Personalized orthotic care is expected to be more effective and cost-effective compared to usual orthotic care.
ID
Source
Brief title
Condition
- Neuromuscular disorders
Health condition
Patients with neuromuscular disorders
Research involving
Sponsors and support
Intervention
- Medical device
Outcome measures
Primary outcome
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.
Secondary outcome
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).
Background summary
Rationale: Leg muscle strength is often impaired in people with neuromuscular disorders (NMD). This leads to mobility problems such as increased walking effort, diminished speed and increased risk of falling. Leg orthoses are commonly provided to improve mobility. A multidisciplinary guideline was developed to provide individually matched leg orthoses. Application of this personalized orthotic care approach shows preliminary effectiveness compared to usual orthotic care in persons with NMD. However, the cost-effectiveness remains to be investigated. Objective: To investigate the effectiveness and cost-effectiveness of personalized orthotic care provided in expert centers compared to usual orthotic care in persons with NMD. Study design: A prospective randomized open label blinded end-point study is performed Study population: 70 patients with NMD exhibiting calf muscle weakness and/or quadriceps weakness, who are indicated for a leg orthosis or high orthopedic shoes. Intervention: Participants are randomly assigned to receive personalized orthotic care provided by expert centers (intervention group) or usual orthotic care (control group). Measurements: Participants are assessed at baseline and at 3 and 6 months follow up. The primary endpoints are the change in walking effort (J/kg/m) and achievement of personal treatment goals. Secondary outcomes include walking speed, gait biomechanics, stability, physical functioning, falling and satisfaction. An economic evaluation will be conducted from a societal and healthcare perspective. Resource utilization and resource use will be based on the EQ-5D-5L and cost questionnaires respectively. Relevance: This study is the first to study the cost-effectiveness of personalized orthotic care compared to usual care in persons with NMD. Personalized orthotic care is expected to improve mobility more compared to usual care, which could lead to long-term cost savings in health care.
Study objective
Personalized orthotic care is expected to be more effective and cost-effective compared to usual orthotic care.
Study design
Primary and secondary outcomes will be assessed at baseline (T1) and at 3 and 6 months after orthotic treatment (T2 and T3 respectively).
Intervention
Personalized orthotic care
Age
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.
Design
Recruitment
IPD sharing statement
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7511 |
| CCMO | NL67268.018.18 |
| OMON | NL-OMON55650 |