Status:
RECRUITING
Evaluating Methods to Replicate Stumbles and Slips During Walking
Lead Sponsor:
Össur Iceland ehf
Collaborating Sponsors:
University of Iceland
Conditions:
Fall Prevention
Balance, Falls
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This protocol outlines a study designed to investigate three different methodologies for inducing gait perturbations. Subjects will be divided into two groups: prosthetic users and able-bodied indivi...
Eligibility Criteria
Inclusion
- 40 kg \< body weight \< 136kg
- Cognitive ability to understand all instructions and questionnaires in the study
- Willing and able to participate in the study and following the protocol
- Age ≥ 18 years
- Able to walk independently without the use of assistive device such as a cane or walker
- Able-bodied subjects OR Regular prosthesis users for at least 1 year with unilateral lower limb amputation at or below the transfemoral level (or equivalent level limb deficiency)
Exclusion
- Subjects with pain which can affect their mobility
- Users with socket comfort score less than 7
- Subjects with cognitive impairment
- Pregnant subjects
- Musculoskeletal disorders or neurological conditions that affect motor function, gait or balance
- Use of medications that are known to impair balance and coordination
- Any other conditions deemed by the investigator to make participation unsafe
Key Trial Info
Start Date :
May 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07175714
Start Date
May 26 2025
End Date
December 31 2025
Last Update
September 16 2025
Active Locations (2)
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1
University of Iceland
Reykjavik, Iceland, 102
2
Össur Iceland ehf.
Reykjavik, Iceland, 110