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Impact of Physical Therapy Intervention on Foot and Ankle Function

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ClinicalTrials.gov Identifier: NCT04930406
Recruitment Status : Recruiting
First Posted : June 18, 2021
Last Update Posted : June 18, 2021
Sponsor:
Information provided by (Responsible Party):
Children's Hospitals and Clinics of Minnesota

Brief Summary:
This research study will investigate the effect of physical therapy intervention on the function of the foot and ankle in children and adolescents with cancer not involving the brain or spinal cord. Children undergoing treatment for cancer can suffer from decreased flexibility, strength, balance and endurance from the cancer and from direct effects of the chemotherapy agents. These deficits have been shown to continue years after treatment end with adult survivors of cancer being less physically active then their siblings. Children, whose chemotherapy includes neurotoxic agents such as vincristine, can develop damage to their peripheral nervous system affecting the strength, sensation, and flexibility in their hands and feet. This can then lead to a change in their walking pattern and likely contributes to decreased physical activity level and fatigue. The principal investigator is currently involved in research with Dr. Laura Gilchrist and Dr. Mary C. Hooke establishing the reliability and validity of a measurement tool to quantify peripheral neuropathy, identifying physical impairments of children with cancer during treatment, and comparing physical performance in children after treatment completion with and without physical therapy intervention. The principal investigator is also completing data analysis on a pilot study investigating the use of ankle foot orthotics in children and adolescents with non-CNS cancer. In this study, the investigators will further the research by measuring the effect of physical therapy intervention on measurements involving the function and structure of the ankle and foot. The investigators will compare participants who have and have not received physical therapy intervention during cancer treatment by administering measurements detailing the function of the foot and ankle in order to further evaluate the benefit of physical therapy for children with cancer. Physical therapy intervention involving children and adolescents with cancer focuses on minimizing the physical impairments caused by chemotherapy and radiation treatment, as well as promoting normal development of motor skills typically obtained by a child in their age group. In the oncology population, physical therapy often targets the foot and ankle as this is most affected by peripheral neuropathy. Interventions include strengthening, balance training, stretching, and orthotic use to allow normal motor skills. Families are instructed in exercises that can be completed at home to further improve their function. This study will examine the difference in the function of the foot and ankle years after intervention in participants who have and have not received these interventions. The investigators will measure neuropathy, ankle flexibility, ankle strength, foot posture, gait mechanics, and endurance in order to fully examine the foot and ankle as well as evaluate relationships between the variables in long-term survivors of pediatric cancer.

Condition or disease Intervention/treatment
Neoplasms Physical Therapy Modalities Survivorship Other: Physical therapy

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Impact of Physical Therapy Intervention on Foot and Ankle Function in Children and Adolescents With Non-CNS Cancers
Actual Study Start Date : December 18, 2012
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Historical control group
Intervention group Other: Physical therapy
Had to receive 10 or more visits of physical therapy during the cancer treatment period to qualify for intervention group.




Primary Outcome Measures :
  1. Ankle range of motion [ Time Frame: One day study ]
    Active and passive ankle range of motion measured by goniometry

  2. Ankle strength [ Time Frame: One day study ]
    Ankle plantarflexion and dorsiflexion dynamometry and manual muscle testing of ankle dorsiflexion and great toe extension


Secondary Outcome Measures :
  1. Chemotherapy-induced peripheral neuropathy [ Time Frame: One day study ]
    CIPN measured by the Pediatric Modified Total Neuropathy Scale. Scores range from 0 - 32 with higher scores correlating to greater severity in neuropathy. Cut-off score for clinical neuropathy is 4.

  2. Foot posture [ Time Frame: One day study ]
    Standing hindfoot alignment

  3. Gait capacity [ Time Frame: One day study ]
    6-minute walk test

  4. Gait [ Time Frame: One day study ]
    Spatiotemporal parameters of gait measured by Gaitrite system

  5. Running speed [ Time Frame: One day study ]
    Presidential fitness shuttle run

  6. Balance [ Time Frame: One day study ]
    Bruininks-Oseretsky Test of Motor Proficiency balance subtest

  7. Faces pain scale and visual analog scale [ Time Frame: One day study ]
    Faces pain scale and visual analog scale with scores ranging from 0-10 with higher numbers indicating greater pain level.



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Ages Eligible for Study:   7 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Diagnosed with a non-CNS cancer diagnosis with chemotherapy regimen including vincristine, carboplatin, or cisplatin greater than 5 years off of cancer treatment
Criteria

Inclusion Criteria:

  • Historical control group

    • Children and adolescents age 7-30
    • English speaking family
    • Diagnosed with a non-CNS cancer diagnosis with chemotherapy regimen including vincristine, carboplatin, or cisplatin
    • Completed cancer treatment greater than 5 years ago
    • Received less than 2 intervention visits of outpatient physical therapy during cancer treatment

      -• Intervention group

    • Children and adolescents age 7-30
    • English speaking family
    • Completed cancer treatment greater than 5 years ago
    • Greater than 10 physical therapy visits at Children's Hospitals and Clinics of MN
    • Received PT evaluation within 6 months of starting cancer treatment.

Exclusion Criteria:

  • • Neurological impairments prior to cancer diagnosis

    • Developmental disorders (Downs syndrome, chromosomal disorders)
    • Non-English speaking parent/child
    • Lower extremity or pelvic surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04930406


Contacts
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Contact: Lynn R Tanner, PT 612-813-6274 lynn.tanner@childrensmn.org
Contact: Christine Hajduk, BA 612-813-6744 christine.hajduk@childrensmn.org

Locations
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United States, Minnesota
Children's Minnesota Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Lynn R Tanner, PT, MPT    612-813-6274    lynn.tanner@childrensmn.org   
Principal Investigator: Lynn R Tanner, PT, MPT         
Sub-Investigator: Laura Gilchrist, PT, PhD         
Sub-Investigator: Jessica Ovans, PT, DPT         
Sponsors and Collaborators
Children's Hospitals and Clinics of Minnesota
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Responsible Party: Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier: NCT04930406    
Other Study ID Numbers: 1210-108
First Posted: June 18, 2021    Key Record Dates
Last Update Posted: June 18, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No