day versus day-night use ankle-foot orthoses in young children with spastic diplegia

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-11001581

Enrollment

Unknown

Registered

2011-09-13

Start date

2009-01-01

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

Cerebral Palsy

Interventions

A:used the AFOs in day time for 6 to 12 hours and removed at night

B:used the AFOs both day time and night time for near 24h

Eligibility

Sex/Gender

All

Age

1 Years to 4 Years

Inclusion criteria

Inclusion criteria: 1. between 1 and 4 years of age; 2. a diagnosis of spastic diplegic CP affecting both lower limbs; 3. ability to walk independently, with or without an assistive device, for short distances (Gross Motor Function Classification System [GMFCS] levels I–II.).

Exclusion criteria

Exclusion criteria: 1. unstable seizures; 2. any orthopedic surgery for spasticity within the preceding 6 months; 3. botulinum toxin injections within the preceding 3 months and suffering from any other diseases that interfered with physical activity; 4. existence of serious cognitive disabilities that hindered communication or cooperation.

Design outcomes

Primary

Measure	Time frame
88 item Gross Motor Function Measuremant;	—

Secondary

Measure	Time frame
root mean square of sEMG;Measurements of passive ankle dorsiflexion;	—

Countries

China

Contacts

Public ContactXiaoke Zhao

toky@live.com+86 13851771689

Outcome results

None listed

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