To assess the effectiveness and cost-effectiveness of personalized orthotic care to improve functioning in patients with NMD compared to standard orthotic care.
ID
Source
Brief title
Condition
- Neuromuscular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measures to evaluate the clinical effectiveness are the
change in walking effort (in J/kg/m) from baseline to 6 months post treatment,
as measured by the 6-minute walk test, and achievement of personal treatment
goals, measured with the goal attainment scale.
Secondary outcome
Secondary outcomes will be: walking speed (6-minute walk test); stability and
pain during walking (11-point NRS); gait pattern (3D gait analysis);
health-related quality of life (EQ-5D-5L); physical functioning (SF36-physical
functioning subscale); perceived fatigue (FSS); fear of falling (FES-1), fall
rate (questionnaire); and satisfaction (D-Quest and NRS).
Background summary
People with neuromuscular disorders (NMD) often experience mobility problems
due to reduced leg muscle strength. Walking effort is usually increased and
speed diminished with increased risk of falling. To reduce mobility problems,
leg orthoses are provided. However, there is large variety in types of orthoses
that are applied and they are often insufficiently matched to the complex
health needs of NMD patients. Failure to achieve functional success obviously
limits the cost-effectiveness of leg orthoses. Therefore, in 2012, a
multidisciplinary guideline was developed to provide leg orthoses matched to
the patients* individual health needs. Application of such personalized leg
orthoses shows promising results with respect to improving functioning when
compared to usual care. However, the effectiveness and the cost-effectiveness
of this personalized approach are unknown.
Study objective
To assess the effectiveness and cost-effectiveness of personalized orthotic
care to improve functioning in patients with NMD compared to standard orthotic
care.
Study design
A prospective randomized open label blinded end-point study with an economic
evaluation and measurements at baseline (T1) and at 3 months (T2) and 6 months
(T3) follow up.
Intervention
Participants will be randomized (ratio 1:1) to the intervention group,
receiving personalized orthotic care delivered by 2 expert centres according to
the guideline for leg orthoses of the Dutch Society of Rehabilitation Medicine,
or the control group receiving standard orthotic care delivered at general
rehabilitation centres and hospitals.
Study burden and risks
Patients are asked to visit the Academic Medical Center minimum 3 times over
the study period of 10 months to participate in the study measurements and to
fill out questionnaires. The duration of the measurements will be approximately
3.5 hours. Baseline as well as follow-up measurements are non-invasive.
Practical relevance of the study is that this extensive evaluation of
personalized orthotic care and implementation thereof in rehabilitation care in
the Netherlands could result in health benefits for patients and long-term cost
savings for society.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL67268.018.18 |
| Other | NL7511 |
| OMON | NL-OMON26149 |