Reliability and Validity of Continuous Inter-limb Stability

NCT06987019 | Recruiting

• 1 other identifier: A5147-P
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Amputation, Lower Limb

Keywords

Transtibial amputation; Gait evaluation

Outcome Measures

Primary Outcomes (6)

• 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.

  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).

  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.

  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.

  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.

  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.

  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

  3 times at visits 2-4 (once per visit) (will occur within 1 week)

Study Arms (1)

Reliability and Validity

EXPERIMENTAL

Reliability and Validity of Inter-limb Stability using 3D motion capture, functional outcome measures, and wearable devices

Other: 3D motion capture, wearable devices, and functional outcome measures

Interventions

3D motion capture, wearable devices, and functional outcome measures OTHER

Gait evaluation, Hill and Stair Assessment Indices, 6 minute walk test, AMPPro, Timed Up and Go

Reliability and Validity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA NY Harbor Healthcare System, New York, NY

New York, New York, 10010-5011, United States

RECRUITING

MeSH Terms

Interventions

Wearable Electronic Devices

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Study Officials

• Alexis Sidiropoulos, PhD

  VA NY Harbor Healthcare System, New York, NY

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexis Sidiropoulos, PhD

CONTACT

(212) 686-7500; alexis.sidiropoulos@va.gov

Jason Maikos, PhD

CONTACT

(212) 686-7500; Jason.Maikos@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: May 23, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: After study completion

Locations

US (1)