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Clinical Trials/NCT05976087
NCT05976087
Active, not recruiting
Not Applicable

Improving Grasp Function in People With Sensorimotor Impairments by Combining Electrical Stimulation With a Robotic Hand Orthosis

Andrea Cimolato1 site in 1 country20 target enrollmentJuly 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Andrea Cimolato
Enrollment
20
Locations
1
Primary Endpoint
Change in Range of Motion with electrical stimulation and without no electrical stimulation
Status
Active, not recruiting
Last Updated
8 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2023
End Date
June 30, 2030
Last Updated
8 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Andrea Cimolato
Responsible Party
Sponsor Investigator
Principal Investigator

Andrea Cimolato

Study coordinator

ETH Zurich

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
  • Pacemaker
  • Cybersickness

Outcomes

Primary Outcomes

Change in Range of Motion with electrical stimulation and without no electrical stimulation

Time Frame: up to one month before; thorugh study completition (average 1 month); up to one month after

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

Time Frame: up to one month before; thorugh study completition (average 1 month); up to one month after

Semmes-Weinstein Monofilament Test will be used to assess the residual tactile feedback

Change between functional tasks with sensory feedback and with no sensory feedback in grasping force

Time Frame: up to one month before; thorugh study completition (average 1 month); up to one month after

Grasping forces will be assessed during functional performance of the subjects

Change between functional tasks with sensory feedback and with no sensory feedback in number of virtual egg successful grasping

Time Frame: up to one month before; thorugh study completition (average 1 month); up to one month after

Number of successful transportations of fragile objects over an obstacle

Change between tasks with sensory feedback and with no sensory feedback in arm joints kinemtics

Time Frame: up to one month before; thorugh study completition (average 1 month); up to one month after

Joint kinematics measurements will be measured with motion capture systems during functional performance of the subjects

Change in functional tasks performance with sensory feedback and without sensory feedback quantified by the number of successful grasp and release tasks

Time Frame: up to one month before; thorugh study completition (average 1 month); up to one month after

Number of successful transportation of objects over an obstacle

Secondary Outcomes

  • Measures of self-body representation(up one week before first session; thorugh study completition (average 1 month); up one week after last session)
  • Change from baseline performance between tasks accomplished with sensory feedback and with no sensory feedback in Embodiment(up one week before first session and up one week after last session)
  • Change in Telescoping measures between different conditions(up one week before first session and up one week after last session)
  • Change in Proprioceptive drift between different conditions(up one week before first session and up one week after last session)
  • Change in experienced physical, mental, and social effects(up one week before first session and up one week after last session)
  • Measures of body-space representation(up one week before first session; thorugh study completition (average 1 month); up one week after last session)

Study Sites (1)

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