Fall PreventionNCT07175714
Evaluating Methods to Replicate Stumbles and Slips During Walking
A study testing Methodologies to induce gait perturbations in people with Fall Prevention and Balance, Falls, run by Össur Iceland ehf at 2 sites in Iceland.
Trial 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 individuals. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fall Prevention, Balance, Falls, Amputation of Lower Limb
- What is being tested?
- Methodologies to induce gait perturbations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesIceland
- Study dates
- 26 May 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Iceland2 sites, 2 recruiting
- Not yet recruiting
University of Iceland
Reykjavik, 102
Kristín Briem, Doctor, +354 525 4096, kbriem@hi.is
Kristín Briem, Doctor
- Recruiting
Össur Iceland ehf.
Reykjavik, 110
Laurine Roussillon, Master, +354 822 1812, lroussillon@ossur.com
Thor Fridriksson, Doctor
About this study
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.
- Conditions
- Fall Prevention, Balance, Falls, Amputation of Lower Limb
- Being tested
- Methodologies to induce gait perturbations
- Keywords
- amputation, falls, fall prevention, balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methodologies to induce gait perturbationsOther
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
| Study group | Role | What they receive |
|---|---|---|
| Able-Bodied Individuals Arm | Experimental | Able-bodied subjects will undergo the same series of gait perturbation tests for comparison of adaptive gait responses. Receives: Other: Methodologies to induce gait perturbations |
| Prosthetic Users | Experimental | Amputee subjects will undergo a series of gait perturbation tests to evaluate adaptive responses. Receives: Other: Methodologies to induce gait perturbations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start26 May 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fall PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Össur Iceland ehf
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Iceland
- Responsible party
- Sponsor
- Investigators
- Thor Fridriksson, Doctor, Principal investigator, Össur Iceland ehf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175714
- Sponsor's protocol ID
- CIP2024100353
- Status last verified
- Sep 2025
- First submitted
- 6 Aug 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Methods to Replicate Stumbles and Slips During Walking
- ClinicalTrials.gov ID
- NCT07175714
- Acronym / sponsor ID
- CIP2024100353
- Conditions
- Fall Prevention, Balance, Falls, Amputation of Lower Limb
- Keywords
- amputation, falls, fall prevention, balance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Össur Iceland ehfIndustry (pharma, biotech, devices)
- Collaborators
- University of Iceland
- Study start
- 26 May 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Able-Bodied Individuals Arm | Experimental | Other: Methodologies to induce gait perturbationsAble-bodied subjects will undergo the same series of gait perturbation tests for comparison of adaptive gait responses. |
| Prosthetic Users | Experimental | Other: Methodologies to induce gait perturbationsAmputee subjects will undergo a series of gait perturbation tests to evaluate adaptive responses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methodologies to induce gait perturbationsMethod 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 | Other | Able-Bodied Individuals Arm, Prosthetic Users |
Primary outcome
Effectiveness of Gait Perturbation Methods in Inducing Stumble or Fall Events
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.
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.
Subjective Evaluation of Gait Perturbation Methodologies
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.
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.
Safety Perception of Gait Perturbation Methodologies
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.
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.
Unpredictability of Gait Perturbation Methodologies
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.
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.
Consistency of Gait Perturbation Incidence Rates Over Time
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thor Fridriksson, Doctor principal investigator
Össur Iceland ehf
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methodologies to induce gait perturbations in people with Fall Prevention and Balance, Falls, run by Össur Iceland ehf at 2 sites in Iceland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iceland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurine Roussillon, Master (+3548221812, lroussillon@ossur.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of Gait Perturbation Methods in Inducing Stumble or Fall Events (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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.