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StrokeSENSIBLE-EXONCT05976087

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

A study testing SensoExo in people with Stroke and Spinal Cord Injuries, run by Andrea Cimolato at 1 site in Switzerland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SensoExo
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteSwitzerland
Study dates
1 Jul 2023to 30 Jun 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • Neuroengineering Lab

    Zurich, Canton of Zurich, 8001

Other trials in Switzerland

About this study

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.

Read more

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.

Being tested
SensoExo
Keywords
sensorimotor, TENS, FES, exoskeleton, wearable robotics
Medical subject headings
Stroke, Spinal Cord Injuries, Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SensoExoDevice

    combination of sensory feedback and the use of soft exoskeleton

Study groups in NCT05976087
Study groupRoleWhat they receive
Experimental groupExperimentalNot described
Receives: Device: SensoExo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Range of motion will be measured and compared among conditions

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

  2. 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

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

  3. 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

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

  4. 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

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

  5. 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

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

  6. 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

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

Secondary outcomes (6)
  1. Change in experienced physical, mental, and social effects

    Neuro-QuL measurement system will be as assessment tool

    Measured: up one week before first session and up one week after last session

  2. 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.

    Measured: up one week before first session and up one week after last session

  3. 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.

    Measured: up one week before first session and up one week after last session

  4. 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))

    Measured: up one week before first session and up one week after last session

  5. 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.

    Measured: up one week before first session; thorugh study completition (average 1 month); up one week after last session

  6. 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.

    Measured: up one week before first session; thorugh study completition (average 1 month); up one week after last session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2023
  2. Study start1 Jul 2023
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Jun 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05976087
Sponsor's protocol ID
1-010428
Acronym
SENSIBLE-EXO
Status last verified
Aug 2025
First submitted
19 Jul 2023
Last updated
19 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dannenbaum RM, Dykes RW. Sensory loss in the hand after sensory stroke: therapeutic rationale. Arch Phys Med Rehabil. 1988 Oct;69(10):833-9.

    PubMed 3178450
  • Carey LM, Matyas TA, Oke LE. Sensory loss in stroke patients: effective training of tactile and proprioceptive discrimination. Arch Phys Med Rehabil. 1993 Jun;74(6):602-11. doi: 10.1016/0003-9993(93)90158-7.

    PubMed 8503750
  • Finnerup NB, Johannesen IL, Fuglsang-Frederiksen A, Bach FW, Jensen TS. Sensory function in spinal cord injury patients with and without central pain. Brain. 2003 Jan;126(Pt 1):57-70. doi: 10.1093/brain/awg007.

    PubMed 12477697
  • Fujimoto ST, Longhi L, Saatman KE, Conte V, Stocchetti N, McIntosh TK. Motor and cognitive function evaluation following experimental traumatic brain injury. Neurosci Biobehav Rev. 2004 Jul;28(4):365-78. doi: 10.1016/j.neubiorev.2004.06.002.

    PubMed 15341032
  • Dannenbaum RM, Jones LA. The assessment and treatment of patients who have sensory loss following cortical lesions. J Hand Ther. 1993 Apr-Jun;6(2):130-8. doi: 10.1016/s0894-1130(12)80294-8.

    PubMed 8343879
  • Kwakkel G, Kollen BJ, van der Grond J, Prevo AJ. Probability of regaining dexterity in the flaccid upper limb: impact of severity of paresis and time since onset in acute stroke. Stroke. 2003 Sep;34(9):2181-6. doi: 10.1161/01.STR.0000087172.16305.CD. Epub 2003 Aug 7.

    PubMed 12907818
  • Wade DT. Measuring arm impairment and disability after stroke. Int Disabil Stud. 1989 Apr-Jun;11(2):89-92. doi: 10.3109/03790798909166398.

    PubMed 2698395
  • Fuhrer MJ, Rintala DH, Hart KA, Clearman R, Young ME. Relationship of life satisfaction to impairment, disability, and handicap among persons with spinal cord injury living in the community. Arch Phys Med Rehabil. 1992 Jun;73(6):552-7.

    PubMed 1622304
  • Noreau L, Fougeyrollas P. Long-term consequences of spinal cord injury on social participation: the occurrence of handicap situations. Disabil Rehabil. 2000 Mar 10;22(4):170-80. doi: 10.1080/096382800296863.

    PubMed 10798305
  • Butzer T, Lambercy O, Arata J, Gassert R. Fully Wearable Actuated Soft Exoskeleton for Grasping Assistance in Everyday Activities. Soft Robot. 2021 Apr;8(2):128-143. doi: 10.1089/soro.2019.0135. Epub 2020 Jun 18.

    PubMed 32552422
  • Beekhuizen KS. New perspectives on improving upper extremity function after spinal cord injury. J Neurol Phys Ther. 2005 Sep;29(3):157-62. doi: 10.1097/01.npt.0000282248.15911.38.

    PubMed 16398948
  • Lambercy O, Dovat L, Yun H, Wee SK, Kuah CW, Chua KS, Gassert R, Milner TE, Teo CL, Burdet E. Effects of a robot-assisted training of grasp and pronation/supination in chronic stroke: a pilot study. J Neuroeng Rehabil. 2011 Nov 16;8:63. doi: 10.1186/1743-0003-8-63.

    PubMed 22087842
  • Marquez-Chin C, Popovic MR. Functional electrical stimulation therapy for restoration of motor function after spinal cord injury and stroke: a review. Biomed Eng Online. 2020 May 24;19(1):34. doi: 10.1186/s12938-020-00773-4.

    PubMed 32448143
  • Ciancibello J, King K, Meghrazi MA, Padmanaban S, Levy T, Ramdeo R, Straka M, Bouton C. Closed-loop neuromuscular electrical stimulation using feedforward-feedback control and textile electrodes to regulate grasp force in quadriplegia. Bioelectron Med. 2019 Nov 1;5:19. doi: 10.1186/s42234-019-0034-y. eCollection 2019.

    PubMed 32232108
  • Prochazka A, Gauthier M, Wieler M, Kenwell Z. The bionic glove: an electrical stimulator garment that provides controlled grasp and hand opening in quadriplegia. Arch Phys Med Rehabil. 1997 Jun;78(6):608-14. doi: 10.1016/s0003-9993(97)90426-3.

    PubMed 9196468

Questions about this trial

What is this clinical trial studying?

A study testing SensoExo in people with Stroke and Spinal Cord Injuries, run by Andrea Cimolato at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05976087, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.

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SENSIBLE-EXO Clinical Trial NCT05976087 | AzTrials