Clinical trial NCT04102826: Restoration of Arm Function in People With High-level Tetraplegia
Official title: Personalised Approach to Restoration of Arm Function in People With High-level Tetraplegia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incomplete Spinal Cord Injury
Lead sponsor: Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
Sponsor class: OTHER_GOV
Collaborators: name: Engineering and Physical Sciences Research Council, UK
name: Keele University
First posted: 2019-09-25
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Primary outcomes:
measure: Change in Canadian Occupational Performance Measure (COPM)
timeFrame: At baseline and at study completion for each participant. Study completion will be up to 6 months after the baseline measurement.
Secondary outcomes:
Other outcomes:
Locations:
city: Oswestry
country: United Kingdom
facility: Neil Postans
state: Shropshire
Study officials:
affiliation: RJAH Orthopaedic Hospital NHS Foundation Trust
name: Neil Postans, PhD
role: PRINCIPAL_INVESTIGATOR
References: