Dual-tasking for Individuals With Lower Limb Amputation: Exploring the Relationship to Falls and Instrumental Activities of Daily Living

NCT05119192 | Completed

• 2 other identifiers: A3640-MRX003640-01A1
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Veterans with dysvascular lower limb amputation (LLA) have a high fall risk, which persists despite completion of conventional rehabilitation. The presence of fall risk could be a primary reason for the high disability and low quality of life outcomes in this Veteran population. A potential novel intervention for this population is to train performance of tasks that require both physical and cognitive attention (i.e., dual-tasking). Therefore, the purpose of this study is to explore relationships between dual-task performance and self-reported falls for Veterans with dysvascular LLA. Further, dual-tasking occurs during everyday life and this project will examine the association between dual-task performance and participation in activities of daily living (basic and instrumental). The results will form the foundation for development and future study of a novel dual-task training program for Veterans with dysvascular LLA.

Conditions

Amputation

Keywords

Dual-task; Falls; Activities of Daily Living; Lower-limb amputation; Avascular Amputation

Outcome Measures

Primary Outcomes (1)

• Dual-task Performance

  Dual-task performance will be classified into one of 4 categories (gait priority trade off, cognitive priority trade off, mutual interference, or mutual facilitation) based on performance in 3 different 2-minute conditions (gait single task, cognitive single task, dual-task). The gait task will be overground walking on a 12 meter obstacle-free course with a 1 meter turning area. Gait speed (m/s) will be calculated using the total distance covered over the 2 minutes. The cognitive task will be serial subtractions of seven, starting between 590-599. A corrected response rate will be calculated as: responses per second\*percent of correct responses. Dual-task performance will represent a participant's performance on improvement or decline on both gait and cognitive performance comparing single and dual-tasking. For example, mutual interference would be a decline in both gait (slower speed), and cognitive (lower corrected response ratio) from single to dual-tasking.

  Baseline

Secondary Outcomes (3)

• Self-reported falls

  Baseline

• Modified Barthel Index

  Baseline

• Frenchay Activities Index

  Baseline

Study Arms (1)

Veterans with Dysvascular Lower Limb Amputation

Self-report assessments, performance-based assessments, and optional individual interview with Veterans with dysvascular lower limb amputation.

Eligibility Criteria

• Age: 50 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Veterans with dysvascular lower-limb amputation

You may qualify if:

• unilateral, transtibial, or transfemoral LLA
• diagnosis of diabetes mellitus or peripheral artery disease
• age 50 to 89 years
• able to ambulate around the home with or without an assistive device
• at least one year since LLA

You may not qualify if:

• trauma or cancer-related etiology of the LLA
• decisionally challenged individuals (SLUMS score in "Dementia" range)
• prisoners
• active cancer treatment
• clinical discretion of principle investigator to exclude patients who are determined to be unsafe and/or inappropriate to participate in the described intervention

Sponsors & Collaborators

• VA Office of Research and Development: lead
• VA Eastern Colorado Health Care System: collaborator

Study Sites (1)

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045, United States

Location

Biospecimen

Retention: NONE RETAINED

no biospecimen retention

Study Officials

• Laura A. Swink, PhD

  Rocky Mountain Regional VA Medical Center, Aurora, CO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 15, 2021
• Study Start: December 1, 2021
• Primary Completion: November 30, 2023
• Study Completion: December 31, 2023
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)