Lower Limb InjuryNCT06923293
Improving Walking After a Lower Limb Injury Using a Custom Motorized Orthosis
A study testing Utilization of motorized orthosis in people with Lower Limb Injury, run by Kessler Foundation at 1 site in United States.
Trial summary
The purpose of this research study is to assess the ease, convenience, and efficacy of walking when using a motor powered ankle foot orthosis (AFO) brace, in adults who have had a lower limb injury. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lower Limb Injury
- What is being tested?
- Utilization of motorized orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2025to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a lower limb injury greater than a year ago.
- Be 18-80 years old.
- Be able to stand for 30 minutes.
- Have enough range of motion in my ankle to comfortably wear the AFO.
- Be able to follow directions and commands.
- Be willing and able to give informed consent.
- Be able and willing to comply with study procedures, verbal instructions, and follow-up requirements.
Who cannot join
- Have any joint or muscle tightness that would limit my movement while walking with the AFO.
- Have any medical issue that prevents me from supporting my weight and walking (e.g. orthopedic injuries, pain, severe spasticity).
- Have any medical issues that affect my unaffected side.
- Have skin issues that would prevent wearing the device.
- Have a pre-existing condition that caused exercise intolerance. (Documented uncontrolled hypertension, coronary artery disease, abnormal heart rate or rhythm, or congestive heart failure).
- Have been hospitalized for heart attack, heart surgery or acute heart failure within 3 months of enrollment in study.
Show all 9Show fewer
- Have nervous system issues that affect my movement (for example Parkinson's disease, multiple sclerosis).
- Have additional orthopedic issues that interfere with my walking or limit my range of motion in my legs.
- Have any other medical conditions that my doctor or physical therapist feels would affect my ability to use the device.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Kessler Foundation
West Orange, New Jersey, 07052
Kate Chervin, 9733243560, kgoworek@kesslerfoundation.org
Sharon Franco, 9733243521, sfranco@kesslerfoundation.org
About this study
Official title: Individualizing Powered Orthotic Intervention for Improved Gait Outcomes Using ML-enabled Methods
The purpose of this research study is to assess the ease, convenience, and efficacy of walking when using a motor powered ankle foot orthosis (AFO) brace, in adults who have had a lower limb injury.
Read the detailed description
The long-term goal of this project is to improve the outcomes of robot-assisted exercise interventions for patients with reconstructed lower limb following high-energy lower extremity traumas using novel machine learning methods to enable individualized ankle foot orthosis (AFO) designs and self-adaptive AFO assistance.
The main hypothesis predicts greater comfort and lower pain levels when using the new AFO as well as improvements in gait mechanics, which will outperform those induced by patients' daily-use AFOs. The main goal is this adaptive assistance will encourage the wearer's active engagement in RAGT thereby promoting patient self-efficacy/satisfaction and leading to improvements in ambulation after a 6-week rehabilitation program.
- Conditions
- Lower Limb Injury
- Being tested
- Utilization of motorized orthosis
- Medical subject headings
- Leg Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Utilization of motorized orthosisDevice
While part of this study, participants will be fitted for the motorized orthosis and will complete walking tests with and without the AFO.
| Study group | Role | What they receive |
|---|---|---|
| Adults with lower limb injury | Experimental | All enrolled subjects will be asked to complete the intervention. Receives: Device: Utilization of motorized orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
10MWT (Aim 1)
10 meter walk test to evaluate walking speed after lower limb injury and in response to the intervention. Walking evaluated without versus with the motorized orthosis.
Measured: Measured before and after 6 week intervention to assess change from baseline.
TUG (Aim 1)
Timed up and go (TUG) test to measure functional balance and walking ability after lower limb injury and in response to the intervention. Walking evaluated without versus with the motorized orthosis.
Measured: Measured before and after 6 week intervention to assess change from baseline.
6MWT (Aim 1)
6 minute walking test to evaluate endurance after lower limb injury and in response to the intervention. Walking evaluated without versus with the motorized orthosis.
Measured: Measured before and after 6 week intervention to assess change from baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start1 Jun 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb InjuryStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Stevens Institute of Technology
- Responsible party
- Principal investigator, Karen J. Nolan, PhD, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06923293
- Sponsor's protocol ID
- D-1182-22
- Status last verified
- Aug 2025
- First submitted
- 2 Apr 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualizing Powered Orthotic Intervention for Improved Gait Outcomes Using ML-enabled Methods
- ClinicalTrials.gov ID
- NCT06923293
- Acronym / sponsor ID
- D-1182-22
- Conditions
- Lower Limb Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- Stevens Institute of Technology
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 11 Apr 2025 (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.
The purpose of this research study is to assess the ease, convenience, and efficacy of walking when using a motor powered ankle foot orthosis (AFO) brace, in adults who have had a lower limb injury.
Detailed description
The long-term goal of this project is to improve the outcomes of robot-assisted exercise interventions for patients with reconstructed lower limb following high-energy lower extremity traumas using novel machine learning methods to enable individualized ankle foot orthosis (AFO) designs and self-adaptive AFO assistance.
The main hypothesis predicts greater comfort and lower pain levels when using the new AFO as well as improvements in gait mechanics, which will outperform those induced by patients' daily-use AFOs. The main goal is this adaptive assistance will encourage the wearer's active engagement in RAGT thereby promoting patient self-efficacy/satisfaction and leading to improvements in ambulation after a 6-week rehabilitation program.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with lower limb injury | Experimental | Device: Utilization of motorized orthosisAll enrolled subjects will be asked to complete the intervention. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Have a lower limb injury greater than a year ago.
- Be 18-80 years old.
- Be able to stand for 30 minutes.
- Have enough range of motion in my ankle to comfortably wear the AFO.
- Be able to follow directions and commands.
Key exclusion criteria (9 listed)
- Have any joint or muscle tightness that would limit my movement while walking with the AFO.
- Have any medical issue that prevents me from supporting my weight and walking (e.g. orthopedic injuries, pain, severe spasticity).
- Have any medical issues that affect my unaffected side.
- Have skin issues that would prevent wearing the device.
- Have a pre-existing condition that caused exercise intolerance. (Documented uncontrolled hypertension, coronary artery disease, abnormal heart rate or rhythm, or congestive heart failure).
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 |
|---|---|---|
| Utilization of motorized orthosisWhile part of this study, participants will be fitted for the motorized orthosis and will complete walking tests with and without the AFO. | Device | Adults with lower limb injury |
Primary outcome
10MWT (Aim 1)
Time frame: Measured before and after 6 week intervention to assess change from baseline.
10 meter walk test to evaluate walking speed after lower limb injury and in response to the intervention. Walking evaluated without versus with the motorized orthosis.
TUG (Aim 1)
Time frame: Measured before and after 6 week intervention to assess change from baseline.
Timed up and go (TUG) test to measure functional balance and walking ability after lower limb injury and in response to the intervention. Walking evaluated without versus with the motorized orthosis.
6MWT (Aim 1)
Time frame: Measured before and after 6 week intervention to assess change from baseline.
6 minute walking test to evaluate endurance after lower limb injury and in response to the intervention. Walking evaluated without versus with the motorized orthosis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Utilization of motorized orthosis in people with Lower Limb Injury, run by Kessler Foundation 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 7 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 26 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kate Goworek (973-324-3560 ext. 3560, kgoworek@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10MWT (Aim 1) (time frame: Measured before and after 6 week intervention to assess change from baseline.). 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?
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 26 Aug 2025.