AmputationNCT07387744
Assessing Ambulatory and Non-ambulatory Community Mobility in People With Lower Limb Amputation
A study testing Clinical Descriptive Measures related to amputation collected, GPS device education/distributed and activPAL device education/distributed in people with Amputation, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
Mobility is a fundamental aspect of daily life, enabling individuals to participate in social, occupational, and recreational activities. Community mobility, defined as movement in environments outside the home, is particularly important for quality-of-life. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Amputation
- What is being tested?
- Clinical Descriptive Measures related to amputation collected, GPS device education/distributed and activPAL device education/distributed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2026to Aug 2027
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral or bilateral major lower limb amputation (e.g., proximal to or through the ankle joint)
- >6 months since LLA Fitted with a prosthetic limb
- Fitted with a prosthetic limb
- Use a wheelchair or scooter for mobility for part of a day at least once per week
Who cannot join
- Unstable heart condition (including unstable angina, uncontrolled cardiac dysrhythmia, acute myocarditis, hypertension, and acute pericarditis)
- Acute systemic infection Prisoner or institutionalized such that self-determined mobility is restricted
- Prisoner or institutionalized such that self-determined mobility is restricted
- Decisionally challenged individuals (Modified Telephone Interview for Cognitive Status score ≤24)
- Undergoing active cancer treatment
- Participating in prosthetic rehabilitation
- Clinical discretion of the principal investigator to exclude patients who are determined to be unsafe and/or inappropriate to participate in the protocol
- Inability to communicate verbally in English
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, 23298
Paul Kline, 804-828-4483, klinep@vcu.edu
Paul Kline
About this study
Mobility is a fundamental aspect of daily life, enabling individuals to participate in social, occupational, and recreational activities. Community mobility, defined as movement in environments outside the home, is particularly important for quality-of-life. Following lower limb amputation (LLA), mobility limitations are common and persistent. With rehabilitation and prosthetic training, many regain the ability to ambulate but results vary as only 25 - 58% of patients regain ambulatory ability and less than half of those who become ambulatory achieve sufficient ability to walk in community settings. As a result, ~40% of people with LLA are ambulatory but also use wheeled mobility (e.g., wheelchair, scooter) for some or all of their community mobility tasks. To date, the complementary role of wheeled and ambulatory mobility in maximizing community mobility has been overlooked, with clinical research overwhelmingly focused on assessing and improving ambulatory ability despite its impracticality for many community settings.
Read the detailed description
Poor understanding of the multiple mobility modes used by people with lower limb amputation (LLA) is a likely contributor high rates of self-reported disability, poor social engagement, and lower quality of life. Understanding mobility patterns in this population is essential for developing targeted interventions, optimizing assistive technologies, and improving overall community mobility. This study addresses three limitations in rigor of prior research on community mobility in people with LLA: 1) minimal use of objectively-monitored community mobility, 2) unknown contexts of ambulatory and wheeled mobility behaviors, 3) unclear relationship between patient and clinical factors influencing mode of community mobility.
- Conditions
- Amputation
- Being tested
- Clinical Descriptive Measures related to amputation collected, GPS device education/distributed, activPAL device education/distributed, Questionnaire Assessments completed
- Keywords
- Lower Limb Amputation (LLA), Global Positioning System (GPS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Descriptive Measures related to amputation collectedOther
On Visit 1 (baseline) Clinical measures will be collected including: Amputation level, date of amputation, amputation etiology, assistive device used and Medicare K level. The measures are intended for demographic and descriptive use.
GPS device education/distributedOther
The QStarz GPS data logger will be worn for all waking hours (from 8 am to 8 pm or beyond if awake), even on days they do not plan to leave home. The device is worn on a belt, in a pocket, or in a bag/pouch. Education on how to wear, maintain and charge the device will be provided.
activPAL device education/distributedOther
Participants will wear a thigh-mounted activPAL micro accelerometer on their non-amputated limb (or longest residual limb if bilateral amputation). The activPAL sensor is small and lightweight, secured to the thigh with a waterproof dressing, and participants are instructed to wear it at all times (including sleep) unless swimming. Education on how to wear the device will be provided.
Questionnaire Assessments completedOther
For visit #1 only, the following assessments will be completed: World Health Organization Quality of Life Brief Assessment (WHOQOL-BREF), Prosthesis Evaluation Questionnaire - Mobility subscale, Locomotor Capabilities Index, Modified telephone interview for cognitive status, Life Space Assessment, Houghton Scale, World health organization disability assessment schedule 2.0 (WHODAS) and Activities-specific balance confidence scale
| Study group | Role | What they receive |
|---|---|---|
| Lower Limb Amputation (LLA) Participants | Experimental | People with lower limb amputation will be targeted as this is the population of interest for this study. Receives: Other: Clinical Descriptive Measures related to amputation collected; Other: GPS device education/distributed; Other: activPAL device education/distributed; Other: Questionnaire Assessments completed |
What is being measured
The primary outcome is the main question the study is designed to answer.
World Health Organization Quality of Life Brief Assessment (WHOQOL-BREF)
The (WHOQOL-BREF) is a standardized assessment of an individual's perceived quality of life across physical, psychological, social, and environmental domains. The WHOQOL-BREF is a widely used, 26-item self-report questionnaire from the World Health Organization that assesses an individual's Quality of Life (QOL) across four core domains: Physical Health, Psychological Health, Social Relationships, and Environment, plus two additional items for overall QOL and health. It's a brief, cross-culturally valid tool, derived from the longer WHOQOL-100, providing reliable data for research and clinical use by asking about experiences over the past two weeks on a 5-point scale. Higher scores (closer to 100) indicate better quality of life within that domain. Not evaluating any change, just a snapshot in time at Visit 1.
Measured: Visit 1 (Baseline) only/no repeated measures
Prosthesis Evaluation Questionnaire - Mobility subscale
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 more mobility. Not evaluating any change, just a snapshot in time at Visit 1.
Measured: Visit 1 (Baseline) only/no repeated measures
Locomotor Capabilities Index
The Locomotor Capabilities Index measures a person's perceived ability to perform everyday mobility tasks using their prosthesis. The Locomotor Capabilities Index (LCI) is a validated, 14-item self-administered questionnaire used to assess the walking ability and independence of lower-limb amputees using a prosthesis. It evaluates a patient's perceived capability-what they believe they can do-rather than their actual everyday performance. The max score is 42. Not evaluating any change, just a snapshot in time at Visit 1.
Measured: Visit 1 (Baseline) only/no repeated measures
Modified telephone interview for cognitive status
The Modified telephone interview for cognitive status is a brief, 13-item structured screening of global cognitive function suitable for remote administration. It is widely used in large-scale epidemiological studies and clinical practice to differentiate between normal aging, mild cognitive impairment (MCI), and dementia. Scores on the TICS-M range from 0 to 50, with higher scores indicating better cognitive health. Not evaluating any change, just a snapshot in time at Visit 1.
Measured: Visit 1 (Baseline) only/no repeated measures
Life Space Assessment
The Life Space Assessment quantifies how far, how often, and how independently a person moves through their environment in daily life. A score of 60 or below is the standard threshold indicating restricted life-space.
Assessment calculation:
Frequency: How often did they reach this level (1 = <1x/week, 2 = 1-3x/week, 3 = 4-6x/week, 4 = daily)? Independence: Did they require help (1 = personal assistance, 1.5 = equipment only, 2
= no equipment or personal assistance)? The Composite LSA Score (0-120) is calculated by multiplying the Level (1-5) × Frequency (1-4) × Independence (1-2) for each of the five levels and summing the results.
Not evaluating any change, just a snapshot in time at Visit 1.
Measured: Visit 1 (Baseline) only/no repeated measures
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. Not evaluating any change, just a snapshot in time at Visit 1.
Measured: Visit 1 (Baseline) only/no repeated measures
World health organization disability assessment schedule 2.0 (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. Not evaluating any change, just a snapshot in time at Visit 1.
Measured: Visit 1 (Baseline) only/no repeated measures
Activities-specific balance confidence scale
The 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. Not evaluating any change, just a snapshot in time at Visit 1.
Measured: Visit 1 (Baseline) only/no repeated measures
GPS Outcomes (spatial and temporal metrics of community mobility):Total Distance Traveled (m)
On visit #1 subjects are provided with the device and education. The device will be worn 10-21 days (based on scheduling logistics). Total Distance Traveled data will be downloaded and reported in meters (m) as an aggregate mean.
Measured: Data collected visit #1 through visit #2, data collected for 10-21 days, downloaded on Visit #2
GPS Outcomes (spatial and temporal metrics of community mobility): Average movement speed (km/hr)
On visit #1 subjects are provided with the device and education. The device will be worn 10-21 days (based on scheduling logistics). Average Movement data will be downloaded and reported in (km/hr) as an aggregate mean
Measured: Data collected visit #1 through visit #2, data collected for 10-21 days, downloaded on Visit #2
GPS Outcomes (spatial and temporal metrics of community mobility): Size of movement area (km2)
On visit #1 subjects are provided with the device and education. The device will be worn 10-21 days (based on scheduling logistics). Size of movement area data will be downloaded and reported in (km2) as an aggregate mean
Measured: Data collected visit #1 through visit #2, data collected for 10-21 days, downloaded on Visit #2
GPS Outcomes (spatial and temporal metrics of community mobility): Percentage of time spent outside the home
On visit #1 subjects are provided with the device and education. The device will be worn 10-21 days (based on scheduling logistics). Percentage of time spent outside the home data will be downloaded and reported in minutes as an aggregate mean.
Measured: Data collected visit #1 through visit #2, data collected for 10-21 days, downloaded on Visit #2
GPS Outcomes (spatial and temporal metrics of community mobility): Mean and median distance from home
On visit #1 subjects are provided with the device and education. The device will be worn 10-21 days (based on scheduling logistics). Mean and median distance from home will be downloaded and reported in (m) as an aggregate mean.
Measured: Data collected visit #1 through visit #2, data collected for 10-21 days, downloaded on Visit #2
GPS Outcomes (spatial and temporal metrics of community mobility): Number of locations visited
On visit #1 subjects are provided with the device and education. The device will be worn 10-21 days (based on scheduling logistics). The number of locations visited will be downloaded and reported as a total number
Measured: Data collected visit #1 through visit #2, data collected for 10-21 days, downloaded on Visit #2
GPS Outcomes (spatial and temporal metrics of community mobility): Max distance from home (km)
On visit #1 subjects are provided with the device and education. The device will be worn 10-21 days (based on scheduling logistics). Max distance from home (km) will be downloaded and reported as an aggregate mean.
Measured: Data collected visit #1 through visit #2, data collected for 10-21 days, downloaded on Visit #2
GPS Outcomes (spatial and temporal metrics of community mobility): Frequency of out-of-home trips
On visit #1 subjects are provided with the device and education. The device will be worn 10-21 days (based on scheduling logistics). Frequency of out-of-home trips data will be downloaded and reported as an overall total number.
Measured: Data collected visit #1 through visit #2, data collected for 10-21 days, downloaded on Visit #2
GPS Outcomes (spatial and temporal metrics of community mobility): Time and distance on foot
On visit #1 subjects are provided with the device and education. The device will be worn 10-21 days (based on scheduling logistics). Time and distance on foot will be downloaded and reported as an aggregate mean
Measured: Data collected visit #1 through visit #2, data collected for 10-21 days, downloaded on Visit #2
activPAL Accelerometry: Daily duration (in minutes) of sitting, standing, and stepping
On visit #1 subjects are provided with the device and education. The device will be worn 10-21 days (based on scheduling logistics). Daily duration (in minutes) of sitting, standing, and stepping will be downloaded and reported as an aggregate mean.
Measured: Data collected visit #1 through visit #2, data collected for 10-21 days, downloaded on Visit #2
activPAL Accelerometry: Daily step count
On visit #1 subjects are provided with the device and education. The device will be worn 10-21 days (based on scheduling logistics). Daily step count data will be downloaded and reported as an aggregate mean.
Measured: Data collected visit #1 through visit #2, data collected for 10-21 days, downloaded on Visit #2
activPAL Accelerometry: Daily walking bouts stepping cadence
On visit #1 subjects are provided with the device and education. The device will be worn 10-21 days (based on scheduling logistics). The stepping cadence of daily walking bouts will be downloaded and reported as an aggregate mean.
Measured: Data collected visit #1 through visit #2, data collected for 10-21 days, downloaded on Visit #2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start21 Apr 2026
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective cohort study
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Paul Kline, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07387744
- Sponsor's protocol ID
- HM20033204
- Other IDs
- K12TR004364
- Status last verified
- Jul 2026
- First submitted
- 27 Jan 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Ambulatory and Non-ambulatory Community Mobility in People With Lower Limb Amputation
- ClinicalTrials.gov ID
- NCT07387744
- Acronym / sponsor ID
- HM20033204
- Conditions
- Amputation
- Keywords
- Lower Limb Amputation (LLA), Global Positioning System (GPS)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 21 Apr 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 4 Feb 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.
Mobility is a fundamental aspect of daily life, enabling individuals to participate in social, occupational, and recreational activities. Community mobility, defined as movement in environments outside the home, is particularly important for quality-of-life. Following lower limb amputation (LLA), mobility limitations are common and persistent. With rehabilitation and prosthetic training, many regain the ability to ambulate but results vary as only 25 - 58% of patients regain ambulatory ability and less than half of those who become ambulatory achieve sufficient ability to walk in community settings. As a result, ~40% of people with LLA are ambulatory but also use wheeled mobility (e.g., wheelchair, scooter) for some or all of their community mobility tasks. To date, the complementary role of wheeled and ambulatory mobility in maximizing community mobility has been overlooked, with clinical research overwhelmingly focused on assessing and improving ambulatory ability despite its impracticality for many community settings.
Detailed description
Poor understanding of the multiple mobility modes used by people with lower limb amputation (LLA) is a likely contributor high rates of self-reported disability, poor social engagement, and lower quality of life. Understanding mobility patterns in this population is essential for developing targeted interventions, optimizing assistive technologies, and improving overall community mobility. This study addresses three limitations in rigor of prior research on community mobility in people with LLA: 1) minimal use of objectively-monitored community mobility, 2) unknown contexts of ambulatory and wheeled mobility behaviors, 3) unclear relationship between patient and clinical factors influencing mode of community mobility.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| Lower Limb Amputation (LLA) Participants | Experimental | Other: Clinical Descriptive Measures related to amputation collected, Other: GPS device education/distributed, Other: activPAL device education/distributed, Other: Questionnaire Assessments completedPeople with lower limb amputation will be targeted as this is the population of interest for this study. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Unilateral or bilateral major lower limb amputation (e.g., proximal to or through the ankle joint)
- >6 months since LLA Fitted with a prosthetic limb
- Fitted with a prosthetic limb
- Use a wheelchair or scooter for mobility for part of a day at least once per week
Key exclusion criteria (8 listed)
- Unstable heart condition (including unstable angina, uncontrolled cardiac dysrhythmia, acute myocarditis, hypertension, and acute pericarditis)
- Acute systemic infection Prisoner or institutionalized such that self-determined mobility is restricted
- Prisoner or institutionalized such that self-determined mobility is restricted
- Decisionally challenged individuals (Modified Telephone Interview for Cognitive Status score ≤24)
- Undergoing active cancer treatment
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 |
|---|---|---|
| Clinical Descriptive Measures related to amputation collectedOn Visit 1 (baseline) Clinical measures will be collected including: Amputation level, date of amputation, amputation etiology, assistive device used and Medicare K level. The measures are intended for demographic and descriptive use. | Other | Lower Limb Amputation (LLA) Participants |
| GPS device education/distributedThe QStarz GPS data logger will be worn for all waking hours (from 8 am to 8 pm or beyond if awake), even on days they do not plan to leave home. The device is worn on a belt, in a pocket, or in a bag/pouch. Education on how to wear, maintain and charge the device will be provided. | Other | Lower Limb Amputation (LLA) Participants |
| activPAL device education/distributedParticipants will wear a thigh-mounted activPAL micro accelerometer on their non-amputated limb (or longest residual limb if bilateral amputation). The activPAL sensor is small and lightweight, secured to the thigh with a waterproof dressing, and participants are instructed to wear it at all times (including sleep) unless swimming. Education on how to wear the device will be provided. | Other | Lower Limb Amputation (LLA) Participants |
| Questionnaire Assessments completedFor visit #1 only, the following assessments will be completed: World Health Organization Quality of Life Brief Assessment (WHOQOL-BREF), Prosthesis Evaluation Questionnaire - Mobility subscale, Locomotor Capabilities Index, Modified telephone interview for cognitive status, Life Space Assessment, Houghton Scale, World health organization disability assessment schedule 2.0 (WHODAS) and Activities-specific balance confidence scale | Other | Lower Limb Amputation (LLA) Participants |
Primary outcome
World Health Organization Quality of Life Brief Assessment (WHOQOL-BREF)
Time frame: Visit 1 (Baseline) only/no repeated measures
The (WHOQOL-BREF) is a standardized assessment of an individual's perceived quality of life across physical, psychological, social, and environmental domains. The WHOQOL-BREF is a widely used, 26-item self-report questionnaire from the World Health Organization that assesses an individual's Quality of Life (QOL) across four core domains: Physical Health, Psychological Health, Social Relationships, and Environment, plus two additional items for overall QOL and health. It's a brief, cross-culturally valid tool, derived from the longer WHOQOL-100, providing reliable data for research and clinical use by asking about experiences over the past two weeks on a 5-point scale. Higher scores (closer to 100) indicate better quality of life within that domain. Not evaluating any change, just a snapshot in time at Visit 1.
Prosthesis Evaluation Questionnaire - Mobility subscale
Time frame: Visit 1 (Baseline) only/no repeated measures
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 more mobility. Not evaluating any change, just a snapshot in time at Visit 1.
Locomotor Capabilities Index
Time frame: Visit 1 (Baseline) only/no repeated measures
The Locomotor Capabilities Index measures a person's perceived ability to perform everyday mobility tasks using their prosthesis. The Locomotor Capabilities Index (LCI) is a validated, 14-item self-administered questionnaire used to assess the walking ability and independence of lower-limb amputees using a prosthesis. It evaluates a patient's perceived capability-what they believe they can do-rather than their actual everyday performance. The max score is 42. Not evaluating any change, just a snapshot in time at Visit 1.
Modified telephone interview for cognitive status
Time frame: Visit 1 (Baseline) only/no repeated measures
The Modified telephone interview for cognitive status is a brief, 13-item structured screening of global cognitive function suitable for remote administration. It is widely used in large-scale epidemiological studies and clinical practice to differentiate between normal aging, mild cognitive impairment (MCI), and dementia. Scores on the TICS-M range from 0 to 50, with higher scores indicating better cognitive health. Not evaluating any change, just a snapshot in time at Visit 1.
Life Space Assessment
Time frame: Visit 1 (Baseline) only/no repeated measures
The Life Space Assessment quantifies how far, how often, and how independently a person moves through their environment in daily life. A score of 60 or below is the standard threshold indicating restricted life-space. Assessment calculation: Frequency: How often did they reach this level (1 = <1x/week, 2 = 1-3x/week, 3 = 4-6x/week, 4 = daily)? Independence: Did they require help (1 = personal assistance, 1.5 = equipment only, 2 = no equipment or personal assistance)? The Composite LSA Score (0-120) is calculated by multiplying the Level (1-5) × Frequency (1-4) × Independence (1-2) for each of the five levels and summing the results. Not evaluating any change, just a snapshot in time at Visit 1.
Houghton Scale
Time frame: Visit 1 (Baseline) only/no repeated measures
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. Not evaluating any change, just a snapshot in time at Visit 1.
World health organization disability assessment schedule 2.0 (WHODAS)
Time frame: Visit 1 (Baseline) only/no repeated measures
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. Not evaluating any change, just a snapshot in time at Visit 1.
Activities-specific balance confidence scale
Time frame: Visit 1 (Baseline) only/no repeated measures
The 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. Not evaluating any change, just a snapshot in time at Visit 1.
GPS Outcomes (spatial and temporal metrics of community mobility):Total Distance Traveled (m)
Time frame: Data collected visit #1 through visit #2, data collected for 10-21 days, downloaded on Visit #2
On visit #1 subjects are provided with the device and education. The device will be worn 10-21 days (based on scheduling logistics). Total Distance Traveled data will be downloaded and reported in meters (m) as an aggregate mean.
GPS Outcomes (spatial and temporal metrics of community mobility): Average movement speed (km/hr)
Time frame: Data collected visit #1 through visit #2, data collected for 10-21 days, downloaded on Visit #2
On visit #1 subjects are provided with the device and education. The device will be worn 10-21 days (based on scheduling logistics). Average Movement data will be downloaded and reported in (km/hr) as an aggregate mean
GPS Outcomes (spatial and temporal metrics of community mobility): Size of movement area (km2)
Time frame: Data collected visit #1 through visit #2, data collected for 10-21 days, downloaded on Visit #2
On visit #1 subjects are provided with the device and education. The device will be worn 10-21 days (based on scheduling logistics). Size of movement area data will be downloaded and reported in (km2) as an aggregate mean
GPS Outcomes (spatial and temporal metrics of community mobility): Percentage of time spent outside the home
Time frame: Data collected visit #1 through visit #2, data collected for 10-21 days, downloaded on Visit #2
On visit #1 subjects are provided with the device and education. The device will be worn 10-21 days (based on scheduling logistics). Percentage of time spent outside the home data will be downloaded and reported in minutes as an aggregate mean.
GPS Outcomes (spatial and temporal metrics of community mobility): Mean and median distance from home
Time frame: Data collected visit #1 through visit #2, data collected for 10-21 days, downloaded on Visit #2
On visit #1 subjects are provided with the device and education. The device will be worn 10-21 days (based on scheduling logistics). Mean and median distance from home will be downloaded and reported in (m) as an aggregate mean.
GPS Outcomes (spatial and temporal metrics of community mobility): Number of locations visited
Time frame: Data collected visit #1 through visit #2, data collected for 10-21 days, downloaded on Visit #2
On visit #1 subjects are provided with the device and education. The device will be worn 10-21 days (based on scheduling logistics). The number of locations visited will be downloaded and reported as a total number
GPS Outcomes (spatial and temporal metrics of community mobility): Max distance from home (km)
Time frame: Data collected visit #1 through visit #2, data collected for 10-21 days, downloaded on Visit #2
On visit #1 subjects are provided with the device and education. The device will be worn 10-21 days (based on scheduling logistics). Max distance from home (km) will be downloaded and reported as an aggregate mean.
GPS Outcomes (spatial and temporal metrics of community mobility): Frequency of out-of-home trips
Time frame: Data collected visit #1 through visit #2, data collected for 10-21 days, downloaded on Visit #2
On visit #1 subjects are provided with the device and education. The device will be worn 10-21 days (based on scheduling logistics). Frequency of out-of-home trips data will be downloaded and reported as an overall total number.
GPS Outcomes (spatial and temporal metrics of community mobility): Time and distance on foot
Time frame: Data collected visit #1 through visit #2, data collected for 10-21 days, downloaded on Visit #2
On visit #1 subjects are provided with the device and education. The device will be worn 10-21 days (based on scheduling logistics). Time and distance on foot will be downloaded and reported as an aggregate mean
activPAL Accelerometry: Daily duration (in minutes) of sitting, standing, and stepping
Time frame: Data collected visit #1 through visit #2, data collected for 10-21 days, downloaded on Visit #2
On visit #1 subjects are provided with the device and education. The device will be worn 10-21 days (based on scheduling logistics). Daily duration (in minutes) of sitting, standing, and stepping will be downloaded and reported as an aggregate mean.
activPAL Accelerometry: Daily step count
Time frame: Data collected visit #1 through visit #2, data collected for 10-21 days, downloaded on Visit #2
On visit #1 subjects are provided with the device and education. The device will be worn 10-21 days (based on scheduling logistics). Daily step count data will be downloaded and reported as an aggregate mean.
activPAL Accelerometry: Daily walking bouts stepping cadence
Time frame: Data collected visit #1 through visit #2, data collected for 10-21 days, downloaded on Visit #2
On visit #1 subjects are provided with the device and education. The device will be worn 10-21 days (based on scheduling logistics). The stepping cadence of daily walking bouts will be downloaded and 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 27 Jul 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?
A study testing Clinical Descriptive Measures related to amputation collected, GPS device education/distributed and activPAL device education/distributed in people with 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 4 inclusion and 8 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 27 Jul 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?
World Health Organization Quality of Life Brief Assessment (WHOQOL-BREF) (time frame: Visit 1 (Baseline) only/no repeated measures). The study lists 20 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 27 Jul 2026.