Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-24 @ 7:02 PM
NCT ID:
NCT07090057
Eligibility Criteria:
Inclusion Criteria (All of the following criteria must be met):
* Ability to provided informed consent/assent in English.
* Pediatric patients (4-17 years) who have consented for surgery for the management of equinus contracture \* (either TA lengthening or GN recession) at the Stollery Children's Hospital
* Known underlying diagnosis of any of the following: idiopathic toe walking, cerebral palsy, hereditary spastic paraparesis, traumatic brain injury, spinal cord injury/tethering, hereditary sensory-motor neuropathy, stroke
* Ability to maintain hindfoot and midfoot neutral during assessment
* Passive plantarflexion on affected side greater than 20° and greater than degree of equinus contracture.
* Note: may be isolated or in conjunction with other orthopaedic procedures; in bilateral ankle equinus procedures, data will be collected bilaterally, but included as a single participant (i.e., single randomization).
Exclusion Criteria (Any one or more of the following):
* Unable to provide informed consent/assent in English.
* Previous surgery for equinus
* Limb deficiency on affected side
* Knee flexion contracture of greater than 5°
* Surgical intervention of the lower extremities below the affected knee in the last twelve months
* BoNTA injections below the affected knee within the last six months
* Known or suspected arthrofibrosis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
17 Years
Study:
NCT07090057
Study Brief:
Protocol Section:
NCT07090057