Back to resultsACTive Exoskeleton for Unilaterally-Assisted Locomotion (ACTUAL) (ACTUAL)
Primary Purpose
Stroke Sequelae, Gait, Hemiplegic
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Exoskeleton stroke group
Sponsored by
About this trial
This is an interventional treatment trial for Stroke Sequelae focused on measuring User centered design, Stroke, Gait rehabilitation, Hemiparesis, Exoskeleton
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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 neoplasic 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.
Sites / Locations
- Fondazione Don Carlo Gnocchi IRCCSRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exoskeleton Stroke group
Healthy control group
Arm Description
This group will receive gait rehabilitation with the exoskeleton for 20 sessions in clinic.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in score on the Ashworth scale
The Ashworth scale is a muscle tone assessment scale used to assess the resistance experienced during passive range of motion
Change in score on the Muscle Manual Test (MMT)
MMT is a standardized set of assessments that measure muscle strength and function
Change in time (sec) taken to Timed up and Go
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance.
Change time (sec) taken to complete the Five time sit to stand (5xSTS)
The 5xSTS measures the amount of time it takes for a patient to sit and stand five times in succession with arms folded across their chest.
Change in score on the Stroke impact Scale (SIS) questionnaire
The Stroke Impact Scale (SIS) is a self-report questionnaire that evaluates disability and health-related quality of life after stroke
Change in time (sec) taken to complete the 10 meter walking test (10mwt)
The 10 meters walking test (10MWT) is a test in which the participant is timed while walking 10m at their comfortable speed.
Changes in movement parameters extracted from the kinematics of the body.
Kinematics of the lower limb will be recorded using a 9 camera optoelectronic system during 3D motor acts.
The system will measure the 3D coordinates of spherical markers attached to body landmarks to compute hip, knee and ankle angles.
Data processing will provide measures of deviations from physiological movement.
Correlation between brain activity parameters and motor activity parameters
Brain activity data acquired with electroencephalogram (EEG) correlated with data from electromyographic systems.
Data processing will provide measures of deviations from physiological movement.
Full Information
NCT ID
NCT06061601
First Posted
July 4, 2023
Last Updated
September 22, 2023
Sponsor
Fondazione Don Carlo Gnocchi Onlus
Collaborators
Istituto Italiano di Tecnologia
1. Study Identification
Unique Protocol Identification Number
NCT06061601
Brief Title
ACTive Exoskeleton for Unilaterally-Assisted Locomotion (ACTUAL)
Acronym
ACTUAL
Official Title
Use of a Lower Limb Exoskeleton in Locomotor Rehabilitation of Stroke Patients: Feasibility, Safety and a Pilot Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 12, 2021 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Don Carlo Gnocchi Onlus
Collaborators
Istituto Italiano di Tecnologia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Sequelae, Gait, Hemiplegic
Keywords
User centered design, Stroke, Gait rehabilitation, Hemiparesis, Exoskeleton
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A pilot intervention feasibility study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exoskeleton Stroke group
Arm Type
Experimental
Arm Description
This group will receive gait rehabilitation with the exoskeleton for 20 sessions in clinic.
Arm Title
Healthy control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Exoskeleton stroke group
Other Intervention Name(s)
TWIN-Acta exoskeleton
Intervention Description
The exoskeleton stroke group will receive gait rehabilitation with the TWIN-Acta exoskeleton
Primary Outcome Measure Information:
Title
Change in meters walked during the Two minute walking test
Description
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.
Time Frame
Baseline (T0) and after 4 weeks (T1) and after 3 months (T2)
Secondary Outcome Measure Information:
Title
Change in score on the Ashworth scale
Description
The Ashworth scale is a muscle tone assessment scale used to assess the resistance experienced during passive range of motion
Time Frame
Baseline (T0) and after 4 weeks (T1)
Title
Change in score on the Muscle Manual Test (MMT)
Description
MMT is a standardized set of assessments that measure muscle strength and function
Time Frame
Baseline (T0) and after 4 weeks (T1)
Title
Change in time (sec) taken to Timed up and Go
Description
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance.
Time Frame
Baseline (T0) and after 4 weeks (T1)
Title
Change time (sec) taken to complete the Five time sit to stand (5xSTS)
Description
The 5xSTS measures the amount of time it takes for a patient to sit and stand five times in succession with arms folded across their chest.
Time Frame
Baseline (T0) and after 4 weeks (T1) and after 3 months (T2)
Title
Change in score on the Stroke impact Scale (SIS) questionnaire
Description
The Stroke Impact Scale (SIS) is a self-report questionnaire that evaluates disability and health-related quality of life after stroke
Time Frame
Baseline (T0) and after 4 weeks (T1) and after 3 months (T2)
Title
Change in time (sec) taken to complete the 10 meter walking test (10mwt)
Description
The 10 meters walking test (10MWT) is a test in which the participant is timed while walking 10m at their comfortable speed.
Time Frame
Baseline (T0) and after 4 weeks (T1) and after 3 months (T2)
Title
Changes in movement parameters extracted from the kinematics of the body.
Description
Kinematics of the lower limb will be recorded using a 9 camera optoelectronic system during 3D motor acts.
The system will measure the 3D coordinates of spherical markers attached to body landmarks to compute hip, knee and ankle angles.
Data processing will provide measures of deviations from physiological movement.
Time Frame
Baseline (T0) and after 4 weeks (T1)
Title
Correlation between brain activity parameters and motor activity parameters
Description
Brain activity data acquired with electroencephalogram (EEG) correlated with data from electromyographic systems.
Data processing will provide measures of deviations from physiological movement.
Time Frame
Baseline (T0) and after 4 weeks (T1)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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 neoplasic 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Johanna Jonsdottir, PhD
Phone
+39 0230408
Email
jjonsdottir@dongnocchi.it
First Name & Middle Initial & Last Name or Official Title & Degree
Maurizio Ferrarin, PhD
Phone
+39 0230408
Email
mferrarin@dongnocchi.it
Facility Information:
Facility Name
Fondazione Don Carlo Gnocchi IRCCS
City
Milan
ZIP/Postal Code
20148
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johanna Jonsdottir, PhD
Phone
+39 0230408
Email
jjonsdottir@dongnocchi.it
First Name & Middle Initial & Last Name & Degree
Maurizio Ferrarin, PhD
Email
mferrarin@dongnocchi.it
12. IPD Sharing Statement
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ACTive Exoskeleton for Unilaterally-Assisted Locomotion (ACTUAL)
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