Feasibility, functionality and comfort of a novel concept Ankle-Foot-Orthosis for equinus foot

Completed

• Conditions: equinus foot; spastic foot deformity; 10028302; 10007963

• Registration Number: NL-OMON52812
• Lead Sponsor: Revalidatiegeneeskunde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1) a. Chronic stroke phase (defined as first stroke > 6 months)
b. Traumatic Brain Injury (> 6 months)
c. Hypoxic Brain Injury (> 6 months)
d. Cerebral Palsy
e. Multiple Sclerosis (relapse free in the previous 3 months)
f. Chronic incomplete spinal cord injury (> 6 months, ASIA score C or D)
2) Spastic paresis of the triceps surea muscles of the right or left leg
a. MAS>=2 (n=5)
b. MAS not restricted (n=25)
3) Equinus or equinovarus foot deformity of the affected spastic side (as
mentioned under criteria no. 2), defined as an increased passive ankle joint
stiffness and limited active range of motion of the affected side compared to
the non-affected side
4) Prescribed walking aid (orthotic shoes or AFO)

Exclusion Criteria

1) Age < 18 years
2) Drop foot (tibialis paresis)
3) Surgical treatment on the affected leg for spastic paresis
4) Inability to walk (with or without walking aid)
5) Inability to understand measurement instructions

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Active RoM at single joint level and during gait are primary outcomes.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Comfort and walkability based on PROMs and from instrumented gait analysis are<br /><br>secondary outcomes.</p><br>