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The Effects of Ankle Foot Orthoses on Gait Efficiency in Children With Acute Lymphoblastic Leukemia and Foot Drop


N/A
6 Years
18 Years
Not Enrolling
Both
Foot Drop, Acute Lymphoblastic Leukemia

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Trial Information

The Effects of Ankle Foot Orthoses on Gait Efficiency in Children With Acute Lymphoblastic Leukemia and Foot Drop


1. This study will determine the impact of Ankle Foot Orthoses (AFO) wear on gait
efficiency in children with ALL and Chemotherapy-Induced Peripheral Neuropathy (CIPN).

2. The study hypothesizes that children with CIPN will have lower net oxygen consumption
during the six minute walk test while wearing AFO as compared to their net oxygen
consumption during a six minute walk test while not wearing AFO.

3. The study will assess whether gait efficiency while using an AFO persists after one
month of use.

4. The study will hypothesize that the benefits of AFO use on gait efficiency persist
after one month of wear.


Inclusion Criteria:



1. Research participant is diagnosed with childhood ALL and currently being treated on
the TOTAL XVI protocol at 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Primary outcome of this study will analyze the net oxygen consumption during the six minute walk test among study participants under the two walking conditions, with and without AFO.

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Kirsten K Ness, PT, Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Institutional Review Board

Study ID:

GAIT09

NCT ID:

NCT01001390

Start Date:

October 2009

Completion Date:

December 2013

Related Keywords:

  • Foot Drop
  • Acute Lymphoblastic Leukemia
  • Acute Lymphoblastic leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Peroneal Neuropathies

Name

Location
St. Jude Children's Research Hospital Memphis, Tennessee  38105-2794