Spinal Cord InjuriesNCT06137456
First Report of a New Exoskeleton in Incomplete Spinal Cord Injury
A study testing Exoskeletal robotic therapy for walking. and Conventional exercise therapy in people with Spinal Cord Injuries and Walking, Difficulty, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to compare the effects of exoskeletal robotic therapy and conventional exercise therapy in incomplete spinal cord injury (SCI). The main questions it aims to answer are: Is exoskeletal robotic therapy effective in improving functional ambulation in SCI? Is exoskeletal robotic therapy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Walking, Difficulty
- What is being tested?
- Exoskeletal robotic therapy for walking. and Conventional exercise therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 1 Nov 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- SCI below T4,
- Patients with AIS (American Spinal Injury Association Impairment Scale) C or D injury,
- Bilateral quadriceps femoris manual test scores ≥ 2,
- Upper extremity manual muscle test scores = 5,
- Participants with adequate spinal stabilization
Who cannot join
- Severe spasticity (Modified Ashworth Scale ≥ 3),
- Difference in leg length,
- Pregnancy, osteoporosis,
- Contracture, or limited range of motion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: First Report of a New Exoskeleton in Incomplete Spinal Cord Injury: FreeGait®
The goal of this clinical trial is to compare the effects of exoskeletal robotic therapy and conventional exercise therapy in incomplete spinal cord injury (SCI). The main questions it aims to answer are:
- Is exoskeletal robotic therapy effective in improving functional ambulation in SCI?
- Is exoskeletal robotic therapy effective in enhancing Activities of Daily Living in SCI?
Participants treated with either:
- Exoskeletal robotic therapy along with conventional exercise therapy, or
- Only conventional exercise therapy.
Read the detailed description
Background: Intensive walking practice is a task that requires performance above the limits of conventional therapy. As a solution, robot-assisted exoskeletons that allow walking on the ground are produced. The exoskeletons can allow the user to perform intense, targeted, and multi-repetitive movements and at the same time provide stability and balance during walking. In this study, a new robot-supported exoskeleton system was used for gait and balance rehabilitation. This study is important as the first clinical study of a new walking system. The primary aim of the study was to evaluate the effect of the FreeGait® exoskeleton system (BAMA Technology, Ankara, Türkiye) on gait parameters in patients with motor incomplete spinal cord injury. The secondary aim was to assess its impact on quality of life and independence.
Methods: Fourteen participants with incomplete spinal cord injury were included in the study. An average of 20.7 sessions of exoskeleton therapy was administered to the study group. Gait training was attempted to be diversified as much as possible during the exoskeleton training. 10MWT, Timed Up and Go Test (TUG), WISCI II, Berg Balance Scale (BBS), Visual Analogue Scale (VAS) for fear of falling, Spinal Cord Independence Measure (SCIM III), World Health Organization Quality of Life Scale-Short Form (WHOQOL - BREF) were used for evaluation.
Results: WISCI II levels improved significantly in the study group (p = 0.031). Overground walking speed means calculated from 10MWT increased by 66%, twofold compared to the control group (p = 0.016, p = 0.063, respectively). The mobility subscale of SCIM III, the total SCIM III scores, and the WHOQOL-BREF physical health domain score increased significantly, contrary to the control group (p < 0.05). However, there was no difference in the mean change of all measurements between groups (p > 0.05).
Conclusions: Gait training with the new exoskeleton system contributes to functional walking skills. It is possible that the residual motor learning ability, together with the balance and compensation mechanisms, played a role in the outcome. It is also important that this improvement in functional mobility is reflected in ADLs. It can be supposed that walking in different patterns, and speeds gives a way to simulate daily living conditions, which is the basis of the achievements in this study.
- Conditions
- Spinal Cord Injuries, Walking, Difficulty
- Being tested
- Exoskeletal robotic therapy for walking., Conventional exercise therapy
- Medical subject headings
- Spinal Cord Injuries, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exoskeletal robotic therapy for walking.Device
Exoskeletal robotic therapy for walking. Therapy sessions were scheduled for 40 minutes each. The study group performed exoskeleton walking and balance exercises 3 days a week.
Conventional exercise therapyOther
Conventional treatment consisted of walking and balance exercises, stretching, strengthening, and mobility exercises, for 40 minutes, 5 days a week.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Participants were involved in exoskeletal robotic therapy three days a week and conventional therapy five days a week for a maximum of eight weeks. Receives: Device: Exoskeletal robotic therapy for walking. |
| Control group | Active comparator | Participants were involved in conventional therapy five days a week for a maximum of eight weeks. Receives: Other: Conventional exercise therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking Index in Spinal Cord Injury II
Walking Index in Spinal Cord Injury II for walking independence level assessment
Measured: 23 months
Secondary outcomes (6)
Ten-Meter Walking Test
Ten-Meter Walking Test for overground walking speed assessment
Measured: 23 months
Timed Up and Go Test
Timed Up and Go Test overground walking assessment
Measured: 23 months
Berg Balance Scale
Berg Balance Scale for balance assessment
Measured: 23 months
Visual Analogue Scale
Visual Analogue Scale (VAS) for fear of falling assessment
Measured: 23 months
Spinal Cord Independence Measure (SCIM III)
Spinal Cord Independence Measure (SCIM III) for activity of daily living assessment
Measured: 23 months
World Health Organization Quality of Life Scale-Short Form (WHOQOL - BREF)
World Health Organization Quality of Life Scale-Short Form (WHOQOL - BREF) for quality of life assessment
Measured: 23 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Jan 2022
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)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 Ankara City Hospital BilkentThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06137456
- Sponsor's protocol ID
- AnkaraCHBilkent-PMR-MSS-02
- Status last verified
- Nov 2023
- First submitted
- 14 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Finlayson ML, Peterson EW. Falls, aging, and disability. Phys Med Rehabil Clin N Am. 2010 May;21(2):357-73. doi: 10.1016/j.pmr.2009.12.003.
PubMed 20494282Contreras-Vidal JL, A Bhagat N, Brantley J, Cruz-Garza JG, He Y, Manley Q, Nakagome S, Nathan K, Tan SH, Zhu F, Pons JL. Powered exoskeletons for bipedal locomotion after spinal cord injury. J Neural Eng. 2016 Jun;13(3):031001. doi: 10.1088/1741-2560/13/3/031001. Epub 2016 Apr 11.
PubMed 27064508Esquenazi A, Talaty M, Packel A, Saulino M. The ReWalk powered exoskeleton to restore ambulatory function to individuals with thoracic-level motor-complete spinal cord injury. Am J Phys Med Rehabil. 2012 Nov;91(11):911-21. doi: 10.1097/PHM.0b013e318269d9a3.
PubMed 23085703Fouad K, Tetzlaff W. Rehabilitative training and plasticity following spinal cord injury. Exp Neurol. 2012 May;235(1):91-9. doi: 10.1016/j.expneurol.2011.02.009. Epub 2011 Feb 17.
PubMed 21333646Leech KA, Kinnaird CR, Holleran CL, Kahn J, Hornby TG. Effects of Locomotor Exercise Intensity on Gait Performance in Individuals With Incomplete Spinal Cord Injury. Phys Ther. 2016 Dec;96(12):1919-1929. doi: 10.2522/ptj.20150646. Epub 2016 Jun 16.
PubMed 27313241Barbeau H, Norman K, Fung J, Visintin M, Ladouceur M. Does neurorehabilitation play a role in the recovery of walking in neurological populations? Ann N Y Acad Sci. 1998 Nov 16;860:377-92. doi: 10.1111/j.1749-6632.1998.tb09063.x.
PubMed 9928326Dobkin B, Barbeau H, Deforge D, Ditunno J, Elashoff R, Apple D, Basso M, Behrman A, Harkema S, Saulino M, Scott M; Spinal Cord Injury Locomotor Trial Group. The evolution of walking-related outcomes over the first 12 weeks of rehabilitation for incomplete traumatic spinal cord injury: the multicenter randomized Spinal Cord Injury Locomotor Trial. Neurorehabil Neural Repair. 2007 Jan-Feb;21(1):25-35. doi: 10.1177/1545968306295556.
PubMed 17172551Yang JF, Musselman KE, Livingstone D, Brunton K, Hendricks G, Hill D, Gorassini M. Repetitive mass practice or focused precise practice for retraining walking after incomplete spinal cord injury? A pilot randomized clinical trial. Neurorehabil Neural Repair. 2014 May;28(4):314-24. doi: 10.1177/1545968313508473. Epub 2013 Nov 8.
PubMed 24213960Colombo G, Wirz M, Dietz V. Driven gait orthosis for improvement of locomotor training in paraplegic patients. Spinal Cord. 2001 May;39(5):252-5. doi: 10.1038/sj.sc.3101154.
PubMed 11438840Hesse S, Uhlenbrock D. A mechanized gait trainer for restoration of gait. J Rehabil Res Dev. 2000 Nov-Dec;37(6):701-8.
PubMed 11321006Hesse S. Treadmill training with partial body weight support after stroke: a review. NeuroRehabilitation. 2008;23(1):55-65.
PubMed 18356589Calabro RS, Cacciola A, Berte F, Manuli A, Leo A, Bramanti A, Naro A, Milardi D, Bramanti P. Robotic gait rehabilitation and substitution devices in neurological disorders: where are we now? Neurol Sci. 2016 Apr;37(4):503-14. doi: 10.1007/s10072-016-2474-4. Epub 2016 Jan 18.
PubMed 26781943Esquenazi A, Talaty M, Jayaraman A. Powered Exoskeletons for Walking Assistance in Persons with Central Nervous System Injuries: A Narrative Review. PM R. 2017 Jan;9(1):46-62. doi: 10.1016/j.pmrj.2016.07.534. Epub 2016 Aug 24.
PubMed 27565639Bolliger M, Blight AR, Field-Fote EC, Musselman K, Rossignol S, Barthelemy D, Bouyer L, Popovic MR, Schwab JM, Boninger ML, Tansey KE, Scivoletto G, Kleitman N, Jones LAT, Gagnon DH, Nadeau S, Haupt D, Awai L, Easthope CS, Zorner B, Rupp R, Lammertse D, Curt A, Steeves J. Lower extremity outcome measures: considerations for clinical trials in spinal cord injury. Spinal Cord. 2018 Jul;56(7):628-642. doi: 10.1038/s41393-018-0097-8. Epub 2018 Apr 27.
PubMed 29700477Jackson 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 19086706
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Report of a New Exoskeleton in Incomplete Spinal Cord Injury: FreeGait®
- ClinicalTrials.gov ID
- NCT06137456
- Acronym / sponsor ID
- AnkaraCHBilkent-PMR-MSS-02
- Conditions
- Spinal Cord Injuries, Walking, Difficulty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 18 Nov 2023 (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 goal of this clinical trial is to compare the effects of exoskeletal robotic therapy and conventional exercise therapy in incomplete spinal cord injury (SCI). The main questions it aims to answer are:
- Is exoskeletal robotic therapy effective in improving functional ambulation in SCI?
- Is exoskeletal robotic therapy effective in enhancing Activities of Daily Living in SCI?
Participants treated with either:
- Exoskeletal robotic therapy along with conventional exercise therapy, or
- Only conventional exercise therapy.
Detailed description
Background: Intensive walking practice is a task that requires performance above the limits of conventional therapy. As a solution, robot-assisted exoskeletons that allow walking on the ground are produced. The exoskeletons can allow the user to perform intense, targeted, and multi-repetitive movements and at the same time provide stability and balance during walking. In this study, a new robot-supported exoskeleton system was used for gait and balance rehabilitation. This study is important as the first clinical study of a new walking system. The primary aim of the study was to evaluate the effect of the FreeGait® exoskeleton system (BAMA Technology, Ankara, Türkiye) on gait parameters in patients with motor incomplete spinal cord injury. The secondary aim was to assess its impact on quality of life and independence.
Methods: Fourteen participants with incomplete spinal cord injury were included in the study. An average of 20.7 sessions of exoskeleton therapy was administered to the study group. Gait training was attempted to be diversified as much as possible during the exoskeleton training. 10MWT, Timed Up and Go Test (TUG), WISCI II, Berg Balance Scale (BBS), Visual Analogue Scale (VAS) for fear of falling, Spinal Cord Independence Measure (SCIM III), World Health Organization Quality of Life Scale-Short Form (WHOQOL - BREF) were used for evaluation.
Results: WISCI II levels improved significantly in the study group (p = 0.031). Overground walking speed means calculated from 10MWT increased by 66%, twofold compared to the control group (p = 0.016, p = 0.063, respectively). The mobility subscale of SCIM III, the total SCIM III scores, and the WHOQOL-BREF physical health domain score increased significantly, contrary to the control group (p < 0.05). However, there was no difference in the mean change of all measurements between groups (p > 0.05).
Conclusions: Gait training with the new exoskeleton system contributes to functional walking skills. It is possible that the residual motor learning ability, together with the balance and compensation mechanisms, played a role in the outcome. It is also important that this improvement in functional mobility is reflected in ADLs. It can be supposed that walking in different patterns, and speeds gives a way to simulate daily living conditions, which is the basis of the achievements in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: Exoskeletal robotic therapy for walking.Participants were involved in exoskeletal robotic therapy three days a week and conventional therapy five days a week for a maximum of eight weeks. |
| Control group | Active comparator | Other: Conventional exercise therapyParticipants were involved in conventional therapy five days a week for a maximum of eight weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- SCI below T4,
- Patients with AIS (American Spinal Injury Association Impairment Scale) C or D injury,
- Bilateral quadriceps femoris manual test scores ≥ 2,
- Upper extremity manual muscle test scores = 5,
- Participants with adequate spinal stabilization
Key exclusion criteria (4 listed)
- Severe spasticity (Modified Ashworth Scale ≥ 3),
- Difference in leg length,
- Pregnancy, osteoporosis,
- Contracture, or limited range of motion
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 |
|---|---|---|
| Exoskeletal robotic therapy for walking.Exoskeletal robotic therapy for walking. Therapy sessions were scheduled for 40 minutes each. The study group performed exoskeleton walking and balance exercises 3 days a week. | Device | Study group |
| Conventional exercise therapyConventional treatment consisted of walking and balance exercises, stretching, strengthening, and mobility exercises, for 40 minutes, 5 days a week. | Other | Control group |
Primary outcome
Walking Index in Spinal Cord Injury II
Time frame: 23 months
Walking Index in Spinal Cord Injury II for walking independence level assessment
6 secondary outcomes
Ten-Meter Walking Test
Time frame: 23 months
Timed Up and Go Test
Time frame: 23 months
Berg Balance Scale
Time frame: 23 months
Visual Analogue Scale
Time frame: 23 months
Spinal Cord Independence Measure (SCIM III)
Time frame: 23 months
World Health Organization Quality of Life Scale-Short Form (WHOQOL - BREF)
Time frame: 23 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 18 Nov 2023.
- Background: PubMed 20494282Finlayson ML, Peterson EW. Falls, aging, and disability. Phys Med Rehabil Clin N Am. 2010 May;21(2):357-73. doi: 10.1016/j.pmr.2009.12.003.
- Background: PubMed 27064508Contreras-Vidal JL, A Bhagat N, Brantley J, Cruz-Garza JG, He Y, Manley Q, Nakagome S, Nathan K, Tan SH, Zhu F, Pons JL. Powered exoskeletons for bipedal locomotion after spinal cord injury. J Neural Eng. 2016 Jun;13(3):031001. doi: 10.1088/1741-2560/13/3/031001. Epub 2016 Apr 11.
- Background: PubMed 23085703Esquenazi A, Talaty M, Packel A, Saulino M. The ReWalk powered exoskeleton to restore ambulatory function to individuals with thoracic-level motor-complete spinal cord injury. Am J Phys Med Rehabil. 2012 Nov;91(11):911-21. doi: 10.1097/PHM.0b013e318269d9a3.
- Background: PubMed 21333646Fouad K, Tetzlaff W. Rehabilitative training and plasticity following spinal cord injury. Exp Neurol. 2012 May;235(1):91-9. doi: 10.1016/j.expneurol.2011.02.009. Epub 2011 Feb 17.
- Background: PubMed 27313241Leech KA, Kinnaird CR, Holleran CL, Kahn J, Hornby TG. Effects of Locomotor Exercise Intensity on Gait Performance in Individuals With Incomplete Spinal Cord Injury. Phys Ther. 2016 Dec;96(12):1919-1929. doi: 10.2522/ptj.20150646. Epub 2016 Jun 16.
- Background: PubMed 9928326Barbeau H, Norman K, Fung J, Visintin M, Ladouceur M. Does neurorehabilitation play a role in the recovery of walking in neurological populations? Ann N Y Acad Sci. 1998 Nov 16;860:377-92. doi: 10.1111/j.1749-6632.1998.tb09063.x.
- Background: PubMed 17172551Dobkin B, Barbeau H, Deforge D, Ditunno J, Elashoff R, Apple D, Basso M, Behrman A, Harkema S, Saulino M, Scott M; Spinal Cord Injury Locomotor Trial Group. The evolution of walking-related outcomes over the first 12 weeks of rehabilitation for incomplete traumatic spinal cord injury: the multicenter randomized Spinal Cord Injury Locomotor Trial. Neurorehabil Neural Repair. 2007 Jan-Feb;21(1):25-35. doi: 10.1177/1545968306295556.
- Background: PubMed 24213960Yang JF, Musselman KE, Livingstone D, Brunton K, Hendricks G, Hill D, Gorassini M. Repetitive mass practice or focused precise practice for retraining walking after incomplete spinal cord injury? A pilot randomized clinical trial. Neurorehabil Neural Repair. 2014 May;28(4):314-24. doi: 10.1177/1545968313508473. Epub 2013 Nov 8.
- Background: PubMed 11438840Colombo G, Wirz M, Dietz V. Driven gait orthosis for improvement of locomotor training in paraplegic patients. Spinal Cord. 2001 May;39(5):252-5. doi: 10.1038/sj.sc.3101154.
- Background: PubMed 11321006Hesse S, Uhlenbrock D. A mechanized gait trainer for restoration of gait. J Rehabil Res Dev. 2000 Nov-Dec;37(6):701-8.
- Background: PubMed 18356589Hesse S. Treadmill training with partial body weight support after stroke: a review. NeuroRehabilitation. 2008;23(1):55-65.
- Background: PubMed 26781943Calabro RS, Cacciola A, Berte F, Manuli A, Leo A, Bramanti A, Naro A, Milardi D, Bramanti P. Robotic gait rehabilitation and substitution devices in neurological disorders: where are we now? Neurol Sci. 2016 Apr;37(4):503-14. doi: 10.1007/s10072-016-2474-4. Epub 2016 Jan 18.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exoskeletal robotic therapy for walking. and Conventional exercise therapy in people with Spinal Cord Injuries and Walking, Difficulty, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 5 inclusion and 4 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 18 Nov 2023. 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 Turkey (Türkiye). 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?
Walking Index in Spinal Cord Injury II (time frame: 23 months). 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 NCT06137456, which also lists 32 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 18 Nov 2023.