Effectiveness of a Powered Exoskeleton Combined With FES for Patients With Chronic SCI: a RCT
NCT ID: NCT05187650
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
34 participants
INTERVENTIONAL
2022-03-18
2027-12-31
Brief Summary
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Combining FES and overground robotic therapy within the same therapy session could potentially merge and potentiate the effects of each separate treatment, making it a very powerful and efficient therapy method. Up to date, however, comparative studies evaluating benefits of this combined approach (i.e., powered exoskeleton and FES) to robotic therapy without FES are missing.
Detailed Description
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Another well-established technique for the treatment of such secondary health problems is functional electrical stimulation (FES). FES is a common and established method for the rehabilitation of persons with spinal cord injury. Several studies have documented positive effects of FES like, e.g., avoiding disuse and denervation atrophy, improving muscle force, power output and endurance, changing muscle fibre type, increasing cross sectional area of muscles, increasing muscle mass, activation of nerve sprouting, motor learning and reducing spasticity. In addition, FES has been shown to improve bladder, bowel and sexual function, cardiovascular fitness (by increasing aerobic capacity), reduce body fat mass and prevent and treat pressure ulcers by increasing muscular blood flow. Moreover, FES treatment has also been shown to have an impact on body function by improving lower limb function as well as trunk stability and function.
The power elicited by the muscle through electrical stimulation can be used for locomotion. To do so, undesired limb motion is often restricted by passive orthoses or pedals in order to efficiently use the muscle contraction from the user to safely provide the power for forward propulsion. The usefulness of such systems, however, is often limited due to the rapid initiation of muscle fatigue. This is one reason (amongst others) why hybrid FES-robotic solutions have been developed, which supplement the power produced by electrical stimulation with motorized assistance. This approach reduces the power that needs to be produced by the muscles, allowing for FES application for longer training sessions before fatigue occurs. By doing so, such hybrid powered exoskeletons offer the physiological health benefits similar to FES cycling, while simultaneously enhancing the user's mobility. The addition of FES to a powered exoskeleton also synergistically reduces the motor torques of the device, reducing battery drain and therefore increasing the maximum range of the exoskeleton.
While it sounds perfectly reasonable, from a technical and physiological perspective, to combine powered exoskeletons and FES to such hybrid bionic systems, there is only anecdotal evidence for their clinical usefulness and efficacy in patients with SCI. Here the investigators propose a randomized controlled trial investigating the effect of the combined application of the EksoNR powered exoskeleton (Ekso Bionics, Richmond, CA, USA) and FES (FES RehaMove2, Hasomed, Magdeburg, Germany) compared to Ekso therapy alone on functional outcomes and secondary health parameters.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Ekso and FES
Participants will train for 8 weeks, 3 times per week (i.e. 24 sessions in total) for 30 minutes effective training time per session using the EksoNR powered exoskeleton combined with gait-synchronized FES using the FES RehaMove2.
Ekso (EksoNR, Ekso Bionics)
The EksoNR is a powered exoskeleton designed to be used in a rehabilitation setting. The device meets the provision of the Council Directive 93/42/EEC concerning medical devices and is used for gait training in neurorehabilitation.
FES (RehaMove2, Hasomed)
RehaMove 2 sends electrical impulses via electrodes to nerves to evoke muscle contraction. The device meets the provision of the Council Directive 93/42/EEC concerning medical devices.
Ekso without FES
Participants will train for 8 weeks, 3 times per week (i.e. 24 sessions in total) for 30 minutes effective training time per session using the EksoNR powered exoskeleton without applying FES.
Ekso (EksoNR, Ekso Bionics)
The EksoNR is a powered exoskeleton designed to be used in a rehabilitation setting. The device meets the provision of the Council Directive 93/42/EEC concerning medical devices and is used for gait training in neurorehabilitation.
Interventions
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Ekso (EksoNR, Ekso Bionics)
The EksoNR is a powered exoskeleton designed to be used in a rehabilitation setting. The device meets the provision of the Council Directive 93/42/EEC concerning medical devices and is used for gait training in neurorehabilitation.
FES (RehaMove2, Hasomed)
RehaMove 2 sends electrical impulses via electrodes to nerves to evoke muscle contraction. The device meets the provision of the Council Directive 93/42/EEC concerning medical devices.
Eligibility Criteria
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Inclusion Criteria
* traumatic or non-traumatic lesion
* capacity to stand up and perform a 10MWT with or without medical aids
* partially wheelchair dependent
* intact lower motoneuron on the segmental innervation level of M. glutaeus maximus, Mm. ischiocrurales, M. tibialis anterior and M. quadriceps (to guarantee the stimulability with FES)
Exclusion Criteria
* orthopedic limitations (acute fractures of the lower limb)
* contractures
* heterotrophic ossification
* spasticity (modified Ashworth Scale \>3)
* skin injuries of the lower limbs in areas where the skin has contact with the exoskeleton
* Unstable circulation (unable to stand for at least 10 minutes)
* acute deep vein thrombosis
* pregnancy (tested in women of childbearing age (15 - 49 years))
18 Years
ALL
No
Sponsors
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Mario Widmer
NETWORK
Responsible Party
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Mario Widmer
Principal Investigator
Principal Investigators
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Mario Widmer, PhD
Role: PRINCIPAL_INVESTIGATOR
Swiss Paraplegic Research, Nottwil
Locations
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Swiss Paraplegic Centre
Nottwil, Canton of Lucerne, Switzerland
Countries
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Central Contacts
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Facility Contacts
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Mario Widmer, PhD
Role: primary
References
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Shackleton C, Evans R, Shamley D, West S, Albertus Y. Effectiveness of over-ground robotic locomotor training in improving walking performance, cardiovascular demands, secondary complications and user-satisfaction in individuals with spinal cord injuries: A systematic review. J Rehabil Med. 2019 Oct 29;51(10):723-733. doi: 10.2340/16501977-2601.
Spungen AM, Bauman WA, Biswas K, Jones KM, Snodgrass AJ, Goetz LL, Gorman PH, Kirshblum S, Sabharwal S, White KT, Asselin PK, Morin KG, Cirnigliaro CM, Huang GD. The design of a randomized control trial of exoskeletal-assisted walking in the home and community on quality of life in persons with chronic spinal cord injury. Contemp Clin Trials. 2020 Sep;96:106102. doi: 10.1016/j.cct.2020.106102. Epub 2020 Aug 12.
Gater DR Jr, Dolbow D, Tsui B, Gorgey AS. Functional electrical stimulation therapies after spinal cord injury. NeuroRehabilitation. 2011;28(3):231-48. doi: 10.3233/NRE-2011-0652. No abstract available.
Gorgey AS, Harnish CR, Daniels JA, Dolbow DR, Keeley A, Moore J, Gater DR. A report of anticipated benefits of functional electrical stimulation after spinal cord injury. J Spinal Cord Med. 2012 Mar;35(2):107-12. doi: 10.1179/204577212X13309481546619.
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.
Kozlowski AJ, Bryce TN, Dijkers MP. Time and Effort Required by Persons with Spinal Cord Injury to Learn to Use a Powered Exoskeleton for Assisted Walking. Top Spinal Cord Inj Rehabil. 2015 Spring;21(2):110-21. doi: 10.1310/sci2102-110. Epub 2015 Apr 12.
Zeilig 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.
Ha KH, Murray SA, Goldfarb M. An Approach for the Cooperative Control of FES With a Powered Exoskeleton During Level Walking for Persons With Paraplegia. IEEE Trans Neural Syst Rehabil Eng. 2016 Apr;24(4):455-66. doi: 10.1109/TNSRE.2015.2421052. Epub 2015 Apr 23.
Charlifue S, Post MW, Biering-Sorensen F, Catz A, Dijkers M, Geyh S, Horsewell J, Noonan V, Noreau L, Tate D, Sinnott KA. International Spinal Cord Injury Quality of Life Basic Data Set. Spinal Cord. 2012 Sep;50(9):672-5. doi: 10.1038/sc.2012.27. Epub 2012 Mar 27.
Other Identifiers
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2021-08
Identifier Type: -
Identifier Source: org_study_id