Impact of Physical Therapy Intervention on Foot and Ankle Function

Impact of Physical Therapy Intervention on Foot and Ankle Function in Children and Adolescents With Non-CNS Cancers

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.

Study Overview

• Status: Recruiting
• Conditions: Neoplasms; Survivorship; Physical Therapy Modalities
• Intervention / Treatment: Other: Physical therapy

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Lynn R Tanner, PT; Phone Number: 612-813-6274; Email: lynn.tanner@childrensmn.org
• Study Contact Backup: Name: Christine Hajduk, BA; Phone Number: 612-813-6744; Email: christine.hajduk@childrensmn.org

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Recruiting
      • Children's Minnesota
      • Contact: Lynn R Tanner, PT, MPT; Phone Number: 612-813-6274; Email: lynn.tanner@childrensmn.org
      • Principal Investigator: Lynn R Tanner, PT, MPT
      • Sub-Investigator: Laura Gilchrist, PT, PhD
      • Sub-Investigator: Jessica Ovans, PT, DPT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 30 years (Child, Adult)
• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.
Historical control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ankle range of motion	Active and passive ankle range of motion measured by goniometry	One day study
Ankle strength	Ankle plantarflexion and dorsiflexion dynamometry and manual muscle testing of ankle dorsiflexion and great toe extension	One day study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chemotherapy-induced peripheral neuropathy	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.	One day study
Foot posture	Standing hindfoot alignment	One day study
Gait capacity	6-minute walk test	One day study
Gait	Spatiotemporal parameters of gait measured by Gaitrite system	One day study
Running speed	Presidential fitness shuttle run	One day study
Balance	Bruininks-Oseretsky Test of Motor Proficiency balance subtest	One day study
Faces pain scale and visual analog scale	Faces pain scale and visual analog scale with scores ranging from 0-10 with higher numbers indicating greater pain level.	One day study

Collaborators and Investigators

• Sponsor: Children's Hospitals and Clinics of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2012
• Primary Completion (Actual): December 13, 2021
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: April 27, 2021
• First Submitted That Met QC Criteria: June 14, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 1210-108

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No