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NCT05138211
Effects of Unilateral Robotic Assistance on Compensation Strategies and Muscular Activity During Hemiparetic Gait
NA trial testing Exoskeleton assisted gait on a treadmill in Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis) in 10 participants. Completed in 30 April 2022.
1 March 2022
Quick facts
| Lead sponsor | Spanish National Research Council |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 10 |
| Start date | 18 October 2021 |
| Primary completion | 1 March 2022 |
| Estimated completion | 30 April 2022 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Exoskeleton assisted gait on a treadmill
Conditions studied
- Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis) — all drugs for Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis) →
Sponsor
Spanish National Research Council
Who can join
Adults 18 to 85, any sex, with Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Hemiparetic gait is characterized by strong asymmetries that could severely affect the quality of life of stroke survivors. This asymmetry is due to motor deficits in the paretic leg and the resulting compensations in the non-paretic limb. In this study, the investigators aim to evaluate the effect of actively promoting gait symmetry in hemiparetic patients by assessing the motion and muscular activity of both paretic and non-paretic lower limbs. To this end, the investigators use a unilateral active Knee-Ankle-Foot Orthosis able to assist the paretic limb of hemiparetic patients during gait. The system is able to synchronize its action with the movement of the unassisted joints, promoting a natural and intuitive interaction. The device generates assistance to induce a healthy gait pattern on the paretic leg. The hypothesis is that a proper and natural interaction between the user and the exoskeleton would enable the patients to consider the robot action as a part of their own gait capability, improving their gait quality as consequence. Hemiparetic asymmetry is not only due to impairments in the affected limb, but also it is the consequence of biomechanical compensatory mechanisms that might arose in the non-paretic leg. The aim of this study is to assess the adaptation process of the subject to the exoskeleton assistance, and to evaluate the effects of such human-robot interaction in both paretic and non-paretic legs.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Robotic exoskeleton embodiment in post-stroke hemiparetic patients: an experimental study about the integration of the assistance provided by the REFLEX knee exoskeleton.
Lora-Millan JS, Sanchez-Cuesta FJ, Romero JP, Moreno JC, et al · · 2023 · cited 4× · PMID 38129592 · DOI 10.1038/s41598-023-50387-8
Verify or expand the search:
- PubMed search for NCT05138211
- Europe PMC full search
- ASCO Meeting Library
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Related trials
Other trials of Exoskeleton assisted gait on a treadmill
Trials testing the same drug.
- NCT05138185 — Proof-of-concept of a Robotic Knee Exoskeleton in Healthy Subjects and Hemiparetic Patients During Gait. · NA · completed
Other recruiting trials for Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis)
Currently open trials in the same condition.
- NCT05887440 — Isokinetic Strength Training in Hemiparetic Patient With Knee Extension Thrust · NA · recruiting
- NCT06107010 — Effects of Atalante Exoskeleton on Gait Recovery in Non- or Poorly Ambulatory Patients With Hemiparesis in the Acute/Sub · NA · recruiting
Other Spanish National Research Council trials
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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 NCT05138211 (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 Spanish National Research Council
- Last refreshed: 26 October 2022
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing