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Improving Grasp Function in People With Sensorimotor Impairments by Combining Electrical Stimulation With a Robotic Hand Orthosis (SENSIBLE-EXO)

Primary Purpose

Stroke, Spinal Cord Injuries, Traumatic Brain Injury

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
SensoExo
Sponsored by
Andrea Cimolato
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring sensorimotor, TENS, FES, exoskeleton, wearable robotics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Impairment of the motor and sensory functions of the hand in chronic stage The subject should have good proximal arm function (i.e. good shoulder abduction and elevation) Exclusion Criteria: Cognitive and communication deficits impairment Prior or current psychological diseases such as borderline, schizophrenia, Depression or Maniac Depression Major comprehension and memory deficits Pregnancy Epilepsy Pacemaker Cybersickness

Sites / Locations

  • Neuroengineering LabRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental group

Arm Description

Outcomes

Primary Outcome Measures

Change in Range of Motion with electrical stimulation and without no electrical stimulation
Range of motion will be measured and compared among conditions
Change in the area with tactile feedback in the hand with electrical stimulation and with no electrical stimulation
Semmes-Weinstein Monofilament Test will be used to assess the residual tactile feedback
Change in functional tasks performance with sensory feedback and without sensory feedback quantified by the number of successful grasp and release tasks
Number of successful transportation of objects over an obstacle
Change between functional tasks with sensory feedback and with no sensory feedback in number of virtual egg successful grasping
Number of successful transportations of fragile objects over an obstacle
Change between functional tasks with sensory feedback and with no sensory feedback in grasping force
Grasping forces will be assessed during functional performance of the subjects
Change between tasks with sensory feedback and with no sensory feedback in arm joints kinemtics
Joint kinematics measurements will be measured with motion capture systems during functional performance of the subjects

Secondary Outcome Measures

Change in experienced physical, mental, and social effects
Neuro-QuL measurement system will be as assessment tool
Change in Proprioceptive drift between different conditions
To measure embodiment subjects will be asked after VR sessions to indicate where they feel their arm without looking at the limb in real world. This is a measure of embodiment.
Change in Telescoping measures between different conditions
To measure embodiment subjects will be asked after VR sessions to indicate how long they feel their arm without looking at the limb in real world. This is a measure of embodiment.
Change from baseline performance between tasks accomplished with sensory feedback and with no sensory feedback in Embodiment
Embodiment will be measured with questionnaires (from -3 to +3, +3 totally agrees; two questions are from 1 to 10 (to measure vividness, where 10 is max vividness) and from 1 to 100 (to measure prevalence, where 100 is max duration of the embodiment feeling))
Measures of self-body representation
This will be measured in virtual reality by means of ad-hoc Body Landmark test. This is a body representation measurements.
Measures of body-space representation
This will be measured in virtual reality by means of ad-hoc Hand Peri personal Space test. This is a body representation measurements.

Full Information

First Posted
July 19, 2023
Last Updated
July 27, 2023
Sponsor
Andrea Cimolato
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1. Study Identification

Unique Protocol Identification Number
NCT05976087
Brief Title
Improving Grasp Function in People With Sensorimotor Impairments by Combining Electrical Stimulation With a Robotic Hand Orthosis
Acronym
SENSIBLE-EXO
Official Title
Improving Grasp Function in People With Sensorimotor Impairments by Combining Electrical Stimulation With a Robotic Hand Orthosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
June 30, 2026 (Anticipated)
Study Completion Date
June 30, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Andrea Cimolato

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Hand motor and sensory impairments resulting from neurological disorders or injuries affect more than 50 million individuals worldwide. Conditions such as stroke, spinal cord injury (SCI), and traumatic brain injury (TBI) can cause long-term hand impairments, greatly impacting daily activities and social integration. Since traditional physiotherapy has limited effectiveness in rehabilitation, assistive devices helping in performing in daily activities have emerged as a necessary solution. Soft exoskeletons offer advantages as they are more comfortable and adaptable for the user, but they often struggle to generate sufficient force. On the other hand, electrical stimulation garments, like e-sleeves, show promise by stimulating nerves and muscles in the forearm. However, achieving precise and stable movement control remains challenging due to difficulties in electrode placement for targeted stimulation. Furthermore, none of the currently available devices are capable of artificially restoring lost sensation in users' hands, limiting their ability to manipulate with fragile objects. Recognizing these limitations, our study proposes a solution that combines a standard hand soft exoskeleton with: (i) electrical stimulation to the fingers' flexor and extensor muscles to generate artificial muscle contractions synchronized with the exoskeleton motion, compensating for the lack of gripping force, and (ii) electrical stimulation to the nerves to artificially restore the lost sensation of touch, enabling users to receive feedback on the force they are applying when interacting with the environment. The investigators refer to this proposed combination as Sensible-Exo. To achieve this goal, our project aims to evaluate the functional improvements in assistive and rehabilitative scenarios using SensoExo in comparison to use only the exoskeleton or having no support at all. The exoskeleton will be coupled with an electrical stimulating sleeve capable of delivering non-invasive electrical stimulation in the form of Functional Electrical Stimulation (FES) and Transcutaneous Electrical Nerve Stimulation (TENS). A glove with embedded force and bending sensors will be used to modulate the electrical stimulation. Additionally, apart from studying the enhancement of functional tasks, the investigators will explore improvements in body perception, representation, and multi-sensory integration. Indeed, the investigators also aim at identifying the way patients perceive their body by means of ad-hoc virtual reality assessments that has been developed. Before each assessment patient will perform some predefined movement in virtual reality to familiarize with it and increase embodiment. During the study, participants will perform a range of tasks based on their residual abilities, including motor tasks (e.g., grab and release, Toronto Rehabilitation Institute Hand Function Test, grip force regulation test, virtual egg test), cognitive tasks (dual tasks), and assessments of body representation and perception. Some of these tasks will be conducted in Virtual Reality environments, both with and without active stimulation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Spinal Cord Injuries, Traumatic Brain Injury
Keywords
sensorimotor, TENS, FES, exoskeleton, wearable robotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
SensoExo
Intervention Description
combination of sensory feedback and the use of soft exoskeleton
Primary Outcome Measure Information:
Title
Change in Range of Motion with electrical stimulation and without no electrical stimulation
Description
Range of motion will be measured and compared among conditions
Time Frame
up to one month before; thorugh study completition (average 1 month); up to one month after
Title
Change in the area with tactile feedback in the hand with electrical stimulation and with no electrical stimulation
Description
Semmes-Weinstein Monofilament Test will be used to assess the residual tactile feedback
Time Frame
up to one month before; thorugh study completition (average 1 month); up to one month after
Title
Change in functional tasks performance with sensory feedback and without sensory feedback quantified by the number of successful grasp and release tasks
Description
Number of successful transportation of objects over an obstacle
Time Frame
up to one month before; thorugh study completition (average 1 month); up to one month after
Title
Change between functional tasks with sensory feedback and with no sensory feedback in number of virtual egg successful grasping
Description
Number of successful transportations of fragile objects over an obstacle
Time Frame
up to one month before; thorugh study completition (average 1 month); up to one month after
Title
Change between functional tasks with sensory feedback and with no sensory feedback in grasping force
Description
Grasping forces will be assessed during functional performance of the subjects
Time Frame
up to one month before; thorugh study completition (average 1 month); up to one month after
Title
Change between tasks with sensory feedback and with no sensory feedback in arm joints kinemtics
Description
Joint kinematics measurements will be measured with motion capture systems during functional performance of the subjects
Time Frame
up to one month before; thorugh study completition (average 1 month); up to one month after
Secondary Outcome Measure Information:
Title
Change in experienced physical, mental, and social effects
Description
Neuro-QuL measurement system will be as assessment tool
Time Frame
up one week before first session and up one week after last session
Title
Change in Proprioceptive drift between different conditions
Description
To measure embodiment subjects will be asked after VR sessions to indicate where they feel their arm without looking at the limb in real world. This is a measure of embodiment.
Time Frame
up one week before first session and up one week after last session
Title
Change in Telescoping measures between different conditions
Description
To measure embodiment subjects will be asked after VR sessions to indicate how long they feel their arm without looking at the limb in real world. This is a measure of embodiment.
Time Frame
up one week before first session and up one week after last session
Title
Change from baseline performance between tasks accomplished with sensory feedback and with no sensory feedback in Embodiment
Description
Embodiment will be measured with questionnaires (from -3 to +3, +3 totally agrees; two questions are from 1 to 10 (to measure vividness, where 10 is max vividness) and from 1 to 100 (to measure prevalence, where 100 is max duration of the embodiment feeling))
Time Frame
up one week before first session and up one week after last session
Title
Measures of self-body representation
Description
This will be measured in virtual reality by means of ad-hoc Body Landmark test. This is a body representation measurements.
Time Frame
up one week before first session; thorugh study completition (average 1 month); up one week after last session
Title
Measures of body-space representation
Description
This will be measured in virtual reality by means of ad-hoc Hand Peri personal Space test. This is a body representation measurements.
Time Frame
up one week before first session; thorugh study completition (average 1 month); up one week after last session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Impairment of the motor and sensory functions of the hand in chronic stage The subject should have good proximal arm function (i.e. good shoulder abduction and elevation) Exclusion Criteria: Cognitive and communication deficits impairment Prior or current psychological diseases such as borderline, schizophrenia, Depression or Maniac Depression Major comprehension and memory deficits Pregnancy Epilepsy Pacemaker Cybersickness
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Cimolato, PhD
Phone
+41772466601
Email
andrea.cimolato@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stanisa Raspopovic, PhD
Organizational Affiliation
ETH Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neuroengineering Lab
City
Zürich
State/Province
Zurich
ZIP/Postal Code
8001
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stanisa Raspopovic, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
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Improving Grasp Function in People With Sensorimotor Impairments by Combining Electrical Stimulation With a Robotic Hand Orthosis

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