Effect of Ankle Foot Orthosis in spastic gait dosrders

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00038693

Enrollment

Registered

2025-12-15

Start date

2026-01-15

Completion date

Unknown

Last updated

2026-01-12

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

Conditions

Spasticity, Ankle Foot Orthosis, Cerebral Palsy

Interventions

Group 1: All participants will receive their AFOs as part of standard clinical care provided by the Department of Technical Orthopedics at the University Hospital Heidelberg.

Eligibility

Sex/Gender

All

Age

6 Years to 16 Years

Inclusion criteria

Inclusion criteria: Children and adolescents aged 6 to 16 years Diagnosis of a clinically confirmed spasticity in lower extremities Prescribed an ankle-foot orthosis (AFO as part of their standard clinical care) Adequate cognitive, psychological, and physical capacity to comply with study procedures Consent: Written informed consent provided (for minors, parental or legal guardian consent is required)

Exclusion criteria

Exclusion criteria: Received botulinum toxin injections within the past 3 months Had orthopedic surgery involving the lower limbs in the past 12 months Present with cognitive or behavioral impairments that would prevent understanding instructions or participating reliably in assessments Unable or unwilling to comply with the study procedures

Design outcomes

Primary

Measure	Time frame
The primary outcomes of study will be effcts of Ankle Foot Orthosis (AFOs) on 3D gait analysis outcomes including gait kinematics, kintetics and spatitemporal parameters collected from two sessions (T1: a few days after reciveing the AFOs and T2 almost 3 months after T1). the data will be collected from two condition of barefoot walking and walking with AFOs in Gait lab of Heidelberg University Hospital.	—

Measure

Time frame

The primary outcomes of study will be effcts of Ankle Foot Orthosis (AFOs) on 3D gait analysis outcomes including gait kinematics, kintetics and spatitemporal parameters collected from two sessions (T1: a few days after reciveing the AFOs and T2 almost 3 months after T1). the data will be collected from two condition of barefoot walking and walking with AFOs in Gait lab of Heidelberg University Hospital.

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Secondary

Measure	Time frame
The secondry outcomes will be effects of AFOs on functional mobility tests (2 Minute Walk Test and L-Test),.Questionnaire-based evaluation, using the QUEST (Quebec User Evaluation of Satisfaction with Assistive Technology) to assess user satisfaction with the assigned assistive device, and the EQ-5D-3L (European Quality of Life, 5 Dimensions, 3-Level version) to assess quality of life. Also the wearing time of the orthosis over a 3-month period using tempreture sensors.	—

Measure

Time frame

The secondry outcomes will be effects of AFOs on functional mobility tests (2 Minute Walk Test and L-Test),.Questionnaire-based evaluation, using the QUEST (Quebec User Evaluation of Satisfaction with Assistive Technology) to assess user satisfaction with the assigned assistive device, and the EQ-5D-3L (European Quality of Life, 5 Dimensions, 3-Level version) to assess quality of life. Also the wearing time of the orthosis over a 3-month period using tempreture sensors.

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Countries

Germany

Contacts

Public ContactSebastian Wolf

Heildelberg University Hospital

Sebastian.Wolf@med.uni-heidelberg.de+49 6221 56-26724

Outcome results

None listed

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