Limb DeficienciesNCT05230004
Innovative Prosthetic Systems for Pediatric Limb Loss to Accommodate Growth
A study testing iFIT prosthesis in people with Limb Deficiencies and Pediatric ALL, run by University of Pennsylvania at 1 site in United States.
Trial summary
An immediate fit adjustable prosthetic system is being investigated for children. The age range being recruited is from 3 years up to 18 years old. Phase I of this study will involve developing a final prototype by conducting in-lab testing on children with limb loss. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Limb Deficiencies, Pediatric ALL
- What is being tested?
- iFIT prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2022to 2 Jun 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Four months post-amputation
- Subjects who have lost a limb due to any cause: trauma, congenital limb loss, dysvascular causes (peripheral vascular disease and diabetes), or malignancy will all be eligible for inclusion.
- Intact, protective sensation in their residual limbs.
Who cannot join
- open skin lesions
- excessive pain in the residual limb (phantom pain, residual limb pain, or neuroma)
- neurological disorders (e.g., stroke, severe polyneuropathy) causing weakness in the contralateral leg or marked gait impairment
- inability to follow instructions for trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn Medicine Rittenhouse
Philadelphia, Pennsylvania, 19146
About this study
An immediate fit adjustable prosthetic system is being investigated for children. The age range being recruited is from 3 years up to 18 years old. Phase I of this study will involve developing a final prototype by conducting in-lab testing on children with limb loss. Phase II will involve a two month home trial to further evaluate the comfort and usability of the socket. Outcome measures include a PEQ-based questionnaire, socket pressure measures and gait analysis.
Read the detailed description
Design Phase I is a testing session to obtain feedback on initial prototype designs for the immediate fit prostheses. This research will focus on PI observations and participant feedback through survey and comments during the in-person testing. There may be multiple appointments for participants during this time the device design is refined. In-lab testing only will occur. This information will influence the overall design of the final prosthesis.
PHASE I: For Phase I children with lower limb limb loss (below the knee or above the knee) age 3-12 are being recruited. Subjects should be able to ambulate with or without assistive devices. They will supply measurements and limb images prior to the appointment.
During the initial appointment, each participant will be consented and completed roughly 2-3 hours of device testing. The participant will be fit with an adjustable prosthetic by the PI. After ambulating in the lab, they will give feedback on the comfort, stability and ease of use of the prosthesis. Participants may be asked to return several times for future testing sessions once changes or alterations are made to the prosthesis design to see if these have been effective. The child and their parent will fill out a PEQ based questionnaire on their conventional prosthesis and the investigational device after fitting.
Phase II: We will be recruiting children ages 3-18 with lower limb loss to be with an adjustable prosthesis and wear it for a 2 month home trial. Children may be recruited at other locations such as the Children's Hospital of Philadelphia and Ai./duPont Nemours in Delaware. The child and their parent will fill out questionnaires on their current prosthesis as well as have pressure data and a gait analysis completed. Once they have worn the prosthesis for 2 months they will return and complete these same outcome measures.
Gait biomechanical analysis: This analysis will be conducted by having several reflective markers placed on the participant's lower body. The subject will then walk a minimum of 6 times along a 10meter walkway while being recorded by the motion analysis system. This will be conducted in both the adjustable and conventional prosthesis.
Internal pressure measurements of the socket using Fujifilm pressure paper will also be obtained. Five spots will be assessed by placing the paper on the participant's liner and then they will put on their socket and walk for 1 minute. This will be completed on both the test and conventional socket.
- Conditions
- Limb Deficiencies, Pediatric ALL
- Being tested
- iFIT prosthesis
- Keywords
- prosthesis, limb deficiency, limb loss, pediatric
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iFIT prosthesisDevice
An adjustable modular prosthesis that can be fit in a single session. Fully adjustable by wearer.
| Study group | Role | What they receive |
|---|---|---|
| Phase II | Experimental | Phase II involves a two month home trial to determine the comfort and utility of an adjustable prosthetic system for children. Children will be fit at several different locations by their prosthetist with the adjustable socket. They will complete several questionnaires on their current device, as well as have internal socket pressures and a gait analysis completed. They will return one month later to complete the same outcome measures on their conventional device. They will also be given activity monitors to track their activity through the duration of the project. Receives: Device: iFIT prosthesis |
| Phase I | Experimental | Phase I involves developing a final design for an adjustable, immediate fit prosthesis. We will recruit 5-10 participants age 3-12 to complete in-lab testing and evaluation of several designs. This testing will lead to the final product design to be tested in Phase II. Receives: Device: iFIT prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Prosthetic Evaluation Questionnaire
12 questions selected from the Prosthetic Evaluation Questionnaire were used to rate the prosthesis on comfort, stability, and utility. The questions featured a rating scale from 1-poor to 5-excellent. The range for scores is 12 to 60 total points. Higher scores are considered better.
Measured: Phase II: 2 months; Phase I: 1 day (approximately 2-3 hours)
Internal Socket Peak Overall Pressure
Fujifilm pressure paper will be taped to the participant's liner on five different locations. They will don their socket and walk for approximately 2 minutes at a self-selected walking speed to assess internal socket pressures. The pressures from the five sites are averaged to obtain one overall peak internal socket pressure.
Measured: Phase II: 2 months; Phase I: 1 day (approximately 2-3 hours)
Average Gait Speed
Participants will walk at a self-selected walking speed while being recorded by 3d motional analysis cameras. They will walk across a 10 meter runway six times in their conventional socket and six times in the test socket to determine average walking speed.
Measured: Phase II: 2 months; Phase I: 1 day (approximately 2-3 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start18 Aug 2022
- Primary completion7 Mar 2025
- Study completion2 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Limb DeficienciesStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia
- Responsible party
- Principal investigator, Timothy Dillingham, University of Pennsylvania
- Investigators
- Timothy R Dillingham, MS,MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05230004
- Sponsor's protocol ID
- 849980
- Status last verified
- Jun 2026
- First submitted
- 13 Jan 2022
- Last updated
- 2 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McCloskey C, Kenia J, Shofer F, Marschalek J, Dillingham T. Improved Self-Reported Comfort, Stability, and Limb Temperature Regulation with an Immediate Fit, Adjustable Transtibial Prosthesis. Arch Rehabil Res Clin Transl. 2020 Dec;2(4):100090. doi: 10.1016/j.arrct.2020.100090. Epub 2020 Nov 2.
PubMed 33381750Kenia J, Wolf B, Marschalek J, Dillingham T. An Immediate Fit, Adjustable, Modular Prosthetic System for Addressing World-Wide Limb Loss Disability. Arch Rehabil Res Clin Transl. 2021 Mar 15;3(2):100120. doi: 10.1016/j.arrct.2021.100120. eCollection 2021 Jun.
PubMed 34179756
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Prosthetic Systems for Pediatric Limb Loss to Accommodate Growth
- ClinicalTrials.gov ID
- NCT05230004
- Acronym / sponsor ID
- 849980
- Conditions
- Limb Deficiencies, Pediatric ALL
- Keywords
- prosthesis, limb deficiency, limb loss, pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia
- Study start
- 18 Aug 2022 (actual)
- Primary completion
- 7 Mar 2025 (actual)
- Study completion
- 2 Jun 2026 (actual)
- First posted
- 8 Feb 2022 (actual)
- Results
- Posted 2 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An immediate fit adjustable prosthetic system is being investigated for children. The age range being recruited is from 3 years up to 18 years old. Phase I of this study will involve developing a final prototype by conducting in-lab testing on children with limb loss. Phase II will involve a two month home trial to further evaluate the comfort and usability of the socket. Outcome measures include a PEQ-based questionnaire, socket pressure measures and gait analysis.
Detailed description
Design Phase I is a testing session to obtain feedback on initial prototype designs for the immediate fit prostheses. This research will focus on PI observations and participant feedback through survey and comments during the in-person testing. There may be multiple appointments for participants during this time the device design is refined. In-lab testing only will occur. This information will influence the overall design of the final prosthesis.
PHASE I: For Phase I children with lower limb limb loss (below the knee or above the knee) age 3-12 are being recruited. Subjects should be able to ambulate with or without assistive devices. They will supply measurements and limb images prior to the appointment.
During the initial appointment, each participant will be consented and completed roughly 2-3 hours of device testing. The participant will be fit with an adjustable prosthetic by the PI. After ambulating in the lab, they will give feedback on the comfort, stability and ease of use of the prosthesis. Participants may be asked to return several times for future testing sessions once changes or alterations are made to the prosthesis design to see if these have been effective. The child and their parent will fill out a PEQ based questionnaire on their conventional prosthesis and the investigational device after fitting.
Phase II: We will be recruiting children ages 3-18 with lower limb loss to be with an adjustable prosthesis and wear it for a 2 month home trial. Children may be recruited at other locations such as the Children's Hospital of Philadelphia and Ai./duPont Nemours in Delaware. The child and their parent will fill out questionnaires on their current prosthesis as well as have pressure data and a gait analysis completed. Once they have worn the prosthesis for 2 months they will return and complete these same outcome measures.
Gait biomechanical analysis: This analysis will be conducted by having several reflective markers placed on the participant's lower body. The subject will then walk a minimum of 6 times along a 10meter walkway while being recorded by the motion analysis system. This will be conducted in both the adjustable and conventional prosthesis.
Internal pressure measurements of the socket using Fujifilm pressure paper will also be obtained. Five spots will be assessed by placing the paper on the participant's liner and then they will put on their socket and walk for 1 minute. This will be completed on both the test and conventional socket.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase II | Experimental | Device: iFIT prosthesisPhase II involves a two month home trial to determine the comfort and utility of an adjustable prosthetic system for children. Children will be fit at several different locations by their prosthetist with the adjustable socket. They will complete several questionnaires on their current device, as well as have internal socket pressures and a gait analysis completed. They will return one month later to complete the same outcome measures on their conventional device. They will also be given activity monitors to track their activity through the duration of the project. |
| Phase I | Experimental | Device: iFIT prosthesisPhase I involves developing a final design for an adjustable, immediate fit prosthesis. We will recruit 5-10 participants age 3-12 to complete in-lab testing and evaluation of several designs. This testing will lead to the final product design to be tested in Phase II. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Four months post-amputation
- Subjects who have lost a limb due to any cause: trauma, congenital limb loss, dysvascular causes (peripheral vascular disease and diabetes), or malignancy will all be eligible for inclusion.
- Intact, protective sensation in their residual limbs.
Key exclusion criteria (4 listed)
- open skin lesions
- excessive pain in the residual limb (phantom pain, residual limb pain, or neuroma)
- neurological disorders (e.g., stroke, severe polyneuropathy) causing weakness in the contralateral leg or marked gait impairment
- inability to follow instructions for trial
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 |
|---|---|---|
| iFIT prosthesisAn adjustable modular prosthesis that can be fit in a single session. Fully adjustable by wearer. | Device | Phase I, Phase II |
Primary outcome
Modified Prosthetic Evaluation Questionnaire
Time frame: Phase II: 2 months; Phase I: 1 day (approximately 2-3 hours)
12 questions selected from the Prosthetic Evaluation Questionnaire were used to rate the prosthesis on comfort, stability, and utility. The questions featured a rating scale from 1-poor to 5-excellent. The range for scores is 12 to 60 total points. Higher scores are considered better.
Internal Socket Peak Overall Pressure
Time frame: Phase II: 2 months; Phase I: 1 day (approximately 2-3 hours)
Fujifilm pressure paper will be taped to the participant's liner on five different locations. They will don their socket and walk for approximately 2 minutes at a self-selected walking speed to assess internal socket pressures. The pressures from the five sites are averaged to obtain one overall peak internal socket pressure.
Average Gait Speed
Time frame: Phase II: 2 months; Phase I: 1 day (approximately 2-3 hours)
Participants will walk at a self-selected walking speed while being recorded by 3d motional analysis cameras. They will walk across a 10 meter runway six times in their conventional socket and six times in the test socket to determine average walking speed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33381750McCloskey C, Kenia J, Shofer F, Marschalek J, Dillingham T. Improved Self-Reported Comfort, Stability, and Limb Temperature Regulation with an Immediate Fit, Adjustable Transtibial Prosthesis. Arch Rehabil Res Clin Transl. 2020 Dec;2(4):100090. doi: 10.1016/j.arrct.2020.100090. Epub 2020 Nov 2.
- Background: PubMed 34179756Kenia J, Wolf B, Marschalek J, Dillingham T. An Immediate Fit, Adjustable, Modular Prosthetic System for Addressing World-Wide Limb Loss Disability. Arch Rehabil Res Clin Transl. 2021 Mar 15;3(2):100120. doi: 10.1016/j.arrct.2021.100120. eCollection 2021 Jun.
- This is the website for the adult adjustable prosthetic systemLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Limb Deficiencies
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Not yet recruiting
PhiCube for Bilateral Upper Limb Neuromotor and Cognitive Rehabilitation in Adults
Stroke, Parkinson Disease
Not yet recruiting
Auto-calibrating System for Upper Limb Disability Assessment, Neurological and Occupational Rehabilitation
Stroke, Amyotrophic Lateral Sclerosis
Active, not recruiting
Single-stage Surgery With Antibiotic-loaded Hydrogel Coated Implants Versus Two Stage Surgery for Secondary Prevention of Complex Chronic Periprosthetic Hip Joint Infection
Hip Prosthesis Infection
Enrolling by invitationObservational study
Development and Validation of the FBIndex to Determine the Risk of Falls for Patients With Neuromuscular Disorders
Inclusion Body Myositis, Myotonic Dystrophy
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.
Timothy R Dillingham, MS,MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iFIT prosthesis in people with Limb Deficiencies and Pediatric ALL, run by University of Pennsylvania 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 3 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 2 Jul 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?
Yes. Results are posted in the registry (first posted 2 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Modified Prosthetic Evaluation Questionnaire (time frame: Phase II: 2 months; Phase I: 1 day (approximately 2-3 hours)). The study lists 3 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 NCT05230004, which also lists 2 linked publications.
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 2 Jul 2026.