Spinal Cord InjuriesNCT04964635
TETRAGRIP II - Usability Trial of an FES Orthosis for People With Tetraplegia.
A study testing TetraGrip II system in people with Spinal Cord Injuries and Tetraplegia, run by Bournemouth University at 1 site in United Kingdom.
Trial summary
Functional Electrical Stimulation is an established technique in which small electrical impulses are used to cause a contraction in muscles and thereby enable movement, in people with neurological or musculoskeletal problems who are unable to undertake those movements themselves. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Spinal Cord Injuries, Tetraplegia
- What is being tested?
- TetraGrip II system
- Type of treatment
- Medical device
- How many people
- 4 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Oct 2021to 31 Aug 2022
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a spinal cord injury that has resulted in tetraplegia affecting hand function.
- Minimal spasticity of wrist muscle.
- Able to do shoulder elevation.
- Upper limb passive range of motion should be within normal limit.
- Age group: 18 years and above.
- Able to understand and comply with assessment procedures.
- Able to give informed consent.
- Able to produce a muscle contraction using electrical stimulation in sufficient muscles produce a functional grip.
Who cannot join
- Using a cardiac pacemaker, defibrillator or other sensitive implanted device.
- Pregnant or planning to become pregnant over the course of the study.
- A history of poorly controlled epilepsy.
- If there is malignancy on the hand or arm.
- If younger than 18
- Severe contracture of wrist and finger joints.
- Painful shoulder.
- Suffering from significant autonomic dysreflexia in response to FES.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Salisbury District Hospital
Salisbury, Wiltshire, SP2 8BJ
About this study
Functional Electrical Stimulation is an established technique in which small electrical impulses are used to cause a contraction in muscles and thereby enable movement, in people with neurological or musculoskeletal problems who are unable to undertake those movements themselves. People with spinal cord injuries of the neck at C5, C6 and C7 account for 35% of all spinal cord injuries. Despite this, there is only one commercial FES (Functional Electrical Stimulation) based orthosis currently available. Even that has limitations in that it as it has a single size rigid exoskeleton it does not fit all people who could benefit and also due to its rigidity it does not allow people with lower injuries to utilise any remaining tenodesis grip. As a result, it is not widely used within the spinal injured communities. Therefore what is required is a more flexible system that can benefit a larger number of people whilst still being affordable within the constraints of the NHS. A previous INSPIRE funded project, TETRAGRIP I demonstrated that a surface FES system controlled by an inertial sensor, measuring movement of the opposite shoulder, could meet this specification and was successfully tried on two people with tetraplegia. What is now required is a more detailed study in which the principle components of that system are incorporated into a practical device suitable for use at home without clinical supervision. It is therefore proposed to develop and build such a system and to conduct extended home based trials in three people with tetraplegia.
- Conditions
- Spinal Cord Injuries, Tetraplegia
- Being tested
- TetraGrip II system
- Medical subject headings
- Spinal Cord Injuries, Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TetraGrip II systemDevice
This main aim of this whole research project is to evaluate the performance of the TetraGrip II system in improving the upper limb functions in people with C4-C7 tetraplegia i.e. people who have damaged their spinal cord in the neck resulting in loss of function in all four limbs. The Tetragrip system uses a technique called Functional Electrical Stimulation (FES) in which small electrical impulses are used to activate paralysed muscles and hence provide movement. The stimulation is controlled by sensors which measure the movement of the other shoulder and enable the person to regain the use of their hand via stimulating electrodes placed on the skin over the relevant muscles.
The feasibility of using this FES based system in restoring the upper arm functions will be evaluated by clinically trying the device on participants with C4-C7 tetraplegia.
What is being measured
The primary outcome is the main question the study is designed to answer.
Grasp Release Test (GRT)
Test to be completed both with and without the device - exercise daily for 30 minutes, building up to 60 minutes over a four week period
Measured: Start of study - 30 minutes building up to 60 minutes over a four week period
Grasp Release Test (GRT)
Test to be completed both with and without the device - exercise daily for 30 minutes, building up to 60 minutes over a four week period
Measured: At the end of the clinical phase (week 10) - 30 minutes building up to 60 minutes over a four week period
Grasp Release Test (GRT)
Test to be completed both with and without the device - exercise daily for 30 minutes, building up to 60 minutes over a four week period
Measured: At the end of the home phase for participants taking the device home (week 18) - 30 minutes building up to 60 minutes over a four week period
Secondary outcomes (6)
Measurement of palmar grip
Test to be completed both with and without the device
Measured: At the start of the study - 30 minutes
Measurement of pinch grip
Test to be completed both with and without the device
Measured: At the start of the study - 30 minutes
Measurement of palmar grip
Test to be completed both with and without the device
Measured: At the end of the clinical phase (week 10) - 30 minutes
Measurement of pinch grip
Test to be completed both with and without the device
Measured: At the end of the clinical phase (week 10) - 30 minutes
Measurement of palmar grip
Test to be completed both with and without the device
Measured: At the end of the home phase for participants taking the device home (week 18) - 30 minutes
Measurement of pinch grip
Test to be completed both with and without the device
Measured: At the end of the home phase for participants taking the device home (week 18) - 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start26 Oct 2021
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bournemouth University
- Sponsor type
- University, hospital or other
- Collaborators
- Salisbury NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Ian Swain, Professor, Study director, Professor in Technology & DesignPaul Taylor, Professor, Principal investigator, Consultant Clinical Scientist - Salisbury District Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04964635
- Sponsor's protocol ID
- RED 10356
- Status last verified
- Nov 2022
- First submitted
- 23 Jun 2021
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TETRAGRIP II - Usability Trial of an FES Orthosis for People With Tetraplegia.
- ClinicalTrials.gov ID
- NCT04964635
- Acronym / sponsor ID
- RED 10356
- Conditions
- Spinal Cord Injuries, Tetraplegia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Bournemouth UniversityUniversity, hospital or other
- Collaborators
- Salisbury NHS Foundation Trust
- Study start
- 26 Oct 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 16 Jul 2021 (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.
Functional Electrical Stimulation is an established technique in which small electrical impulses are used to cause a contraction in muscles and thereby enable movement, in people with neurological or musculoskeletal problems who are unable to undertake those movements themselves. People with spinal cord injuries of the neck at C5, C6 and C7 account for 35% of all spinal cord injuries. Despite this, there is only one commercial FES (Functional Electrical Stimulation) based orthosis currently available. Even that has limitations in that it as it has a single size rigid exoskeleton it does not fit all people who could benefit and also due to its rigidity it does not allow people with lower injuries to utilise any remaining tenodesis grip. As a result, it is not widely used within the spinal injured communities. Therefore what is required is a more flexible system that can benefit a larger number of people whilst still being affordable within the constraints of the NHS. A previous INSPIRE funded project, TETRAGRIP I demonstrated that a surface FES system controlled by an inertial sensor, measuring movement of the opposite shoulder, could meet this specification and was successfully tried on two people with tetraplegia. What is now required is a more detailed study in which the principle components of that system are incorporated into a practical device suitable for use at home without clinical supervision. It is therefore proposed to develop and build such a system and to conduct extended home based trials in three people with tetraplegia.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Have a spinal cord injury that has resulted in tetraplegia affecting hand function.
- Minimal spasticity of wrist muscle.
- Able to do shoulder elevation.
- Upper limb passive range of motion should be within normal limit.
- Age group: 18 years and above.
Key exclusion criteria (8 listed)
- Using a cardiac pacemaker, defibrillator or other sensitive implanted device.
- Pregnant or planning to become pregnant over the course of the study.
- A history of poorly controlled epilepsy.
- If there is malignancy on the hand or arm.
- If younger than 18
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 |
|---|---|---|
| TetraGrip II systemThis main aim of this whole research project is to evaluate the performance of the TetraGrip II system in improving the upper limb functions in people with C4-C7 tetraplegia i.e. people who have damaged their spinal cord in the neck resulting in loss of function in all four limbs. The Tetragrip system uses a technique called Functional Electrical Stimulation (FES) in which small electrical impulses are used to activate paralysed muscles and hence provide movement. The stimulation is controlled by sensors which measure the movement of the other shoulder and enable the person to regain the use of their hand via stimulating electrodes placed on the skin over the relevant muscles. The feasibility of using this FES based system in restoring the upper arm functions will be evaluated by clinically trying the device on participants with C4-C7 tetraplegia. | Device | – |
Primary outcome
Grasp Release Test (GRT)
Time frame: Start of study - 30 minutes building up to 60 minutes over a four week period
Test to be completed both with and without the device - exercise daily for 30 minutes, building up to 60 minutes over a four week period
Grasp Release Test (GRT)
Time frame: At the end of the clinical phase (week 10) - 30 minutes building up to 60 minutes over a four week period
Test to be completed both with and without the device - exercise daily for 30 minutes, building up to 60 minutes over a four week period
Grasp Release Test (GRT)
Time frame: At the end of the home phase for participants taking the device home (week 18) - 30 minutes building up to 60 minutes over a four week period
Test to be completed both with and without the device - exercise daily for 30 minutes, building up to 60 minutes over a four week period
6 secondary outcomes
Measurement of palmar grip
Time frame: At the start of the study - 30 minutes
Measurement of pinch grip
Time frame: At the start of the study - 30 minutes
Measurement of palmar grip
Time frame: At the end of the clinical phase (week 10) - 30 minutes
Measurement of pinch grip
Time frame: At the end of the clinical phase (week 10) - 30 minutes
Measurement of palmar grip
Time frame: At the end of the home phase for participants taking the device home (week 18) - 30 minutes
Measurement of pinch grip
Time frame: At the end of the home phase for participants taking the device home (week 18) - 30 minutes
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 14 Nov 2022.
- Individual participant dataSharing planned: Undecided
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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.
Ian Swain, Professor study director
Professor in Technology & Design
Paul Taylor, Professor principal investigator
Consultant Clinical Scientist - Salisbury District Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TetraGrip II system in people with Spinal Cord Injuries and Tetraplegia, run by Bournemouth University at 1 site in United Kingdom.
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 8 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 14 Nov 2022. 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?
Grasp Release Test (GRT) (time frame: Start of study - 30 minutes building up to 60 minutes over a four week period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Nov 2022.