Unilateral Trans Tibial/Femoral Lower Limb AmputationSMARTNCT04120038
Self-Management for Amputee Rehabilitation Using Technology
A study testing Self-Management for Amputee Rehabilitation using Technology [SMART] in people with Unilateral Trans Tibial/Femoral Lower Limb Amputation, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 100 years
- Conditions the study is for
- Unilateral Trans Tibial/Femoral Lower Limb Amputation
- What is being tested?
- Self-Management for Amputee Rehabilitation using Technology [SMART]
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 26 Jan 2021to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 1) people who are unable to use SMART program (e.g., visual, auditory, cognitive, or physical impairments)
Trial locations and contacts
1 site in 1 country.
Canada1 site
GF Strong Rehabilitation Centre
Vancouver, British Columbia, V5Z2G9
About this study
Official title: 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.
Read the 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.
- Being tested
- Self-Management for Amputee Rehabilitation using Technology [SMART]
- Keywords
- Occupational Therapy, Rehabilitation, Lower-Limb Amputations, Amputees, Telehealth, Remote Rehabilitation, Telerehabilitation, E-learning, Education, Self-Management, Ambulation, Coping Strategies, Outcomes, Prevalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| SMART & Peer Support | Experimental | Not described Receives: Device: Self-Management for Amputee Rehabilitation using Technology [SMART] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up & Go Test (TUG)
Functional assessment of walking capacity measured in seconds over 3 meters walkway
Measured: 6 weeks
Secondary outcomes (2)
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)
Measured: 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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start26 Jan 2021
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unilateral Trans Tibial/Femoral Lower Limb AmputationStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Vancouver Coastal Health Research Institute, GF Strong Rehabilitation Centre
- Responsible party
- Principal investigator, William C. Miller, University of British Columbia
- Investigators
- William C Miller, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04120038
- Sponsor's protocol ID
- H19-02241
- Acronym
- SMART
- Status last verified
- Oct 2021
- First submitted
- 7 Oct 2019
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
B Aledi L, Flumignan CD, Trevisani VF, Miranda F Jr. Interventions for motor rehabilitation in people with transtibial amputation due to peripheral arterial disease or diabetes. Cochrane Database Syst Rev. 2023 Jun 5;6(6):CD013711. doi: 10.1002/14651858.CD013711.pub2.
PubMed 37276273
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Management for Amputee Rehabilitation Using Technology (SMART) Phase 2
- ClinicalTrials.gov ID
- NCT04120038
- Acronym / sponsor ID
- SMART / H19-02241
- Keywords
- Occupational Therapy, Rehabilitation, Lower-Limb Amputations, Amputees, Telehealth, Remote Rehabilitation, Telerehabilitation, E-learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Vancouver Coastal Health Research Institute, GF Strong Rehabilitation Centre
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 9 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SMART & Peer Support | Experimental | Device: Self-Management for Amputee Rehabilitation using Technology [SMART] |
Who may qualify
- Ages
- 19 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (1 listed)
- 1) people who are unable to use SMART program (e.g., visual, auditory, cognitive, or physical impairments)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | SMART & Peer Support |
Primary outcome
Timed Up & Go Test (TUG)
Time frame: 6 weeks
Functional assessment of walking capacity measured in seconds over 3 meters walkway
2 secondary outcomes
Ambulatory Self-Confidence Questionnaire (ASCQ)
Time frame: 6 weeks
The Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Derived from this study: PubMed 37276273B Aledi L, Flumignan CD, Trevisani VF, Miranda F Jr. Interventions for motor rehabilitation in people with transtibial amputation due to peripheral arterial disease or diabetes. Cochrane Database Syst Rev. 2023 Jun 5;6(6):CD013711. doi: 10.1002/14651858.CD013711.pub2.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William C Miller, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Management for Amputee Rehabilitation using Technology [SMART] in people with Unilateral Trans Tibial/Femoral Lower Limb Amputation, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up & Go Test (TUG) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04120038, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021.