Restoration of Arm Function in People With High-level Tetraplegia

Study Overview
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Brief Summary
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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.

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

Conditions
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Incomplete Spinal Cord Injury

Intervention / Treatment
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* Device: Functional electrical stimulation (FES)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Functional electrical stimulation (FES)|Functional electrical stimulation combined with mobile arm support to restore upper limb function.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |