AmputationDASHNCT04083456
Dysvascular Amputation Self-Management of Health
A study testing Walking Biobehavioral Intervention in people with Amputation and Diabetes Mellitus, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The purpose of this study is to determine if walking biobehavioral intervention improves physical activity after dysvascular lower limb amputation. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Amputation, Diabetes Mellitus, Peripheral Artery Disease
- What is being tested?
- Walking Biobehavioral Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 31 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Within the age range of 50-85 years
- Confirmed diagnosis of Type II Diabetes Mellitus (DM) and/or Peripheral Artery Disease (PAD)
- Transtibial, knee disarticulation, or transfemoral lower-limb amputation (LLA) (or re-amputation) within the past 12 months
- Participant goal of household walking or better using a prosthesis
Who cannot join
- Trauma or cancer-related etiology of the LLA
- Decisionally challenged individuals (MMSE score below 24)
- Prisoners
- Active cancer treatment
- Recent stroke (within 2 years)
- Clinical discretion of principal 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
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
Official title: Improving Health Self-Management Using Walking Biobehavioral Intervention for People With Dysvascular Lower Limb Amputation
The purpose of this study is to determine if walking biobehavioral intervention improves physical activity after dysvascular lower limb amputation.
Read the detailed description
Sedentary lifestyles and high levels of disability are relevant public and personal health issues resulting from the chronic comorbid condition of dysvascular lower limb amputation. This study examines the use of an evidence-based walking biobehavioral intervention to increase physical activity after dysvascular amputation. The proposed intervention leverages successes in conventional prosthetic rehabilitation, while addressing the complex health conditions and chronic sedentary behaviors that underlie dysvascular amputation, with the ultimate goal of improved physical activity self-management to minimize disability.
- Conditions
- Amputation, Diabetes Mellitus, Peripheral Artery Disease
- Being tested
- Walking Biobehavioral Intervention, Attention Control
- Keywords
- Amputation, Dysvascular Amputation, Diabetes, Peripheral Artery Disease, Physical Activity
- Medical subject headings
- Diabetes Mellitus, Peripheral Arterial Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking Biobehavioral InterventionBehavioural
Each walking biobehavioral training session includes self-monitoring, tailored feedback, identification of barriers and facilitators, problem solving, action planning and encouragement. Self-monitoring of walking behavior will occur with participant use of the FitBit sensor and software, reviewed with the interventionist at each session. Tailored feedback from the FitBit sensor, as well as feedback from the interventionist, will detail progress over time and be compared to baseline data. Barriers and facilitators of reaching activity goals will be discussed with emphasis on problem solving to take advantage of facilitators and minimize/remove participant-specific barriers. Action planning will be based on weekly step goals set collaboratively by the interventionist and participant, based the FitBit data. Finally, encouragement will be provided by the interventionist by putting progress or lack of progress in perspective of the efforts made by the participant.
Attention ControlOther
Attention control sessions will include a brief review of the conventional home-exercises, a summary of all healthcare visits and falls, and interventionist-delivered education on safety topics (e.g., fall prevention, wound care, assistive device use). Outpatient therapists will provide home-based exercises to ensure that the participant receives adequate training and demonstrates safe performance prior to home use. The CTL interventionist will assess and discuss the safe performance of each home-based exercise with CTL group participants. Exercises in the CTL group will only be progressed by the outpatient physical therapist and not during the telehealth sessions.
| Study group | Role | What they receive |
|---|---|---|
| Walking Biobehavioral Intervention (EXP) | Experimental | The EXP group will receive biobehavioral training that is integrated into the conventional outpatient training component and is delivered over 5 months. There will be 10 biobehavioral sessions, 1 of which will be a combined biobehavioral/conventional outpatient session and the other 9 being telehealth sessions. Receives: Behavioral: Walking Biobehavioral Intervention |
| Attention Control (CTL) | Active comparator | The CTL group intervention will include the same conventional outpatient training (10 sessions) as the EXP group and receive the same computer tablets with telehealth software as the EXP group (week 3 of prosthetic training). Receives: Other: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity
The number of steps per day measured with ActivPAL, assessed for 10 days at 3 months and 6 months. 10-day average at 3 months and at 6 months reported.
Measured: 3 months and 6 months
Secondary outcomes (7)
Patient Reported Outcomes Measurement Information System: Self-Efficacy for Managing Symptoms
Measures participant's confidence in managing symptoms of chronic disease. Higher scores indicate greater confidence in symptom management. Values provided are the theta score which are T scores minus 50, divided by 10, where 50 indicates the population mean and 10 is the standard deviation of the T score scale.
Measured: Day 0, 3 months, 6 months and 12 months
Patient Reported Outcomes Measurement Information System: Self-Efficacy for Managing Daily Activities
Measures participant's confidence in managing daily activities. Higher scores indicate greater confidence in managing daily activities. Values provided are the theta score which are T scores minus 50, divided by 10, where 50 indicates the population mean and 10 is the standard deviation of the T score scale.
Measured: Day 0, 3 months, 6 months and 12 months
Patient Reported Outcomes Measurement Information System: Ability to Participate in Social Roles and Activities
Measures participant's ability to participate in social roles and activities. Higher scores indicate more ability to participate. Values provided are the theta score which are T scores minus 50, divided by 10, where 50 indicates the population mean and 10 is the standard deviation of the T score scale."
Measured: Day 0, 3 months, 6 months and 12 months
Prosthesis Evaluation Questionnaire - Mobility Score
Self-reported mobility. Final scores range from 0 (lowest mobility) to 4 (highest mobility)
Measured: Day 0, 3 months, 6 months and 12 months
Timed Up-and-Go Test
Time required to rise from chair, walk 10 feet, turn around and return to sitting in same chair.
Measured: Day 0, 3 months, 6 months and 12 months
World Health Organization-Disability Assessment Schedule 2.0
Self-reported disability. Final scores range from 0 (no disability) to 100 (full disability).
Measured: Day 0, 3 months, 6 months and 12 months
Self-Efficacy for Managing Chronic Disease
Self-reported confidence in managing different aspects of chronic disease. Final scores range from 1 (not at all confident in managing chronic disease) to 10 (totally confident in managing chronic disease).
Measured: Day 0, 3 months, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start1 Nov 2019
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AmputationStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled futility design
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Cory Christiansen, PT, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04083456
- Sponsor's protocol ID
- 19-0534
- Other IDs
- R01NR018450
- Acronym
- DASH
- Status last verified
- Jul 2026
- First submitted
- 19 Aug 2019
- Last updated
- 13 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will publish the trial results data on the ClinicalTrials.gov website, on which the clinical trial will be registered. Sharing of data will include the potential of sharing raw data generated from all clinical assessments under a data-sharing agreement.
Publications
B Aledi L, Flumignan CD, Trevisani VF, Miranda F Jr. Interventions for motor rehabilitation in people with transtibial amputation due to peripheral arterial disease or diabetes. Cochrane Database Syst Rev. 2023 Jun 5;6(6):CD013711. doi: 10.1002/14651858.CD013711.pub2.
PubMed 37276273
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Health Self-Management Using Walking Biobehavioral Intervention for People With Dysvascular Lower Limb Amputation
- ClinicalTrials.gov ID
- NCT04083456
- Acronym / sponsor ID
- DASH / 19-0534
- Conditions
- Amputation, Diabetes Mellitus, Peripheral Artery Disease
- Keywords
- Amputation, Dysvascular Amputation, Diabetes, Peripheral Artery Disease, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 10 Sep 2019 (actual)
- Results
- Posted 13 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if walking biobehavioral intervention improves physical activity after dysvascular lower limb amputation.
Detailed description
Sedentary lifestyles and high levels of disability are relevant public and personal health issues resulting from the chronic comorbid condition of dysvascular lower limb amputation. This study examines the use of an evidence-based walking biobehavioral intervention to increase physical activity after dysvascular amputation. The proposed intervention leverages successes in conventional prosthetic rehabilitation, while addressing the complex health conditions and chronic sedentary behaviors that underlie dysvascular amputation, with the ultimate goal of improved physical activity self-management to minimize disability.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled futility design
| Arm | Type | Receives |
|---|---|---|
| Walking Biobehavioral Intervention (EXP) | Experimental | Behavioral: Walking Biobehavioral InterventionThe EXP group will receive biobehavioral training that is integrated into the conventional outpatient training component and is delivered over 5 months. There will be 10 biobehavioral sessions, 1 of which will be a combined biobehavioral/conventional outpatient session and the other 9 being telehealth sessions. |
| Attention Control (CTL) | Active comparator | Other: Attention ControlThe CTL group intervention will include the same conventional outpatient training (10 sessions) as the EXP group and receive the same computer tablets with telehealth software as the EXP group (week 3 of prosthetic training). |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Within the age range of 50-85 years
- Confirmed diagnosis of Type II Diabetes Mellitus (DM) and/or Peripheral Artery Disease (PAD)
- Transtibial, knee disarticulation, or transfemoral lower-limb amputation (LLA) (or re-amputation) within the past 12 months
- Participant goal of household walking or better using a prosthesis
Key exclusion criteria (6 listed)
- Trauma or cancer-related etiology of the LLA
- Decisionally challenged individuals (MMSE score below 24)
- Prisoners
- Active cancer treatment
- Recent stroke (within 2 years)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walking Biobehavioral InterventionEach walking biobehavioral training session includes self-monitoring, tailored feedback, identification of barriers and facilitators, problem solving, action planning and encouragement. Self-monitoring of walking behavior will occur with participant use of the FitBit sensor and software, reviewed with the interventionist at each session. Tailored feedback from the FitBit sensor, as well as feedback from the interventionist, will detail progress over time and be compared to baseline data. Barriers and facilitators of reaching activity goals will be discussed with emphasis on problem solving to take advantage of facilitators and minimize/remove participant-specific barriers. Action planning will be based on weekly step goals set collaboratively by the interventionist and participant, based the FitBit data. Finally, encouragement will be provided by the interventionist by putting progress or lack of progress in perspective of the efforts made by the participant. | Behavioural | Walking Biobehavioral Intervention (EXP) |
| Attention ControlAttention control sessions will include a brief review of the conventional home-exercises, a summary of all healthcare visits and falls, and interventionist-delivered education on safety topics (e.g., fall prevention, wound care, assistive device use). Outpatient therapists will provide home-based exercises to ensure that the participant receives adequate training and demonstrates safe performance prior to home use. The CTL interventionist will assess and discuss the safe performance of each home-based exercise with CTL group participants. Exercises in the CTL group will only be progressed by the outpatient physical therapist and not during the telehealth sessions. | Other | Attention Control (CTL) |
Primary outcome
Physical Activity
Time frame: 3 months and 6 months
The number of steps per day measured with ActivPAL, assessed for 10 days at 3 months and 6 months. 10-day average at 3 months and at 6 months reported.
7 secondary outcomes
Patient Reported Outcomes Measurement Information System: Self-Efficacy for Managing Symptoms
Time frame: Day 0, 3 months, 6 months and 12 months
Patient Reported Outcomes Measurement Information System: Self-Efficacy for Managing Daily Activities
Time frame: Day 0, 3 months, 6 months and 12 months
Patient Reported Outcomes Measurement Information System: Ability to Participate in Social Roles and Activities
Time frame: Day 0, 3 months, 6 months and 12 months
Prosthesis Evaluation Questionnaire - Mobility Score
Time frame: Day 0, 3 months, 6 months and 12 months
Timed Up-and-Go Test
Time frame: Day 0, 3 months, 6 months and 12 months
World Health Organization-Disability Assessment Schedule 2.0
Time frame: Day 0, 3 months, 6 months and 12 months
Self-Efficacy for Managing Chronic Disease
Time frame: Day 0, 3 months, 6 months and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37276273B Aledi L, Flumignan CD, Trevisani VF, Miranda F Jr. Interventions for motor rehabilitation in people with transtibial amputation due to peripheral arterial disease or diabetes. Cochrane Database Syst Rev. 2023 Jun 5;6(6):CD013711. doi: 10.1002/14651858.CD013711.pub2.
- Individual participant dataSharing planned: Yes. The investigators will publish the trial results data on the ClinicalTrials.gov website, on which the clinical trial will be registered. Sharing of data will include the potential of sharing raw data generated from all clinical assessments under a data-sharing agreement.
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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.
Cory Christiansen, PT, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking Biobehavioral Intervention in people with Amputation and Diabetes Mellitus, run by University of Colorado, Denver 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 4 inclusion and 6 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 13 Aug 2026. 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?
Yes. Results are posted in the registry (first posted 13 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Physical Activity (time frame: 3 months and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04083456, which also lists 1 linked publication.
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 13 Aug 2026.