NCT07090057 The Effect of Targeting the Plantaris Muscle-tendon in Surgical Correction of Ankle Equinus in Children
| NCT ID | NCT07090057 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alberta |
| Condition | Idiopathic Toe Walking |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2023-03-13 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 42 participants in total. It began in 2023-03-13 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Tight ankle muscles can produce ankle equinus (limited ability to pull the foot upward) and occur often in children, significantly impacting their ability to walk. If not treated, children with ankle equinus frequently experience reduced function and long-term foot problems, such as pain. Currently, treatment options include surgery or Botulinum toxin (BoNTA) injection into the large calf muscles that point the foot downwards, aiming to reduce their tightness. However, these treatments can be less effective over time, can create prolonged calf weakness, and may require long-term bracing. Another small muscle in the leg, the plantaris, is believed to have some contribution to equinus in many children. It is sometimes included in treatment plans for equinus but its contribution is poorly understood. It is unclear whether targeting the plantaris alone could lead to better treatment of ankle equinus. Understanding the effect of treatments targeting the plantaris could help clinicians improve the management of ankle equinus. In this study, the investigators will look at the impact of surgical treatment to the plantaris in ankle equinus. The investigators hypothesize that the plantaris is a significant contributor to equinus. In this study, data will be collected from children undergoing surgical correction of ankle equinus, including lengthening of the plantaris and lengthening of the larger muscles producing equinus (the gastrocsoleus mechanism). Children will be randomly assigned to have either their plantaris or the gastrocsoleus lengthening be done first during surgery. All children will have both structures lengthened during surgery, only the order will be varied and all surgical procedures for each patient will be completed in a single setting. In both groups, maximum passive ankle dorsiflexion (upwards bend of the ankle with the knee straight) will be measured before and after each structure is lengthened. The outcome is maximum passive ankle dorsiflexion (upwards bend of the ankle) with the knee straight. The investigators expect that maximum passive ankle dorsiflexion will increase after lengthening of the plantaris. Understanding the contribution of the plantaris muscle in ankle equinus could lead to significant improvements in the treatment of children with tight ankles.
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.
Contact & Investigator
Sukhdeep Dulai, MD, MHSc, FRCSC
PRINCIPAL INVESTIGATOR
University of Alberta
Frequently Asked Questions
Who can join the NCT07090057 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 17 Years, studying Idiopathic Toe Walking. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07090057 currently recruiting?
Yes, NCT07090057 is actively recruiting participants. Contact the research team at Ailar.Ramadi@albertahealthservices.ca for enrollment information.
Where is the NCT07090057 trial being conducted?
This trial is being conducted at Edmonton, Canada.
Who is sponsoring the NCT07090057 clinical trial?
NCT07090057 is sponsored by University of Alberta. The principal investigator is Sukhdeep Dulai, MD, MHSc, FRCSC at University of Alberta. The trial plans to enroll 42 participants.