Personalized orthotic care to improve functioning in patients with neuromuscular disorders

Completed

Conditions: 10029317
flaccid paresis
neuromuscular disorder

Registration Number: NL-OMON55650

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 70

Inclusion Criteria

•minimum age of 18 years;
•weakness of the quadriceps (i.e. MRC score < 5) and/or calf muscles (i.e. MRC
score < 5 or not being able to make a heel-rise on one leg > 3 times);
•experiencing walking problems such as increased walking effort, pain and/or
instability during standing and/or walking;
•able to walk for 6 minutes at comfortable speed with or without assistive
device;
•indicated for an orthosis based upon physical examination and gait analysis;
•motivated to use an orthosis

Exclusion Criteria

•insufficient mastery of the Dutch language.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measures to evaluate the clinical effectiveness are the<br /><br>change in walking effort (in J/kg/m) from baseline to 6 months post treatment,<br /><br>as measured by the 6-minute walk test, and achievement of personal treatment<br /><br>goals, measured with the goal attainment scale.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes will be: walking speed (6-minute walk test); stability and<br /><br>pain during walking (11-point NRS); gait pattern (3D gait analysis);<br /><br>health-related quality of life (EQ-5D-5L); physical functioning (SF36-physical<br /><br>functioning subscale); perceived fatigue (FSS); fear of falling (FES-1), fall<br /><br>rate (questionnaire); and satisfaction (D-Quest and NRS). </p><br>