Walking Intervention for Post-Amputation Care

(DASH Trial)

Overseen By Eliza A. Biondi, MS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Colorado, Denver

Disqualifiers: Cancer, Stroke, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 11

64 Participants Needed

Trial Summary

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that Walking Intervention for Post-Amputation Care is an effective treatment?

The available research does not provide specific data on the effectiveness of Walking Intervention for Post-Amputation Care. Instead, it focuses on other behavior change interventions for different conditions, such as diabetes and chronic illnesses. These studies highlight the importance of behavior change and self-management in improving health outcomes, but they do not directly address the effectiveness of walking interventions for post-amputation care. ^{1 2 3 4 5}

What safety data exists for walking interventions in post-amputation care?

The provided research does not directly address the safety data for walking interventions in post-amputation care. However, it highlights the effectiveness of various interventions, such as biofeedback systems and gait training, in improving physical activity and gait rehabilitation for lower limb amputees. These studies suggest that interventions like overground and treadmill-based gait training, as well as lifestyle interventions, can improve physical and psychosocial functioning. While safety is not explicitly discussed, the effectiveness and focus on improving function imply a level of safety in these interventions. More specific safety data would require further investigation into individual studies or trials. ^{6 7 8 9 10}

Is the Walking Biobehavioral Intervention a promising treatment for people who have had a leg amputation?

Yes, the Walking Biobehavioral Intervention is promising because it can improve physical activity, help with walking balance, and enhance overall health and quality of life for people with leg amputations. ^{6 9 10 11 12}

What is the purpose of this trial?

The purpose of this study is to determine if walking biobehavioral intervention improves physical activity after dysvascular lower limb amputation.

Research Team

Cory Christiansen, PhD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

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.

Inclusion Criteria

I am between 50 and 85 years old.

I have been diagnosed with Type II Diabetes and/or Peripheral Artery Disease.

I had a lower-limb amputation above or below the knee in the last year.

Exclusion Criteria

Prisoners

I am currently receiving treatment for cancer.

My lower limb amputation was due to trauma or cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Conventional Prosthetic Rehabilitation

Participants undergo conventional prosthetic rehabilitation as part of the intervention

3 months

10 sessions (in-person)

Biobehavioral Intervention

Participants receive biobehavioral training integrated into conventional outpatient training

5 months

1 combined session (in-person), 9 sessions (telehealth)

Follow-up

Participants are monitored for maintenance of physical activity and other outcomes

6 months

No-contact phase with FitBit monitoring

Treatment Details

Interventions

• Attention Control
• Walking Biobehavioral Intervention

Trial Overview 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.

Participant Groups

Group I: Walking Biobehavioral Intervention (EXP) Experimental Treatment 1 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 Control 1 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).

Walking Biobehavioral Intervention is already approved in United Kingdom for the following indications:

Approved in United Kingdom as Walking Biobehavioral Intervention for:

• Improving physical activity after dysvascular lower limb amputation
• Managing intermittent claudication in peripheral artery disease

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Findings from Research

A 12-month telephone-delivered intervention for patients with Type 2 diabetes significantly increased physical activity by 26% compared to only 10% in the usual care group, demonstrating its effectiveness in promoting behavior change.

Patients receiving the intervention also showed improved psychological well-being, a reduction in HbA1c levels (indicating better glycemic control), and a decrease in cardiovascular risk, highlighting the intervention's positive impact on overall health status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone-delivered lifestyle support with action planning and motivational interviewing techniques to improve rehabilitation outcomes. Döbler, A., Herbeck Belnap, B., Pollmann, H., et al.[2020]

The biomedical disease model has shown limited success in treating chronic health conditions, highlighting the need for medical education to evolve in addressing behavior-related diseases.

Enhancing medical education through a focus on patient-centered care, effective communication, and individualized training can better prepare physicians to promote health behavior change and tackle complex health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preparing Physicians for the 21 Century: Targeting Communication Skills and the Promotion of Health Behavior Change. Sibille, K., Greene, A., Bush, JP.[2021]

In a study of 112 patients who participated in a 6-session telephone-based cognitive-behavioral physical therapy (CBPT) program after spine surgery, those who met their personalized rehabilitation goals showed significant improvements in physical function at both 6 and 12 months post-surgery.

Goal attainment was linked to better recovery outcomes, emphasizing the importance of setting and achieving specific rehabilitation goals in enhancing physical function after spine surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Centered Goals After Lumbar Spine Surgery: A Secondary Analysis of Cognitive-Behavioral-Based Physical Therapy Outcomes From a Randomized Controlled Trial. Coronado, RA., Master, H., Bley, JA., et al.[2023]

Behavior change interventions can significantly improve health outcomes and quality of life for individuals with chronic conditions like obesity, type 2 diabetes, and heart disease.

The review emphasizes the importance of developing effective, scalable interventions and introduces a user-friendly framework to guide the decision-making process in creating these behavior change strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing Behavior Change Interventions for Self-Management in Chronic Illness: An Integrative Overview. Araújo-Soares, V., Hankonen, N., Presseau, J., et al.[2021]

A brief motivational interviewing-based health behavior change counseling (HBCC) intervention significantly increased patient participation in rehabilitation after surgery for degenerative lumbar spinal stenosis, leading to higher attendance in physical therapy and home exercise programs.

Patients who received the HBCC intervention showed better functional outcomes at both 3 and 6 months post-surgery, with significant reductions in disability and improvements in health status compared to the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health behavior change counseling in surgery for degenerative lumbar spinal stenosis. Part I: improvement in rehabilitation engagement and functional outcomes. Skolasky, RL., Maggard, AM., Li, D., et al.[2022]

A review of 16 studies on interventions for increasing physical activity in individuals with lower limb amputation found that both behavioral and prosthetic approaches had similar methodological quality but mixed results in effectiveness.

There is a lack of comprehensive studies on the efficacy of behavioral interventions, and prosthetic interventions may require more advanced technology to achieve significant improvements in physical activity outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Physical Activity Outcomes in Rehabilitation Interventions for Lower Limb Amputees: a Systematic Review. Jamieson, AG., Murray, L., Buis, A.[2023]

Biofeedback systems have been shown to effectively improve gait rehabilitation in individuals with lower-limb amputation, as highlighted by a systematic review of 31 studies.

The most effective biofeedback methods focus on limb loading and symmetry, with visual feedback being the most commonly used, although challenges remain in usability, especially for elderly users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biofeedback Systems for Gait Rehabilitation of Individuals with Lower-Limb Amputation: A Systematic Review. Escamilla-Nunez, R., Michelini, A., Andrysek, J.[2022]

People with lower-limb loss (PLL) take an average of 5087 steps per day, which is significantly lower than the recommended 10,000 steps for general health, indicating a need for increased physical activity in this population.

The review identified 21 studies involving 515 participants, primarily focusing on transtibial amputations, and highlighted gaps in research regarding physical activity levels and the need for larger, more defined studies to better understand and improve activity in PLL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Scoping Review of Physical Activity in People With Lower-Limb Loss: 10,000 Steps Per Day? Wong, CK., Rissland, MS., Madagan, DM., et al.[2021]

Lifestyle interventions that focus on physical activity and stress management can effectively improve physical fitness, walking capacity, and quality of life for individuals with lower limb amputations, based on a review of 13 studies.

Despite these positive outcomes, the overall methodological quality of the studies was limited, suggesting that further research is needed to confirm these findings and explore additional lifestyle factors like nutrition and smoking habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of (Active) Lifestyle Interventions in People With a Lower Limb Amputation: A Systematic Review. Van Helm, S., Krops, LA., Dekker, R., et al.[2022]

Gait training interventions, both overground and treadmill-based, are essential for lower extremity amputees to address gait asymmetries and improve overall biomechanics, as supported by a systematic review of 18 studies.

Overground training combined with various feedback methods and treadmill training with visual feedback or body weight support were found to significantly enhance gait performance, including improvements in walking distance and movement strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gait Training Interventions for Lower Extremity Amputees: A Systematic Literature Review. Highsmith, MJ., Andrews, CR., Millman, C., et al.[2020]

A short, intensive physiotherapy program significantly improved walking ability and weight-bearing capacity in 58 male unilateral lower limb amputees compared to usual care, with notable results in the 2-minute walk test and physiological cost index.

The study highlights the effectiveness of targeted physiotherapy in enhancing functional performance for amputees, suggesting that such programs should be integrated into rehabilitation practices, even in resource-limited settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term effect of physiotherapy rehabilitation on functional performance of lower limb amputees. Rau, B., Bonvin, F., de Bie, R.[2015]

A 10-month rehabilitation program for nine transfemoral amputees significantly improved their walking speeds, with comfortable gait speed increasing from 0.95 m/s to 1.40 m/s and brisk speed from 1.29 m/s to 1.65 m/s, and these improvements were maintained at a 6-month follow-up.

The program not only eliminated the need for walking aids among participants but also reduced low-back pain, with seven participants even learning to jog, suggesting enhanced mobility and quality of life through this therapeutic approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gait improvement in unilateral transfemoral amputees by a combined psychological and physiotherapeutic treatment. Sjödahl, C., Jarnlo, GB., Persson, BM.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Telephone-delivered lifestyle support with action planning and motivational interviewing techniques to improve rehabilitation outcomes. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Preparing Physicians for the 21 Century: Targeting Communication Skills and the Promotion of Health Behavior Change. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Patient-Centered Goals After Lumbar Spine Surgery: A Secondary Analysis of Cognitive-Behavioral-Based Physical Therapy Outcomes From a Randomized Controlled Trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Developing Behavior Change Interventions for Self-Management in Chronic Illness: An Integrative Overview. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Health behavior change counseling in surgery for degenerative lumbar spinal stenosis. Part I: improvement in rehabilitation engagement and functional outcomes. [2022]

6. Canada pubmed.ncbi.nlm.nih.gov

The Use of Physical Activity Outcomes in Rehabilitation Interventions for Lower Limb Amputees: a Systematic Review. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Biofeedback Systems for Gait Rehabilitation of Individuals with Lower-Limb Amputation: A Systematic Review. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

A Scoping Review of Physical Activity in People With Lower-Limb Loss: 10,000 Steps Per Day? [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of (Active) Lifestyle Interventions in People With a Lower Limb Amputation: A Systematic Review. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Gait Training Interventions for Lower Extremity Amputees: A Systematic Literature Review. [2020]

11. France pubmed.ncbi.nlm.nih.gov

Short-term effect of physiotherapy rehabilitation on functional performance of lower limb amputees. [2015]

12. Sweden pubmed.ncbi.nlm.nih.gov

Gait improvement in unilateral transfemoral amputees by a combined psychological and physiotherapeutic treatment. [2019]