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

Trial Summary

What is the purpose of this trial?

Lower Limb Amputations (LLAs) are a substantial burden on the Canadian health services with nearly 50,000 cases reported between 2006 and 2011. To address the challenging nature of a LLA (e.g., decreased mobility, pain, depression), patients need to go through extensive rehabilitation programs. Effective self-management programs can help those with LLA to monitor their own condition and improve their quality of life. However, a lack of self-management programs, a limited healthcare budget, and a decrease in quality of services (e.g. shorter lengths of stay for inpatients and rapid movement to outpatient services) pose further challenges for patients with LLA. Self-management programs can be provided to clients through online mobile technologies (e.g., tablet) and offer accessible, low-cost, and potentially augmentative rehabilitation after discharge, in both urban and rural areas. To address these needs, an online educational and training platform for individuals with LLA called, Self-Management for Amputee Rehabilitation using Technology (SMART) was designed and developed. SMART focuses on LLA education, prosthetic limb management, and weekly support of peers. It is monitored by a trainer through a website. SMART will be evaluated in men and women with LLA aged 50 years and over, admitted to prosthetic rehabilitation throughout BC and ON. SMART has the potential to influence a client's post-LLA needs with direct (e.g., individual's health) and indirect (e.g., healthcare utilization) benefits. 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 amputation.

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 data supports the effectiveness of the treatment Self-Management for Amputee Rehabilitation Using Technology?

Research shows that telehealth walking exercise programs can help people with lower-limb amputations improve their ability to keep up with walking exercises over time. This suggests that using technology for self-management might be effective in supporting rehabilitation for amputees. ^{1 2 3 4 5}

How is the Self-Management Program for Amputation different from other treatments for amputees?

The Self-Management Program for Amputation is unique because it focuses on empowering individuals to manage their own rehabilitation using technology, which may include telehealth and self-assessment tools, rather than relying solely on standard care or support groups. This approach aims to improve outcomes by encouraging active participation in the rehabilitation process. ^{2 4 6 7 8}

Research Team

William C Miller, PhD

Principal Investigator

The University of British Columbia

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. Netherlands 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. [2022]

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

Walking Exercise Sustainability through Telehealth (WEST) for Veterans with Lower-Limb Amputation: A Study Protocol. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Feasibility of the Nintendo WiiFit™ for improving walking in individuals with a lower limb amputation. [2020]

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

Life habits and prosthetic profile of persons with lower-limb amputation during rehabilitation and at 3-month follow-up. [2009]

5. United States 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. [2023]

6. Sweden pubmed.ncbi.nlm.nih.gov

Clinicians' perspectives on decision making in lower limb amputee rehabilitation. [2022]

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

Self-management improves outcomes in persons with limb loss. [2009]

8. France pubmed.ncbi.nlm.nih.gov

Validity and reliability of Turkish transcultural adaptation of the Prosthetic Limb Users Survey of Mobility. [2023]