An interventional study of Methodologies to induce gait perturbations in Fall Prevention, Balance, Falls and Amputation of Lower Limb, sponsored by Össur Iceland ehf. Recruiting at 2 sites in Iceland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-13.
Sponsored by Össur Iceland ehf (part of Embla Medical hf.) · Not applicable, Interventional, and Basic science
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 individuals.
Each group will undergo a series of tests where controlled perturbations are applied using up to three methodologies with the number depending on factors such as time and fatigue. These methodologies may include mechanical, visual, or auditory perturbations designed to mimic unexpected obstacles or changes in terrain.
Össur Iceland ehf is the lead sponsor of 24 studies on the registry; 5 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.
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Exclusion Criteria:
Able-bodied subjects will undergo the same series of gait perturbation tests for comparison of adaptive gait responses.
Other: Methodologies to induce gait perturbations
Amputee subjects will undergo a series of gait perturbation tests to evaluate adaptive responses.
Other: Methodologies to induce gait perturbations
Method 1: Obstacles deployed at the frond end side of the treadmill Method 2: Obstacles deployed on the side of the treadmill Method 3: Spit-bell treadmill to induce slip perturbations Method 4: String method
Effectiveness of Gait Perturbation Methods in Inducing Stumble or Fall Events
This measure evaluates the effectiveness of various gait perturbation methodologies in successfully inducing perturbation events that result in stumbles or falls. Data will be collected on the number of perturbation events, with a particular focus on those leading to stumbles or falls. The incidence rate will be calculated as the number of perturbation events resulting in stumbles or falls per total number of perturbations. The target outcome is for at least 80% of perturbations to create an event that results in a stumble or fall. Descriptive statistics will be used to summarize the findings and assess the overall effectiveness of the perturbation methods.
Time frame: For each gait perturbation method, events are assessed during its application within a single testing session (approximately 30-60 minutes); multiple methods may be tested per session.
Subjective Evaluation of Gait Perturbation Methodologies
This measure focuses on assessing participant feedback regarding the effectiveness and realism of different gait perturbation methodologies. Participants will provide ratings based on a questionnaire, excluding safety-related questions, to capture their experiences and perceptions. The goal is for all subjects to rate the methodologies as at least neutral or safe. Descriptive statistics will be employed to analyze the ratings, offering valuable insights into user experiences and perceptions of the perturbation methods.
Time frame: Participant feedback is collected immediately after each gait perturbation method within a single testing session (approximately 30-60 minutes); multiple methods may be evaluated per session.
Safety Perception of Gait Perturbation Methodologies
This measure evaluates participants' perceptions of safety regarding the gait perturbation methodologies used in the study. Participants will provide ratings based on a specific safety question from a questionnaire. The aim is for all subjects to rate the safety of the methods as at least neutral or safe. Descriptive statistics will be used to summarize the feedback, ensuring that the perturbation methods are perceived as minimizing the risk of injury and maintaining participant safety.
Time frame: Participant feedback is collected immediately after each gait perturbation method within a single testing session (approximately 30-60 minutes); multiple methods may be evaluated per session.
Unpredictability of Gait Perturbation Methodologies
This measure assesses the extent to which gait perturbation events are unnoticed and unexpected by participants. Feedback will be collected after each perturbation event, using a yes/no question to determine whether participants anticipated the perturbation. The objective is for at least 90% of perturbations to be perceived as unnoticed and unexpected. Descriptive statistics will be utilized to analyze the data, providing insights into the effectiveness of the methodologies in creating genuinely unpredictable perturbation events.
Time frame: Participant feedback is collected immediately after each gait perturbation method within a single testing session (approximately 30-60 minutes); multiple methods may be evaluated per session.
Consistency of Gait Perturbation Incidence Rates Over Time
This measure evaluates the consistency of incidence rates for perturbation events among able-bodied subjects over time. The focus is on comparing the incidence rates of stumbles or falls from the first two perturbations to the last two perturbations. The goal is to ensure that the methodologies lead to a similar number of incidents throughout the study, with no more than a 10% difference observed between these two sets of perturbations. Descriptive statistics will be used to assess the data, ensuring stability and reliability in the perturbation methodologies across the duration of the study.
Time frame: For each gait perturbation method, events are assessed during its application within a single testing session (approximately 30-60 minutes); multiple methods may be tested per session.
Plan to share: No
No publications or documents are linked to this record.
Started May 2025 (actual). Primary completion is estimated for Dec 2026, 19 months after the start.
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