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

NCT05138211 | Completed

• 1 other identifier: REFLEX_HemipareticEMG
• Study Type: interventional
• Target: 10
• 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 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)

Keywords

Hemiparetic Gait; Robotic Knee Exoskeleton

Outcome Measures

Primary Outcomes (5)

• Symmetry of knee flexion/extension kinematics

  The joint motion will be measured by Inertial Sensors

  During the intervention

• 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

• 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

• 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

• 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 Outcomes (2)

• Symmetry of step time

  During the intervention

• Symmetry of step length

  During the intervention

Study Arms (1)

Hemiparetic patients

EXPERIMENTAL

Patients with hemiparetic gait who will be assisted by the exoskeleton action

Device: Exoskeleton assisted gait on a treadmill

Interventions

Exoskeleton assisted gait on a treadmill DEVICE

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.

Hemiparetic patients

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• 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: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• 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: October 18, 2021
• Primary Completion: March 1, 2022
• Study Completion: April 30, 2022
• Last Updated: October 26, 2022

Record last verified: 2022-10

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)