Lower Limb AmputationNCT07831707
The Role of Visual Attention and Environmental Complexity in Real-world Mobility for People With Lower Limb Amputation
An observational study of Lower Limb Amputation, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
Despite high medical expenses (>$500K/patient), mobility improvements achieved during rehabilitation for people with lower limb amputation (LLA) fail to translate into improved real-world outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Limb Amputation
- What is being tested?
- Comprehensive assessment of walking patterns and functional mobility, Comprehensive assessment of eye movements during walking and Questionnaire Assessments completed
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2025to 31 May 2027
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: We will compare gait speed (Aim1) and gaze behavior with eye-tracking glasses (Aim 2) during vision-based (visual puzzles) and non-vision-based (serial subtraction) cognitive-motor dual-tasking while walking on low and high complexity terrain in people with LLA (n=20) and matched controls (n=10).
Who may be able to join
- unilateral transtibial LLA of either dysvascular (diabetes, peripheral vascular disease, and/or infection) or traumatic etiology
- 18 years old minimum
- able to ambulate 2 minutes without rest
- 9 months since LLA
- fitted with terminal prosthesis
- 20/60 vision or better (with or without glasses/contacts)
Who cannot join
- congenital or cancer-related LLA
- ankle-level or above LLA on the contralateral limb
- residual limb wound or contralateral foot ulcer
- unstable heart condition (including unstable angina, uncontrolled cardiac dysrhythmia, acute myocarditis, hypertension, and acute pericarditis)
- acute systemic infection
- prisoner
Show all 15Show fewer
- inability to follow a 3-step command
- concussion/brain injury in the past 12 months
- active cancer treatment
- preexisting neurological condition (i.e., multiple sclerosis, Parkinson's disease)
- participating in prosthetic rehabilitation
- color-blindness
- history of seizure(s)
- inability to read and communicate in English.
- Participants in the control group must meet the non-amputation-related criteria noted above, be within ±2 years and the same biological sex as their paired participants with LLA.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23239
Paul Kline, 804-828-4483, klinep@vcu.edu
Paul Kline
About this study
Despite high medical expenses (>$500K/patient), mobility improvements achieved during rehabilitation for people with lower limb amputation (LLA) fail to translate into improved real-world outcomes. Even with advances in prosthesis technology enabling faster gait speed, greater walking endurance, and improved mobility confidence, people with LLA report persistent dissatisfaction with real-world mobility, limited ability to walk in the community, and difficulty achieving recommended physical activity levels.
Real-world walking requires thinking and moving simultaneously (e.g., cognitive-motor dual-tasking), visually attending to the environment, and navigating varying terrain. In contrast, clinical mobility assessments are usually performed without additional visual or cognitive demands, in controlled environments, and on level surfaces. Current clinical tools used to assess ambulation progression during rehabilitation do not adequately assess these changes in people who have experienced LLA.
Read the detailed description
A step toward rectifying a critical gap in care for those with LLA by quantifying the effect of vision-based and non-vision-based cognitive-motor dual-tasking and high and low complexity terrain on gait speed and gaze behavior. Cognitive-motor dual-task assessment paradigms are well-established in other populations and often used to better approximate real-world walking demands. However, the type of cognitive task used is an important factor. The most common methods for dual-task assessment in people with LLA are limited to cognitive tasks lacking overt visual attention (e.g., serial subtraction - performing repeated subtractions from a given starting number).Although walking while performing non-vision-based cognitive tasks results in slower gait speed than single-task walking, this type of task has limited ecological validity and the observed dual-task performances have not been associated with real-world walking outcomes.
Performing vision-based cognitive-motor dual-tasks is particularly important for people with LLA. Due to lost somatosensory input from the amputated limb, the central nervous system increases dependence on visual input for sensorimotor integration. As a result, people with LLA report needing to "concentrate on every step", and affix their gaze on each subsequent step compared to 3 steps ahead like adults without LLA.
Current clinical assessments fail to detect impairments during mobility tasks requiring visual attention in complex environments. The lack of understanding of the interaction between visual attention and complex environment precludes a comprehensive mobility assessment, allows undetected impairments to persist, and limits translation of rehabilitation gains into improved real-world mobility outcomes.
- Conditions
- Lower Limb Amputation
- Being tested
- Comprehensive assessment of walking patterns and functional mobility, Comprehensive assessment of eye movements during walking, Questionnaire Assessments completed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive assessment of walking patterns and functional mobilityOther
Assessment of accelerometry: Daily duration (minutes) of sitting, standing, stepping, Daily step count, Daily walking bouts stepping cadence, Timed Up and Go and Two-minute Walk Test
Comprehensive assessment of eye movements during walkingOther
Comprehensive assessment of eye movements during walking including Target Fixation Time (seconds; %) and Number of fixations
Questionnaire Assessments completedOther
The following assessments will be completed: World health organization disability assessment schedule 2.0 (WHODAS), and Activities Specific Balance Confidence Scale.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with Lower Limb Amputation (LLA) | 20 participants with below knee amputation. Receives: Other: Comprehensive assessment of walking patterns and functional mobility; Other: Comprehensive assessment of eye movements during walking; Other: Questionnaire Assessments completed | |
| Matched Control | 10 sex- and age-matched control participants. Receives: Other: Comprehensive assessment of walking patterns and functional mobility; Other: Comprehensive assessment of eye movements during walking; Other: Questionnaire Assessments completed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Analysis-Walking Speed
Measure walking speed meters/second. Captured during dual-task and single-task walking, it is used to measure motor performance. Normal Speed: Healthy adults usually walk at 1.2 to 1.4 meters per second.Fall Risk: A speed below 1.0 meter per second shows a higher risk for falls.Frailty Warning: A speed below 0.6 to 0.8 meters per second suggests a high risk of functional decline or disability.
Measured: Visit 1 and visit 2 (which will take place 10-14 days after visit 1)
Gait Analysis-Stride Length
Measure the stride length in meters. stride length is the total distance covered during one full cycle of walking or running with the same foot. It measures the space from where one foot touches the ground to when that exact same foot touches the ground again.
Measured: Visit 1 and visit 2 (which will take place 10-14 days after visit 1)
Gait Analysis-Stride length asymmetry
Assess Stride length asymmetry is an imbalance where the distance covered by the right and left steps differs. Symmetry Index (SI): Compares spatial step metrics or temporal single-limb support times between limbs.Percentage difference: Calculated by contrasting mean left and right step values; values exceeding 10% typically indicate notable dysfunction.
Measured: Visit 1 and visit 2 (which will take place 10-14 days after visit 1)
Cognitive Task Performance Cognitive Task Performance
Accuracy (percentage correct) of each cognitive task. This reflects cognitive performance and is measured in both dual-task and single-task conditions.
Measured: Visit 1 and visit 2 (which will take place 10-14 days after visit 1)
Cognitive Task Performance
Measure Response time (milliseconds)
Measured: Visit 1 and visit 2 (which will take place 10-14 days after visit 1)
Functional Mobility (Two-minute Walk Test)
Two-minute Walk Test measures the total distance a person can walk on a flat, hard surface within two minutes. It evaluates functional mobility, submaximal endurance, and self-paced walking capacity in adults. Recorded to the nearest meter or foot using a measuring wheel, and lap count.
Measured: Visit 1 and visit 2 (which will take place 10-14 days after visit 1)
Functional Mobility (Timed Up and Go)
Timed Up and Go (TUG) test measures functional mobility, dynamic balance, and fall risk by timing how fast a person stands from a chair, walks 3 meters (10 feet), turns around, walks back, and sits down. Under 10-12 seconds: Normal, independent mobility with low fall risk.12-20 seconds: Moderate risk of falling or subtle mobility issues; requires further evaluation.Over 14-20 seconds: High risk for falls; often indicates difficulty moving outside alone or a need for assistive devices.
Measured: Visit 1
Eye Tracking (Target Fixation Time)
Target Fixation Time (seconds; %), The length of time the eye remains relatively still on a target to process detail, reflecting visual attention.
Measured: Visit 1 and visit 2 (which will take place 10-14 days after visit 1)
Eye Tracking (Number of fixations)
Number of fixations is a core metric measuring how many times a person's eyes pause and focus on a specific area or object. High Fixation Count: indicates frequent attention on an area or element. Low Fixation Count: Means an element was quickly passed over, easily understood, or ignored.
Measured: Visit 1 and visit 2 (which will take place 10-14 days after visit 1)
Patient Reported Outcomes (Houghton Scale)
The Houghton Scale assesses a person's confidence and ability in using their prosthesis safely and effectively during everyday mobility tasks. The Houghton Scale is a self-administered, 4-item questionnaire used to assess the functional use of a prosthesis by individuals with lower-limb amputations.It measures how often a patient wears their prosthesis, the types of activities they perform with it, and their perceived stability in various outdoor environments. Total scores range from 0 to 12, with higher scores indicating greater prosthesis use and independence
Measured: Visit 1
Patient Reported Outcomes (PEQ - Mobility subscale)
PEQ - Mobility subscale is the The Prosthesis Evaluation Questionnaire - Mobility subscale, captures a person's self reported ability to move and perform daily activities while using their prosthesis. It uses a 5-point ordinal scale (0-4). 0: Not able or hardly able to 4: No problem or almost fully able. The total scale ranges from 0 to 48. A higher score indicates greater mobility.
Measured: Visit 1
Patient Reported Outcomes (WHODAS)
WHODAS The World health organization disability assessment schedule 2.0 (WHODAS) evaluates how health conditions impact a person's functioning and participation across major life domains over the past 30 days. Items are rated on a 5-point Likert scale: None (0), Mild (1), Moderate (2), Severe (3), and Extreme or Cannot Do (4). While no universal "cut-off" exists, scores placing a patient in the top 10% of the population distribution-roughly >10 for the 12-item simple score or >41 for the 36-item version-likely indicate significant impairment.
Measured: Visit 1
Patient Reported Outcomes (Activities Specific Balance Confidence Scale)
Activities Specific Balance Confidence Scale is a self-report instrument used to measure an individual's confidence in maintaining balance while performing 16 various daily activities. Unlike performance-based tests, it captures the patient's perceived ability to avoid falling or becoming unsteady.Patients rate their confidence for each item on a scale from 0% (no confidence) to 100% (complete confidence). The higher the score,the higher the function and physical activity (range > 80% high function, 50% - 80% moderate function and < 50% low function.
Measured: Visit 1
Accelerometry (Daily duration of sitting, standing, stepping)
Daily duration (minutes) of sitting, standing, and stepping reported as an aggregate mean.
Measured: Between Visit 1 and 2 (which is 10-14 days after visit 1)
Accelerometry (Daily step count)
Daily step count will be measured and reported as an aggregate mean.
Measured: Between Visit 1 and 2 (which is 10-14 days after visit 1)
Accelerometry (Daily walking bouts stepping cadence)
Daily walking bouts stepping cadence will be reported as an aggregate mean
Measured: Between Visit 1 and 2 (which is 10-14 days after visit 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start25 Oct 2025
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb AmputationStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Kline, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07831707
- Sponsor's protocol ID
- HM20030568
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Visual Attention and Environmental Complexity in Real-world Mobility for People With Lower Limb Amputation
- ClinicalTrials.gov ID
- NCT07831707
- Acronym / sponsor ID
- HM20030568
- Conditions
- Lower Limb Amputation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 25 Oct 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 21 Sep 2026 (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.
Despite high medical expenses (>$500K/patient), mobility improvements achieved during rehabilitation for people with lower limb amputation (LLA) fail to translate into improved real-world outcomes. Even with advances in prosthesis technology enabling faster gait speed, greater walking endurance, and improved mobility confidence, people with LLA report persistent dissatisfaction with real-world mobility, limited ability to walk in the community, and difficulty achieving recommended physical activity levels.
Real-world walking requires thinking and moving simultaneously (e.g., cognitive-motor dual-tasking), visually attending to the environment, and navigating varying terrain. In contrast, clinical mobility assessments are usually performed without additional visual or cognitive demands, in controlled environments, and on level surfaces. Current clinical tools used to assess ambulation progression during rehabilitation do not adequately assess these changes in people who have experienced LLA.
Detailed description
A step toward rectifying a critical gap in care for those with LLA by quantifying the effect of vision-based and non-vision-based cognitive-motor dual-tasking and high and low complexity terrain on gait speed and gaze behavior. Cognitive-motor dual-task assessment paradigms are well-established in other populations and often used to better approximate real-world walking demands. However, the type of cognitive task used is an important factor. The most common methods for dual-task assessment in people with LLA are limited to cognitive tasks lacking overt visual attention (e.g., serial subtraction - performing repeated subtractions from a given starting number).Although walking while performing non-vision-based cognitive tasks results in slower gait speed than single-task walking, this type of task has limited ecological validity and the observed dual-task performances have not been associated with real-world walking outcomes.
Performing vision-based cognitive-motor dual-tasks is particularly important for people with LLA. Due to lost somatosensory input from the amputated limb, the central nervous system increases dependence on visual input for sensorimotor integration. As a result, people with LLA report needing to "concentrate on every step", and affix their gaze on each subsequent step compared to 3 steps ahead like adults without LLA.
Current clinical assessments fail to detect impairments during mobility tasks requiring visual attention in complex environments. The lack of understanding of the interaction between visual attention and complex environment precludes a comprehensive mobility assessment, allows undetected impairments to persist, and limits translation of rehabilitation gains into improved real-world mobility outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with Lower Limb Amputation (LLA) | – | Other: Comprehensive assessment of walking patterns and functional mobility, Other: Comprehensive assessment of eye movements during walking, Other: Questionnaire Assessments completed20 participants with below knee amputation. |
| Matched Control | – | Other: Comprehensive assessment of walking patterns and functional mobility, Other: Comprehensive assessment of eye movements during walking, Other: Questionnaire Assessments completed10 sex- and age-matched control participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We will compare gait speed (Aim1) and gaze behavior with eye-tracking glasses (Aim 2) during vision-based (visual puzzles) and non-vision-based (serial subtraction) cognitive-motor dual-tasking while walking on low and high complexity terrain in people with LLA (n=20) and matched controls (n=10).
Key inclusion criteria (6 listed)
- unilateral transtibial LLA of either dysvascular (diabetes, peripheral vascular disease, and/or infection) or traumatic etiology
- 18 years old minimum
- able to ambulate 2 minutes without rest
- 9 months since LLA
- fitted with terminal prosthesis
Key exclusion criteria (15 listed)
- congenital or cancer-related LLA
- ankle-level or above LLA on the contralateral limb
- residual limb wound or contralateral foot ulcer
- unstable heart condition (including unstable angina, uncontrolled cardiac dysrhythmia, acute myocarditis, hypertension, and acute pericarditis)
- acute systemic infection
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 |
|---|---|---|
| Comprehensive assessment of walking patterns and functional mobilityAssessment of accelerometry: Daily duration (minutes) of sitting, standing, stepping, Daily step count, Daily walking bouts stepping cadence, Timed Up and Go and Two-minute Walk Test | Other | Matched Control, Subjects with Lower Limb Amputation (LLA) |
| Comprehensive assessment of eye movements during walkingComprehensive assessment of eye movements during walking including Target Fixation Time (seconds; %) and Number of fixations | Other | Matched Control, Subjects with Lower Limb Amputation (LLA) |
| Questionnaire Assessments completedThe following assessments will be completed: World health organization disability assessment schedule 2.0 (WHODAS), and Activities Specific Balance Confidence Scale. | Other | Matched Control, Subjects with Lower Limb Amputation (LLA) |
Primary outcome
Gait Analysis-Walking Speed
Time frame: Visit 1 and visit 2 (which will take place 10-14 days after visit 1)
Measure walking speed meters/second. Captured during dual-task and single-task walking, it is used to measure motor performance. Normal Speed: Healthy adults usually walk at 1.2 to 1.4 meters per second.Fall Risk: A speed below 1.0 meter per second shows a higher risk for falls.Frailty Warning: A speed below 0.6 to 0.8 meters per second suggests a high risk of functional decline or disability.
Gait Analysis-Stride Length
Time frame: Visit 1 and visit 2 (which will take place 10-14 days after visit 1)
Measure the stride length in meters. stride length is the total distance covered during one full cycle of walking or running with the same foot. It measures the space from where one foot touches the ground to when that exact same foot touches the ground again.
Gait Analysis-Stride length asymmetry
Time frame: Visit 1 and visit 2 (which will take place 10-14 days after visit 1)
Assess Stride length asymmetry is an imbalance where the distance covered by the right and left steps differs. Symmetry Index (SI): Compares spatial step metrics or temporal single-limb support times between limbs.Percentage difference: Calculated by contrasting mean left and right step values; values exceeding 10% typically indicate notable dysfunction.
Cognitive Task Performance Cognitive Task Performance
Time frame: Visit 1 and visit 2 (which will take place 10-14 days after visit 1)
Accuracy (percentage correct) of each cognitive task. This reflects cognitive performance and is measured in both dual-task and single-task conditions.
Cognitive Task Performance
Time frame: Visit 1 and visit 2 (which will take place 10-14 days after visit 1)
Measure Response time (milliseconds)
Functional Mobility (Two-minute Walk Test)
Time frame: Visit 1 and visit 2 (which will take place 10-14 days after visit 1)
Two-minute Walk Test measures the total distance a person can walk on a flat, hard surface within two minutes. It evaluates functional mobility, submaximal endurance, and self-paced walking capacity in adults. Recorded to the nearest meter or foot using a measuring wheel, and lap count.
Functional Mobility (Timed Up and Go)
Time frame: Visit 1
Timed Up and Go (TUG) test measures functional mobility, dynamic balance, and fall risk by timing how fast a person stands from a chair, walks 3 meters (10 feet), turns around, walks back, and sits down. Under 10-12 seconds: Normal, independent mobility with low fall risk.12-20 seconds: Moderate risk of falling or subtle mobility issues; requires further evaluation.Over 14-20 seconds: High risk for falls; often indicates difficulty moving outside alone or a need for assistive devices.
Eye Tracking (Target Fixation Time)
Time frame: Visit 1 and visit 2 (which will take place 10-14 days after visit 1)
Target Fixation Time (seconds; %), The length of time the eye remains relatively still on a target to process detail, reflecting visual attention.
Eye Tracking (Number of fixations)
Time frame: Visit 1 and visit 2 (which will take place 10-14 days after visit 1)
Number of fixations is a core metric measuring how many times a person's eyes pause and focus on a specific area or object. High Fixation Count: indicates frequent attention on an area or element. Low Fixation Count: Means an element was quickly passed over, easily understood, or ignored.
Patient Reported Outcomes (Houghton Scale)
Time frame: Visit 1
The Houghton Scale assesses a person's confidence and ability in using their prosthesis safely and effectively during everyday mobility tasks. The Houghton Scale is a self-administered, 4-item questionnaire used to assess the functional use of a prosthesis by individuals with lower-limb amputations.It measures how often a patient wears their prosthesis, the types of activities they perform with it, and their perceived stability in various outdoor environments. Total scores range from 0 to 12, with higher scores indicating greater prosthesis use and independence
Patient Reported Outcomes (PEQ - Mobility subscale)
Time frame: Visit 1
PEQ - Mobility subscale is the The Prosthesis Evaluation Questionnaire - Mobility subscale, captures a person's self reported ability to move and perform daily activities while using their prosthesis. It uses a 5-point ordinal scale (0-4). 0: Not able or hardly able to 4: No problem or almost fully able. The total scale ranges from 0 to 48. A higher score indicates greater mobility.
Patient Reported Outcomes (WHODAS)
Time frame: Visit 1
WHODAS The World health organization disability assessment schedule 2.0 (WHODAS) evaluates how health conditions impact a person's functioning and participation across major life domains over the past 30 days. Items are rated on a 5-point Likert scale: None (0), Mild (1), Moderate (2), Severe (3), and Extreme or Cannot Do (4). While no universal "cut-off" exists, scores placing a patient in the top 10% of the population distribution-roughly >10 for the 12-item simple score or >41 for the 36-item version-likely indicate significant impairment.
Patient Reported Outcomes (Activities Specific Balance Confidence Scale)
Time frame: Visit 1
Activities Specific Balance Confidence Scale is a self-report instrument used to measure an individual's confidence in maintaining balance while performing 16 various daily activities. Unlike performance-based tests, it captures the patient's perceived ability to avoid falling or becoming unsteady.Patients rate their confidence for each item on a scale from 0% (no confidence) to 100% (complete confidence). The higher the score,the higher the function and physical activity (range > 80% high function, 50% - 80% moderate function and < 50% low function.
Accelerometry (Daily duration of sitting, standing, stepping)
Time frame: Between Visit 1 and 2 (which is 10-14 days after visit 1)
Daily duration (minutes) of sitting, standing, and stepping reported as an aggregate mean.
Accelerometry (Daily step count)
Time frame: Between Visit 1 and 2 (which is 10-14 days after visit 1)
Daily step count will be measured and reported as an aggregate mean.
Accelerometry (Daily walking bouts stepping cadence)
Time frame: Between Visit 1 and 2 (which is 10-14 days after visit 1)
Daily walking bouts stepping cadence will be reported as an aggregate mean
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 21 Sep 2026.
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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.
Paul Kline principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Limb Amputation, run by Virginia Commonwealth University at 1 site in United States.
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 15 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 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 Paul Kline (804-828-4483, klinep@vcu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait Analysis-Walking Speed (time frame: Visit 1 and visit 2 (which will take place 10-14 days after visit 1)). The study lists 16 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 21 Sep 2026.