Protocol for a randomized controlled trial to assess the effect of Self-Management for Amputee Rehabilitation using Technology (SMART): An online self-management program for individuals with lower limb loss.

BACKGROUND: Lower limb loss (LLL) is a distressing experience with psychological, physical, and social challenges. Education is needed to enhance the coping skills and confidence of patients to improve LLL outcomes. However, access to rehabilitation services and education is limited outside of urban centers. To address this service gap, we co-created an eHealth platform, called Self-Management for Amputee Rehabilitation using Technology (SMART). OBJECTIVES: First, we will test the effect of SMART and usual care compared with usual care only on walking capacity and confidence among individuals with LLL. Second, we will describe key implementation factors for program delivery and adoption at the person- and provider-level. METHODS: This is a Type 1 Effectiveness-Implementation Hybrid Design, mixed-methods, multi-site (British Columbia and Ontario, Canada), parallel, assessor-blinded randomized controlled trial. Participants will include adults with unilateral LLL, during early prosthetic fitting (<2 years after casting for initial prosthesis). Participants in both groups will receive usual care. The experimental group will receive SMART with weekly support sessions from a trained peer mentor for goal setting and action planning for six weeks. Participants will be encouraged to continue using SMART for an additional four weeks. The control group will receive usual care, and weekly social contacts for six weeks. The primary outcome measure is walking capacity operationalized as the performance based Timed Up and Go test. The secondary outcome is walking confidence using the Ambulatory Self-Confidence Questionnaire. Outcome measures will be assessed at baseline, immediately post-intervention, and four weeks follow-up. We will describe key implementation factors (such as, participant experience, intervention adoption, fidelity) throughout the study using questionnaires, semi-structured interviews, and direct observation. RESULTS: No participants have been enrolled. CONCLUSIONS: SMART has the potential to provide knowledge and skill development to augment rehabilitation outcomes for adults with LLL. TRIAL REGISTRATION: NCT04953364 in Clinical Trial Registry (https://clinicaltrials.gov/).

Identifying priorities and developing strategies for building capacity in amputation research in Canada.

BACKGROUND: Compared to other patient population groups, the field of amputation research in Canada lacks cohesion largely due to limited funding sources, lack of connection among research scientists, and loose ties among geographically dispersed healthcare centres, research institutes and advocacy groups. As a result, advances in clinical care are hampered and ultimately negatively influence outcomes of persons living with limb loss. OBJECTIVE: To stimulate a national strategy on advancing amputation research in Canada, a consensus-workshop was organized with an expert panel of stakeholders to identify key research priorities and potential strategies to build researcher and funding capacity in the field. METHODS: A modified Delphi approach was used to gain consensus on identifying and selecting an initial set of priorities for building research capacity in the field of amputation. This included an anonymous pre-meeting survey (N = 31 respondents) followed by an in-person consensus-workshop meeting that hosted 38 stakeholders (researchers, physiatrists, surgeons, prosthetists, occupational and physical therapists, community advocates, and people with limb loss). RESULTS: The top three identified research priorities were: (1) developing a national dataset; (2) obtaining health economic data to illustrate the burden of amputation to the healthcare system and to patients; and (3) improving strategies related to outcome measurement in patients with limb loss (e.g. identifying, validating, and/or developing outcome measures). Strategies for moving these priorities into action were also developed. CONCLUSIONS: The consensus-workshop provided an initial roadmap for limb loss research in Canada, and the event served as an important catalyst for stakeholders to initiate collaborations for moving identified priorities into action. Given the increasing number of people undergoing an amputation, there needs to be a stronger Canadian collaborative approach to generate the necessary research to enhance evidence-based clinical care and policy decision-making.IMPLICATIONS FOR REHABILITATIONLimb loss is a growing concern across North America, with lower-extremity amputations occurring due to complications arising from diabetes being a major cause.To advance knowledge about limb loss and to improve clinical care for this population, stronger connections are needed across the continuum of care (acute, rehabilitation, community) and across sectors (clinical, advocacy, industry and research).There are new surgical techniques, technologies, and rehabilitation approaches being explored to improve the health, mobility and community participation of people with limb loss, but further research evidence is needed to demonstrate efficacy and to better integrate them into standard clinical care.

Cognitive-behavioral prevention of postconcussion syndrome in at-risk patients: a pilot randomized controlled trial.

OBJECTIVE: To examine the tolerability and estimate the treatment effect of cognitive-behavioral therapy (CBT) delivered soon after mild traumatic brain injury to patients at risk for chronic postconcussion syndrome (PCS). SETTING: Tertiary rehabilitation center. PARTICIPANTS: Twenty-eight patients with uncomplicated mild traumatic brain injury, determined to be at risk for chronic PCS based on a published algorithm that incorporates subacute postconcussion symptoms and maladaptive illness beliefs (recovery expectations and perceived consequences). They were enrolled within 6 weeks postinjury. DESIGN: Open-label, parallel-group, randomized controlled trial, with masked outcome assessment 3 months after enrolment. Interventions were (1) treatment as usual (education, reassurance, and symptom management strategies) from an occupational therapist, or (2) treatment as usual plus CBT delivered by a psychologist. MAIN MEASURES: Rivermead Postconcussion Symptoms Questionnaire. RESULTS: Four participants (2:2) withdrew. Treatment credibility and satisfaction ratings were high in the CBT group. Treatment effect sizes were moderate for postconcussion symptoms (Cohen d = 0.74) and moderate-large for most secondary outcome measures (Cohen d = 0.62-1.61). Fewer participants receiving CBT had a diagnosis of PCS at follow-up (54% vs 91%, P < .05). CONCLUSION: Our preliminary data suggest that CBT delivered soon after mild traumatic brain injury is well tolerated and may facilitate recovery in patients who are at risk for chronic PCS. A definitive clinical trial is warranted.

A comparison of two prosthetic feet on the multi-joint and multi-plane kinetic gait compensations in individuals with a unilateral trans-tibial amputation.

OBJECTIVE: To determine the effects of two different prosthetic feet on the three-dimensional kinetic patterns of both the prosthetic and sound limbs during unilateral trans-tibial amputee gait. DESIGN: Eleven individuals with a unilateral trans-tibial amputation participated in two walking sessions: once while using the conventional SAFE foot, the other while using the dynamic Flex foot. BACKGROUND: Despite the wide variation in the design of prosthetic feet, the benefits of these prostheses remain unclear. METHODS: During each test session, peak joint moments and powers in the sagittal, transverse and frontal planes were examined, as subjects walked at a comfortable speed. RESULTS: The majority of the kinetic differences that occurred due to the changing of prosthetic foot type were limited to ankle joint variables in the sagittal plane with greater peak moments and power during propulsion for the Flex foot compared to the SAFE foot. However, effects were also found at joints proximal to the prosthesis (e.g. knee) and differences were also found in the kinetics of the sound limb. CONCLUSION: The dynamic Flex foot allowed subjects to rely more heavily on the prosthetic foot for propulsion and stability during walking with minimal compensations at the remaining joints. RELEVANCE: Determining the biomechanical differences between the conventional and dynamic prosthetic feet may advocate the use of one prosthetic foot type over another. This information, when used in conjunction with subjective preferences, may contribute to higher functioning and greater satisfaction for individuals with a lower limb amputation.