Precision orthotics: optimizing ankle foot orthoses to improve gait in neuromuscular diseases

Completed

Conditions: flaccid paresis
muscle disease
10029317

Registration Number: NL-OMON47047

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

-age between 18 and 80 years;
-weakness of the calf muscles (i.e. a MRC score <5 or unable to perform >3 heel rises);
-using an AFO or orthopedic boot (one or both sided);
-able to walk for 5 minutes, with or without walking aids;
-able to walk for 10m barefoot without assistive devices.

Exclusion Criteria

-presence of pes equinus under weight-bearing (dorsiflexion * 0º);
-severe deformity of the ankle/foot that cannot be fitted with a custom-made AFO;
-severe weakness of the upper legs requiring a knee-ankle-foot orthosis;
-body weight > 120 kg.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint will be walking effort (ECW), which will be measured<br /><br>during a 6-minute walk test (6MWT) with simultaneous gas-analysis. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study endpoints will include: joint angles and net joint moments<br /><br>during gait (measured by 3D gait analysis); walking speed (assessed with a<br /><br>6MWT); perceived physical functioning (assessed with the 36-Item Short-Form<br /><br>Health Survey questionnaire); perceived fatigue (measured with the Fatigue<br /><br>Severity Scale); daily step activity (measured with the StepWatch3TM Activity<br /><br>Monitor 3.0 + a motivation dairy); and satisfaction (evaluated on a 10-point<br /><br>Numeric Rating Scale). Additional endpoints will include isometric strength and<br /><br>passive stiffness characteristics of the calf muscles; visualization of the<br /><br>fiber architecture of the calf muscles, assessed with diffusion-tensor magnetic<br /><br>resonance imaging; the AFO stiffness and treatment adherence. </p><br>