NCT06137456

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

1.8 years

First QC Date

November 14, 2023

Last Update Submit

November 14, 2023

Conditions

Spinal Cord InjuriesWalking, Difficulty

Outcome Measures

Primary Outcomes (1)

  • Walking Index in Spinal Cord Injury II

    Walking Index in Spinal Cord Injury II for walking independence level assessment

    23 months

Secondary Outcomes (6)

  • Ten-Meter Walking Test

    23 months

  • Timed Up and Go Test

    23 months

  • Berg Balance Scale

    23 months

  • Visual Analogue Scale

    23 months

  • Spinal Cord Independence Measure (SCIM III)

    23 months

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Other: Conventional exercise therapy

Interventions

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.

Study group
Conventional exercise therapyOTHER

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

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Severe spasticity (Modified Ashworth Scale ≥ 3),
  • Difference in leg length,
  • Pregnancy, osteoporosis,
  • Contracture, or limited range of motion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (32)

  • 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.

    PMID: 20494282BACKGROUND

  • 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.

    PMID: 27064508BACKGROUND

  • 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.

    PMID: 23085703BACKGROUND

  • 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.

    PMID: 21333646BACKGROUND

  • 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.

    PMID: 27313241BACKGROUND

  • 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.

    PMID: 9928326BACKGROUND

  • 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.

    PMID: 17172551BACKGROUND

  • 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.

    PMID: 24213960BACKGROUND

  • 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.

    PMID: 11438840BACKGROUND

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

    PMID: 11321006BACKGROUND

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

    PMID: 18356589BACKGROUND

  • 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.

    PMID: 26781943BACKGROUND

  • 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.

    PMID: 27565639BACKGROUND

  • 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.

    PMID: 29700477BACKGROUND

  • 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.

    PMID: 19086706BACKGROUND

  • 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.

    PMID: 23459122BACKGROUND

  • 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.

    PMID: 18489806BACKGROUND

  • 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.

    PMID: 19675123BACKGROUND

  • 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.

    PMID: 25665539BACKGROUND

  • 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.

    PMID: 17852230BACKGROUND

  • 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.

    PMID: 9626712BACKGROUND

  • 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.

    PMID: 32713291BACKGROUND

  • 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.

    PMID: 28616027BACKGROUND

  • 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.

    PMID: 30482328BACKGROUND

  • 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.

    PMID: 30254967BACKGROUND

  • 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.

    PMID: 28603663BACKGROUND

  • 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.

    PMID: 19036717BACKGROUND

  • 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.

    PMID: 30183055BACKGROUND

  • 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.

    PMID: 37046307BACKGROUND

  • 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.

    PMID: 22241194BACKGROUND

  • 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.

    PMID: 28447605BACKGROUND

  • Sipal MS, Yasar E, Ozisler Z, Adiguzel E, Yildirim S, Deler O, Kirdis S, Celik HI, Ulusahin SB, Kayalar G, Karaduman AA. First report of a new exoskeleton in incomplete spinal cord injury: FreeGait(R). J Spinal Cord Med. 2024 Nov 22:1-11. doi: 10.1080/10790268.2024.2426314. Online ahead of print.

    PMID: 39576286DERIVED

MeSH Terms

Conditions

Spinal Cord InjuriesMobility Limitation

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2023

First Posted

November 18, 2023

Study Start

January 1, 2022

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

November 18, 2023

Record last verified: 2023-11

Locations

TU(1)