Clinical trial · Interventional
The Effects of Ankle Foot Orthoses on Gait Efficiency in Children With Acute Lymphoblastic Leukemia and Foot Drop
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study closed due to poor accrual and difficulty with participant compliance.
Summary
Brief summary (as posted)
This study is designed to see if children with acute lymphoblastic leukemia who have developed foot drop during treatment for their leukemia consume less oxygen when walking with or without an ankle brace designed to support their foot during walking. In this study children with foot drop are asked to walk for six minutes with and without brace on their ankle. During each walk, the amount of oxygen used is measured. The child wears a face mask which is attached to a device that records how much oxygen they use. The amount of oxygen used during the walk with the brace on will be compared to the amount of oxygen used with the brace off.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Foot Drop | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AFO Device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Group One
- description
- Group one will take a six minute walk test with AFO device, and after a rest of fifteen minutes, they will take another six minute walk test without AFO, with similar speed to the previous test.
- interventionNames
- Device: AFO Device
- type
- OTHER
- label
- Group Two
- description
- Group two will take a six minute walk test without AFO device, and after a rest of fifteen minutes, they will take another six minute walk test with AFO, with similar speed to the previous test.
- interventionNames
- Device: AFO Device
Primary outcomes (1)
- measure
- Net Oxygen Consumption During the Six Minute Walk Test Among Study Participants Under the Two Walking Conditions, With and Without AFO.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Research participant is diagnosed with childhood ALL and currently being treated on the TOTAL XVI protocol at St. Jude Children's Research Hospital (SJCRH) 2. Research participant is from 6 to 18 years of age at the time of the scheduled evaluation 3. Research participant has chemotherapy-induced peripheral neuropathy resulting in foot drop 4. Research participant will be receiving AFO 5. Research participant has a hemoglobin level greater than 8 g/dL and a platelet count above 50 x 109/L Exclusion Criteria: 1. Participant has Down Syndrome or other known congenital developmental delays 2. Participant has a platelet count lower than 50 x 109/L and a hemoglobin level less than 8 g/dL 3. Participant has a lower extremity amputation, congenital deformity of the lower limb or an acute fracture of the lower limb 4. Participant has symptomatic osteonecrosis in the lower extremities
References
Publications (0)
Data not yet available