TETRAGRIP II - Usability Trial of an FES Orthosis for People With Tetraplegia.

• ClinicalTrials.gov Identifier: NCT04964635
• Recruitment Status: Completed
• First Posted: July 16, 2021
• Last Update Posted: November 14, 2022
• Sponsor: Bournemouth University
• Collaborator: Salisbury NHS Foundation Trust
• Information provided by (Responsible Party): Bournemouth University

Study Description

Brief 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. 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.

Condition or disease	Intervention/treatment	Phase
Spinal Cord Injuries; Tetraplegia	Device: TetraGrip II system	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 4 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: TETRAGRIP II - Usability Trial of an FES Orthosis for People With Tetraplegia.
• Actual Study Start Date: October 26, 2021
• Actual Primary Completion Date: August 31, 2022
• Actual Study Completion Date: August 31, 2022

Arms and Interventions

Intervention Details:

• Device: TetraGrip II system

  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.

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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
3. 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

Secondary Outcome Measures :

1. Measurement of palmar grip [ Time Frame: At the start of the study - 30 minutes ]
   Test to be completed both with and without the device
2. Measurement of pinch grip [ Time Frame: At the start of the study - 30 minutes ]
   Test to be completed both with and without the device
3. Measurement of palmar grip [ Time Frame: At the end of the clinical phase (week 10) - 30 minutes ]
   Test to be completed both with and without the device
4. Measurement of pinch grip [ Time Frame: At the end of the clinical phase (week 10) - 30 minutes ]
   Test to be completed both with and without the device
5. Measurement of palmar grip [ Time Frame: At the end of the home phase for participants taking the device home (week 18) - 30 minutes ]
   Test to be completed both with and without the device
6. Measurement of pinch grip [ Time Frame: At the end of the home phase for participants taking the device home (week 18) - 30 minutes ]
   Test to be completed both with and without the device

Other Outcome Measures:

1. Two Point Discrimination Test [ Time Frame: At the start of the study ]
   Test to be completed both with and without the device
2. Two Point Discrimination Test [ Time Frame: At the end of the clinical phase (week 10) ]
   Test to be completed both with and without the device
3. Two Point Discrimination Test [ Time Frame: At the end of the home phase for participants taking the device home (week 18) ]
   Test to be completed both with and without the device

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

United Kingdom

Salisbury District Hospital

Salisbury, Wiltshire, United Kingdom, SP2 8BJ

Sponsors and Collaborators

Bournemouth University

Salisbury NHS Foundation Trust

Investigators

• Study Director: Ian Swain, Professor; Professor in Technology & Design
• Principal Investigator: Paul Taylor, Professor; Consultant Clinical Scientist - Salisbury District Hospital

More Information

• Responsible Party: Bournemouth University
• ClinicalTrials.gov Identifier: NCT04964635
• Other Study ID Numbers: RED 10356
• First Posted: July 16, 2021
• Last Update Posted: November 14, 2022
• Last Verified: November 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Spinal Cord Injuries; Quadriplegia; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations