MedTrace Logo

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

NCT05138211 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-10-26

No results posted yet for this study

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.

Conditions

  • Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis)

Interventions

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. 1. \- Training session: The patient will wear the robotic exoskeleton to familiarize with the action of the device. 2. \- 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. 3. \- Random Velocity session: the session will be divided into the same trials than the Ramp Velocity Session.

Sponsors & Collaborators

  • Hospital Beata María Ana

    collaborator OTHER

  • Spanish National Research Council

    lead OTHER_GOV

Principal Investigators

  • Julio S. Lora-Millan · Spanish National Research Council

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-18
Primary Completion
2022-03-01
Completion
2022-04-30

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05138211 on ClinicalTrials.gov