Clinical trial NCT06987019: Reliability and Validity of Continuous Inter-limb Stability
Official title: Reliability and Validity of Continuous Inter-Limb Stability in Veterans With Lower Limb Loss
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amputation, Lower Limb
Keywords: Transtibial amputation
Gait evaluation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2025-05-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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
* FIM scores less than Level 6 for locomotion and transfers

Primary outcomes:
measure: Reliability of Continuous Inter-limb Stability
timeFrame: 3 times at visits 2-4 (once per visit) (will occur within 1 week)
measure: Convergent Validity of Continuous Inter-limb Stability - TUG
timeFrame: Once at visit 2 of 4 (Baseline)
measure: Convergent Validity of Continuous Inter-limb Stability - 6MWT
timeFrame: Once at visit 2 of 4 (Baseline)
measure: Convergent Validity of Continuous Inter-limb Stability - SAI
timeFrame: Once at visit 2 of 4 (Baseline)
measure: Convergent Validity of Continuous Inter-limb Stability - HAI
timeFrame: Once at visit 2 of 4 (Baseline)
measure: Convergent Validity of Continuous Inter-limb Stability - AMPPro
timeFrame: Once at visit 2 of 4 (Baseline)
Secondary outcomes:
measure: Strength of association between wearable technology and 3D motion capture to measure inter-limb stability
timeFrame: 3 times at visits 2-4 (once per visit) (will occur within 1 week)
Other outcomes:
Locations:
city: New York
country: United States
facility: VA NY Harbor Healthcare System, New York, NY
state: New York
Study officials:
affiliation: VA NY Harbor Healthcare System, New York, NY
name: Alexis Sidiropoulos, PhD
role: PRINCIPAL_INVESTIGATOR
References: