Skip to content

New personalized 3D printed Ankle Foot Orthosis on gait deficiencies in stroke patients: A Pilot Study

New personalized 3D printed Ankle Foot Orthosis on gait deficiencies in stroke patients: A Pilot Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800019196
Enrollment
Unknown
Registered
2018-10-30
Start date
2018-11-01
Completion date
Unknown
Last updated
2018-11-05

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

Conditions

stroke

Interventions

Group A:3D printed ankle foot orthosis
Group B:traditional ankle foot orthosis

Sponsors

Zhujiang Hospital, Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosis of stroke with gait deficiencies; 2. a single unilateral ischemic or hemorrhagic supratentorial stroke leading to hemiparesis; 3. Ashworth scale score of less than 2; 4. To be able to maintain independent unsupported stance with or without an AFO for at least 90s; 5. To be able to walk for a least 10 meters with or without an assistive device; 6. a need for a AFO device for ambulation (based on evaluation by the clinic team); 7. ability to follow simple verbal instructions; 8. at least 18 years of age.

Exclusion criteria

Exclusion criteria: 1. a history of other significant neurologic or orthopedic disorders; 2. significant coronal plane deformity or plantar flexion contracture; 3. fluctuation edema of the hemiplegic low extremities; 4. several weakness of low extremities requiring a knee-ankle-foot orthosis; 5. subjects suffering from severe comprehensive aphasia or hemispatial neglect; 6. subjects using medication or with non-stroke related disorders that could affect balance.

Design outcomes

Primary

MeasureTime frame
spatiotemporal gait variable;Root mean square values;

Secondary

MeasureTime frame
Berg balance scale;Timed up and Go test;Modified Rivermead mobility index;10-m walking test;

Countries

China

Contacts

Public ContactGuozhi Huang

Zhujiang Hospital, Southern Medical University

drhuang66@163.com+86 18666087186

Outcome results

None listed

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