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ID
Source
Brief title
Health condition
Stroke
Sponsors and support
Intervention
Outcome measures
Primary outcome
Active ankle RoM at single joint and activity level
Secondary outcome
PROMs
Background summary
A large population of stroke patients suffer from increased passive ankle joint stiffness and limited active range of motion (RoM) impairing their gait. In order to improve gait, current ankle-foot-orthoses (AFOs) counteract this so called equinus foot to neutral position by providing continuous stretch towards dorsiflexion. These AFOs further increase joint stiffness at the cost of active RoM. Therefore, we elaborated on a new AFO concept to compensate (instead of increase) the excessive passive ankle joint stiffness. We have now developed a first wearable prototype AFO based on this concept, to be tested in our clinical population of stroke patients. We will test the feasibility, functionality and comfort of the AFO using a within-subject design (n=30) at single joint level (i.e. ankle movement only) and at activity level (gait) with the new AFO at different levels of stiffness compensation. Overall comfort will be assessed by patient reported outcome measures (PROMs). Results of the study will be used to further optimize the AFO design and future study protocols.
Study objective
Higher stiffness compensation leads to increased passive and active ankle dorsiflexion
Study design
One measurement
Intervention
new AFO
Inclusion criteria
Chronic stroke phase (defined as first stroke > 6 months); Spastic paresis of the Triceps Surae muscles of the left or right leg; Equinus or equinovarus foot deformity of the affected side defined as increased passive ankle joint stiffness and limited active RoM of the affected side compared to the non-affected side; Prescribed walking aid (orthotic shoes or AFO)
Exclusion criteria
Age < 18 years; Drop foot (tibialis paresis); Surgical treatment on the affected leg for spastic paresis; Inability to walk (with or without walking aid); Inability to understand measurement instructions
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL8358 |
| Other | METC LDD : P19.063 |