Improving Walking After a Lower Limb Injury Using a Custom Motorized Orthosis

This study is testing a motorized orthosis (a brace that helps with movement) to see if it can improve walking for adults who have had a lower limb injury more than a year ago. Researchers want to understand if using this motorized orthosis makes walking easier and more comfortable, and if it improves how people walk. To join, you need to be between 18 and 80 years old, able to stand for 30 minutes, and have enough ankle movement to wear the brace. The study aims to enroll 19 participants. Success will be measured by changes in walking tests, like how far you can walk in a certain time, before and after using the orthosis for 6 weeks. The current recruitment status is unclear.

Study design: This is an interventional study with a planned enrollment of 19 participants. It is not specified if it is randomized or blinded.
What's involved: You will be fitted for the motorized orthosis and complete walking tests with and without the brace. The intervention period is 6 weeks.
Compensation: Not stated in the trial record.
Follow-up: Walking ability will be measured before and after the 6-week intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Improving Walking After a Lower Limb Injury Using a Custom Motorized Orthosis

Recruiting

NAAges 18–80InterventionalTreatment

Kessler Foundation

~19 participants

Updated 2025-08-26 on ClinicalTrials.gov

What's tested:Utilization of motorized orthosis

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

10MWT (Aim 1)

Measured over Measured before and after 6 week intervention to assess change from baseline.

+2 more outcomes measured

Conditions

Lower Limb Injury

NCT06923293

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

Kessler Foundation
West Orange, New Jerseystudy coordinator listed
Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Kate Goworek

[email protected]

973-324-3560 · ext. 3560

Email the study team

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Eligibility criteria

Inclusion

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.

Exclusion

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.

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.

What this trial measures

10MWT (Aim 1)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)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)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.

Trialytics