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Short term clinical effectiveness of a fabric based ankle foot orthosis for post-stroke gait dysfunction: a prospective within-subject study

Short term clinical effectiveness of a fabric based ankle foot orthosis for post-stroke gait dysfunction: a prospective within-subject study

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260620004
Enrollment
20
Registered
2026-06-20
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Stroke Post-stroke gait dysfunction Hemiparetic gait Foot drop Stroke Hemiparesis Ankle-Foot Orthoses Gait Walking Rehabilitation Stroke Rehabilitation Foot Drop Orthotic Devices Mobility Limitation

Interventions

Participants with post stroke gait dysfunction will undergo gait assessment while wearing a fabric based ankle foot orthosis to evaluate short term effects on walking performance and mobility
Experimental Device
Fabric based AFO

Sponsors

-
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Adults aged 18 years or older 2.Diagnosis of ischemic or hemorrhagic stroke confirmed by medical records 3.Presence of gait dysfunction related to impaired ankle control, such as reduced foot clearance or toe drag during walking 4.Ability to ambulate at least 10 meters with or without a walking aid 5.Medically stable and able to follow simple instructions 6.Willingness to participate and provide written informed consent, In cases where the participant is unable to sign, a fingerprint may be used in place of a signature, or a legally authorized representative may sign on behalf of the participant, with the presence of a witness.

Exclusion criteria

Exclusion criteria: 1.Severe cognitive impairment or communication disorder that precludes understanding of study procedures 2.Severe lower limb musculoskeletal conditions unrelated to stroke that significantly affect gait (severe osteoarthritis, recent fracture) 3.Fixed ankle contracture or severe deformity preventing proper fitting of the ankle foot orthosis. 4.Other neurological conditions affecting gait (Parkinson's disease, peripheral neuropathy)

Design outcomes

Primary

MeasureTime frame
Gait speed baseline, immediately use of AFO and 2 weeks after intervention 10-Meter Walk Test (10MWT)

Secondary

MeasureTime frame
Functional walking ability baseline, immediately use of AFO and 2 weeks after intervention Functional Ambulation Category,Toe Drag during walking with device baseline, immediately use of AFO and 2 weeks after intervention Toe drag will be assessed during the 10-Meter Walk Test (10MWT) ,User satisfaction 2 weeks after intervention 5-point Likert scale questionnaire,Adherence 2 weeks after intervention daily AFO usage duration (hours per day),Safety 2 weeks after intervention Falls, Near-falls, Device-related complications (e.g., skin irritation, pressure areas, or wounds)

Countries

Thailand

Contacts

Public ContactJakrapat Sawatruang

Rehabilitation department, Chonburi hospital

jakrapat2538@hotmail.com0859165056

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026