Restoration of Arm Function in People With High-level Tetraplegia

NCT ID: NCT04102826

Last Updated: 2024-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-29
• Study Completion Date: 2023-12-13

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.

Conditions

Incomplete Spinal Cord Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Interventions

Functional electrical stimulation (FES)

Functional electrical stimulation combined with mobile arm support to restore upper limb function.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Engineering and Physical Sciences Research Council, UK

OTHER

Sponsor Role: collaborator

Keele University

OTHER

Sponsor Role: collaborator

Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neil Postans, PhD

Role: PRINCIPAL_INVESTIGATOR

RJAH Orthopaedic Hospital NHS Foundation Trust

Locations

Neil Postans

Oswestry, Shropshire, United Kingdom

Countries

United Kingdom

Other Identifiers

RobertJAH

Identifier Type: -

Identifier Source: org_study_id