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NCT03834324: iCycle
Functional Electrical Stimulation During Cycling in People With Spinal Cord Injury
NA trial testing FES in Spinal Cord Injuries in 11 participants. Completed in 1 March 2018.
29 April 2016
Quick facts
| Lead sponsor | University of Southampton |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 11 |
| Start date | 3 May 2013 |
| Primary completion | 29 April 2016 |
| Estimated completion | 1 March 2018 |
Drugs / interventions tested
- FES — full drug profile →
Conditions studied
- Spinal Cord Injuries — all drugs for Spinal Cord Injuries →
Sponsor
University of Southampton
Who can join
Adults 18 to 90, any sex, with Spinal Cord Injuries. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Neuroscience research that has identified potential for recovery (neuroplasticity) following incomplete SCI has changed clinical practice away from compensation strategies towards optimizing recovery. Important factors include: repetitive exercise, Functional Electrical Stimulation (FES) and appropriate feedback. The iCycle combines repetitive exercise with FES and provides feedback on performance in a virtual cycle race. Unlike previous devices, performance in the race is determined only by voluntary effort (i.e. not torque generated by FES plus voluntary effort). In this study with incomplete SCI participants we will test the iCycle with six inpatients to refine the protocol and make technical improvements. We will then conduct an ABA pilot study (n=10) in which a 3G-connected iCycle is used in people's own homes. We will compare usual care (A) with iCycle exercise (B). Changes in neural connectivity (TMS evoked EMG potentials), muscle strength and walking will be measured as well qualitative analysis of users' views.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
The effects of FES cycling combined with virtual reality racing biofeedback on voluntary function after incomplete SCI: a pilot study.
Duffell LD, Paddison S, Alahmary AF, Donaldson N, et al · · 2019 · cited 18× · PMID 31771600 · DOI 10.1186/s12984-019-0619-4 -
Combining Therapeutic Strategies to Treat the Injured Spinal Cord: A Translational Perspective.
Sherman BC, Schmidt Read M, Hoh DJ, Guest JD, et al · · 2025 · cited 2× · PMID 40929022 · DOI 10.1177/08977151251371710
Verify or expand the search:
- PubMed search for NCT03834324
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of FES
Trials testing the same drug.
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- NCT05765435 — A 12-Week Home-Based Electrical Stimulation Program for Strength in Adults With Knee Osteoarthritis · NA · terminated
- NCT05253989 — Pilot Study of EMG-Directed Virtual-Reality Experience Training for Motor Stroke Rehabilitation · NA · unknown
- NCT03440632 — Functional Electrical Stimulation During Walking in Cerebral Palsy · NA · completed
- NCT02975180 — FES in Young Children With Perinatal Stroke · NA · completed
Other recruiting trials for Spinal Cord Injuries
Currently open trials in the same condition.
- NCT07109804 — Cuneiform Nucleus (CnF) Deep Brain Stimulation for Gait Facilitation Following Spinal Cord Injury · NA · recruiting
- NCT07472985 — Protocol for Rapid Onset of Mobilization in Patients With Traumatic Spinal Cord Injury II (PROMPT-SCI II) Trial · NA · recruiting
- NCT07210411 — Acute and Chronic Repercussion of Spinal Cord Stimulation After Spinal Cord Injury · NA · recruiting
- NCT07488793 — Remote Ischemic Conditioning for PwSCI · NA · recruiting
- NCT07536386 — Self-balancing Personal Exoskeleton for SCI (WIP) · NA · recruiting
Other University of Southampton trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03834324 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Southampton
- Last refreshed: 8 October 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03834324.
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