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The study closed due to poor accrual and difficulty with participant compliance.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group One | Other | 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. |
|
| Group Two | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AFO Device | Device | Ankle Foot Orthoses impact on net oxygen consumption. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Net Oxygen Consumption During the Six Minute Walk Test Among Study Participants Under the Two Walking Conditions, With and Without AFO. | Net oxygen consumption is calculated by the formula: [net oxygen consumption = walking oxygen consumption - sitting oxygen consumption], then adjusted by total mass in kg, including body mass, the mass of the socks, appropriate shoes, helmet, mouth piece system, and for the with AFO trials, the mass of the brace. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Improvement in Gait Efficiency While Using an AFO | The difference of net oxygen consumption between wearing AFO and without wearing AFO (difference = wearing AFO - without wearing AFO) will be compared between the baseline study and one month later by using repeated measures analysis in which the effect of time will be tested controlling for other confounding variables. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kirsten K Ness, PT, Ph.D | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
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| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
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Participants had a diagnosis of acute lymphoblastic leukemia and had developed foot drop during treatment for their leukemia. Randomization was to one of two reporting groups: (1) With then without AFO, and (2) Without then with AFO.
Two participants were enrolled at St. Jude Children's Research Hospital (SJCRH) between February 2010 and January 2011. The study was terminated due to poor accrual and poor participant compliance.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: With Then Without AFO | Group one participants were to complete a six minute walk test with ankle foot orthoses (AFO), and after a rest of fifteen minutes, they were to complete another six minute walk test without AFO, with similar speed to the previous test. The process was to be repeated one month later. |
| FG001 | Group 2: Without Then With AFO | Group two participants were to complete a six minute walk test without ankle foot orthoses (AFO), and after a rest of fifteen minutes, they were to complete another six minute walk test with AFO, with similar speed to the previous test. The process was to be repeated one month later. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Two participants were enrolled, however, neither participant continued to wear their ankle foot orthoses after the initial visit.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: With Then Without AFO | Group one participants were to complete a six minute walk test with ankle foot orthoses (AFO), and after a rest of fifteen minutes, they were to complete another six minute walk test without AFO, with similar speed to the previous test. The process was to be repeated one month later. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Net Oxygen Consumption During the Six Minute Walk Test Among Study Participants Under the Two Walking Conditions, With and Without AFO. | Net oxygen consumption is calculated by the formula: [net oxygen consumption = walking oxygen consumption - sitting oxygen consumption], then adjusted by total mass in kg, including body mass, the mass of the socks, appropriate shoes, helmet, mouth piece system, and for the with AFO trials, the mass of the brace. | No data was collected for analysis. Two participants were enrolled, however, neither participant agreed to wear an ankle foot orthoses. | Posted | Baseline |
|
Participants were to be monitored for possible adverse events from the time of enrollment through the six-month follow-up testing. The study terminated early, and no adverse events were experienced.
Two participants were enrolled in Group 1 (With Then Without AFO). No participants were enrolled in Group 2 (Without Then With AFO).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1: With Then Without AFO | Group one participants were to complete a six minute walk test with ankle foot orthoses (AFO), and after a rest of fifteen minutes, they were to complete another six minute walk test without AFO, with similar speed to the previous test. The process was to be repeated one month later. |
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The study was terminated due to poor accrual and poor participant compliance.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kirsten K. Ness, PT, PhD | St. Jude Children's Research Hospital | 866-966-5934 | info@stjude.org |
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| ID | Term |
|---|---|
| D020427 | Peroneal Neuropathies |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| One month after baseline evaluation |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | Number of Participants With Improvement in Gait Efficiency While Using an AFO | The difference of net oxygen consumption between wearing AFO and without wearing AFO (difference = wearing AFO - without wearing AFO) will be compared between the baseline study and one month later by using repeated measures analysis in which the effect of time will be tested controlling for other confounding variables. | No data was collected for analysis. Two participants were enrolled, however, neither participant agreed to wear an ankle foot orthoses. | Posted | One month after baseline evaluation |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Group 2: Without Then With AFO | Group two participants were to complete a six minute walk test without ankle foot orthoses (AFO), and after a rest of fifteen minutes, they were to complete another six minute walk test with AFO, with similar speed to the previous test. The process was to be repeated one month later. | 0 | 0 | 0 | 0 |
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| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |