Improving Ambulatory Community Access After Paralysis

Technology

Standing/walking/mobility

Online since 1 November 2021, updated 898 days ago

About this trial

This is a rehabilitation trial to test the use of a functional electrical simulator (FES) to improve walking function in individuals with partial paralysis. Participants will have a stimulator surgically implanted into the abdomen; connected wires (electrodes) will be inserted into leg muscles. The trial will determine how well the stimulator improves hip, knee and ankle function to improve walking. After recovery from surgery, participants will engage in exercise at home and at the laboratory, and will be assessed for walking function after 1, 3, 6, and 12 months.

Included participants

Gender

All

Age

18 - 75 years

Injury level

C1 - S5

Severity (AIS)?

AIS-A

AIS-B

AIS-C

AIS-D

Time since injury

≥ 6 months

Injury type

Traumatic

Healthy volunteers

C1-S5

Additionally, participants must

NOT have other implanted device, e.g. pacemaker

What’s involved

Type

Technology

Details

· Surgery to insert the device and electrodes into the abdomen and leg muscles. · The participant will stay in hospital for 2-5 days after the surgery. · Exercise after the surgery for 6 weeks. · Further testing sessions after 1, 3, 6, and 12 months.

Potential benefits

Main benefits

Standing/walking/mobility

Additional benefits

Arm/hand function

General health

Mental health and psychosocial factors

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

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