Restoration of Arm Function in People With High-level Tetraplegia
Primary Purpose
Incomplete Spinal Cord Injury
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Functional electrical stimulation (FES)
Sponsored by
About this trial
This is an interventional device feasibility trial for Incomplete Spinal Cord Injury
Eligibility Criteria
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.
Sites / Locations
- Neil PostansRecruiting
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04102826
First Posted
September 9, 2019
Last Updated
November 10, 2021
Sponsor
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
Collaborators
Engineering and Physical Sciences Research Council, UK, Keele University
1. Study Identification
Unique Protocol Identification Number
NCT04102826
Brief Title
Restoration of Arm Function in People With High-level Tetraplegia
Official Title
Personalised Approach to Restoration of Arm Function in People With High-level Tetraplegia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 29, 2021 (Actual)
Primary Completion Date
July 31, 2022 (Anticipated)
Study Completion Date
October 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
Collaborators
Engineering and Physical Sciences Research Council, UK, Keele University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incomplete Spinal Cord Injury
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Functional electrical stimulation (FES)
Intervention Description
Functional electrical stimulation combined with mobile arm support to restore upper limb function.
Primary Outcome Measure Information:
Title
Change in Canadian Occupational Performance Measure (COPM)
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Neil Postans, PhD
Phone
00441691404532
Email
neil.postans@nhs.net
First Name & Middle Initial & Last Name or Official Title & Degree
Teresa Jones
Phone
00441691404143
Email
teresa.jones6@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil Postans, PhD
Organizational Affiliation
RJAH Orthopaedic Hospital NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neil Postans
City
Oswestry
State/Province
Shropshire
ZIP/Postal Code
SY10 7AG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neil Postans, PhD
Phone
0044 1691 404666
Email
neil.postans@nhs.net
First Name & Middle Initial & Last Name & Degree
Claire Wright
Phone
0044 1691 404139
Email
clairewright8@nhs.net
12. IPD Sharing Statement
Plan to Share IPD
No
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Restoration of Arm Function in People With High-level Tetraplegia
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