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

NCT05138185 | Completed

• 1 other identifier: REFLEX_TechValidation
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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 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 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)

Keywords

Hemiparetic Gait; Robotic Knee Exoskeleton

Outcome Measures

Primary Outcomes (1)

• Feasibility of the prototype device

  The joints motion is measured by Inertial Sensors

  During the last two minutes of the intervention

Secondary Outcomes (2)

• Symmetry of step length from thigh and shank kinematics

  During the last two minutes of the intervention

• Symmetry of step time

  During the last two minutes of the intervention

Interventions

Exoskeleton assisted gait on a treadmill DEVICE

Subjects were instructed to walk on a treadmill at a constant speed during trials of 5 minutes. All subjects carried out four trials: (1) NoExo: subjects only wore the sensors to acquire their basal motion; (2) Free: subjects wore the exoskeleton although the actuator was mechanically decoupled, so it enabled the free movement of the knee; (3) Echo: the device provided gait assistance following the Echo-control strategy; and (4) Pattern: the device provided gait assistance following the Pattern strategy. During trials, patients wore a safety harness that did not support any weight. Previously to the execution of the trials, the gait velocity was self-selected by the subjects to a comfortable level. Subjects rested between trials for five minutes. Healthy subjects also performed a previous trial under variable gait speed. They walked over the treadmill as in the NoExo condition, although the gait speed randomly varies from 1km/h to 3km/h in 0.2km/h steps for 15 seconds at least.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Acute musculoskeletal diseases
• Peripheral vascular diseases
• Acute cardiopulmonary diseases
• Acute neurological diseases
• Excessive spasticity in any joint of the lower limb (Ashworth scale\> 2)
• Joint mobility restriction of lower limb joints due to any cause
• Pain due to impaired mobility of the lower limb
• Inability to use robotic exoskeleton prototypes due to his/her health condition.

Sponsors & Collaborators

• Spanish National Research Council: lead
• Hospital Beata María Ana: collaborator

Study Sites (1)

Hospital Beata María Ana

Madrid, 28041, Spain

Location

MeSH Terms

Conditions

Paresis; Hemiplegia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Paralysis

Study Officials

• Julio S. Lora-Millan

  Spanish National Research Council

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Responsible Engineer

Study Record Dates

• First Submitted: October 23, 2021
• First Posted: November 30, 2021
• Study Start: February 15, 2021
• Primary Completion: April 20, 2021
• Study Completion: April 20, 2021
• Last Updated: November 30, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Immediately following publication, no end date
• Access Criteria: Access will be subject to methodologically sound proposals and it will be approval by scientific investigator (julio.lora@csic.es)

Locations

ES (1)