NCT04930406

Impact of Physical Therapy Intervention on Foot and Ankle Function

Status unknown Last updated 20 February 2024

What this trial tests

trial testing Physical therapy in Neoplasms in 80 participants. Status unknown.

Timeline

18 December 2012

Primary endpoint
13 December 2021

31 December 2024

Quick facts

Lead sponsor	Children's Hospitals and Clinics of Minnesota
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	80
Start date	18 December 2012
Primary completion	13 December 2021
Estimated completion	31 December 2024
Sites	1 location across United States

Drugs / interventions tested

• Physical therapy

Conditions studied

• Neoplasms — all drugs for Neoplasms →
• Physical Therapy Modalities — all drugs for Physical Therapy Modalities →
• Survivorship — all drugs for Survivorship →

Sponsor

Children's Hospitals and Clinics of Minnesota

Who can join

Adults 7 to 30, any sex, with Neoplasms or Physical Therapy Modalities. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.