Clinical trial NCT05119192: Dual-tasking for Individuals With Lower Limb Amputation: Exploring the Relationship to Falls and Instrumental Activities of Daily Living
Official title: Dual-Tasking for Individuals With Lower Limb Amputation: Exploring the Relationship to Falls and Instrumental Activities of Daily Living
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amputation
Keywords: Dual-task
Falls
Activities of Daily Living
Lower-limb amputation
Avascular Amputation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: VA Eastern Colorado Health Care System
First posted: 2021-11-15
Enrollment: 48
Sex: ALL
Minimum age (years): 50
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Veterans with dysvascular lower-limb amputation

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Dual-task Performance
timeFrame: Baseline
Secondary outcomes:
measure: Self-reported falls
timeFrame: Baseline
measure: Modified Barthel Index
timeFrame: Baseline
measure: Frenchay Activities Index
timeFrame: Baseline
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Rocky Mountain Regional VA Medical Center, Aurora, CO
state: Colorado
Study officials:
affiliation: Rocky Mountain Regional VA Medical Center, Aurora, CO
name: Laura A. Swink, PhD
role: PRINCIPAL_INVESTIGATOR
References: