Gait, Drop FootIOPNNCT03655587
Impact of an Orthotic Intervention in Children With Peripheral Neuropathy
A study testing Solid ankle foot orthotic and Resting night splint in people with Gait, Drop Foot and Chemotherapy-induced Peripheral Neuropathy, run by Children's Hospitals and Clinics of Minnesota at 2 sites in United States.
Trial summary
This research study will investigate the effect of two orthotic (brace) devices for the ankle and foot on walking and ankle flexibility in children with cancer not involving the brain or spinal cord. Read more about this study
- Who is it for?
- Ages 5 to 14 years
- Conditions the study is for
- Gait, Drop Foot, Chemotherapy-induced Peripheral Neuropathy, Acute Lymphocytic Leukemia, Pediatric
- What is being tested?
- Solid ankle foot orthotic and Resting night splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Sep 2016to 18 May 2022
- Phase
- Interventional
- 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 5 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1)between 5-14 years of age; 2)demonstrated neuropathy as evidenced by a Ped-mTNS score>4; 3)normalized step length more than 1 standard deviation below mean for age26 ; 4)ankle DF PROM <10 degrees ; 5) able to give assent according to institutional guidelines; and 6) have parental consent to participate.
Who cannot join
- 1)lower extremity sarcomas; 2) central nervous system tumors; 3) an antecedent neurological, developmental, or genetic disorder; and 4)osteonecrosis (ON) 5)Less than antigravity dorsiflexion strength 6) neuroblastoma
Trial locations and contacts
2 sites in 1 country.
United States2 sites
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Children's Minnesota
Minneapolis, Minnesota, 55123
About this study
Official title: Impact of an Orthotic Intervention on Physical Function in Children With Chemotherapy-induced Peripheral Neuropathy
This research study will investigate the effect of two orthotic (brace) devices for the ankle and foot on walking and ankle flexibility in children with cancer not involving the brain or spinal cord.
Read the detailed description
This research study will investigate the effect of two orthotic (brace) devices for the ankle and foot on walking and ankle flexibility in children 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 impairments have been shown to continue years after treatment end, with adult survivors of cancer being less physically active than their siblings. Children, whose chemotherapy includes 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 ankle flexibility and likely contributes to decreased physical activity level and fatigue.
In our clinical practice and pilot work, we know that solid ankle orthotics can be effective in improving gait quality and ankle flexibility. However, in other areas of the country, researchers have published on the effectiveness of using a different type of brace, called a resting night splint, to improve gait and ankle function. Thus, we are studying the comparative efficacy of these two approaches.
Our published pilot study demonstrated that children with cancer were able to wear solid ankle orthotics without an impact on their safety. This study will further the research by comparing the effect of the solid ankle foot orthotic against a resting splint worn at night on walking and ankle flexibility in children with cancer.
Ankle foot orthotics improve a walking pattern by positioning the foot and ankle so that the toe can clear the floor more easily and the child can take a longer step. This decreases the energy needed for a child to walk, allowing the ability to walk longer distances or increase physical activity level. The AFO will also increase ankle flexibility by stretching the muscle while walking. If the child or adolescent walks with an increased step length, they will give a greater stretch to the calf muscles while walking. In contrast, the resting night splint can increase ankle flexibility by providing a gentle stretch to the calf muscles while sleeping, therefore allowing improved ankle movement when walking and a longer step length. We will examine the impact of these orthotics on walking, ankle flexibility, ankle strength, aerobic capacity, self-reported fatigue, as well as the ability of the children to wear the orthotic as prescribed and the severity of the damage to the nervous system.
Children and adolescents who are found to have ankle weakness, ankle tightness, and damage to their peripheral nervous system as a result of cancer treatment will be referred to the study by the treating physical therapist (PT). The PT will contact the investigators and they will invite the child or adolescent to participate in the study. Using previously established measurements in children with cancer, we will measure walking pattern, ankle strength, ankle flexibility, foot posture, level of physical activity, and level of fatigue prior to the orthotic intervention. The subject will then be randomized between an 8-week AFO or RNS intervention. The orthotic will be made with a small temperature sensor that will collect data on wearing time of the brace. After 8 weeks of orthotic wear, we will repeat the measurements and compare results between the two orthotic types.
- Conditions
- Gait, Drop Foot, Chemotherapy-induced Peripheral Neuropathy, Acute Lymphocytic Leukemia, Pediatric, Rhabdomyosarcoma, Wilms Tumor
- Being tested
- Solid ankle foot orthotic, Resting night splint
- Medical subject headings
- Gait Disorders, Neurologic, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Rhabdomyosarcoma, Wilms Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solid ankle foot orthoticDevice
Resting night splintDevice
| Study group | Role | What they receive |
|---|---|---|
| Solid ankle foot orthotic | Experimental | This is a leg brace that is made to fit the contour of the patient's foot, ankle, and lower leg. The two pull solid ankle AFO is fabricated from a rigid polypropylene outer boot and a more flexible silicone inner boot. It is commonly used in rehabilitation to improve gait in pediatric and adult populations. A certified orthotist fabricates the device. This device is lawfully marketed in the United States. It is not regulated by the FDA. Receives: Device: Solid ankle foot orthotic |
| Resting night splint | Active comparator | An ankle resting night spring (RNS) is an off-the-shelf device that provides static sagittal plane dorsiflexion. The RNS is worn nocturnally to provide maximal stretch/length to the gastrocsoleus to maintain or increase dorsiflexion ROM and/or to prevent further regressions in ankle range. It is not regulated by the FDA. Receives: Device: Resting night splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Step length
Length of the step in participant's gait measured by the gaitrite analysis system
Measured: 8 weeks
Secondary outcomes (4)
Ankle range of motion
Passive and active ankle dorsiflexion measured by goniometry
Measured: 8 weeks
Ankle strength
Ankle dorsiflexion and plantarflexion strength measured by dynamometer
Measured: 8 weeks
Gait capacity
Measured by the 6-minute walk test distance
Measured: 8 weeks
Foot posture
Measured by the foot posture index
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start20 Sep 2016
- Primary completion18 May 2022
- Study completion18 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait, Drop FootStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each group gets one of the 2 types of orthotics.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospitals and Clinics of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Pine Tree Apple Tennis Classic Foundation, St. Jude Children's Research Hospital
- Responsible party
- Sponsor
- Investigators
- Lynn Tanner, MPT, Principal investigator, Children's Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03655587
- Sponsor's protocol ID
- 1510-105
- Acronym
- IOPN
- Status last verified
- Feb 2023
- First submitted
- 30 Aug 2018
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Orthotic Intervention on Physical Function in Children With Chemotherapy-induced Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT03655587
- Acronym / sponsor ID
- IOPN / 1510-105
- Conditions
- Gait, Drop Foot, Chemotherapy-induced Peripheral Neuropathy, Acute Lymphocytic Leukemia, Pediatric, Rhabdomyosarcoma, Wilms Tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Children's Hospitals and Clinics of MinnesotaUniversity, hospital or other
- Collaborators
- Pine Tree Apple Tennis Classic Foundation, St. Jude Children's Research Hospital
- Study start
- 20 Sep 2016 (actual)
- Primary completion
- 18 May 2022 (actual)
- Study completion
- 18 May 2022 (actual)
- First posted
- 31 Aug 2018 (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 two orthotic (brace) devices for the ankle and foot on walking and ankle flexibility in children with cancer not involving the brain or spinal cord.
Detailed description
This research study will investigate the effect of two orthotic (brace) devices for the ankle and foot on walking and ankle flexibility in children 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 impairments have been shown to continue years after treatment end, with adult survivors of cancer being less physically active than their siblings. Children, whose chemotherapy includes 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 ankle flexibility and likely contributes to decreased physical activity level and fatigue.
In our clinical practice and pilot work, we know that solid ankle orthotics can be effective in improving gait quality and ankle flexibility. However, in other areas of the country, researchers have published on the effectiveness of using a different type of brace, called a resting night splint, to improve gait and ankle function. Thus, we are studying the comparative efficacy of these two approaches.
Our published pilot study demonstrated that children with cancer were able to wear solid ankle orthotics without an impact on their safety. This study will further the research by comparing the effect of the solid ankle foot orthotic against a resting splint worn at night on walking and ankle flexibility in children with cancer.
Ankle foot orthotics improve a walking pattern by positioning the foot and ankle so that the toe can clear the floor more easily and the child can take a longer step. This decreases the energy needed for a child to walk, allowing the ability to walk longer distances or increase physical activity level. The AFO will also increase ankle flexibility by stretching the muscle while walking. If the child or adolescent walks with an increased step length, they will give a greater stretch to the calf muscles while walking. In contrast, the resting night splint can increase ankle flexibility by providing a gentle stretch to the calf muscles while sleeping, therefore allowing improved ankle movement when walking and a longer step length. We will examine the impact of these orthotics on walking, ankle flexibility, ankle strength, aerobic capacity, self-reported fatigue, as well as the ability of the children to wear the orthotic as prescribed and the severity of the damage to the nervous system.
Children and adolescents who are found to have ankle weakness, ankle tightness, and damage to their peripheral nervous system as a result of cancer treatment will be referred to the study by the treating physical therapist (PT). The PT will contact the investigators and they will invite the child or adolescent to participate in the study. Using previously established measurements in children with cancer, we will measure walking pattern, ankle strength, ankle flexibility, foot posture, level of physical activity, and level of fatigue prior to the orthotic intervention. The subject will then be randomized between an 8-week AFO or RNS intervention. The orthotic will be made with a small temperature sensor that will collect data on wearing time of the brace. After 8 weeks of orthotic wear, we will repeat the measurements and compare results between the two orthotic types.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Each group gets one of the 2 types of orthotics.
| Arm | Type | Receives |
|---|---|---|
| Solid ankle foot orthotic | Experimental | Device: Solid ankle foot orthoticThis is a leg brace that is made to fit the contour of the patient's foot, ankle, and lower leg. The two pull solid ankle AFO is fabricated from a rigid polypropylene outer boot and a more flexible silicone inner boot. It is commonly used in rehabilitation to improve gait in pediatric and adult populations. A certified orthotist fabricates the device. This device is lawfully marketed in the United States. It is not regulated by the FDA. |
| Resting night splint | Active comparator | Device: Resting night splintAn ankle resting night spring (RNS) is an off-the-shelf device that provides static sagittal plane dorsiflexion. The RNS is worn nocturnally to provide maximal stretch/length to the gastrocsoleus to maintain or increase dorsiflexion ROM and/or to prevent further regressions in ankle range. It is not regulated by the FDA. |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1)between 5-14 years of age; 2)demonstrated neuropathy as evidenced by a Ped-mTNS score>4; 3)normalized step length more than 1 standard deviation below mean for age26 ; 4)ankle DF PROM <10 degrees ; 5) able to give assent according to institutional guidelines; and 6) have parental consent to participate.
Key exclusion criteria (1 listed)
- 1)lower extremity sarcomas; 2) central nervous system tumors; 3) an antecedent neurological, developmental, or genetic disorder; and 4)osteonecrosis (ON) 5)Less than antigravity dorsiflexion strength 6) neuroblastoma
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 |
|---|---|---|
| Solid ankle foot orthotic | Device | Solid ankle foot orthotic |
| Resting night splint | Device | Resting night splint |
Primary outcome
Step length
Time frame: 8 weeks
Length of the step in participant's gait measured by the gaitrite analysis system
4 secondary outcomes
Ankle range of motion
Time frame: 8 weeks
Ankle strength
Time frame: 8 weeks
Gait capacity
Time frame: 8 weeks
Foot posture
Time frame: 8 weeks
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 10 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Gait, Drop Foot
Not yet recruiting
Walking Ankle Robot for Foot Drop in Aging and Disabled Populations: A Demonstration Project
Foot Drop, Peripheral Nervous System Diseases
Not yet recruiting
Seated Ankle Robot for Foot Drop in Aging and Disabled Populations: A Demonstration Project
Peripheral Nervous System Diseases, Gait Disorders, Neurologic
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.
Lynn Tanner, MPT principal investigator
Children's Minnesota
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Solid ankle foot orthotic and Resting night splint in people with Gait, Drop Foot and Chemotherapy-induced Peripheral Neuropathy, run by Children's Hospitals and Clinics of Minnesota at 2 sites 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 1 inclusion and 1 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 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Step length (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2023; AzTrials last refreshed its copy on 7 Nov 2026.