Restoration of Arm Function in People With High-level Tetraplegia

November 10, 2021 updated by: Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

Personalised Approach to Restoration of Arm Function in People With High-level Tetraplegia

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Canadian Occupational Performance Measure (COPM)
Time Frame: At baseline and at study completion for each participant. Study completion will be up to 6 months after the baseline measurement.
The COPM is a questionnaire based assessment of performance and satisfaction of functional tasks. The COPM measures an individuals self-perception of occupational performance over time. This is a 10 point scale, with 1 indicating poor performance and low satisfaction, and 10 indicating very good performance and high satisfaction. The scale is applied to up to 5 problems identified by an individual that affect their everyday life. An average score is then calculated.
At baseline and at study completion for each participant. Study completion will be up to 6 months after the baseline measurement.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

Collaborators

Engineering and Physical Sciences Research Council, UK
Keele University

Investigators

  • Principal Investigator: Neil Postans, PhD, RJAH Orthopaedic Hospital NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2021

Primary Completion (Anticipated)

July 31, 2022

Study Completion (Anticipated)

October 31, 2022

Study Registration Dates

First Submitted

September 9, 2019

First Submitted That Met QC Criteria

September 24, 2019

First Posted (Actual)

September 25, 2019

Study Record Updates

Last Update Posted (Actual)

November 11, 2021

Last Update Submitted That Met QC Criteria

November 10, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RobertJAH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Incomplete Spinal Cord Injury

Clinical Trials on Functional electrical stimulation (FES)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lebanon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe