Status:

COMPLETED

Restoration of Arm Function in People With High-level Tetraplegia

Lead Sponsor:

Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

Collaborating Sponsors:

Engineering and Physical Sciences Research Council, UK

Keele University

Conditions:

Incomplete Spinal Cord Injury

Eligibility:

All Genders

18+ years

Phase:

NA

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 elec...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

September 29 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 13 2023

Estimated Enrollment :

4 Patients enrolled

Trial Details

Trial ID

NCT04102826

Start Date

September 29 2021

End Date

December 13 2023

Last Update

July 23 2024

Active Locations (1)

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Neil Postans

Oswestry, Shropshire, United Kingdom, SY10 7AG