NCT06061601

ACTive Exoskeleton for Unilaterally-Assisted Locomotion (ACTUAL)

Use of a Lower Limb Exoskeleton in Locomotor Rehabilitation of Stroke Patients: Feasibility, Safety and a Pilot Clinical Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Fondazione Don Carlo Gnocchi Onlus · Academic / Other
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Walking difficulties are common symptoms after stroke, significantly reducing quality of life. Walking recovery is therefore one of the main priorities of rehabilitation. Wearable powered exoskeletons have been developed to provide lower limb assistance and enable training for persons with gait impairments by using typical physiological movement patterns. Exoskeleton were originally designed for individuals without any walking capacities, such as subjects with a complete spinal cord injury. Recent systematic reviews suggested that lower limb exoskeletons could be valid tools to restore independent walking in subjects with residual motor function, such as persons post-stroke.The aim of the study was to identify the end-users needs and to develop a user-centered-based control system for the TWIN lower limb exoskeleton to provide an efficient post-stroke rehabilitation of gait. The investigators thus carried out the development and validation through evaluation sessions performed on healthy clinical experts and persons with stroke to evaluate TWIN-Acta usability, acceptability, and barriers of usage. A phase two includes a pilot study of efficacy of using the TWINActa for gait rehabilitation for persons with stroke.

Detailed description

The aim of the study was to identify the end-users needs and to develop a user-centered-based control system for the TWIN lower limb exoskeleton to provide post-stroke rehabilitation. The investigators thus carry out the development and validation of TWIN-Acta: a novel control suite for TWIN, specifically designed for gait rehabilitation of persons post stroke through use of typical physiological movement patterns. The study will be carried out in two phases. In the first user-centered developmental phase data on usability, acceptability, and limitations to system usage will be collected from clinical experts and persons with stroke through questionnaires and semi-structured interviews.This developmental phase will follow a user-centered approach: it will be based on focus group sessions with clinical and biomechanical experts to define the design specifications for the new control modality of the exoskeleton; consequently evaluation sessions consisting of physical testing of the TWIN-Acta will be carried out by healthy clinical experts and persons with stroke to evaluate TWIN-Acta usability, acceptability, and barriers of usage. In the second phase of the study a pilot study including 20 sessions of gait rehabilitation of persons at least three month post stroke will be carried out in clinic with the TWIN exoskeleton including the TWIN-Acta control suite. Outcomes will be verified at baseline and following the intervention through feasibility measures, patient reported outcomes, clinical measures of gait ability and through EMG and 3D gait analysis. The quantitative values will be compared to data of healthy controls walking in the exoskeleton in one session but not receiving any intervention.

Conditions

• Stroke Sequelae
• Gait, Hemiplegic

Interventions

Type	Name	Description
DEVICE	Exoskeleton stroke group	The exoskeleton stroke group will receive gait rehabilitation with the TWIN-Acta exoskeleton

Timeline

• Start date: 2021-04-12
• Primary completion: 2024-06-30
• Completion: 2024-07-31
• First posted: 2023-09-29
• Last updated: 2024-08-09

Locations

1 site across 1 country: Italy