Recruiting

Motor Powered AFO

Sponsor:

Kessler Foundation

Code:

NCT06923293

Conditions

Lower Limb Injury

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Utilization of motorized orthosis

Study Details

Brief 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.

Conditions

Lower Limb Injury

Study ID

NCT06923293

Start date

Jun 1, 2025

Status verified date

Aug, 2025

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

19 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Adults with lower limb injury

All enrolled subjects will be asked to complete the intervention.

Interventions

Utilization of motorized orthosis

While part of this study, participants will be fitted for the motorized orthosis and will complete walking tests with and without the AFO.

Primary outcome measure

  • 10MWT (Aim 1) [ Time Frame: Measured before and after 6 week intervention to assess change from baseline. ]
  • TUG (Aim 1) [ Time Frame: Measured before and after 6 week intervention to assess change from baseline. ]
  • 6MWT (Aim 1) [ Time Frame: Measured before and after 6 week intervention to assess change from baseline. ]

Central Contacts and Locations

Central contacts

Kate Goworek

973-324-3560kgoworek@kesslerfoundation.org

Locations

Kessler Foundation

Recruiting

West Orange, New Jersey, United States, 07052

Contacts

Kate Chervin

9733243560kgoworek@kesslerfoundation.org

Sharon Franco

9733243521sfranco@kesslerfoundation.org

Principal Investigator:

Karen J Nolan

More Information

Sponsor

Kessler Foundation

Last update posted

Aug 26, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2025-08-26.