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CompletedNCT04930406Updated Nov 5, 2026

Impact of Physical Therapy Intervention on Foot and Ankle Function

An observational study in Neoplasms, Physical Therapy Modalities and Survivorship, sponsored by Children's Hospitals and Clinics of Minnesota. Completed at 1 site in United States. Open to participants aged 7 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by Children's Hospitals and Clinics of Minnesota · Observational

Updated Nov 5, 2026Now CompletedStudy completion moved+1 moreGo to Updates ↓
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
74
Ages
7 Years to 30 Years
Sex
All
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Study 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.

02

Conditions studied

  • Neoplasms
  • Physical Therapy Modalities
  • Survivorship

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03

In context

Neoplasms

10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.

This study's enrollment of 74 is below the median of 200 across 2,638 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Children's Hospitals and Clinics of Minnesota is the lead sponsor of 49 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
7 Years to 30 Years
Sexes eligible
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

    • Neurological impairments prior to cancer diagnosis

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

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
74 participants (actual)
Patient registry
No

Groups and cohorts

  • Historical control group
  • Intervention group

    Other: Physical therapy

Interventions

  • OtherPhysical therapy

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

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What researchers measure

Primary outcomes

  1. Ankle range of motion

    Active and passive ankle range of motion measured by goniometry

    Time frame: One day study

  2. Ankle strength

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

    Time frame: One day study

Secondary outcomes

  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.

    Time frame: One day study

  2. Foot posture

    Standing hindfoot alignment

    Time frame: One day study

  3. Gait capacity

    6-minute walk test

    Time frame: One day study

  4. Gait

    Spatiotemporal parameters of gait measured by Gaitrite system

    Time frame: One day study

  5. Running speed

    Presidential fitness shuttle run

    Time frame: One day study

  6. Balance

    Bruininks-Oseretsky Test of Motor Proficiency balance subtest

    Time frame: 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.

    Time frame: One day study

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Study locations

1 site
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References and documents

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 ↗
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Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Ran from Dec 2012 to primary completion in Dec 2021, 107 months.

Completion moved once since we started tracking on Sep 25, 2026: Dec 2024 → Apr 2022, on Nov 5, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Apr 27, 2021
First posted
Jun 18, 2021
StartActual
Dec 18, 2012
Primary completionActual
Dec 13, 2021
CompletionActual
Apr 29, 2022was Dec 2024
Last update
Nov 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Completed
changed Nov 5, 2026
Study completion
Dec 31, 2024→Apr 29, 2022 (actual)
Nov 5, 2026
Enrollment
80 (estimated)→74 (actual)
Nov 5, 2026
Publications
1 publication citing this study linked from PubMed, e.g. PubMed 41915863 ↗
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    Recruiting→Completed
    Publications 1 publication citing this study linked from PubMed, e.g. PubMed 41915863 ↗
    Study completion Dec 31, 2024→Apr 29, 2022 (now actual)
    Enrollment 80 (estimated)→74 (actual)
    + 4 other changes: verification date, contact details, site details and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT04930406
Lead sponsor
Children's Hospitals and Clinics of Minnesota
Responsible party
Sponsor
First posted
Jun 18, 2021
Start date
Dec 18, 2012
Primary completion
Dec 13, 2021
Completion
Apr 29, 2022
Last update
Nov 5, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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