ACTive Exoskeleton for Unilaterally-Assisted Locomotion (ACTUAL)

NCT06061601 | Completed DMC

• 1 other identifier: ESOFDG-IIT 2.0
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Stroke Sequelae; Gait, Hemiplegic

Keywords

User centered design; Stroke; Gait rehabilitation; Hemiparesis; Exoskeleton

Outcome Measures

Primary Outcomes (1)

• Change in meters walked during the Two minute walking test

  The subjects were instructed to walk at their usual speed for 2 minutes while the distance they covered in 2 minutes was recorded in meters.

  Baseline (T0) and after 4 weeks (T1) and after 3 months (T2)

Secondary Outcomes (8)

• Change in score on the Ashworth scale

  Baseline (T0) and after 4 weeks (T1)

• Change in score on the Muscle Manual Test (MMT)

  Baseline (T0) and after 4 weeks (T1)

• Change in time (sec) taken to Timed up and Go

  Baseline (T0) and after 4 weeks (T1)

• Change time (sec) taken to complete the Five time sit to stand (5xSTS)

  Baseline (T0) and after 4 weeks (T1) and after 3 months (T2)

• Change in score on the Stroke impact Scale (SIS) questionnaire

  Baseline (T0) and after 4 weeks (T1) and after 3 months (T2)

Study Arms (2)

Exoskeleton Stroke group

EXPERIMENTAL

This group will receive gait rehabilitation with the exoskeleton for 20 sessions in clinic.

Device: Exoskeleton stroke group

Healthy control group

NO INTERVENTION

The quantitative data, including EMG and 3D kinematics, from 10 healthy controls walking with the exoskeleton will serve as comparative data for the experimental group.

Interventions

Exoskeleton stroke group DEVICE

The exoskeleton stroke group will receive gait rehabilitation with the TWIN-Acta exoskeleton

Also known as: TWIN-Acta exoskeleton

Exoskeleton Stroke group

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy subjects
• Age 30-75 anni;
• kg ≤ weight ≤90 kg
• 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;
• kg ≤ Weight ≤90 kg
• cm ≤ Height ≤ 192 cm
• Thigh length: 355 ÷ 475 mm;
• Length of tibia: 405 ÷ 485 mm;
• Pelvic width: 690 ÷ 990 mm;

You may not qualify if:

• Healthy subjects
• Prosthetic implants
• Musculoskeletal, neurological, cardiovascular and pulmonary disorders that may impair gait;
• State of pregnancy or breastfeeding.
• 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;

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• Istituto Italiano di Tecnologia: collaborator

Study Sites (1)

Fondazione Don Carlo Gnocchi IRCCS

Milan, 20148, Italy

Location

MeSH Terms

Conditions

Gait Disorders, Neurologic; Stroke; Paresis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A pilot intervention feasibility study

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: September 29, 2023
• Study Start: April 12, 2021
• Primary Completion: June 30, 2024
• Study Completion: July 31, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

IT (1)