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Effects of Ankle - Foot Orthosis - Footwear Combination Tuning on Energy Expenditure and Gait in Children with Cerebral Palsy

Effects of Ankle- Foot Orthosis -Footwear Combination Tuning on Energy Expenditure and Gait in Children with Cerebral Palsy

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260206006
Enrollment
7
Registered
2026-02-06
Start date
2026-01-12
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

Children aged 6-12 years with cerebral palsy (CP) presenting with a crouch gait pattern and classified as Gross Motor Function Classification System - Expanded and Revised (GMFCS-ER) Levels I-III. Cerebral palsy, energy expenditure, Ankle-Foot Orthosis - Footwear Combination tuning, gait

Interventions

Walking with flexible, non-supportive textile shoes simulating barefoot walking,Walking with the participants&#039
own solid ankle foot orthoses paired with flat-soled shoes with zero heel elevation,Walking with heel height adjusted using a wedge to achieve a shank-to-vertical angle of 7 degrees,Walking with heel
Flat-Shoes (Baseline Condition),Flat Ankle Foot Orthosis Footwear combination ,Tuned Ankle Foot Orthosis Footwear combination with 7 degrees degrees, Ankle Foot Orthosis Footwear combination with 7 de

Sponsors

Faculty of Medicine Siriraj Hospital Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. A diagnosis of bilateral spastic cerebral palsy (spastic diplegia). 2. Age between 6 and 12 years inclusive. 3. Presence of a crouch gait pattern. 4. The ability to understand and follow verbal instructions. 5. The capability to walk independently for at least 4 minutes continuously without rest, which typically corresponds to GMFCS Levels I, II, or III. 6. Current users of custom-made solid or ground reaction AFOs. 7. Properly fitting solid or ground reaction AFOs free from any damage.

Exclusion criteria

Exclusion criteria: 1. Presence of a flexion contracture greater than 10 degrees at the hip, knee, or both. 2. Children with underlying health conditions that may affect their ability to participate in the study. 3. Non-compliance or inability to attend all scheduled sessions of the study protocol. 4. Children with cerebral palsy who present with severe spasticity, defined as a score of 3 and above on the Modified Ashworth Scale (MAS) in the affected lower limb, will be excluded from the study. 5. History of lower limb surgery within the past 6 months.

Design outcomes

Primary

MeasureTime frame
Energy Expenditure During each intervention condition at each study visit Oxygen cost of walkingm

Secondary

MeasureTime frame
Gait performance During each intervention condition at each study visit Joint kinematic/ Measured using three-dimensional motion capture system

Countries

Thailand

Contacts

Public ContactSunday Ndomba

Sirindhorn School of Prosthetics and Orthotics, Faculty of Medicine Siriraj Hospital Mahidol University

sundayerwin.ndo@student.mahidol.ac.th0956836532

Outcome results

None listed

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