Impact of Physical Therapy Intervention on Foot and Ankle Function

NCT04930406 | Recruiting

• 1 other identifier: 1210-108
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasms; Physical Therapy Modalities; Survivorship

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Chemotherapy-induced peripheral neuropathy

  One day study

• Foot posture

  One day study

• Gait capacity

  One day study

• Gait

  One day study

• Running speed

  One day study

Study Arms (2)

Historical control group

Intervention group

Other: Physical therapy

Interventions

Physical therapy OTHER

Had to receive 10 or more visits of physical therapy during the cancer treatment period to qualify for intervention group.

Intervention group

Eligibility Criteria

• Age: 7 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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.

You may not qualify if:

• Neurological impairments prior to cancer diagnosis
• Developmental disorders (Downs syndrome, chromosomal disorders)
• Non-English speaking parent/child
• Lower extremity or pelvic surgery

Sponsors & Collaborators

• Children's Hospitals and Clinics of Minnesota: lead

Study Sites (1)

Children's Minnesota

Minneapolis, Minnesota, 55404, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Central Study Contacts

Lynn R Tanner, PT

CONTACT

612-813-6274; lynn.tanner@childrensmn.org

Christine Hajduk, BA

CONTACT

612-813-6744; christine.hajduk@childrensmn.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: June 18, 2021
• Study Start: December 18, 2012
• Primary Completion: December 13, 2021
• Study Completion: December 31, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

US (1)