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ACTive Exoskeleton for Unilaterally-Assisted Locomotion (ACTUAL)

NCT06061601 · Fondazione Don Carlo Gnocchi ETS · Updated 9 Aug 2024

What is being tested
Exoskeleton stroke group
For
Stroke Sequelae; Gait, Hemiplegic
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 30 years to 75 years. About 10 people. The full rules are on the registry page.
Where
Italy
When
Starts or started 12 April 2021, ends 31 July 2024. Registered 29 Sept 2023.
Results
None posted yet.

In the researchers' words

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.
ClinicalTrials.gov, NCT06061601

Sites

  • Fondazione Don Carlo Gnocchi IRCCSMilan, Italy