flaccid paresis neuromuscular disorder
Conditions
Interventions
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 Soc
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: •minimum age of 18 years; •weakness of the quadriceps (i.e. MRC score 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
Exclusion criteria: •insufficient mastery of the Dutch language.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Netherlands
Outcome results
None listed