Self-Management Program for Amputation

(SMART Trial)

Overseen By William C Miller, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Disqualifiers: Congestive heart failure, dementia, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

82 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a self-management program for individuals with lower limb amputations to determine its impact on quality of life. The program, called SMART, is an online platform offering education, limb management tips, and peer support. Participants will either use the SMART platform or receive a care booklet and weekly check-ins for six weeks. The trial seeks participants in British Columbia or Ontario, Canada, who have had a leg amputation due to diabetes or vascular disease and received their prosthesis within the last two years. Eligible participants should also have internet access and speak English. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance self-management strategies for amputees.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on self-management and rehabilitation, so it's likely you can continue your current meds, but you should confirm with the trial coordinators.

What prior data suggests that this self-management program is safe for individuals with lower limb amputations?

Research has shown that the SMART program is a six-week online tool designed to help individuals with lower limb amputations manage their daily lives. This program includes weekly support from a peer mentor and focuses on setting goals and planning actions to enhance everyday activities.

Since SMART is an online program rather than a medication or physical treatment, traditional side effects associated with drugs are not a concern. Instead, the focus is on how effectively participants use the program and manage their own care. The program is designed to be user-friendly and supportive, making it likely that most people will find it comfortable to use.

As this trial tests the program itself and not a new drug or invasive treatment, safety concerns are minimal. Participants receive guidance and support online, which should help address any issues that arise. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SMART program for amputees because it offers a comprehensive, interactive approach that's different from traditional care options like informational booklets and periodic check-ins. SMART combines mental and physical wellness strategies, personalized prosthetic limb management, and weekly peer-support sessions via Zoom. What sets it apart is its online platform that promotes motivation, goal setting, and action planning while allowing participants to connect with trainers at any time through a secure website. This holistic and flexible approach aims to empower individuals in managing their condition more effectively, potentially leading to better outcomes and improved quality of life.

What evidence suggests that the SMART program is effective for lower limb amputations?

Research has shown that self-management programs like SMART, which participants in this trial may receive, can aid individuals with lower limb amputations by enhancing their health management skills. SMART is an online program offering support through weekly phone or video calls, assisting participants in setting goals and making plans. Studies have found that programs like SMART can boost knowledge and skills, potentially improving recovery. The program emphasizes mental and physical health, limb care, and prosthetic limb use. These features make SMART a promising option for those seeking to enhance their quality of life after amputation. ^{1 2 3 6 7}

Who Is on the Research Team?

William C Miller, PhD

Principal Investigator

The University of British Columbia

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 50 in British Columbia or Ontario, Canada, who have had one lower limb amputated above or below the knee due to diabetes or vascular disease. They must have received their initial prosthesis casting within the last two years and have access to a computer or tablet with internet.

Inclusion Criteria

Self-identifies as being able to speak and read English.

I got my first prosthesis fitting within the last 2 years.

I am 50 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the SMART intervention or control care booklet for 6 weeks. The SMART group uses a tablet for daily self-management activities, including mental and physical wellness, prosthetic limb management, and weekly peer-support calls.

6 weeks

Weekly virtual visits via Zoom

Retention Effect

The retention effect of the SMART program is assessed for 4 weeks after the initial treatment phase.

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of ambulation confidence and walking capacity.

10 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Control
• SMART

Trial Overview The SMART program is being tested against a control group. It's an online platform offering education on lower limb amputation (LLA), prosthetic management, and weekly peer support. The study aims to see if this technology can improve self-management after discharge from rehabilitation services.

How Is the Trial Designed?

Group I: SMART Experimental Treatment 1 Intervention

The experimental group will receive access to SMART online platform (6 weeks). SMART includes mental and physical wellness, residual/prosthetic limb managements, use of a prosthesis and weekly peer-support calls or video call over Zoom, hosted by University of British Columbia, depends on participant's preference, promoting motivation and establishing goal setting and action planning. SMART will also allow asynchronous contact with trainers through a secure website.

Group II: Control Active Control 1 Intervention

The control group will receive a care booklet and weekly contacts for 6 weeks.

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

Individuals with lower-limb amputation showed significant improvements in daily living activities during rehabilitation, but their social roles, such as employment and community involvement, remained low and unchanged after discharge.

At discharge, a high percentage of patients (58%) used their prosthesis for over 9 hours a day, and this usage increased significantly post-discharge, indicating good prosthetic adaptation and locomotor capability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Life habits and prosthetic profile of persons with lower-limb amputation during rehabilitation and at 3-month follow-up. Zidarov, D., Swaine, B., Gauthier-Gagnon, C.[2009]

This study involves 78 veterans aged 50 to 89 with lower-limb amputation, testing an 18-month telehealth walking exercise self-management program against a control education group to see if it improves walking sustainability.

The program aims to combat sedentary lifestyles post-amputation by providing ongoing support, and its results could help integrate self-management strategies into standard care for veterans, promoting healthier lifestyles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Walking Exercise Sustainability through Telehealth (WEST) for Veterans with Lower-Limb Amputation: A Study Protocol. Hanlon, SL., Swink, LA., Akay, RB., et al.[2023]

A community-based self-management intervention for individuals with major limb loss significantly reduced depression rates, with participants being 50% less likely to be depressed immediately after treatment and 40% less likely at a 6-month follow-up.

Participants in the self-management group also experienced improved functional status and higher self-efficacy, particularly benefiting those who were younger than 65 years or less than 3 years post-amputation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-management improves outcomes in persons with limb loss. Wegener, ST., Mackenzie, EJ., Ephraim, P., et al.[2009]

Veteran amputees who received specialized rehabilitation services achieved significantly greater mobility and self-care function gains, with an average increase of 8.0 points in motor Functional Independence Measure (FIM) scores compared to those who received consultative rehabilitation.

The timing of rehabilitation (early vs. late) did not affect the outcomes for patients with delayed rehabilitation, indicating that specialized rehabilitation is crucial for recovery regardless of when it starts, especially for patients with more complex clinical profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostic differences for functional recovery after major lower limb amputation: effects of the timing and type of inpatient rehabilitation services in the Veterans Health Administration. Stineman, MG., Kwong, PL., Xie, D., et al.[2023]

Clinicians face challenges in estimating the outcomes of prosthetic use for amputees, leading to inconsistencies in decision-making across different rehabilitation centers in the UK.

There is a need for national prescription guidelines to ensure equitable access to prosthetic components, as factors like budget constraints and risk aversion can hinder the provision of necessary high-cost items.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinicians' perspectives on decision making in lower limb amputee rehabilitation. Sansam, K., O'Connor, RJ., Neumann, V., et al.[2022]

The Nintendo WiiFit™ was found to be a feasible and safe adjunct therapy for individuals with lower limb amputation, with no adverse events reported during the study involving 6 participants.

Participants showed significant improvements in walking capacity and other physical performance measures, with a median adherence rate of 80% and positive feedback on the program's enjoyment and acceptability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of the Nintendo WiiFit™ for improving walking in individuals with a lower limb amputation. Imam, B., Miller, WC., McLaren, L., et al.[2020]

The Locomotor Capabilities Index-5 (LCI-5) demonstrated high reliability and sensitivity to change in assessing locomotor capabilities in 110 patients with lower limb amputation undergoing prosthetic training.

The study established a minimal clinically important difference (MCID) of 7 points on the LCI-5, indicating a meaningful improvement in locomotor function, with a larger improvement threshold set at 12 points, which can help guide patient assessments post-training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensitivity to change and minimal clinically important difference of the Locomotor Capabilities Index-5 in people with lower limb amputation undergoing prosthetic training. Franchignoni, F., Traballesi, M., Monticone, M., et al.[2022]

The Turkish version of the Prosthetic Limb Users Survey of Mobility (PLUS-M-T) has been validated as a reliable tool for assessing mobility in lower-limb amputees, showing high test-retest reliability (ICC = 0.85) and internal consistency (Cronbach alpha = 0.94).

There is a strong correlation between the PLUS-M-T scores and the Amputee Mobility Scale scores (r = 0.84), indicating that the PLUS-M-T effectively measures mobility in individuals using prosthetic limbs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validity and reliability of Turkish transcultural adaptation of the Prosthetic Limb Users Survey of Mobility. Yosmaoglu, S., Yazicioglu, G., Demir, Y., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36803503/

self-management for amputee rehabilitation using ... SMART is a six-week online program with weekly contact of a peer mentor with lower limb loss who supported patients with goal-setting and action-planning.

2. tandfonline.com tandfonline.com/doi/abs/10.1080/09638288.2023.2178678

self-management for amputee rehabilitation using ... SMART is a six-week online program with weekly contact of a peer mentor with lower limb loss who supported patients with goal-setting and action-planning.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04953364

Self-Management for Amputee Rehabilitation Using ... The purpose of this randomized controlled trial is to evaluate the effect of SMART in community dwelling older adults with unilateral, above or below, knee ...

4. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0278418

Protocol for a randomized controlled trial to assess the effect ... SMART has the potential to provide knowledge and skill development to augment rehabilitation outcomes for adults with LLL.

5. open.library.ubc.ca open.library.ubc.ca/soa/cIRcle/collections/ubctheses/24/items/1.0407336

development of a co-created eHealth program and feasibility ... Purpose: To co-create an online self-management program for individuals with LLL, Self-Management for Amputee Rehabilitation using Technology (SMART), through ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40489351/

Feasibility of self-management for amputee rehabilitation ... We developed an online self-management program for individuals with LLL called Self-Management for Amputee Rehabilitation using Technology ( ...

7. journals.plos.org journals.plos.org/plosone/article/file?type=printable&id=10.1371/journal.pone.0278418

Protocol for a randomized controlled trial to assess the effect ... To address this service gap, we co-created an eHealth platform, called Self-Management for Amputee Rehabilitation using Technology (SMART).