Restoration of Arm Function in People With High-level Tetraplegia

  • STATUS
    Recruiting
  • End date
    Oct 31, 2021
  • participants needed
    10
  • sponsor
    Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
Updated on 23 January 2021

Summary

Functional electrical stimulation (FES) has been used to activate paralysed muscles and restore movement after spinal cord injury and stroke. This technology involves the application of low-level electrical currents to the nerves and muscles to cause muscle contraction where the user's ability to achieve that through voluntary means has been lost.

Providing control of muscle contraction in a coordinated way can mean that users are able once again to produce functional movements in otherwise paralysed limbs.

Routine clinical use is limited to the prevention of drop foot in the lower limb following stroke and occasional therapeutic use in the hand and shoulder. Systems providing functional reach and grasp, however, have not achieved clinical or commercial success. This project aims to develop methods for personalising assistive technology to restore arm function in people with high-level spinal cord injury. The investigators will use a combination of electrical stimulation to elicit forces in muscles no longer under voluntary control, and mobile arm supports to compensate for insufficient muscle force where necessary. The investigators will use computational models specific to an individual's functional limitations to produce patient-specific interventions. The project will be in three phases: building a model to predict the effects of electrical stimulation on a paralysed arm with arm support, development of methodologies using this model to optimise the arm support and stimulation system, and testing of stimulation controllers designed using this approach.

Details
Condition Incomplete Spinal Cord Injury
Treatment Functional Electrical Stimulation (FES)
Clinical Study IdentifierNCT04102826
SponsorRobert Jones and Agnes Hunt Orthopaedic and District NHS Trust
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Incomplete Spinal Cord Injury?
Do you have any of these conditions: Do you have Incomplete Spinal Cord Injury??
Patients with mid- to high-level spinal cord injury resulting in partial or full paralysis of the upper limb will be eligible for inclusion in the study. In addition, they must be
Able to give informed consent
Able to remain comfortably seated with provision of trunk stability
Medically stable and at least six weeks from injury; and
Have sufficient passive range of motion without discomfort

Exclusion Criteria

Have orthopaedic implants across or between electrode sites
Have active cardiac implant
Have poor skin conditions, scar or carcinogenic tissue at site of stimulation
Have uncontrolled pain
Have uncontrolled epilepsy
Have skin reactions to electrodes
Have open wounds or injuries; and
Are pregnant or planning for a pregnancy
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