Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2025-12-24 @ 3:42 PM
NCT ID:
NCT05119192
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.
Detailed Description:
Purpose: To explore the relationship between dual-task performance, self-reported falls, and activities of daily living for Veterans with lower limb amputation.
Dual-task performance will be assessed using overground ambulation and serial subtraction. Dual-tasking will then be compared to single-task silent walking or seated serial subtraction to determine the category each participant falls into: gait-priority trade off, cognitive-priority trade off, mutual facilitation, or mutual interference. Self-reported falls with be assessed with questionnaires including recent falls (1 month, 1 year), number of falls, fall injuries, and near-falls. Activities of daily living will be assessed using the Modified Barthel Index, and Frenchay Activities Index. Other self-report descriptive questionnaires include: demographic information, the Functional Comorbidities Index, and the Falls Behavioral Scale for the Older Person. Other performance measures include: the Berg Balance Scale, and the SLUMS cognitive screen.
Aim 1: Compare the proportion of participants experiencing mutual interference during dual-task walking between fall groups (Non-fall is 1 fall vs. Recurrent-fall is \>1 fall).
Aim 2: Identify the relationships dual-task effects have with self-reported participation in activities of daily living (basic and instrumental ADLs).
Aim 3: Qualitatively explore the effects of dual-tasking on self-reported fall or near-fall dual-task scenarios. Veterans with dysvascular LLA (n 30) will participate in semi-structured interviews describing these scenarios, and dual-task awareness in fall prevention.
Study:
NCT05119192
Study Brief:
Protocol Section:
NCT05119192