Personalized orthotic care to improve functioning in patients with neuromuscular diseases

Not Applicable

Completed

Conditions: <p>Patients with neuromuscular disorders</p>
10029317

Registration Number: NL-OMON26149

Lead Sponsor: Amsterdam UMC, location AMC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 70

Inclusion Criteria

1. Minimum age of 18 years; 2. Weakness of the quadriceps (i.e. MRC < 5) and/or calf muscles (i.e. MRC < 5 or not being able to make a heel-rise on one leg > 3 times); 3. Experiencing walking problems such as increased effort, pain and/or instability during standing and/or walking; 4. Able to walk for 6 minutes at comfortable walking speed with or without assistive device; 5. Indicated for a leg orthosis or high orthopedic shoes (OS); 6. Motivated to use an orthosis/OS.

Exclusion Criteria

1. 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 are change in walking effort (J/kg/m) assessed during a 6-minute walk test (6MWT) at comfortable speed and the achievement of personal treatment goals defined with the goal attainment scale (GAS) at 6 months follow up.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes include comfortable speed (6MWT), gait biomechanics (3D gait analysis), stability (10-point NRS), physical functioning (SF36 physical functioning scale), falling (falls questionnaire), satisfaction (D-QUEST and self-designed questionnaire), quality of life (EQ-5D-5L) and costs (cost questionnaire).</p><br>