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Orthoses for people with stroke (AFOOT)

Which is the better ankle foot orthosis for people with stroke?

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN98287938
Enrollment
166
Registered
2015-05-06
Start date
2012-07-01
Completion date
Unknown
Last updated
2016-10-17

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

Conditions

Stroke Circulatory System

Interventions

Two types of ankle foot orthosis (AFO) prescribed to correct foot drop. Participants are randomised to either an off-the-shelf, commonly used medium priced Leaf Spring AFO
or a custom made AFO, where the design is decided by the clinical orthotist. Both AFO are offered as standard care.

Sponsors

University of Manchester
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Have a diagnosis of stroke 2. Be living at home or residential care (or in hospital with discharge plans confirmed) 3. Satisfy the referral criteria to their local Orthotics Service 4. Have impaired dorsiflexion – which limits heel strike (the heel hits the ground first when taking a step forwards) 5. Have no contractures at the ankle (sufficient range of movement at the affected ankle for the heel to be in contact with the floor while standing) 6. Be able to walk 5m (approx across a typical living room), without the assistance of another person but maybe with the assistance of a walking aid 7. Be able to consent

Exclusion criteria

Exclusion criteria: 1. Any co-morbities of sufficient severity to limit mobility 2. Any condition which precludes them from wearing an AFO (e.g., severely oedematous ankles/feet; severe skin conditions/abrasions; inability to wear footwear)

Design outcomes

Primary

MeasureTime frame
Patient Satisfaction Questionnaire Measured at week 6 and 12.

Secondary

MeasureTime frame
1. Walking speed and gait analysis, measured by the GAITRite automated walkway & manual counts of speed and step count over 5m (measured at baseline, 6 weeks and 12 weeks) 2. Modified Functional Walking Categories (MFWC) (measured at baseline, 6 weeks and 12 weeks) 3. Falls Efficacy Scale - International (FES-I) (measured at baseline, 6 weeks and 12 weeks)

Countries

United Kingdom

Contacts

Public ContactSarah Tyson
sarah.tyson@manchester.ac.uk44 (0)161 306 7781

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026