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OpenTrials
Completed

NCT Number: NCT04120038

Self-Management for Amputee Rehabilitation Using Technology

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.

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Key information

Conditions

Unilateral Trans Tibial/Femoral Lower Limb Amputation

Age range

19 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GF Strong Rehabilitation Centre

Vancouver, British Columbia, V5Z2G9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Self-Management for Amputee Rehabilitation using Technology [SMART]

Device

Participants will complete a 6-week tablet-based education program for individuals with LLA that will provide them with self-management education.

Primary outcomes

  1. Timed Up & Go Test (TUG)

    Time frame: 6 weeks

    Functional assessment of walking capacity measured in seconds over 3 meters walkway

Secondary outcomes

  1. Ambulatory Self-Confidence Questionnaire (ASCQ)

    Time frame: 6 weeks

    22-item questionnaire where participants are asked to rate questions on a scale from 0 (not confident at all) to 10( extremely confident)

  2. The Center for Epidemiologic Studies Depression Scale (CES-D)

    Time frame: 6 weeks

    Self-rating measure assessing depression, with final scores ranging from 0 to 60, with total score above 23 indicating clinical depression

Other outcomes

  1. Revised Amputee Body Image Scale (ABIS-R)

    Time frame: 6 weeks

    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.

  2. Pain Questionnaire

    Time frame: 6 weeks

    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)

  3. Activities Specific Balance Confidence Scale (ABC).

    Time frame: 6 weeks

    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.

  4. Barthel Index (BI)

    Time frame: 6 weeks

    10-item scale that measures independence in self-care and mobility

  5. Satisfaction With Life Scale (SWLS)

    Time frame: 6 weeks

    5-item measure scored on a Likert scale from 1 (strongly disagree) to 7 (strongly agree).

  6. Self-Report Habit Index (SRHI).

    Time frame: 6 weeks

    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

  7. Short Musculoskeletal Function Assessment (SMFA)

    Time frame: 6 weeks

    Items 1-34 of an assessment of difficulties with daily activities and experiencing problems because of injury.

  8. Physical Activity Identity (PAI)

    Time frame: 6 weeks

    9-item questionnaire used to assess the extent physical activity is integrated within the concept of self.

  9. Patient Education Material Assessment Tool (PEMAT)

    Time frame: 6 weeks

    26-item questionnaire used to assess the understandability and actionability of an educational intervention from the perspective of participants.

  10. Perceived Usefulness Questionnaire (PUQ)

    Time frame: 6 weeks

    17-item questionnaire used to assess the perceived usefulness, ease-of-use, intention to continue usage, and satisfaction of SMART.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • GF Strong Rehabilitation Centre
  • Vancouver Coastal Health Research Institute

Registry information

Official study title

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

Acronym: SMART

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 9, 2019
Registry last updated
Oct 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.