Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05138211
Other study ID # REFLEX_HemipareticEMG
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 18, 2021
Est. completion date April 30, 2022

Study information

Verified date October 2022
Source Spanish National Research Council
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Read more »
Read more »

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Exoskeleton assisted gait on a treadmill
The experimental protocol is divided in three sessions. During all of them, the patient will walk on a treadmill for 6 minutes while wearing a safety harness and the robotic exoskeleton in the paretic leg. - Training session: The patient will wear the robotic exoskeleton to familiarize with the action of the device. - Ramp Velocity Session: the session will be divided into five trials: (a) Pre, the patient will not wear the device; (b) Free, the patient will wear the robot but it is mechanically decoupled so it will enable the free knee movement; (c) Active, the robot will assist the gait until 75% maximum gait velocity ; (d) MaxActive, the robot will assist the gait until maximum gait velocity ; and (e) Post, the patient will repeat the Pre condition. Velocity will increase from comfortable velocity to the maximum and then come back to the comfortable one. - Random Velocity session: the session will be divided into the same trials than the Ramp Velocity Session.

Locations

Country Name City State
Spain Hospital Beata María Ana Madrid

Sponsors (2)

Lead Sponsor Collaborator
Spanish National Research Council Hospital Beata María Ana

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Symmetry of knee flexion/extension kinematics The joint motion will be measured by Inertial Sensors During the intervention
Primary Symmetry of Integrated EMG in Rectus Femoris The muscle activity data will be acquired by EMG sensors according to the SENIAM guidelines During the intervention
Primary Symmetry of Integrated EMG in Biceps Femoris Long Head The muscle activity data will be acquired by EMG sensors according to the SENIAM guidelines During the intervention
Primary Symmetry of Integrated EMG in Tibialis Anterior The muscle activity data will be acquired by EMG sensors according to the SENIAM guidelines During the intervention
Primary Symmetry of Integrated EMG in Medial Gastrocnemius The muscle activity data will be acquired by EMG sensors according to the SENIAM guidelines During the intervention
Secondary Symmetry of step time Floor contact events are detected by FSRs During the intervention
Secondary Symmetry of step length Thigh and shank kinematics measured by inertial sensors During the intervention
See also
  Status Clinical Trial Phase
Recruiting NCT06107010 - Effects of Atalante Exoskeleton on Gait Recovery in Non- or Poorly Ambulatory Patients With Hemiparesis in the Acute/Subacute Phase (Month 1 to 4) N/A
Completed NCT05138185 - Proof-of-concept of a Robotic Knee Exoskeleton in Healthy Subjects and Hemiparetic Patients During Gait. N/A
Recruiting NCT04673838 - The Effect of Lower Limb Sensory Training on Functional Capacity in Hemiparetic Individuals N/A
Recruiting NCT05887440 - Isokinetic Strength Training in Hemiparetic Patient With Knee Extension Thrust N/A