First Report of a New Exoskeleton in Incomplete Spinal Cord Injury

Spinal Cord Injuries Clinical Trial

Official title:

First Report of a New Exoskeleton in Incomplete Spinal Cord Injury: FreeGait®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06137456
• Other study ID #: AnkaraCHBilkent-PMR-MSS-02
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: November 1, 2023

Study information

• Verified date: November 2023
• Source: Ankara City Hospital Bilkent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: November 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Severe spasticity (Modified Ashworth Scale = 3),

• Difference in leg length,

• Pregnancy, osteoporosis,

• Contracture, or limited range of motion

Related Conditions & MeSH terms

• Mobility Limitation
• Spinal Cord Injuries
• Walking, Difficulty
• Wounds and Injuries

Intervention

Device:
• 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.

Other:
• Conventional exercise therapy
Conventional treatment consisted of walking and balance exercises, stretching, strengthening, and mobility exercises, for 40 minutes, 5 days a week.

Locations

Country	Name	City	State
Turkey	Ankara City Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

References & Publications (31)

Ahuja CS, Wilson JR, Nori S, Kotter MRN, Druschel C, Curt A, Fehlings MG. Traumatic spinal cord injury. Nat Rev Dis Primers. 2017 Apr 27;3:17018. doi: 10.1038/nrdp.2017.18. — View Citation

Barbeau 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. — View Citation

Baunsgaard CB, Nissen UV, Brust AK, Frotzler A, Ribeill C, Kalke YB, Leon N, Gomez B, Samuelsson K, Antepohl W, Holmstrom U, Marklund N, Glott T, Opheim A, Penalva JB, Murillo N, Nachtegaal J, Faber W, Biering-Sorensen F. Exoskeleton gait training after spinal cord injury: An exploratory study on secondary health conditions. J Rehabil Med. 2018 Sep 28;50(9):806-813. doi: 10.2340/16501977-2372. — View Citation

Bolliger 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. — View Citation

Calabro 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. — View Citation

Colombo 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. — View Citation

Contreras-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. — View Citation

de Franca IS, Coura AS, de Franca EG, Basilio NN, Souto RQ. [Quality of life of adults with spinal cord injury: a study using the WHOQOL-bref]. Rev Esc Enferm USP. 2011 Dec;45(6):1364-71. doi: 10.1590/s0080-62342011000600013. Portuguese. — View Citation

Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. doi: 10.1017/s0033291798006667. — View Citation

Ditunno JF Jr, Ditunno PL, Scivoletto G, Patrick M, Dijkers M, Barbeau H, Burns AS, Marino RJ, Schmidt-Read M. The Walking Index for Spinal Cord Injury (WISCI/WISCI II): nature, metric properties, use and misuse. Spinal Cord. 2013 May;51(5):346-55. doi: 10.1038/sc.2013.9. Epub 2013 Mar 5. — View Citation

Dobkin 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. — View Citation

Esquenazi 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. — View Citation

Esquenazi 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. — View Citation

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. — View Citation

Fouad 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. — View Citation

Gorgey AS. Robotic exoskeletons: The current pros and cons. World J Orthop. 2018 Sep 18;9(9):112-119. doi: 10.5312/wjo.v9.i9.112. eCollection 2018 Sep 18. — View Citation

Hesse S, Uhlenbrock D. A mechanized gait trainer for restoration of gait. J Rehabil Res Dev. 2000 Nov-Dec;37(6):701-8. — View Citation

Hesse S. Treadmill training with partial body weight support after stroke: a review. NeuroRehabilitation. 2008;23(1):55-65. — View Citation

Itzkovich M, Gelernter I, Biering-Sorensen F, Weeks C, Laramee MT, Craven BC, Tonack M, Hitzig SL, Glaser E, Zeilig G, Aito S, Scivoletto G, Mecci M, Chadwick RJ, El Masry WS, Osman A, Glass CA, Silva P, Soni BM, Gardner BP, Savic G, Bergstrom EM, Bluvshtein V, Ronen J, Catz A. The Spinal Cord Independence Measure (SCIM) version III: reliability and validity in a multi-center international study. Disabil Rehabil. 2007 Dec 30;29(24):1926-33. doi: 10.1080/09638280601046302. Epub 2007 Mar 5. — View Citation

Jackson 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. — View Citation

Laut J, Porfiri M, Raghavan P. The Present and Future of Robotic Technology in Rehabilitation. Curr Phys Med Rehabil Rep. 2016 Dec;4(4):312-319. doi: 10.1007/s40141-016-0139-0. Epub 2016 Nov 19. — View Citation

Leech 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. — View Citation

Li Y, Hollis ER 2nd. The role of motor network reorganization during rehabilitation. Neural Regen Res. 2017 May;12(5):745-746. doi: 10.4103/1673-5374.206641. No abstract available. — View Citation

Sahin F, Yilmaz F, Ozmaden A, Kotevolu N, Sahin T, Kuran B. Reliability and validity of the Turkish version of the Berg Balance Scale. J Geriatr Phys Ther. 2008;31(1):32-7. doi: 10.1519/00139143-200831010-00006. — View Citation

Spampinato D, Celnik P. Multiple Motor Learning Processes in Humans: Defining Their Neurophysiological Bases. Neuroscientist. 2021 Jun;27(3):246-267. doi: 10.1177/1073858420939552. Epub 2020 Jul 25. — View Citation

Unalan H, Misirlioglu TO, Erhan B, Akyuz M, Gunduz B, Irgi E, Arslan HE, Baltaci A, Aslan S, Palamar D, Kutlu A, Majlesi J, Akarirmak U, Karamehmetoglu SS. Validity and reliability study of the Turkish version of Spinal Cord Independence Measure-III. Spinal Cord. 2015 Jun;53(6):455-60. doi: 10.1038/sc.2014.249. Epub 2015 Feb 10. — View Citation

van Hedel HJ; EMSCI Study Group. Gait speed in relation to categories of functional ambulation after spinal cord injury. Neurorehabil Neural Repair. 2009 May;23(4):343-50. doi: 10.1177/1545968308324224. Epub 2008 Nov 25. — View Citation

Wirz M, Muller R, Bastiaenen C. Falls in persons with spinal cord injury: validity and reliability of the Berg Balance Scale. Neurorehabil Neural Repair. 2010 Jan;24(1):70-7. doi: 10.1177/1545968309341059. Epub 2009 Aug 12. — View Citation

Wirz M, van Hedel HJA. Balance, gait, and falls in spinal cord injury. Handb Clin Neurol. 2018;159:367-384. doi: 10.1016/B978-0-444-63916-5.00024-0. — View Citation

Wright MA, Herzog F, Mas-Vinyals A, Carnicero-Carmona A, Lobo-Prat J, Hensel C, Franz S, Weidner N, Vidal J, Opisso E, Rupp R. Multicentric investigation on the safety, feasibility and usability of the ABLE lower-limb robotic exoskeleton for individuals with spinal cord injury: a framework towards the standardisation of clinical evaluations. J Neuroeng Rehabil. 2023 Apr 12;20(1):45. doi: 10.1186/s12984-023-01165-0. — View Citation

Yang 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. — View Citation

* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Walking Index in Spinal Cord Injury II	Walking Index in Spinal Cord Injury II for walking independence level assessment	23 months
Secondary	Ten-Meter Walking Test	Ten-Meter Walking Test for overground walking speed assessment	23 months
Secondary	Timed Up and Go Test	Timed Up and Go Test overground walking assessment	23 months
Secondary	Berg Balance Scale	Berg Balance Scale for balance assessment	23 months
Secondary	Visual Analogue Scale	Visual Analogue Scale (VAS) for fear of falling assessment	23 months
Secondary	Spinal Cord Independence Measure (SCIM III)	Spinal Cord Independence Measure (SCIM III) for activity of daily living assessment	23 months
Secondary	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	23 months