Self-Management for Amputee Rehabilitation Using Technology (SMART)

Self-Management for Amputee Rehabilitation Using Technology (SMART) Phase 2

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.

Study Overview

• Status: Completed
• Conditions: Unilateral Trans Tibial/Femoral Lower Limb Amputation
• Intervention / Treatment: Device: Self-Management for Amputee Rehabilitation using Technology [SMART]

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z2G9
      • GF Strong Rehabilitation Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SMART & Peer Support	Device: Self-Management for Amputee Rehabilitation using Technology [SMART]; Participants will complete a 6-week tablet-based education program for individuals with LLA that will provide them with self-management education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timed Up & Go Test (TUG)	Functional assessment of walking capacity measured in seconds over 3 meters walkway	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ambulatory Self-Confidence Questionnaire (ASCQ)	22-item questionnaire where participants are asked to rate questions on a scale from 0 (not confident at all) to 10( extremely confident)	6 weeks
The Center for Epidemiologic Studies Depression Scale (CES-D)	Self-rating measure assessing depression, with final scores ranging from 0 to 60, with total score above 23 indicating clinical depression	6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Revised Amputee Body Image Scale (ABIS-R)	14-item measure that evaluates self perception of body image in individuals with LLA, exploring their feelings about physical appearance, levels of anxiety and comfort in various social situations after amputation. Total ABIS-R score ranges from 20-100, greater score indicates higher body image disturbance.	6 weeks
Pain Questionnaire	A questionnaire will be used to assess both pain frequency and intensity over one week in three categories: residual limb pain (pain in the above portion of the amputated site), phantom limb pain (pain in the missing portion of the limb), and the nonpainful phantom limb sensation (sensations in the missing portion of the limb which were not painful)	6 weeks
Activities Specific Balance Confidence Scale (ABC).	16-item self-report measure that assesses perceived balance confidence, which is important for mobility. Total ABC score ranges from 0-100, with greater score indicating higher levels of balance confidence.	6 weeks
Barthel Index (BI)	10-item scale that measures independence in self-care and mobility	6 weeks
Satisfaction With Life Scale (SWLS)	5-item measure scored on a Likert scale from 1 (strongly disagree) to 7 (strongly agree).	6 weeks
Self-Report Habit Index (SRHI).	12-item questionnaire based on the 7-point Likert scale with the range of total score between 0 to 84, which higher scores show the stronger habit strength	6 weeks
Short Musculoskeletal Function Assessment (SMFA)	Items 1-34 of an assessment of difficulties with daily activities and experiencing problems because of injury.	6 weeks
Physical Activity Identity (PAI)	9-item questionnaire used to assess the extent physical activity is integrated within the concept of self.	6 weeks
Patient Education Material Assessment Tool (PEMAT)	26-item questionnaire used to assess the understandability and actionability of an educational intervention from the perspective of participants.	6 weeks
Perceived Usefulness Questionnaire (PUQ)	17-item questionnaire used to assess the perceived usefulness, ease-of-use, intention to continue usage, and satisfaction of SMART.	6 weeks

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Vancouver Coastal Health Research Institute; GF Strong Rehabilitation Centre

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 26, 2021
• Primary Completion (ACTUAL): August 31, 2021
• Study Completion (ACTUAL): August 31, 2021

Study Registration Dates

• First Submitted: October 7, 2019
• First Submitted That Met QC Criteria: October 8, 2019
• First Posted (ACTUAL): October 9, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 15, 2021
• Last Update Submitted That Met QC Criteria: October 7, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Rehabilitation; Prevalence; Telehealth; Occupational Therapy; Telerehabilitation; Outcomes; Self-Management; Ambulation; Education; Coping Strategies; E-learning; Amputees; Lower-Limb Amputations; Remote Rehabilitation
• Other Study ID Numbers: H19-02241

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No