NCT07338162

Brief Summary

This study aimed to evaluate the effectiveness of serial casting as a modality of management of lower limb deformities in patients with spastic cerebral palsy (equinous - equinovarus).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 3, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

1.3 years

First QC Date

January 3, 2026

Last Update Submit

January 3, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluation of ankle range of motion

    Ankle range of motion was assessed.

    3 months after the procedure

Secondary Outcomes (4)

  • Tone of the calf muscle

    3 months after the procedure

  • Detection of ankle kinematics during gait

    3 months after the procedure

  • Incidence of true equinous in patients with spastic cerebral palsy

    3 months after the procedure

  • Modified Ashworth Scale (MAS) score

    3 months after the procedure

Study Arms (2)

Group A

ACTIVE COMPARATOR

Children with spastic cerebral palsy who is subjected to a selected physical therapy program once a day/3 times a week for three successive weeks mainly consisted of stretching and strengthening exercises, weight bearing, balance, proprioception, and ambulation training.

Other: Physical therapy program

Group B

EXPERIMENTAL

Children with spastic cerebral palsy who is additionally subjected to three consecutive casts applied for five days each and will be removed in the last two days in each week to conduct the same selected physical therapy program.

Other: Three consecutive casts + Physical therapy program

Interventions

Children with spastic cerebral palsy who is subjected to a selected physical therapy program once a day/3 times a week for three successive weeks mainly consisted of stretching and strengthening exercises, weight bearing, balance, proprioception, and ambulation training.

Group A

Children with spastic cerebral palsy who is additionally subjected to three consecutive casts applied for five days each and will be removed in the last two days in each week to conduct the same selected physical therapy program.

Group B

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients from 3 to 12 years old.
  • Both sex.
  • Spastic cerebral palsy patients with true equinous.
  • Modified Ashworth Scale score of 2 or 3 in the plantar flexor muscle complex.
  • Gross Motor Functional Classification System Level I, II \& III.

You may not qualify if:

  • Patients with bony joint limitation.
  • Previous surgeries (tendon lengthening).
  • Patients received Botulinum toxin A injections in the last six months.
  • Patients with apparent equinus as a compensation for knee or hip flexion while dorsiflexion range is preserved at the lower extremity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 12613, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopaedic Surgery specialist at Al-Helal Hospital, Egypt.

Study Record Dates

First Submitted

January 3, 2026

First Posted

January 13, 2026

Study Start

October 1, 2022

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

January 13, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations