An interventional study of Functional electrical stimulation (FES) in Incomplete Spinal Cord Injury, sponsored by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-23.
Sponsored by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust · Not applicable, Interventional, and Device feasibility
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.
1,950 studies on the registry are indexed under Spinal Cord Injuries; 507 are open to participants now.
This study's enrollment of 4 is below the median of 24 across 1,567 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust is the lead sponsor of 36 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Functional electrical stimulation combined with mobile arm support to restore upper limb function.
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.
Time frame: At baseline and at study completion for each participant. Study completion will be up to 6 months after the baseline measurement.
Plan to share: No
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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust