NCT06061601Completed
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
Source: ClinicalTrials.gov · Last updated 9 Aug 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 4 Jul 2023
- Start date
- 12 Apr 2021
- Primary completion date
- 30 Jun 2024
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Diseases
- Stroke
- NCT number
- NCT06061601
What you commit to
- Study type: Interventional
- Participants enrolled: 10
- From 12 Apr 2021 to the primary completion date, 30 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects with stroke
- Mini Mental State Examination \< 23/30;
- Clinical records of visuospatial and ideomotor apraxia, behavioral disorders (e.g. depression, aggression), neglect, major visual impairment and severe osteoporosis;
- Non stabilized fractures;
- Cranial injury;
- Other diseases attributable to cardio-respiratory problemsi;
- State of pregnancy or breastfeeding;
- Previous or concurrent neoplastic malignancy;
- Chronic inflammatory diseases with joint involvement of the lower limbs;
- Serious spasticity (Ashworth\>3);
- Pelvic fractures and unstable column;
- Significant limitations of passive ROM of hips and knees;
- Problems with skin integrity at the interface surfaces with the device or that would prevent sitting.
Other illness
- Healthy subjects
- Prosthetic implants
- Musculoskeletal, neurological, cardiovascular and pulmonary disorders that may impair gait;
- State of pregnancy or breastfeeding.
Who the study is looking for
- Healthy subjects
- Age 30-75 anni;
- 50 kg ≤ weight ≤90 kg
- 150 cm ≤ height ≤ 192 cm
- Thigh length: 355 ÷ 475 mm;
- Length of tibia: 405 ÷ 485 mm;
- Width pelvis: 690 ÷ 990 mm;
- Shoe number: 36 ÷ 45
- Subjects with stroke
- Age 30-75 anni;
- 50 kg ≤ Weight ≤90 kg
- 150 cm ≤ Height ≤ 192 cm
- Thigh length: 355 ÷ 475 mm;
- Length of tibia: 405 ÷ 485 mm;
- Pelvic width: 690 ÷ 990 mm;
- Shoe number: 36 ÷ 45;
- Stroke diagnosis at least 3 months and within 24 months;
- First unilateral haemorrhagic or ischemic stroke classified as complete or partial infarction of the anterior circulation and infarction of the lacunar circulation (Oxford Stroke Classification: TACS -Total Anterior Circulation Stroke, PACS - Partial Anterior Circulation Stroke, LACS -Lacunar Stroke). These criteria may include hemiplegia, hemianopia, motor and/or sensory deficits, and disturbance/impairment of superior cortical and subcortical function;
- FAC (Functional Ambulation Category) 1, 2 and 3 (subjects with ambulation dependent on supervisor or continuous or intermittent physical assistance);
- At least MRC (Medical Research Council) of the triceps surae equal to 1 or greater (required to produce the biofeedback tone or for exoskeleton control).
Age in the registry: 30 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Don Carlo Gnocchi IRCCS Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.