spain.
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 8 inclusion and 6 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 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Lower extremity motor score (time frame: Change from Baseline Lower Extremity Motor Score at 2 months). The study lists 7 primary outcomes in all. 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 NCT03477123, which also lists 12 linked publications.
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 7 Jul 2020.