Evaluating Methods to Replicate Stumbles and Slips During Walking
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorÖssur Iceland ehf
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Subjects with pain which can affect their mobility
Users with socket comfort score less than 7
Subjects with cognitive impairment
Pregnant subjects
Trial design
Design model
Parallel
Treatments tested in this trial
Methodologies to induce gait perturbations
Other interventionMethod 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
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Able-Bodied Individuals ArmExperimental treatment 1 intervention
Group B: Prosthetic UsersExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.2
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.3
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.4
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Össur Iceland ehf
Lead sponsor
University of Iceland
Collaborator
Source ClinicalTrials.gov