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NeoplasmsNCT04930406

Impact of Physical Therapy Intervention on Foot and Ankle Function

An observational study of Neoplasms and Physical Therapy Modalities, run by Children's Hospitals and Clinics of Minnesota at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 7 to 30 yearsHealthy volunteers can take part
What is being tested?
Physical therapy
How many people
74 participants
Where
1 siteUnited States
Study dates
18 Dec 2012to 29 Apr 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

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

Who may be able to join

  • 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
Show all 12Show fewer
  • -• 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Children's Minnesota

    Minneapolis, Minnesota, 55404

Other trials in United States

About this study

Official title: 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.

Being tested
Physical therapy
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical therapyOther

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

Study groups in NCT04930406
Study groupRoleWhat they receive
Historical control groupNot described
Intervention groupNot described
Receives: Other: Physical therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ankle range of motion

    Active and passive ankle range of motion measured by goniometry

    Measured: One day study

  2. Ankle strength

    Ankle plantarflexion and dorsiflexion dynamometry and manual muscle testing of ankle dorsiflexion and great toe extension

    Measured: One day study

Secondary outcomes (7)
  1. 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.

    Measured: One day study

  2. Foot posture

    Standing hindfoot alignment

    Measured: One day study

  3. Gait capacity

    6-minute walk test

    Measured: One day study

  4. Gait

    Spatiotemporal parameters of gait measured by Gaitrite system

    Measured: One day study

  5. Running speed

    Presidential fitness shuttle run

    Measured: One day study

  6. Balance

    Bruininks-Oseretsky Test of Motor Proficiency balance subtest

    Measured: One day study

  7. 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.

    Measured: One day study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2021
  2. Study start18 Dec 2012
  3. Primary completion13 Dec 2021
  4. Study completion29 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04930406
Sponsor's protocol ID
1210-108
Status last verified
Nov 2026
First submitted
27 Apr 2021
Last updated
5 Nov 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Tanner LR, Wacker KI, Ovans JA, Gilchrist LS. The Sustained Impact of Physical Therapy on Physical Function in Long-Term Survivors of Pediatric Cancer. Pediatr Phys Ther. 2026 Apr 1;38(2):287-294. doi: 10.1097/PEP.0000000000001295. Epub 2026 Mar 31.

    PubMed 41915863

Questions about this trial

What is this clinical trial studying?

An observational study of Neoplasms and Physical Therapy Modalities, run by Children's Hospitals and Clinics of Minnesota at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ankle range of motion (time frame: One day study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04930406, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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