ovel, user-friendly, home-based electrostimulation-induced muscle activation in people with a spinal cord injury*

Conditions: paraplegia
spinal cord injury
10041543

Registration Number: NL-OMON45626

Lead Sponsor: Vrije Universiteit

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

* Age 18-75 years
* ASIA Impairment Scale A-B with intact reflex arcs (i.e. spastic paralysis)
* Lesion level * Time since injury >6 months
* No current pressure ulcers/damage to skin covering the ischial tuberosities and/or lower limbs
* Able to tolerate stimulation (i.e. no autonomic dysreflexia induced)

Exclusion Criteria

* An intolerance to or contraindication for electrical stimulation
* A history of severe autonomic dysreflexia or severe cognitive or communicative disorders
* A flaccid paralysis or areflexia

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure will be the feasibility of using the shorts garment<br /><br>during the 3 months. More specifically:<br /><br><br /><br>* Compliance (% of days worn, average time worn per day)<br /><br>* Recruitment rate (ratio of patients recruited and total number of patients<br /><br>invited)<br /><br>* Willingness of participants to be randomised into a randomised controlled<br /><br>trial<br /><br>* Time spent for instrumentation<br /><br>* Ability to wear the ES garment under normal clothing without<br /><br>discomfort/difficulties<br /><br>* Able to continue with day to day activities without impairment<br /><br>* Able to put the garment on themselves<br /><br>* Willingness to continue to use the garment</p><br>

Secondary Outcome Measures