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Walking Intervention for Post-Amputation Care (DASH Trial)

N/A
Recruiting
Led By Cory Christiansen, PT, PhD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Within the age range of 50-85 years
Confirmed diagnosis of Type II Diabetes Mellitus (DM) and/or Peripheral Artery Disease (PAD)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 12
Awards & highlights

DASH Trial Summary

This trial will test if a walking intervention can help increase physical activity for people who have recently undergone a dysvascular lower limb amputation.

Who is the study for?
This trial is for adults aged 50-85 who've had a lower-limb amputation within the last year due to diabetes or peripheral artery disease. They should aim to walk using a prosthesis and not be undergoing active cancer treatment, have had trauma or cancer-related limb loss, recent stroke, cognitive challenges, or any condition making it unsafe to participate as judged by the study leader.Check my eligibility
What is being tested?
The study is testing if a walking biobehavioral intervention can help improve physical activity in people after losing a limb below the knee due to poor blood flow or diabetes. Participants will either receive this special walking program or an attention control which serves as a comparison.See study design
What are the potential side effects?
Since this trial involves physical activity interventions rather than medication, side effects may include muscle soreness, fatigue, and potential skin irritation from prosthetic use during increased walking exercises.

DASH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 50 and 85 years old.
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I have been diagnosed with Type II Diabetes and/or Peripheral Artery Disease.
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I had a lower-limb amputation above or below the knee in the last year.
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I aim to walk around the house or better with a prosthesis.

DASH Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Physical Activity
Secondary outcome measures
PROMIS: Ability to participate in social roles and activities
PROMIS: Self-Efficacy for Managing Daily Activities
Patient Reported Outcomes Measurement Information System (PROMIS): Self-Efficacy for Managing Symptoms
+4 more
Other outcome measures
Activities-specific Balance Confidence Scale
Biobehavioral Practitioner Intervention Fidelity
FitBit Use Adherence
+4 more

DASH Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Walking Biobehavioral Intervention (EXP)Experimental Treatment1 Intervention
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.
Group II: Attention Control (CTL)Active Control1 Intervention
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).

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,729 Previous Clinical Trials
2,143,314 Total Patients Enrolled
17 Trials studying Diabetes
13,572 Patients Enrolled for Diabetes
National Institute of Nursing Research (NINR)NIH
577 Previous Clinical Trials
10,375,743 Total Patients Enrolled
3 Trials studying Diabetes
5,444 Patients Enrolled for Diabetes
Cory Christiansen, PT, PhDPrincipal InvestigatorUniversity of Colorado, Denver

Media Library

Walking Biobehavioral Intervention Clinical Trial Eligibility Overview. Trial Name: NCT04083456 — N/A
Diabetes Research Study Groups: Walking Biobehavioral Intervention (EXP), Attention Control (CTL)
Diabetes Clinical Trial 2023: Walking Biobehavioral Intervention Highlights & Side Effects. Trial Name: NCT04083456 — N/A
Walking Biobehavioral Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT04083456 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still vacancies for individuals to join in this research?

"Confirmed. Clinicaltrials.gov provides evidence that this clinical trial is in search of participants, the initial post date being November 1st 2019 with recent edits made April 13th 2022."

Answered by AI

Who is most suited to take part in this medical experiment?

"This medical trial is accepting patients between the ages of 50 and 85 with amputations. Currently, 64 people are sought for enrollment in this clinical study."

Answered by AI

What is the current number of participants in this trial?

"Affirmative. Clinicaltrials.gov records demonstrate that this research initiative, which was originally posted on November 1st 2019, is currently seeking participants. 64 people are required at one medical centre to make up the total enrolment for this study."

Answered by AI

Are individuals aged 45 and over being accepted into this research?

"This trial is exclusively open to those aged 50-85. In contrast, there are 195 trials accessible to minors and 1134 clinical trials available for elderly persons."

Answered by AI
~9 spots leftby Jan 2025