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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)

Must not have

Active cancer treatment

Trauma or cancer-related etiology of the LLA

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 12

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently receiving treatment for cancer.

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My lower limb amputation was due to trauma or cancer.

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I have not had a stroke in the past 2 years.

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My mental state test score is 24 or higher.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 12

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Physical Activity

Secondary study objectives

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 study objectives

Activities-specific Balance Confidence Scale

Biobehavioral Practitioner Intervention Fidelity

FitBit Use Adherence

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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).

0 / 6Eligibility criteria met