Patient preference to guide AFO prescription

Patient’s preference as guidance in the decision-making process of prescribing off-the-shelf carbon ankle foot orthoses

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28247

Enrollment

Registered

2020-10-21

Start date

2020-10-21

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurological disorders

Interventions

Two off-the-shelf carbon AFOs: i) Toe-OFF (AllardInt, Helsingborg, Sweden) and ii) Sprystep Max (Thuasne, Levallois-Perret, France).

Eligibility

Inclusion criteria

Inclusion criteria: - Age >18 years old <80 years old - Neurological disorders, such as stroke, MS, spinal cord injury - At least 6 months post injury-onset to ensure a stable neurological condition - Reduced ankle push-off power (clinically assessed by functional testing) -

Exclusion criteria

Exclusion criteria: - Using orthopedic shoes in combination with AFO - Receiving focal treatment for spasticity (e.g.with botulinum toxin) within 6 months - Calf muscle hypertonia (Modified Ashworth scale (MAS) >2/5) - Hip flexor and extensor weakness (MRC<4/5) - Knee extensor weakness (MRC<4/5) - Patient with neuropathic and/or orthopedic comorbidities that affect AFO efficacy - Patient with cognitive impairment(s) not being able to follow instructions

Design outcomes

Secondary

Measure	Time frame
- % agreement between patient’s preference at baseline and at evaluation - Relation between L-test performance and joint kinematics and kinetics - % agreement between patient’s preference and AFO efficacy in terms of walking speed and gait adaptability - % agreement between orthotist’s preference and AFO efficacy in terms of L-test performance, walking speed and gait adaptability - Spatiotemporal parameters - Joint kinematics and kinetics - Shank-to-vertical angle (SVA) - AFO stiffness - AFO satisfaction score - AFO adherence	—

Measure

Time frame

- % agreement between patient’s preference at baseline and at evaluation - Relation between L-test performance and joint kinematics and kinetics - % agreement between patient’s preference and AFO efficacy in terms of walking speed and gait adaptability - % agreement between orthotist’s preference and AFO efficacy in terms of L-test performance, walking speed and gait adaptability - Spatiotemporal parameters - Joint kinematics and kinetics - Shank-to-vertical angle (SVA) - AFO stiffness - AFO satisfaction score - AFO adherence

—

Primary

Measure	Time frame
% agreement between patient’s preference and AFO efficacy in terms of L-test performance	—

Contacts

Public ContactLysanne de Jong

Sint Maartenskliniek

l.dejong@maartenskliniek.nl0243272564

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)