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

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 Overview

• Status: Completed
• Conditions: Spinal Cord Injuries; Tetraplegia
• Intervention / Treatment: Device: TetraGrip II system

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Wiltshire
    • Salisbury, Wiltshire, United Kingdom, SP2 8BJ
      • Salisbury District Hospital

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of palmar grip	Test to be completed both with and without the device	At the start of the study - 30 minutes
Measurement of pinch grip	Test to be completed both with and without the device	At the start of the study - 30 minutes
Measurement of palmar grip	Test to be completed both with and without the device	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	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	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	At the end of the home phase for participants taking the device home (week 18) - 30 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Two Point Discrimination Test	Test to be completed both with and without the device	At the start of the study
Two Point Discrimination Test	Test to be completed both with and without the device	At the end of the clinical phase (week 10)
Two Point Discrimination Test	Test to be completed both with and without the device	At the end of the home phase for participants taking the device home (week 18)

Collaborators and Investigators

• Sponsor: Bournemouth University
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2021
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: June 23, 2021
• First Submitted That Met QC Criteria: July 15, 2021
• First Posted (Actual): July 16, 2021

Study Record Updates

• Last Update Posted (Actual): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 10, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Paralysis; Spinal Cord Injuries; Quadriplegia
• Other Study ID Numbers: RED 10356

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No