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.
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
- Conditions the study is for
- Neoplasms, Physical Therapy Modalities, Survivorship
- 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.
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.
- Conditions
- Neoplasms, Physical Therapy Modalities, Survivorship
- 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 group | Role | What they receive |
|---|---|---|
| Historical control group | Not described | |
| Intervention group | Not described Receives: Other: Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle range of motion
Active and passive ankle range of motion measured by goniometry
Measured: One day study
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)
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
Foot posture
Standing hindfoot alignment
Measured: One day study
Gait capacity
6-minute walk test
Measured: One day study
Gait
Spatiotemporal parameters of gait measured by Gaitrite system
Measured: One day study
Running speed
Presidential fitness shuttle run
Measured: One day study
Balance
Bruininks-Oseretsky Test of Motor Proficiency balance subtest
Measured: 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.
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.
- First posted18 Jun 2021
- Study start18 Dec 2012
- Primary completion13 Dec 2021
- Study completion29 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Children's Hospitals and Clinics of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Physical Therapy Intervention on Foot and Ankle Function in Children and Adolescents With Non-CNS Cancers
- ClinicalTrials.gov ID
- NCT04930406
- Acronym / sponsor ID
- 1210-108
- Conditions
- Neoplasms, Physical Therapy Modalities, Survivorship
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Children's Hospitals and Clinics of MinnesotaUniversity, hospital or other
- Study start
- 18 Dec 2012 (actual)
- Primary completion
- 13 Dec 2021 (actual)
- Study completion
- 29 Apr 2022 (actual)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Historical control group | – | – |
| Intervention group | – | Other: Physical therapy |
Who may qualify
- Ages
- 7 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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
Key inclusion criteria (12 listed)
- Historical control group
- -• Intervention group
Key exclusion criteria (4 listed)
- • Neurological impairments prior to cancer diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical therapyHad to receive 10 or more visits of physical therapy during the cancer treatment period to qualify for intervention group. | Other | Intervention group |
Primary outcome
Ankle range of motion
Time frame: One day study
Active and passive ankle range of motion measured by goniometry
Ankle strength
Time frame: One day study
Ankle plantarflexion and dorsiflexion dynamometry and manual muscle testing of ankle dorsiflexion and great toe extension
7 secondary outcomes
Chemotherapy-induced peripheral neuropathy
Time frame: One day study
Foot posture
Time frame: One day study
Gait capacity
Time frame: One day study
Gait
Time frame: One day study
Running speed
Time frame: One day study
Balance
Time frame: One day study
Faces pain scale and visual analog scale
Time frame: One day study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Derived from this study: PubMed 41915863Tanner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.