Amputation, Lower LimbCSNCT06987019
Reliability and Validity of Continuous Inter-limb Stability
A study testing 3D motion capture, wearable devices, and functional outcome measures in people with Amputation, Lower Limb, run by VA Office of Research and Development at 1 site in United States.
Trial summary
To date, there is no valid and reliable measure of continuous inter-limb stability available to healthcare teams treating people with lower limb loss. Determining these characteristics of this parameter for this population is important because superior stability has been linked to increased physical activity and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation, Lower Limb
- What is being tested?
- 3D motion capture, wearable devices, and functional outcome measures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to 31 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any individual with unilateral transtibial limb loss
- A well-fitting prosthesis (as determined by a board-certified prosthetist through standardized prosthetic guidelines) for a minimum of one month
- Able to achieve a "Level 6 - Modified Independence" score on the Functional Independence Measure (FIM) for 2 mobility items (locomotion and transfers)
Who cannot join
- Individuals with active wounds/ulcers or significant musculoskeletal comorbidities on their intact limb that would impair ability to participate in biomechanical evaluations
- Any comorbidity that results in rapid limb volume changes (i.e., end stage renal disease with dialysis)
- A poorly fitting socket
- Cognitive deficit(s) or mental pathology (e.g., dementia, amnesia) that would prevent the participant from understanding and following directions and limit the participant's ability to participate fully in the study
- Women who are pregnant or who plan to become pregnant during their participation in study activities
- Functional Independence Measure (FIM) scores less than Level 6 for locomotion and transfers
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
VA NY Harbor Healthcare System, New York, NY
New York, New York, 10010-5011
Alexis Sidiropoulos, PhD, (212) 686-7500, alexis.sidiropoulos@va.gov
Alexis Sidiropoulos, PhD
About this study
Official title: Reliability and Validity of Continuous Inter-Limb Stability in Veterans With Lower Limb Loss
To date, there is no valid and reliable measure of continuous inter-limb stability available to healthcare teams treating people with lower limb loss. Determining these characteristics of this parameter for this population is important because superior stability has been linked to increased physical activity and strength in similar populations, making it a potential vital contributor to mobility improvement of Veterans with limb loss. It is also crucial that healthcare providers can easily measure continuous stability in the clinic instead of relying on expensive laboratory equipment. The overall goals of this study are to determine the reliability and validity of continuous inter-limb stability of Veterans with lower limb loss and determine if this parameter can be captured using accessible wearable technology. Consequently, clinicians can improve continuous stability through proper rehabilitation to positively impact the functional mobility and overall quality of life of Veterans with lower limb loss.
Read the detailed description
There is currently no valid or reliable biomechanical variable available to objectively measure the continuous stability of Veterans with lower limb loss. However, continuous inter-limb stability represents a potential target to improve whole-body dynamics, as it is an important measure of functional mobility in individuals with lower limb loss. Determining the reliability and validity of this measure is critical for limb loss care teams since these features are fundamental to interpretability and assessment of this parameter. Unlike traditional clinical assessments of stability that focus on the time of task execution, Relative Phase (RP) analysis, which is a novel methodology that can be used to evaluate continuous stability, uses both space and time within one outcome variable. While previous literature supports the use of continuous stability for mobility challenged populations, such as individuals with limb loss, it has yet to be shown reliable and valid for such populations. Therefore, the first aim of this study is to identify the reliability and validity of continuous inter-limb stability in individuals with transtibial limb loss (TLL) using RP analysis. For this parameter to be used clinically, it is vital to provide rehabilitation specialists the ability to assess continuous stability within the clinical setting. To date, this factor of functional mobility has only been evaluated using 3-dimensional (3-D) motion capture, which is costly and inaccessible to most rehabilitation clinics. Therefore, the second aim of this study is to identify the strength of the association between wearable technology (using inertial measurement units) and 3-D motion capture system for evaluation of continuous interlimb stability of individuals with TLL. The central hypothesis is that continuous stability evaluated using RP analysis will be a reliable and valid measure of functional mobility for Veterans with TLL and that data captured via wearable technology will be strongly associated with 3-D analysis. Twenty Veterans with TLL will be recruited and enrolled via the Prosthetic or Physical Medicine Departments at Veterans Affairs New York Harbor Healthcare System, where all data collection will occur. To measure test re-test reliability, participants will undergo 3 sessions of 3-D gait analysis while walking at a moderate speed (1.3m/s) until 15 walking cycles are captured, with 1 day between sessions. RP analysis will be used to identify the continuous inter-limb stability of gait patterns. Participants will be fit with wearable technology and data will be collected concurrently. To measure convergent validity, participants will perform functional outcome measures including the Timed Up and Go test, 6 Minute Walk Test, Hill and Stair Assessment Indexes, and Amputee Mobility Predictor. Data from 40 participants are required to appropriately power the analysis of convergent validity. To achieve this power, data from 20 participants collected during a previously funded Department of Defense study will be leveraged and added to the data of the 20 participants collected during the proposed study. This is possible due to identical data collection techniques in both studies. To assess the level of agreement between the data obtained from the 3 sessions, Intraclass Correlation Coefficients will be calculated for each variable, in addition to Cohen's kappa statistics and Pearson correlation coefficients. To assess convergent validity, Pearson and Spearman rank correlation coefficients will quantify the strength and direction of the relationships between the outcome measures and continuous stability. Substantiating the use of continuous stability in Veterans with TLL will afford healthcare providers information necessary to accurately detect and appropriately address stability deficiencies, which is critical since superior stability is linked to increased physical activity leading to an enhanced overall quality of life of Veterans with limb loss. Verifying the reliability and validity of this parameter will lead to its confident application for future studies focused on effectiveness, optimization, and rehabilitation.
- Conditions
- Amputation, Lower Limb
- Being tested
- 3D motion capture, wearable devices, and functional outcome measures
- Keywords
- Transtibial amputation, Gait evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D motion capture, wearable devices, and functional outcome measuresOther
Gait evaluation, Hill and Stair Assessment Indices, 6 minute walk test, AMPPro, Timed Up and Go
| Study group | Role | What they receive |
|---|---|---|
| Reliability and Validity | Experimental | Reliability and Validity of Inter-limb Stability using 3D motion capture, functional outcome measures, and wearable devices Receives: Other: 3D motion capture, wearable devices, and functional outcome measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability of Continuous Inter-limb Stability
Reliability will be evaluated using Deviation Phase using Relative Phase Analysis. Deviation Phase measures the continuous stability of two oscillating segments throughout a cyclical movement. Relative Phase Analysis is a dynamical systems based methodology that is used to calculated the continuous stability of a movement, such as walking. Deviation Phase ranges from 0-180 degrees, with a lower value indicating better organization of the neuromuscular system.
Measured: 3 times at visits 2-4 (once per visit) (will occur within 1 week)
Convergent Validity of Continuous Inter-limb Stability - TUG
The TUG measures physical mobility in individuals with lower limb loss. This measures the time it takes for an individual to stand up from a standard arm chair, walk a distance of 10 feet, turn, walk back to the chair, and sit down. This is measured in time (seconds).
Measured: Once at visit 2 of 4 (Baseline)
Convergent Validity of Continuous Inter-limb Stability - 6MWT
The 6MWT measure function and endurance. This test measures the distance an individual can walk in 6 minutes without help. This is measured in meters.
Measured: Once at visit 2 of 4 (Baseline)
Convergent Validity of Continuous Inter-limb Stability - SAI
The SAI is a graded qualitative scale on how an individual with lower limb amputation negotiates up and down a staircase. This is measured on a scale of 0-13.
Measured: Once at visit 2 of 4 (Baseline)
Convergent Validity of Continuous Inter-limb Stability - HAI
The HAI is a graded qualitative scale on how an individual with lower limb amputation negotiates up and down a ramp. This is measured on a scale from 0-11.
Measured: Once at visit 2 of 4 (Baseline)
Convergent Validity of Continuous Inter-limb Stability - AMPPro
The AMPPro is a 21 item instrument designed to measure basic prosthetic mobility of individuals with lower extremity amputation. This is scored from 0-47.
Measured: Once at visit 2 of 4 (Baseline)
Secondary outcomes (1)
Strength of association between wearable technology and 3D motion capture to measure inter-limb stability
Correlation between IMUs and Motion Capture. Xsens IMUs consist of 3 measurement sensor categories: accelerometer, gyroscope, and magnetometer, with measurements of all 3 axes. The accelerometer provides linear acceleration of the deice. The Gyroscope measures the angular rate and is then integrated to determine the angle of the sensor. The magnetometer detects magnetic field, use as an external reference frame. The 3 signals combine to produce a sensor coordinate system, while the signal variety eliminates drift effects commonly found in gyroscopic measurements.
Measured: 3 times at visits 2-4 (once per visit) (will occur within 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start1 Apr 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amputation, Lower LimbStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Alexis Sidiropoulos, PhD, Principal investigator, VA NY Harbor Healthcare System, New York, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06987019
- Sponsor's protocol ID
- A5147-P
- Other IDs
- 1I21RX005147-01A1
- Acronym
- CS
- Status last verified
- Sep 2026
- First submitted
- 11 Apr 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be stored in a curated data repository that makes the data underlying scientific publications discoverable, freely usable, and citable, while promoting openly available research integrated with scholarly literature.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of Continuous Inter-Limb Stability in Veterans With Lower Limb Loss
- ClinicalTrials.gov ID
- NCT06987019
- Acronym / sponsor ID
- CS / A5147-P
- Conditions
- Amputation, Lower Limb
- Keywords
- Transtibial amputation, Gait evaluation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 May 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.
To date, there is no valid and reliable measure of continuous inter-limb stability available to healthcare teams treating people with lower limb loss. Determining these characteristics of this parameter for this population is important because superior stability has been linked to increased physical activity and strength in similar populations, making it a potential vital contributor to mobility improvement of Veterans with limb loss. It is also crucial that healthcare providers can easily measure continuous stability in the clinic instead of relying on expensive laboratory equipment. The overall goals of this study are to determine the reliability and validity of continuous inter-limb stability of Veterans with lower limb loss and determine if this parameter can be captured using accessible wearable technology. Consequently, clinicians can improve continuous stability through proper rehabilitation to positively impact the functional mobility and overall quality of life of Veterans with lower limb loss.
Detailed description
There is currently no valid or reliable biomechanical variable available to objectively measure the continuous stability of Veterans with lower limb loss. However, continuous inter-limb stability represents a potential target to improve whole-body dynamics, as it is an important measure of functional mobility in individuals with lower limb loss. Determining the reliability and validity of this measure is critical for limb loss care teams since these features are fundamental to interpretability and assessment of this parameter. Unlike traditional clinical assessments of stability that focus on the time of task execution, Relative Phase (RP) analysis, which is a novel methodology that can be used to evaluate continuous stability, uses both space and time within one outcome variable. While previous literature supports the use of continuous stability for mobility challenged populations, such as individuals with limb loss, it has yet to be shown reliable and valid for such populations. Therefore, the first aim of this study is to identify the reliability and validity of continuous inter-limb stability in individuals with transtibial limb loss (TLL) using RP analysis. For this parameter to be used clinically, it is vital to provide rehabilitation specialists the ability to assess continuous stability within the clinical setting. To date, this factor of functional mobility has only been evaluated using 3-dimensional (3-D) motion capture, which is costly and inaccessible to most rehabilitation clinics. Therefore, the second aim of this study is to identify the strength of the association between wearable technology (using inertial measurement units) and 3-D motion capture system for evaluation of continuous interlimb stability of individuals with TLL. The central hypothesis is that continuous stability evaluated using RP analysis will be a reliable and valid measure of functional mobility for Veterans with TLL and that data captured via wearable technology will be strongly associated with 3-D analysis. Twenty Veterans with TLL will be recruited and enrolled via the Prosthetic or Physical Medicine Departments at Veterans Affairs New York Harbor Healthcare System, where all data collection will occur. To measure test re-test reliability, participants will undergo 3 sessions of 3-D gait analysis while walking at a moderate speed (1.3m/s) until 15 walking cycles are captured, with 1 day between sessions. RP analysis will be used to identify the continuous inter-limb stability of gait patterns. Participants will be fit with wearable technology and data will be collected concurrently. To measure convergent validity, participants will perform functional outcome measures including the Timed Up and Go test, 6 Minute Walk Test, Hill and Stair Assessment Indexes, and Amputee Mobility Predictor. Data from 40 participants are required to appropriately power the analysis of convergent validity. To achieve this power, data from 20 participants collected during a previously funded Department of Defense study will be leveraged and added to the data of the 20 participants collected during the proposed study. This is possible due to identical data collection techniques in both studies. To assess the level of agreement between the data obtained from the 3 sessions, Intraclass Correlation Coefficients will be calculated for each variable, in addition to Cohen's kappa statistics and Pearson correlation coefficients. To assess convergent validity, Pearson and Spearman rank correlation coefficients will quantify the strength and direction of the relationships between the outcome measures and continuous stability. Substantiating the use of continuous stability in Veterans with TLL will afford healthcare providers information necessary to accurately detect and appropriately address stability deficiencies, which is critical since superior stability is linked to increased physical activity leading to an enhanced overall quality of life of Veterans with limb loss. Verifying the reliability and validity of this parameter will lead to its confident application for future studies focused on effectiveness, optimization, and rehabilitation.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reliability and Validity | Experimental | Other: 3D motion capture, wearable devices, and functional outcome measuresReliability and Validity of Inter-limb Stability using 3D motion capture, functional outcome measures, and wearable devices |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Any individual with unilateral transtibial limb loss
- A well-fitting prosthesis (as determined by a board-certified prosthetist through standardized prosthetic guidelines) for a minimum of one month
- Able to achieve a "Level 6 - Modified Independence" score on the Functional Independence Measure (FIM) for 2 mobility items (locomotion and transfers)
Key exclusion criteria (6 listed)
- Individuals with active wounds/ulcers or significant musculoskeletal comorbidities on their intact limb that would impair ability to participate in biomechanical evaluations
- Any comorbidity that results in rapid limb volume changes (i.e., end stage renal disease with dialysis)
- A poorly fitting socket
- Cognitive deficit(s) or mental pathology (e.g., dementia, amnesia) that would prevent the participant from understanding and following directions and limit the participant's ability to participate fully in the study
- Women who are pregnant or who plan to become pregnant during their participation in study activities
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 |
|---|---|---|
| 3D motion capture, wearable devices, and functional outcome measuresGait evaluation, Hill and Stair Assessment Indices, 6 minute walk test, AMPPro, Timed Up and Go | Other | Reliability and Validity |
Primary outcome
Reliability of Continuous Inter-limb Stability
Time frame: 3 times at visits 2-4 (once per visit) (will occur within 1 week)
Reliability will be evaluated using Deviation Phase using Relative Phase Analysis. Deviation Phase measures the continuous stability of two oscillating segments throughout a cyclical movement. Relative Phase Analysis is a dynamical systems based methodology that is used to calculated the continuous stability of a movement, such as walking. Deviation Phase ranges from 0-180 degrees, with a lower value indicating better organization of the neuromuscular system.
Convergent Validity of Continuous Inter-limb Stability - TUG
Time frame: Once at visit 2 of 4 (Baseline)
The TUG measures physical mobility in individuals with lower limb loss. This measures the time it takes for an individual to stand up from a standard arm chair, walk a distance of 10 feet, turn, walk back to the chair, and sit down. This is measured in time (seconds).
Convergent Validity of Continuous Inter-limb Stability - 6MWT
Time frame: Once at visit 2 of 4 (Baseline)
The 6MWT measure function and endurance. This test measures the distance an individual can walk in 6 minutes without help. This is measured in meters.
Convergent Validity of Continuous Inter-limb Stability - SAI
Time frame: Once at visit 2 of 4 (Baseline)
The SAI is a graded qualitative scale on how an individual with lower limb amputation negotiates up and down a staircase. This is measured on a scale of 0-13.
Convergent Validity of Continuous Inter-limb Stability - HAI
Time frame: Once at visit 2 of 4 (Baseline)
The HAI is a graded qualitative scale on how an individual with lower limb amputation negotiates up and down a ramp. This is measured on a scale from 0-11.
Convergent Validity of Continuous Inter-limb Stability - AMPPro
Time frame: Once at visit 2 of 4 (Baseline)
The AMPPro is a 21 item instrument designed to measure basic prosthetic mobility of individuals with lower extremity amputation. This is scored from 0-47.
1 secondary outcome
Strength of association between wearable technology and 3D motion capture to measure inter-limb stability
Time frame: 3 times at visits 2-4 (once per visit) (will occur within 1 week)
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 30 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be stored in a curated data repository that makes the data underlying scientific publications discoverable, freely usable, and citable, while promoting openly available research integrated with scholarly literature.
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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.
Alexis Sidiropoulos, PhD principal investigator
VA NY Harbor Healthcare System, New York, NY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D motion capture, wearable devices, and functional outcome measures in people with Amputation, Lower Limb, run by VA Office of Research and Development 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 3 inclusion and 6 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 30 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 Alexis Sidiropoulos, PhD ((212) 686-7500, alexis.sidiropoulos@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability of Continuous Inter-limb Stability (time frame: 3 times at visits 2-4 (once per visit) (will occur within 1 week)). The study lists 6 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 30 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.