Effectiveness of a Powered Exoskeleton Combined With FES for Patients With Chronic SCI: a RCT

NCT05187650 | Recruiting

• 1 other identifier: 2021-08
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

While there are a number of prospective studies evaluating powered exoskeletons in SCI patients, to date, not a single well-designed, randomized clinical trial has been published. However, there is evidence for beneficial effects of over-ground exoskeleton therapy on walking function post-intervention from a meta-analysis on non-randomized, uncontrolled studies. Functional electrical stimulation (FES), on the other hand, is a common and established method for the rehabilitation of persons with SCI and has been demonstrated to be beneficial in, e.g., improving muscle force, power output and endurance. 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.

Conditions

Spinal Cord Injuries; Gait Disorders, Neurologic

Keywords

SCI; Functional Electrical Stimulation; Exoskeleton; Robotic device; Robotic overground gait training

Outcome Measures

Primary Outcomes (1)

• change in preferred walking speed from baseline (Visit 1) to post-training (Visit 2) as measured by using the 10MWT

  The 10MWT is a quantitative measurement of lower extremity function. Patients are instructed to walk 10 meters at their preferred speed. Time is measured while the individual walks the set distance (10 meters). The distance covered is divided by the time it took the individual to walk that distance.

  within 3 days post-training

Secondary Outcomes (12)

• change from baseline (Visit 1) in preferred walking speed, measured by the 10MWT, at Visit 3

  3 months post intervention

• Changes from baseline at Visit 2 and Visit 3 in maximal walking speed measured by the 10MWT

  within 3 days post-training, 3 months post intervention

• Changes from baseline at Visit 2 and Visit 3 in gait function as measured by the Walking Index for Spinal Cord Injury II (WISCI II)

  within 3 days post-training, 3 months post intervention

• Changes from baseline at Visit 2 and Visit 3 in endurance as measured by the 6 Minute Walk Test (6mWT)

  within 3 days post-training, 3 months post intervention

• Changes from baseline at Visit 2 and Visit 3 in balance function as measured by the Mini-Balance Evaluation Systems Test (Mini-BESTest)

  within 3 days post-training, 3 months post intervention

Other Outcomes (1)

• Participant characteristics

  3 months post intervention

Study Arms (2)

Ekso and FES

EXPERIMENTAL

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.

Device: Ekso (EksoNR, Ekso Bionics); Device: FES (RehaMove2, Hasomed)

Ekso without FES

ACTIVE COMPARATOR

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.

Device: Ekso (EksoNR, Ekso Bionics)

Interventions

FES (RehaMove2, Hasomed) DEVICE

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 and FES

Ekso (EksoNR, Ekso Bionics) DEVICE

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.

Ekso and FES; Ekso without FES

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• chronic, incomplete SCI (\> 1 year, AIS B-D)
• 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)

You may not qualify if:

• Exoskeleton device related contraindications: \> 100 kg body weight; Body height: \< 155 cm or \> 190 cm; pelvic width: \> 46 cm
• 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))

Sponsors & Collaborators

• Mario Widmer: lead

Study Sites (1)

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, 6207, Switzerland

RECRUITING

Related Publications (9)

• 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.

  PMID: 31511902 BACKGROUND

• 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.

  PMID: 32800962 BACKGROUND

• 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.

  PMID: 21558629 BACKGROUND

• 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.

  PMID: 22525324 BACKGROUND

• 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.

  PMID: 18209742 BACKGROUND

• 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.

  PMID: 26364280 BACKGROUND

• 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.

  PMID: 22333043 BACKGROUND

• 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.

  PMID: 25915961 BACKGROUND

• 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.

  PMID: 22450884 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mario Widmer, PhD

  Swiss Paraplegic Research, Nottwil

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mario Widmer, PhD

CONTACT

+41 41 939 51 97; mario.widmer@paraplegie.ch

Ines Bersch, PhD

CONTACT

+41 419 39 42 06; ines.bersch@paraplegie.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors will be blinded to treatment allocation and study participants will be instructed not to talk to assessors about their treatment within the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: assessor-blinded, exploratory, randomized controlled trial

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: January 12, 2022
• Study Start: March 18, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)