Proof of concept functional prototype INES full exoskelet

• Conditions: paralysis; Cerebral palsy; 10029317

• Registration Number: NL-OMON53255
• Lead Sponsor: Sint Maartenskliniek

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 8

Inclusion Criteria

1) Healthy (young) adults (n=4)
-Age > 16 years old
-Weight 20-55 kg
-Height 1.34-1.60 m
-No conditions that affects walking ability
-No cognitive problems

2) Young adults with cerebral palsy (n=4)
-Age >16 years old
-Bilateral cerebral palsy
-GMFCS II-IV
-Weight 20-55 kg
-Height 1.34-1.60 m
-No severe cognitive problems
-No severe spasticity
-No severe limited range of motion in ankle, knee and hip joints.
-No severe bone deformations

Exclusion Criteria

-Temporary complaints affecting walking (such as a sprained ankle)
- (Little) wounds on body parts that are in contact with the exoskeleton
-Severe secondary health conditions ( such as cardiovascular problems)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure is usability that will be measured with the System<br /><br>Usability Scale (Dutch version). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p> In addition, performance of the defined use cases (Donning, Doffing,<br /><br>Sit-to-stand, Stand-to-sit, Walk) will be described and evaluated. </p><br>