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Completed

NCT Number: NCT04964635

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Salisbury District Hospital

Salisbury, Wiltshire, SP2 8BJ, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TetraGrip II system

Device

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bournemouth University

Other

Collaborators

  • Salisbury NHS Foundation Trust

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 16, 2021
Registry last updated
Nov 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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