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NCT05138211

Effects of Unilateral Robotic Assistance on Compensation Strategies and Muscular Activity During Hemiparetic Gait

Completed NA Last updated 26 October 2022
What this trial tests

NA trial testing Exoskeleton assisted gait on a treadmill in Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis) in 10 participants. Completed in 30 April 2022.

Timeline
18 October 2021
Primary endpoint
1 March 2022
30 April 2022

Quick facts

Lead sponsorSpanish National Research Council
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposebasic science
Enrollment10
Start date18 October 2021
Primary completion1 March 2022
Estimated completion30 April 2022
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

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):

  1. 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:

Other trials of Exoskeleton assisted gait on a treadmill

Trials testing the same drug.

Other recruiting trials for Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis)

Currently open trials in the same condition.

Other Spanish National Research Council trials

Trials by the same sponsor.

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Data sources for this page

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