Stroke Trial, Recruiting NCT06234124 Sponsor: Shirley Ryan AbilityLab Condition: Stroke
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Stroke Trial, Recruiting

NCT06234124
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are at least 3 months past having a stroke
  • People aged 18 or older
  • People who have been prescribed a leg brace (called an AFO) or who a doctor has identified as a possible candidate for one
  • People who are able to walk at least 10 metres, with or without a walking aid such as a cane or walker
  • People whose doctor has confirmed they are medically stable and cleared for participation
  • People whose medications are not expected to change for at least 3 months
  • People who have enough ankle stability while standing
  • People who are able to hear a clicking sound made by the study shoe
  • People who have received approval from their doctor
  • People who are able to give informed consent to participate
  • People who can sit without support and follow a simple three-step instruction
  • People with no unhealed bone or joint injuries in the arms or legs, and no history of severe back pain
  • People who speak English
  • People who are willing to follow an exercise program using both devices for at least 30 minutes a day, at least 5 days a week, for the full 6-month program

Who may not be able to join:

  • People who had a history of falling more than once a week before their stroke
  • People whose walking speed (at their own comfortable pace) is faster than 1.2 metres per second
  • People who would be unable to use the devices safely and who do not have a caregiver available to assist them
  • People with severe obesity, defined as a body mass index (BMI) over 40 (confirm with trial site)
  • People with serious pre-existing heart conditions, a history of heart attack, heart failure, a demand pacemaker, seizures, severe nerve pain, or serious leg problems that would interfere with wearing the study shoe
  • People with severe difficulties with thinking or communication
  • People who are pregnant (assessed by self-report)
  • People with other health conditions that could interfere with the study, such as significant arthritis, joint problems, a history of back injury, nerve or muscle disorders, or epilepsy
  • People with severe osteoporosis (assessed by self-report)
  • People who are currently incarcerated
  • People who are currently receiving Botox injections to the lower legs

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 16 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Arun H Jayaraman, DPT, PhD, Shirley Ryan AbilityLab

Phone: 312-238-8425

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Shirley Ryan AbilityLab
Registry
ClinicalTrials.gov
Start date
3 April 2024
Est. completion
1 January 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Walking Speed (Device Off)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov