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Comparison of the effect of Hinged AFOs with and without vibration on gait and function in children with spastic hemiplegic cerebral palsy

Comparison of the effect of Hinged AFOs with and without vibration on gait and daily function in children with spastic hemiplegic cerebral palsy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200915048725N2
Enrollment
24
Registered
2021-08-01
Start date
2021-07-10
Completion date
Unknown
Last updated
2021-08-30

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

Conditions

Spastic hemiplegic cerebral palsy. Spastic hemiplegic cerebral palsy

Interventions

Intervention 1: The orthosis designed for the intervention group is a hinged AFO. Based on the ability of each participant to control the knee joint, range of motion of the ankle joint in the directio

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 12 Years

Inclusion criteria

Inclusion criteria: Children with spastic hemiplegic cerebral palsy aged 4 to 12 years AFO prescribed by a medical specialist or therapist GMFCS level I to III The child is able to stand independently At least 2 weeks have passed since the previous lower limb orthosis was received At least six months have passed since the last Botox injection in the lower extremities spasticity grade based on Ashworth scale (2 and 3)

Exclusion criteria

Exclusion criteria: Any injuries or wounds at the orthosis site

Design outcomes

Primary

MeasureTime frame
Ankle joint kinematic. Timepoint: Before the intervention and one month after. Method of measurement: Three-dimensional motion analysis.;Knee joint kinematic. Timepoint: Before the intervention and one month after the intervention. Method of measurement: Three-dimensional motion analysis.;Hip joint kinematic. Timepoint: Before the intervention and one month after the intervention. Method of measurement: Three-dimensional motion analysis.;Stride length. Timepoint: Before the intervention and one month after the intervention. Method of measurement: Three-dimensional motion analysis.;Step width. Timepoint: Before the intervention and one month after the intervention. Method of measurement: Three-dimensional motion analysis.;Function. Timepoint: Before the intervention and one month after the intervention and two weeks after weaning of the orthosis. Method of measurement: PEDI questionnaire.;?Speed of walking. Timepoint: Before the intervention and one month after the intervention. Method of measurement: 120 / step length × cadence.;Cadence. Timepoint: Before the intervention and one month after the intervention. Method of measurement: Number of steps per second.;Duration of a complete walking cycle. Timepoint: Before the intervention and one month after the intervention. Method of measurement: According to each participant's gait pattern, the initial contact is detected based on kinematic data and the time interval between two successive initial contacts will be measured.;Spasticity of the gastrosoleus muscles. Timepoint: Before the intervention and one month after the intervention and two weeks after weaning the orthosis. Method of measurement: Ashworth Scale.;Satisfaction. Timepoint: Before the intervention and one month after the intervention. Method of measurement: OPUS Satisfaction Questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Jalali

Iran University of Medical Sciences

jalali.m@iums.ac.ir+98 21 2222 0947

Outcome results

None listed

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