Status:
COMPLETED
ACTive Exoskeleton for Unilaterally-Assisted Locomotion (ACTUAL)
Lead Sponsor:
Fondazione Don Carlo Gnocchi Onlus
Collaborating Sponsors:
Istituto Italiano di Tecnologia
Conditions:
Stroke Sequelae
Gait, Hemiplegic
Eligibility:
All Genders
30-75 years
Phase:
NA
Brief 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...
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 investigator...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- Healthy subjects
- Prosthetic implants
- Musculoskeletal, neurological, cardiovascular and pulmonary disorders that may impair gait;
- State of pregnancy or breastfeeding.
- Exclusion criteria
- 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.
Key Trial Info
Start Date :
April 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06061601
Start Date
April 12 2021
End Date
July 31 2024
Last Update
August 9 2024
Active Locations (1)
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1
Fondazione Don Carlo Gnocchi IRCCS
Milan, Italy, 20148