Clinical trial NCT04120038: Self-Management for Amputee Rehabilitation Using Technology
Official title: Self-Management for Amputee Rehabilitation Using Technology (SMART) Phase 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unilateral Trans Tibial/Femoral Lower Limb Amputation
Keywords: Occupational Therapy
Rehabilitation
Lower-Limb Amputations
Amputees
Telehealth
Remote Rehabilitation
Telerehabilitation
E-learning
Education
Self-Management
Ambulation
Coping Strategies
Outcomes
Prevalence
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Vancouver Coastal Health Research Institute
name: GF Strong Rehabilitation Centre
First posted: 2019-10-09
Enrollment: 12
Sex: ALL
Minimum age (years): 19
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this study is to determine the effect of 6 weeks of the SMART Program on the walking capacity and confidence of individuals with unilateral lower limb amputation (LLA). Our primary hypothesis is that SMART can improve walking capacity in individuals with LLA. Our secondary hypothesis is that SMART can improve ambulation confidence, body function, depression, body image, pain, balance confidence, activities of daily living, satisfaction with life and habit formation for skin monitoring and prosthetic cleaning in individuals with LLA. A post-intervention one on one interview will be conducted to understand SMART acceptability. The entirety of the study, including intervention administration, assessment, and interviews will be conducted online.

Detailed description: Participants will receive an online link to access the SMART platform. Online training on using the SMART platform will be provided for participants. Participants will be asked to complete one education module per week at their own convenience and weekly online meetings with a peer over the 6-week intervention period. The educational modules include psychological adaptation, residual limb management, nutrition/weight control, managing a prosthetic limb, managing chronic conditions and enhancing mobility. The modules include instructional movies, goal setting logs, and quizzes. A module can be stopped or "re-wound" at any point, and the participant's place and work-to-date is automatically saved. The SMART platform will be asynchronously monitored through a web portal by the trainer, who will be a PhD candidate in Rehabilitation Sciences and observe participant progress and provide feedback if required. If there is no online activity within a 7-day (consecutive) period, the trainer will contact the participant to inquire the reasons for inactivity and troubleshoot any problems including technical issues. Clinical outcomes measures will be collected at two timepoints (T1 \& T2). A post-intervention one on one interview will be conducted to explore SMART acceptability.

Eligibility criteria: Inclusion Criteria:

1. adults who are 19 years of age or older.
2. individuals who are post unilateral transtibial/transfemoral amputation and casted an initial prosthesis within the past year.
3. English speaking.
4. living in British Columbia or Ontario, Canada.
5. have access to an internet connectable device (e.g., computer or tablet)

Exclusion Criteria:

1) people who are unable to use SMART program (e.g., visual, auditory, cognitive, or physical impairments)

Primary outcomes:
measure: Timed Up & Go Test (TUG)
timeFrame: 6 weeks
Secondary outcomes:
measure: Ambulatory Self-Confidence Questionnaire (ASCQ)
timeFrame: 6 weeks
measure: The Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: 6 weeks
Other outcomes:
measure: Revised Amputee Body Image Scale (ABIS-R)
timeFrame: 6 weeks
measure: Pain Questionnaire
timeFrame: 6 weeks
measure: Activities Specific Balance Confidence Scale (ABC).
timeFrame: 6 weeks
measure: Barthel Index (BI)
timeFrame: 6 weeks
measure: Satisfaction With Life Scale (SWLS)
timeFrame: 6 weeks
measure: Self-Report Habit Index (SRHI).
timeFrame: 6 weeks
measure: Short Musculoskeletal Function Assessment (SMFA)
timeFrame: 6 weeks
measure: Physical Activity Identity (PAI)
timeFrame: 6 weeks
measure: Patient Education Material Assessment Tool (PEMAT)
timeFrame: 6 weeks
measure: Perceived Usefulness Questionnaire (PUQ)
timeFrame: 6 weeks
Locations:
city: Vancouver
country: Canada
facility: GF Strong Rehabilitation Centre
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: William C Miller, PhD
role: PRINCIPAL_INVESTIGATOR
References: