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

Technology

Arm/hand function

Online since 6 July 2022, updated 898 days ago

About this trial

This is a usability trial to test a home-use device (called Tetragrip II) that delivers functional electrical stimulation (FES) for hand function after cervical spinal cord injury. FES is a technique that applies electrical stimulation through the skin to nerves to activate weakened or paralyzed muscles. This study will investigate the Tetragrip II that is being developed for use in the home without clinical supervision, for hand and arm movements in people with tetraplegia. If included, the participant will complete 10 weeks of Tetragrip II training in the clinic, followed by 8 weeks of unsupervised home use.

Included participants

Gender

All

Age

0 - 90 years

Injury level

C4 - C7

Severity (AIS)?

AIS-A

AIS-B

AIS-C

AIS-D

Time since injury

≤ 90 years

Injury type

Traumatic

Healthy volunteers

C4-C7

Additionally, participants must

NOT have shoulder pain

NOT have an implanted device such as cardiac pacemaker, defibrillator, etc.

NOT known to suffer from significant autonomic dysreflexia in response to FES

What’s involved

Type

Technology

Details

- Electrodes attached to the hand, arm and shoulder in order to activate muscles and record their activity. - Gradually increasing daily hand/arm/shoulder exercises in the clinic from 30 to 60 minutes, with and without the device, over a 4 week period - Testing of upper extremity function before clinical training (i.e. baseline) and after 10 weeks of Tetragrip II training in the clinic. - Testing of upper extremity function after 8 weeks (e.g. week 18) of unsupervised home-use of Tetragrip II.

Potential benefits

Main benefits

Arm/hand function

Additional benefits

General health

Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

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