AmputationDIALNCT05119192
Dual-tasking for Individuals With Lower Limb Amputation: Exploring the Relationship to Falls and Instrumental Activities of Daily Living
An observational study of Amputation, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 89 years
- Conditions the study is for
- Amputation
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Veterans with dysvascular lower-limb amputation
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045
About this study
Official title: Dual-Tasking for Individuals With Lower Limb Amputation: Exploring the Relationship to Falls and Instrumental Activities of Daily Living
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.
Read the 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.
- Conditions
- Amputation
- Keywords
- Dual-task, Falls, Activities of Daily Living, Lower-limb amputation, Avascular Amputation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Veterans with Dysvascular Lower Limb Amputation | Self-report assessments, performance-based assessments, and optional individual interview with Veterans with dysvascular lower limb amputation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (3)
Self-reported falls
Participants will be asked: "How many times have you fallen in the last year?". Participants will be provided with the definition of a fall as: "an unexpected event in which.[you] come to rest on the ground, floor, or lower level" excluding intentional change in position. To account for potential disproportion of Fall groups, follow-up questions will be asked, including: near-falls in the past year, and presence of fear of falling.
Measured: Baseline
Modified Barthel Index
The Modified Barthel Index assesses 10 different ADLs, with the overall score ranging from 0 (total dependence) to 100 (independence). The MBI has been used effectively for individuals with dysvascular LLA one year after amputation, and demonstrates excellent test-retest reliability in the outpatient setting.
Measured: Baseline
Frenchay Activities Index
The Frenchay Activities Index is pragmatic for community-dwelling adults to self-rate participation in three domains: domestic chores, leisure/work, and outdoor activities. Frenchay Activity Index scores range from 15-60, with higher scores indicating greater participation in instrumental ADLs.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start1 Dec 2021
- Primary completion30 Nov 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- VA Eastern Colorado Health Care System
- Responsible party
- Sponsor
- Investigators
- Laura A. Swink, PhD, Principal investigator, Rocky Mountain Regional VA Medical Center, Aurora, CO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05119192
- Sponsor's protocol ID
- A3640-M
- Other IDs
- RX003640-01A1
- Acronym
- DIAL
- Status last verified
- Mar 2024
- First submitted
- 1 Nov 2021
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: When results are published a final de-identified, anonymized data set may be made available to the public, based on availability of resources for the given journal publisher. Care will be taken to ensure that individuals cannot be re-identified in the dataset, with no inclusion of or links to personally identifiable information.
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual-Tasking for Individuals With Lower Limb Amputation: Exploring the Relationship to Falls and Instrumental Activities of Daily Living
- ClinicalTrials.gov ID
- NCT05119192
- Acronym / sponsor ID
- DIAL / A3640-M
- Conditions
- Amputation
- Keywords
- Dual-task, Falls, Activities of Daily Living, Lower-limb amputation, Avascular Amputation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- VA Eastern Colorado Health Care System
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 15 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Veterans with Dysvascular Lower Limb Amputation | – | –Self-report assessments, performance-based assessments, and optional individual interview with Veterans with dysvascular lower limb amputation. |
Who may qualify
- Ages
- 50 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Veterans with dysvascular lower-limb amputation
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dual-task Performance
Time frame: Baseline
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.
3 secondary outcomes
Self-reported falls
Time frame: Baseline
Modified Barthel Index
Time frame: Baseline
Frenchay Activities Index
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: No. When results are published a final de-identified, anonymized data set may be made available to the public, based on availability of resources for the given journal publisher. Care will be taken to ensure that individuals cannot be re-identified in the dataset, with no inclusion of or links to personally identifiable information.
Related trials for Amputation
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Amputation
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Role of Perineural Catheter in Pain Control and Opioid Consumption After Major Amputation of Lower Limb
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Recruiting
Hemocoll, Avitene, or Bone Wax for Cancellous Bone Bleeding After Single-Ray Amputation
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Enrolling by invitation
Early Rehabilitation After Transfemoral Amputation in Moderately Active Patients Using the Avior Knee
Transfemoral Amputees
Recruiting
Bio Leg: Advancing Mobility (BAM)
Amputation of Lower Limb Above Knee, Amputee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura A. Swink, PhD principal investigator
Rocky Mountain Regional VA Medical Center, Aurora, CO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputation, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dual-task Performance (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.