Incomplete Spinal Cord InjuryNCT04102826

Restoration of Arm Function in People With High-level Tetraplegia

A study testing Functional electrical stimulation (FES) in people with Incomplete Spinal Cord Injury, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Incomplete Spinal Cord Injury
What is being tested?: Functional electrical stimulation (FES)
Type of treatment: Medical device
How many people: 4 participants
Where: 1 siteUnited Kingdom
Study dates: 29 Sep 2021to 13 Dec 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Neil Postans
Oswestry, Shropshire, SY10 7AG

Other trials in United Kingdom

About this study

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

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.

Conditions: Incomplete Spinal Cord Injury
Being tested: Functional electrical stimulation (FES)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: At baseline and at study completion for each participant. Study completion will be up to 6 months after the baseline measurement.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Sep 202113 Dec 2023

First posted25 Sep 2019
Study start29 Sep 2021
Primary completion13 Dec 2023
Study completion13 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Incomplete Spinal Cord InjuryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04102826
Sponsor's protocol ID: RobertJAH
Status last verified: Jul 2024
First submitted: 9 Sep 2019
Last updated: 23 Jul 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Implant for Walking After Incomplete SCI
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NeuroSuitUp: Neurorehabilitation Through Synergistic Man-machine Interfaces
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Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
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Feasibility of Transcutaneous Spinal Stimulation in Rehabilitation
Spinal Cord Injuries (Complete and Incomplete), Spinal Cord Injuries (SCI)
Recruiting
Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
Cerebral Palsy, Muscular Dystrophy

All Incomplete Spinal Cord Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Personalised Approach to Restoration of Arm Function in People With High-level Tetraplegia
ClinicalTrials.gov ID: NCT04102826
Acronym / sponsor ID: RobertJAH
Conditions: Incomplete Spinal Cord Injury
Study type: Interventional
Recruitment status: Completed
Enrolment: 4 participants (actual)
Lead sponsor: Robert Jones and Agnes Hunt Orthopaedic and District NHS TrustOther government
Collaborators: Engineering and Physical Sciences Research Council, UK, Keele University
Study start: 29 Sep 2021 (actual)
Primary completion: 13 Dec 2023 (actual)
Study completion: 13 Dec 2023 (actual)
First posted: 25 Sep 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (8 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Functional electrical stimulation (FES)Functional electrical stimulation combined with mobile arm support to restore upper limb function.	Device	–

Primary outcome

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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
Individual participant dataSharing planned: No

Related trials for Incomplete Spinal Cord Injury

Recruiting
Implant for Walking After Incomplete SCI
Spinal Cord Injury (SCI), Gait
Enrolling by invitation
NeuroSuitUp: Neurorehabilitation Through Synergistic Man-machine Interfaces
Spinal Cord Injuries
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruiting
Feasibility of Transcutaneous Spinal Stimulation in Rehabilitation
Spinal Cord Injuries (Complete and Incomplete), Spinal Cord Injuries (SCI)
Recruiting
Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
Cerebral Palsy, Muscular Dystrophy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Neil Postans, PhD principal investigator

RJAH Orthopaedic Hospital NHS Foundation Trust

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04102826.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.