Restoration of Arm Function in People With High-level Tetraplegia

Incomplete Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04102826
• Other study ID #: RobertJAH
• Status: Recruiting
• Phase: N/A
• Start date: September 29, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: September 2021
• Source: Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
• Contact: Neil Postans, PhD
• Phone: 00441691404532
• Email: neil.postans[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: October 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Incomplete Spinal Cord Injury
• Quadriplegia
• Spinal Cord Injuries

Intervention

Device:
• Functional electrical stimulation (FES)
Functional electrical stimulation combined with mobile arm support to restore upper limb function.

Locations

Country	Name	City	State
United Kingdom	Neil Postans	Oswestry	Shropshire

Sponsors (3)

Lead Sponsor	Collaborator
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust	Engineering and Physical Sciences Research Council, UK, Keele University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Canadian Occupational Performance Measure (COPM)	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.