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Proof-of-concept of a Robotic Knee Exoskeleton in Healthy Subjects and Hemiparetic Patients During Gait.

NCT05138185 · Spanish National Research Council · Updated 30 Nov 2021

What is being tested
Exoskeleton assisted gait on a treadmill
For
Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis)
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years to 85 years. About 3 people. The full rules are on the registry page.
Where
Spain
When
Starts or started 15 Feb 2021, ends 20 April 2021. Registered 30 Nov 2021.
Results
None posted yet.

In the researchers' words

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 behavior 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 generate the assistance according to two differents strategies: (1) Replicating the movement of the helathy leg or (2) Inducing 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. We aim to assess the adaptation process of the subject to the exoskeleton…
ClinicalTrials.gov, NCT05138185

Sites

  • Hospital Beata María AnaMadrid, Spain