AmputationNCT06667739
Promoting Physical Activity Following Dysvascular Amputation
A study testing IMPACT-L3 in people with Amputation and Lower Limb Amputation Knee, run by West Park Healthcare Centre at 1 site in Canada.
Trial summary
Loss of a lower limb due to diabetes can have a devastating impact on physical and mental health and quality of life. Individuals are at risk of other diseases such as cardiovascular disease, loss of the other limb and death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation, Lower Limb Amputation Knee
- What is being tested?
- IMPACT-L3
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 23 Jan 2025to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dysvascular LLA (LLA due to diabetes or vascular disease)
- major LLA (at the ankle or above)
- living in the community
- adult at least 18 years of age
- comfortable communicating in English and able to understand basic English
- receptive to using a phone or tablet (e.g., to enable peer coaching, access to modules.
Who cannot join
- actively receiving rehabilitation services related to physical activity/mobility
- recommended medical supervision for physical activity by health care provider, or skin problems preventing usual activity
- not able to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
West Park Healthcare Centre
Toronto, Ontario, M6M 2J5
Crystal MacKay, PhD, crystal.mackay@westpark.org
About this study
Official title: A Behaviour Change Intervention Promoting Physical Activity Following Dysvascular Amputation: a Pilot Study
Loss of a lower limb due to diabetes can have a devastating impact on physical and mental health and quality of life. Individuals are at risk of other diseases such as cardiovascular disease, loss of the other limb and death. Physical activity can reduce risk of chronic disease and improve health outcomes; however, physical activity levels in people with limb loss are low, often due to reduced balance and walking ability. Rehabilitation services are not readily available and the cost of delivering such programs remains high. Working with individuals with lower limb amputation, we created a virtual, peer-led physical activity behaviour change intervention called IMproving Physical Activity through Coaching and Technology following Lower Limb Loss (IMPACT-L3). We will conduct a pilot study to assess feasibility and optimize design of a future trial of effectiveness.
Read the detailed description
Background and Importance: Diabetes-related lower limb amputation (LLA) is a leading cause of disability globally, impacting individuals' physical and mental health and ultimately their quality of life. Individuals with LLA due to diabetes or other vascular disease (dysvascular LLA) often have comorbidities, including higher rates of cardiovascular disease than the general population. They are at risk of amputation in the contralateral limb and have high mortality rates (30% at one year).
There is strong evidence demonstrating that physical activity reduces risk of chronic disease and mortality and improves quality of life. However, people with dysvascular LLA often have reduced strength, balance, walking ability and increased energy expenditure during ambulation. Consequently, they have impaired mobility that can lead to sedentary behaviour. Across studies examining physical activity in people with dysvascular LLA, step counts ranged from 1250 steps/day in older prosthesis users to 3809±2189 steps/day in people with diabetes-related LLA. Unfortunately, limited availability of rehabilitation services for people with LLA and the high cost of delivering healthcare interventions makes provision of support for physical activity challenging. To address this gap, we co-created a physical activity intervention, IMproving Physical Activity through Coaching and Technology following Lower Limb Loss (IMPACT-L3), to support physical activity behaviour change in people with dysvascular LLA. Prior to launching a large trial, a pilot study is required to assess feasibility and optimize design of a future trial. This study aims to assess the feasibility of conducting a definitive randomized controlled trial (RCT) to determine the effectiveness of a virtual peer-led physical activity intervention on levels of physical activity and self-efficacy in people with dysvascular LLA. Specific objectives are to: 1) evaluate feasibility according to indicators of process, resources, management and treatment; 2) explore perceptions of program characteristics, program implementation and study procedures among individuals with LLA; 3) explore the perceived feasibility and acceptability of the program among peer coaches; and 4) inform a sample size calculation for a future trial of effectiveness.
Methods: This pilot study is a parallel group RCT with an embedded qualitative component. The intervention group will have access to once-weekly virtual peer coaching sessions with a gender and level of amputation-matched peer trained in brief action planning; web-based physical activity modules; and a wearable activity monitor for 8 weeks. The control group will continue their usual health care and be offered the intervention at the end of the follow-up period. Data on feasibility of implementing the intervention and conducting the trial will be collected including assessment of process, resource, management and treatment indicators. Progression Criteria: A traffic light approach (red, amber, green) will be used to guide the research team in determining what changes may be required to address identified challenges based on the indicators and in determining the feasibility of progression to a trial. The proposed primary outcomes for a future trial will be measured at baseline, post intervention (week 9) and 4 week follow-up: total physical activity counts per day measured by the ActiGraphTM activity monitor and self-efficacy measured by the Self-efficacy for Exercise scale. Other outcome measures include: the Physical Activity Scale for Individuals with Physical Disability, Frenchay Activity Index, the Center for Epidemiologic Studies Depression Scale, Activities-specific Balance Confidence scale, Prosthesis Evaluation Questionnaire - Mobility Section, and Short Form Health Survey 12 Item survey. Semi-structured interviews will explore feasibility and acceptability of the intervention to participants (~15-20 participants) and peers. Inductive thematic analysis will be employed to analyze qualitative interviews.
- Conditions
- Amputation, Lower Limb Amputation Knee
- Being tested
- IMPACT-L3
- Keywords
- Physical activity, Behaviour change, Peer coaching
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMPACT-L3Behavioural
The intervention is a physical activity behaviour change intervention: IMproving Physical Activity through Coaching and Technology following Lower Limb Loss (IMPACT-L3). Two theories provide a framework for IMPACT-L3. One is social cognitive theory and the other is self-determination theory. As mHealth solutions have the potential to increase access and improve health outcomes, IMPACT-L3 will be delivered entirely virtually.
| Study group | Role | What they receive |
|---|---|---|
| IMPACT-L3 | Experimental | The experimental group will receive virtual peer health coaching (~30 minutes weekly) delivered by a peer trainer over 8 weeks. Peer trainers with dysvascular LLA themselves will be matched to a participant based on gender and level of amputation. The peer will help participants set goals and create an action plan for physical activity. Peers will receive specialized training in brief action planning. Participants will have access to five web-based modules. Modules include content on benefits of physical activity, types of physical activity (strengthening, aerobic, balance, flexibility), intensity of activity (light, moderate, vigorous), and exercise safety. Participants will complete modules weekly at their own pace for the first 5 weeks. To support behaviour change, participants will be provided with a wearable to track their physical activity: an Apple Watch to be worn at the wrist of the non-dominant side. Receives: Behavioral: IMPACT-L3 |
| Control | No intervention | The control group will continue with their usual health care and be offered the intervention program at the end of the follow-up period (wait-list control). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consent rate: the percent of recruited individuals who provide consent per month.
Measured: 8 weeks
Withdrawal Rate: the percent of study participants withdrawing by 9 weeks and 4 week follow-up
Measured: enrollment to 13 weeks
Peer coach adherence: total number of peer coaching sessions attended by the peer-trainer.
Measured: enrollment to 8 weeks
Participant and tester burden: the amount of time it took to administer study outcomes at T1, T2, and T3 and the acceptability of the evaluation time commitment from the perspective of participants.
Measured: Baseline, end of intervention (week 9) and 4 week follow-up
Feasibility of data collection: percentage of participants with complete data on each measure at each evaluation time point.
For accelerometers, the percentage of devices that were returned at baseline and follow-up.
Measured: Baseline, end of intervention (week 9) and 4 week follow-up
Participant processing time: time from initial contact to enrollment.
Measured: 8 weeks
Intervention fidelity: study-specific checklist outlining key components of the intervention completed by peers.
A subset of peer coaching sessions will be recorded and reviewed by research staff.
Measured: enrollment to 8 weeks
Adverse events: the number of adverse events that occurred during physical activity for the intervention.
Adverse events (e.g., falls) will be documented by peers on the standardized form used at each coaching sessions.
Measured: enrollment to 8 weeks
Usage of web-based module: number of completed modules and number of logins.
Measured: enrollment to 8 weeks
Participant recruitment rate: the number and proportion of participants recruited per month
Measured: 8 weeks
Peer recruitment: number of peers recruited
Measured: 2 years
Participant adherence: the percentage of peer coaching sessions participants attend.
Measured: enrollment to 8 weeks
The theoretical framework of acceptability (TFA) questionnaire
Description: A brief questionnaire developed to assess acceptability in the design, evaluation and implementation of interventions.
Measured: week 9
Secondary outcomes (11)
Objective physical activity
A tri-axial accelerometer is a lightweight device used to measure total activity counts. The sum of the total count for the day will be used and averaged over the measurement period.
Measured: Baseline, week 9, 4 week follow-up
Self-efficacy for Exercise Scale
A self-report measure (9 items) that includes situations that may influence physical activity participation. Participants will respond to each item on a 0 (not very confident) to 10 (very confident) scale.
Measured: Baseline, week 9, 4 week follow-up
Self-Regulatory Efficacy for Exercise
8-item measure to assess participants' confidence in their ability to manage their exercise.
Measured: Baseline, week 9, 4 week follow-up
Center for Epidemiologic Studies Depression Scale (CES-D)
The CES-D will assess participant\'s self-rated depressive symptoms. It is a 20-item scale that refers to symptoms in the last week.
Measured: Baseline, week 9, 4 week follow-up
The Physical Activity Scale for Individuals with Physical Disability (PASIPD)
The PASIPD is a 13-item questionnaire with subscales measuring leisure time, household and work-related activities.
Measured: Baseline, week 9, 4 week follow-up
Leisure-Time Physical Activity for People with Disabilities Questionnaire (LTPAQ-D)
The LTPAQ-D is a self-report measure that assesses minutes of mild-, moderate-, and vigorous-intensity leisure time physical activity (i.e., activity that requires physical exertion and that one chooses to do in their free time performed over the past 7 days.
Measured: Baseline, week 9, 4 week follow-up
Activities-specific Balance Confidence scale (ABC)
ABC is a self-report measure used to assess perceived balance confidence.
Measured: Baseline, week 9, 4 week follow-up
Prosthesis Evaluation Questionnaire - Mobility Section (PEQ-MS)
The PEQ-MS score will be used to measure the amount of difficulty completing locomotion tasks.
Measured: Baseline, week 9, 4 week follow-up
Short Form Health Survey 12 Item survey (SF-12)
The SF-12 will be used to measure health related quality of life.
Measured: Baseline, week 9, 4 week follow-up
Frenchay Activities Index (FAI)
The 15-item FAI captures information on social activities. The items reflect the frequency of performance of basic and instrumental activities of daily living over three domains.
Measured: Baseline, week 9, 4 week follow-up
Self Efficacy for Exercise: Dysvascular Lower Limb Amputees
4-item measure will be administered in addition the standardized self-efficacy for exercise measure and self-regulatory efficacy for exercise measure to address contextual factors relevant to dysvascular lower limb amputees.
Measured: Baseline, week 9, 4 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start23 Jan 2025
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This pilot study is a parallel group randomized controlled trial with an embedded qualitative component.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West Park Healthcare Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Crystal MacKay, PhD, Principal investigator, West Park Healthcare Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06667739
- Sponsor's protocol ID
- 24-001-WP
- Status last verified
- Feb 2025
- First submitted
- 23 Aug 2024
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Behaviour Change Intervention Promoting Physical Activity Following Dysvascular Amputation: a Pilot Study
- ClinicalTrials.gov ID
- NCT06667739
- Acronym / sponsor ID
- 24-001-WP
- Conditions
- Amputation, Lower Limb Amputation Knee
- Keywords
- Physical activity, Behaviour change, Peer coaching
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- West Park Healthcare CentreUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 23 Jan 2025 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 31 Oct 2024 (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.
Loss of a lower limb due to diabetes can have a devastating impact on physical and mental health and quality of life. Individuals are at risk of other diseases such as cardiovascular disease, loss of the other limb and death. Physical activity can reduce risk of chronic disease and improve health outcomes; however, physical activity levels in people with limb loss are low, often due to reduced balance and walking ability. Rehabilitation services are not readily available and the cost of delivering such programs remains high. Working with individuals with lower limb amputation, we created a virtual, peer-led physical activity behaviour change intervention called IMproving Physical Activity through Coaching and Technology following Lower Limb Loss (IMPACT-L3). We will conduct a pilot study to assess feasibility and optimize design of a future trial of effectiveness.
Detailed description
Background and Importance: Diabetes-related lower limb amputation (LLA) is a leading cause of disability globally, impacting individuals' physical and mental health and ultimately their quality of life. Individuals with LLA due to diabetes or other vascular disease (dysvascular LLA) often have comorbidities, including higher rates of cardiovascular disease than the general population. They are at risk of amputation in the contralateral limb and have high mortality rates (30% at one year).
There is strong evidence demonstrating that physical activity reduces risk of chronic disease and mortality and improves quality of life. However, people with dysvascular LLA often have reduced strength, balance, walking ability and increased energy expenditure during ambulation. Consequently, they have impaired mobility that can lead to sedentary behaviour. Across studies examining physical activity in people with dysvascular LLA, step counts ranged from 1250 steps/day in older prosthesis users to 3809±2189 steps/day in people with diabetes-related LLA. Unfortunately, limited availability of rehabilitation services for people with LLA and the high cost of delivering healthcare interventions makes provision of support for physical activity challenging. To address this gap, we co-created a physical activity intervention, IMproving Physical Activity through Coaching and Technology following Lower Limb Loss (IMPACT-L3), to support physical activity behaviour change in people with dysvascular LLA. Prior to launching a large trial, a pilot study is required to assess feasibility and optimize design of a future trial. This study aims to assess the feasibility of conducting a definitive randomized controlled trial (RCT) to determine the effectiveness of a virtual peer-led physical activity intervention on levels of physical activity and self-efficacy in people with dysvascular LLA. Specific objectives are to: 1) evaluate feasibility according to indicators of process, resources, management and treatment; 2) explore perceptions of program characteristics, program implementation and study procedures among individuals with LLA; 3) explore the perceived feasibility and acceptability of the program among peer coaches; and 4) inform a sample size calculation for a future trial of effectiveness.
Methods: This pilot study is a parallel group RCT with an embedded qualitative component. The intervention group will have access to once-weekly virtual peer coaching sessions with a gender and level of amputation-matched peer trained in brief action planning; web-based physical activity modules; and a wearable activity monitor for 8 weeks. The control group will continue their usual health care and be offered the intervention at the end of the follow-up period. Data on feasibility of implementing the intervention and conducting the trial will be collected including assessment of process, resource, management and treatment indicators. Progression Criteria: A traffic light approach (red, amber, green) will be used to guide the research team in determining what changes may be required to address identified challenges based on the indicators and in determining the feasibility of progression to a trial. The proposed primary outcomes for a future trial will be measured at baseline, post intervention (week 9) and 4 week follow-up: total physical activity counts per day measured by the ActiGraphTM activity monitor and self-efficacy measured by the Self-efficacy for Exercise scale. Other outcome measures include: the Physical Activity Scale for Individuals with Physical Disability, Frenchay Activity Index, the Center for Epidemiologic Studies Depression Scale, Activities-specific Balance Confidence scale, Prosthesis Evaluation Questionnaire - Mobility Section, and Short Form Health Survey 12 Item survey. Semi-structured interviews will explore feasibility and acceptability of the intervention to participants (~15-20 participants) and peers. Inductive thematic analysis will be employed to analyze qualitative interviews.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This pilot study is a parallel group randomized controlled trial with an embedded qualitative component.
| Arm | Type | Receives |
|---|---|---|
| IMPACT-L3 | Experimental | Behavioral: IMPACT-L3The experimental group will receive virtual peer health coaching (~30 minutes weekly) delivered by a peer trainer over 8 weeks. Peer trainers with dysvascular LLA themselves will be matched to a participant based on gender and level of amputation. The peer will help participants set goals and create an action plan for physical activity. Peers will receive specialized training in brief action planning. Participants will have access to five web-based modules. Modules include content on benefits of physical activity, types of physical activity (strengthening, aerobic, balance, flexibility), intensity of activity (light, moderate, vigorous), and exercise safety. Participants will complete modules weekly at their own pace for the first 5 weeks. To support behaviour change, participants will be provided with a wearable to track their physical activity: an Apple Watch to be worn at the wrist of the non-dominant side. |
| Control | No intervention | –The control group will continue with their usual health care and be offered the intervention program at the end of the follow-up period (wait-list control). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Dysvascular LLA (LLA due to diabetes or vascular disease)
- major LLA (at the ankle or above)
- living in the community
- adult at least 18 years of age
- comfortable communicating in English and able to understand basic English
Key exclusion criteria (3 listed)
- actively receiving rehabilitation services related to physical activity/mobility
- recommended medical supervision for physical activity by health care provider, or skin problems preventing usual activity
- not able to provide informed consent.
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 |
|---|---|---|
| IMPACT-L3The intervention is a physical activity behaviour change intervention: IMproving Physical Activity through Coaching and Technology following Lower Limb Loss (IMPACT-L3). Two theories provide a framework for IMPACT-L3. One is social cognitive theory and the other is self-determination theory. As mHealth solutions have the potential to increase access and improve health outcomes, IMPACT-L3 will be delivered entirely virtually. | Behavioural | IMPACT-L3 |
Primary outcome
Consent rate: the percent of recruited individuals who provide consent per month.
Time frame: 8 weeks
Withdrawal Rate: the percent of study participants withdrawing by 9 weeks and 4 week follow-up
Time frame: enrollment to 13 weeks
Peer coach adherence: total number of peer coaching sessions attended by the peer-trainer.
Time frame: enrollment to 8 weeks
Participant and tester burden: the amount of time it took to administer study outcomes at T1, T2, and T3 and the acceptability of the evaluation time commitment from the perspective of participants.
Time frame: Baseline, end of intervention (week 9) and 4 week follow-up
Feasibility of data collection: percentage of participants with complete data on each measure at each evaluation time point.
Time frame: Baseline, end of intervention (week 9) and 4 week follow-up
For accelerometers, the percentage of devices that were returned at baseline and follow-up.
Participant processing time: time from initial contact to enrollment.
Time frame: 8 weeks
Intervention fidelity: study-specific checklist outlining key components of the intervention completed by peers.
Time frame: enrollment to 8 weeks
A subset of peer coaching sessions will be recorded and reviewed by research staff.
Adverse events: the number of adverse events that occurred during physical activity for the intervention.
Time frame: enrollment to 8 weeks
Adverse events (e.g., falls) will be documented by peers on the standardized form used at each coaching sessions.
Usage of web-based module: number of completed modules and number of logins.
Time frame: enrollment to 8 weeks
Participant recruitment rate: the number and proportion of participants recruited per month
Time frame: 8 weeks
Peer recruitment: number of peers recruited
Time frame: 2 years
Participant adherence: the percentage of peer coaching sessions participants attend.
Time frame: enrollment to 8 weeks
The theoretical framework of acceptability (TFA) questionnaire
Time frame: week 9
Description: A brief questionnaire developed to assess acceptability in the design, evaluation and implementation of interventions.
11 secondary outcomes
Objective physical activity
Time frame: Baseline, week 9, 4 week follow-up
Self-efficacy for Exercise Scale
Time frame: Baseline, week 9, 4 week follow-up
Self-Regulatory Efficacy for Exercise
Time frame: Baseline, week 9, 4 week follow-up
Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: Baseline, week 9, 4 week follow-up
The Physical Activity Scale for Individuals with Physical Disability (PASIPD)
Time frame: Baseline, week 9, 4 week follow-up
Leisure-Time Physical Activity for People with Disabilities Questionnaire (LTPAQ-D)
Time frame: Baseline, week 9, 4 week follow-up
Activities-specific Balance Confidence scale (ABC)
Time frame: Baseline, week 9, 4 week follow-up
Prosthesis Evaluation Questionnaire - Mobility Section (PEQ-MS)
Time frame: Baseline, week 9, 4 week follow-up
Short Form Health Survey 12 Item survey (SF-12)
Time frame: Baseline, week 9, 4 week follow-up
Frenchay Activities Index (FAI)
Time frame: Baseline, week 9, 4 week follow-up
Self Efficacy for Exercise: Dysvascular Lower Limb Amputees
Time frame: Baseline, week 9, 4 week follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Amputation
Recruiting
Bio Leg: Advancing Mobility (BAM)
Amputation of Lower Limb Above Knee, Amputee
Recruiting
Impact of Footwear on Gait in Unilateral Transtibial Amputees
Transtibial Amputation, Lower Limb Amputation
Recruiting
Prosthetic Socket Fit Testing System
Amputation
Recruiting
TENS for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception
Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee
Recruiting
Clinical Feasibility of the IMES Transradial Prosthesis
Amputation
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.
Crystal MacKay, PhD principal investigator
West Park Healthcare Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMPACT-L3 in people with Amputation and Lower Limb Amputation Knee, run by West Park Healthcare Centre 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 6 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 24 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Crystal MacKay, PhD, PT ((613) 533-6103, crystal.mackay@westpark.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consent rate: the percent of recruited individuals who provide consent per month. (time frame: 8 weeks). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2025.