Clinical trial NCT05976087: Improving Grasp Function in People with Sensorimotor Impairments by Combining Electrical Stimulation with a Robotic Hand Orthosis
Official title: Improving Grasp Function in People with Sensorimotor Impairments by Combining Electrical Stimulation with a Robotic Hand Orthosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke
Spinal Cord Injuries
Traumatic Brain Injury
Keywords: sensorimotor
TENS
FES
exoskeleton
wearable robotics
Lead sponsor: ETH Zurich
Sponsor class: OTHER
First posted: 2023-08-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Range of Motion with electrical stimulation and without no electrical stimulation
timeFrame: up to one month before; thorugh study completition (average 1 month); up to one month after
measure: Change in the area with tactile feedback in the hand with electrical stimulation and with no electrical stimulation
timeFrame: up to one month before; thorugh study completition (average 1 month); up to one month after
measure: Change in functional tasks performance with sensory feedback and without sensory feedback quantified by the number of successful grasp and release tasks
timeFrame: up to one month before; thorugh study completition (average 1 month); up to one month after
measure: Change between functional tasks with sensory feedback and with no sensory feedback in number of virtual egg successful grasping
timeFrame: up to one month before; thorugh study completition (average 1 month); up to one month after
measure: Change between functional tasks with sensory feedback and with no sensory feedback in grasping force
timeFrame: up to one month before; thorugh study completition (average 1 month); up to one month after
measure: Change between tasks with sensory feedback and with no sensory feedback in arm joints kinemtics
timeFrame: up to one month before; thorugh study completition (average 1 month); up to one month after
Secondary outcomes:
measure: Change in experienced physical, mental, and social effects
timeFrame: up one week before first session and up one week after last session
measure: Change in Proprioceptive drift between different conditions
timeFrame: up one week before first session and up one week after last session
measure: Change in Telescoping measures between different conditions
timeFrame: up one week before first session and up one week after last session
measure: Change from baseline performance between tasks accomplished with sensory feedback and with no sensory feedback in Embodiment
timeFrame: up one week before first session and up one week after last session
measure: Measures of self-body representation
timeFrame: up one week before first session; thorugh study completition (average 1 month); up one week after last session
measure: Measures of body-space representation
timeFrame: up one week before first session; thorugh study completition (average 1 month); up one week after last session
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Neuroengineering Lab
state: Zurich
Study officials:
affiliation: ETH Zurich
name: Stanisa Raspopovic, PhD
role: PRINCIPAL_INVESTIGATOR
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