| NCT ID | NCT05644522 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shirley Ryan AbilityLab |
| Condition | Cerebrovascular Accident |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 36 participants in total. It began in 2024-03-01 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to evaluate the impact of using the Nomad powered KAFO in people who have had a musculoskeletal or neurological injury that has affected their ability to walk. The main questions it aims to answer are to quantify the effectiveness of the Nomad in improving mobility, balance, frequency of falls, and quality of life in individuals with lower-extremity impairments compared to their own brace, over three months of daily home and community use. Participants will: * Wear a sensor that records everyday activities and mobility. * Perform measures of mobility and different activities of participation using their own brace. * Perform measures of mobility and different activities of participation using the Nomad powered KAFO
Eligibility Criteria
Inclusion Criteria: * Regular and compliant use of a unilateral or bilateral KAFO or SCO or other passive KAFOs for impairment due to neurological or neuromuscular disease, orthopedic disease, or trauma * Cognitive ability to understand and follow the study protocol; willingness to provide informed consent * Willing to wear and charge an activity monitor for three-months home trials. Exclusion Criteria: * Flexion contracture in the knee and/or hip joint in excess of 15 degrees * Non-correctable knee varus/valgus in excess of 15 degrees * Severe spasticity * Inability to stabilize the trunk with or without assistive devices (crutches, canes, etc.)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05644522 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 89 Years, studying Cerebrovascular Accident. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05644522 currently recruiting?
Yes, NCT05644522 is actively recruiting participants. Contact the research team at ajayaraman@sralab.org for enrollment information.
Where is the NCT05644522 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT05644522 clinical trial?
NCT05644522 is sponsored by Shirley Ryan AbilityLab. The trial plans to enroll 36 participants.