Spinal Cord InjuriesNCT05063617
SCI Step Together: Improving Physical Activity Participation Among Individuals With SCI Who Ambulate
A study testing SCI Step Together in people with Spinal Cord Injuries, run by University of British Columbia at 1 site in Canada.
Trial summary
The project aims to test the feasibility of a new digital (mHealth) physical activity support program, delivered through an innovative mHealth platform (Curatio) for individuals living with spinal cord injury (SCI) who walk. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- SCI Step Together
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- 29 Jul 2021to 1 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Can read and write in English
- Own a smartphone or tablet
- Are 19 years of age or older
- Are a Canadian or United States resident
- Have sustained a spinal cord injury
- Walk for their daily mode of mobility
Who cannot join
- Have a spinal cord injury but use a wheelchair as primary mode of mobility
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia Okanagan
Kelowna, British Columbia, V1V 1V7
About this study
Official title: Assessing the Acceptability and Feasibility of an mHealth App to Increase the Quantity and Quality of Physical Activity Experiences Among Individuals With Spinal Cord Injury Who Ambulate
The project aims to test the feasibility of a new digital (mHealth) physical activity support program, delivered through an innovative mHealth platform (Curatio) for individuals living with spinal cord injury (SCI) who walk. The rationale for this project is to understand whether a mHealth intervention for increasing the amount and quality of physical activity is feasible for individuals with SCI who walk. The plan is to assess engagement, acceptability and feasibility in addition to primary outcomes related to physical activity behaviour. The investigators hypothesize that the intervention will be feasible and acceptable to deliver to individuals with SCI who walk. The investigators also hypothesize that the intervention will be engaging but recommendations will be made by participants following the study. Finally, it is hypothesized that compared with individuals in the wait-list control group, individuals in the intervention group will experience the following improvements related to exercise after 8-weeks: fulfillment of basic psychological needs, greater autonomous motivation, have enhanced social support, better action control, improved facilitators for behaviour change, more leisure-time physical activity, better quality participation, and enhanced employment.
Read the detailed description
This randomized controlled trial will examine the feasibility and acceptability of a mobile health (mHealth) application called Stronger Together. Stronger Together is an app that hosts programs for individuals with chronic illnesses and disabilities. In this study, the investigators are developing and testing the Stronger Together program that aims to improve the quantity and quality of physical activity among ambulators with SCI. Furthermore, the study will also collect pilot data on the magnitude of the effects on physical activity participation (quality and quantity) and psychosocial influences on physical activity. Individuals living with SCI who walk and live in Canada or the United States will be recruited for this study and will be assigned to either a wait-list control or intervention group. The wait-list control group will be instructed to maintain current health habits and not to engage in any new physical activity or health programs for the next 8-weeks. The wait-list control group will be invited to access the intervention after 8-weeks.
Potential participants will be immediately directed to complete the consent forms/baseline measures in Qualtrics. Once consent and baseline measures are completed, participants will be randomized into either the wait-list control or intervention condition. The investigators will aim to recruit at least 8-10 participants with consent and baseline measures completed before randomization into conditions in order for there to be enough participants in the program at the same time for peer support. After the first 8-10 participants, individuals will be randomized immediately after baseline testing so that participants randomized to the intervention group can join others in the app right away. Randomization will be done by the investigators using a random numbers generator in blocks of 2 and 4 with even groups in each condition (i.e., n=10 per condition). Waitlist-control participants will be directed to continue normal daily activity. Intervention participants will be directed to the App store to download the Stronger Together app to proceed with app registration. Participants will then be connected with the community coach who is a 'real live person' who monitors in-app activity. Other in-app features include peer discussion groups, behavioural support, and educational modules to support strategies to increase the quantity and quality of physical activity.
The 8-week program features weekly blocks of content. Each week builds from the previous week and targets specific components related to the three basic psychological needs (autonomy, relatedness, competence). The overall cadence of each weekly block is maintained throughout. For example, each week contains: 1) education modules 2) a worksheet or guided practice 3) behavioural support from the community coach and 4) peer support from the discussion group. Participants in the intervention group will be encouraged to use the app as often as needed (but at least once per week) and actively participate in the programming. The community coach (SL) will prompt participants who have not engaged in the app in a week to remind participants to complete weekly modules. In-app data, including user metrics will be collected and analyzed for descriptive patterns and assess correlations with the outcome measures (e.g., is the amount of time spent in-app correlated with changes in behaviour).
Participants in both the intervention and control groups will be asked to participate in eight online questionnaires provided through the survey platform Qualtrics at three different time points (baseline/onboarding, 4- and 8-weeks of using the Stronger Together program). A link to these questionnaires which will be hosted on Qualtrics will be emailed to all participants.
After completing the final online survey (at 8-weeks), participants in the intervention group will be invited to participate in an interview to further explore their experiences and to increase understanding of factors that influence acceptability and satisfaction of the Stronger Together program. The interview will be structured whereby the participant will go through the application with the interviewer to discuss preferred components. This will provide a greater understanding of user engagement.
Additionally, feasibility metrics will be kept and recorded throughout the duration of the study.
- Conditions
- Spinal Cord Injuries
- Being tested
- SCI Step Together
- Keywords
- exercise, health promotion, smartphone, telemedicine, recreation
- Medical subject headings
- Spinal Cord Injuries, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCI Step TogetherDevice
The 8-week program features weekly blocks of content. Each week builds from the previous week and targets specific components related to the three basic psychological needs (autonomy, relatedness, competence). The overall cadence of each weekly block is maintained throughout. For example, each week contains: 1) education modules 2) a worksheet or guided practice to apply the strategies in their own goals for that week along with embedded questions to discuss with their community coach 3) behavioural support from the community coach and 4) peer support from the discussion group.
| Study group | Role | What they receive |
|---|---|---|
| Wait-List Control | No intervention | The wait-list control group will be instructed to maintain their current health habits and not to engage in any new physical activity or health programs for the next 8-weeks. The wait-list control group will be invited to access the intervention after 8-weeks. |
| mHealth Intervention | Experimental | Intervention participants will be directed to the App store to download the Stronger Together app to proceed with app registration. Participants will then be connected with the community coach who is a 'real live person' who monitors in-app activity (this will be the program lead, SL). Other in-app features include peer discussion groups, behavioural support, and educational modules to support strategies to increase the quantity and quality of physical activity. Receives: Device: SCI Step Together |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Divide the total number of participants enrolled by the number of participants contacted
Measured: 8 weeks
Eligibility rate
Number of potential participants excluded from the total number of interested participants
Measured: 8 weeks
Retention rate
Number of participants who completed at least some part of the intervention from those who were randomized
Measured: 8 weeks
Adherence rate
Number of participants who completed testing and follow-up measures
Measured: 8 weeks
Costs
Cost of producing software and app, participant remuneration, and cost of health behaviour coach
Measured: 8 weeks
Staff preparation time
The number of hours it requires staff to recruit partners and participants, liaise participants, and enter participant data
Measured: Feasibility metrics will be recorded throughout the study. Feasibility will be assessed at the end of the 8-weeks.
Number of adverse events
Number of health problems reported over the course of the intervention
Measured: 8 weeks
Compliance
The number of modules completed by each intervention participant in the app
Measured: 8 weeks
Number of log ins
The number of times each intervention group participant logs into the app on a weekly basis
Measured: 8 weeks
Duration of log ins
The duration of each log in for each intervention group participant on a weekly basis
Measured: 8 weeks
Qualitative interview
A semi-structured interview with intervention group participants to explore the experiences with the app
Measured: 8 weeks
Basic Psychological Needs - The Psychological Need Satisfaction in Exercise Scale.
Basic Psychological Needs will be assessed using the The Psychological Need Satisfaction in Exercise Scale (Wilson et al., 2006). This 18-item scale assesses the satisfaction of the psychological needs for exercise using a 6-point Likert scale ranging from 1 (false) to 6 (true) (Wilson et al., 2006). A mean can be calculated for each psychological need (6-items each for autonomy, competence, and relatedness) with a higher score representing greater satisfaction of that need.
Measured: Change in Basic Psychological Needs will be assessed at three time points: Baseline, Week 4, and Week 8
Social Support - Sallis' social support questionnaire
Social support will be measured using a modified version of Sallis' social support questionnaire (Sallis et al., 1987). The 7-item survey uses a 6-point Likert-type scale and assesses emotional support (3 items) and practical support (4 items). A higher score means individuals feel a greater sense of social support.
Measured: Change in Social Support will be assessed at three time points: Baseline, Week 4, and Week 8
Autonomous and Controlled Motivation - The Treatment Self-Regulation for Exercise Scale
Motivation will be assessed by the The Treatment Self-Regulation for Exercise Scale. The 15-item scale uses a 7-point Likert scale ranging from 1 (not at all true) to 7 (very true) to assess why one would engage in exercise activities (Levesque et al., 2007). A higher score is more autonomous motivation.
Measured: Change in Motivation will be assessed at three time points: Baseline, Week 4, and Week 8
Behaviour Change Factors - The Determinants of Physical Activity Questionnaire
Behaviour change factors will be assessed using the The Determinants of Physical Activity Questionnaire. A modified version will be used to assess the following domains targeted in the intervention: Knowledge, Beliefs about Capabilities, Skills, Social Influences, Beliefs about Consequences, Action Planning, Coping Planning, and Goal Conflict (24-items). The questionnaire uses a scale from 1 to 7 with 1 being strongly disagree, and 7 being strongly agree.
Measured: Change in Behaviour Change Factors will be assessed at three time points: Baseline, Week 4, and Week 8
Action Control - The Action Control Scale (Sniehotta et al., 2005).
Action control will be assessed with 6 items that ask participants to indicate the extent to which they self-monitor their physical activity (1 = definitely false; 7 = definitely true). (Sniehotta et al., 2005).
Measured: Change in Action Control will be assessed at three time points: Baseline, Week 4, and Week 8
Secondary outcomes (3)
Leisure-Time Physical Activity - The Leisure-Time Physical Activity Questionnaire
Physical activity will be measured using the The Leisure-Time Physical Activity Questionnaire-SCI (LTPAQ-SCI).
Measured: Change in Leisure-Time Physical Activity will be assessed at three time points: Baseline, Week 4, and Week 8
Quality of Physical Activity Participation - Measure of Experiential Aspects of Participation
Quality of physical activity participation will be assessed using The Measure of Experiential Aspects of Participation (MeEAP).The scale is a questionnaire to assess the six experiential aspects of participation (i.e., belongingness, meaning, mastery, engagement, challenge, and autonomy) across life domains (Caron et al., 2019). The scale is completed separately for each life domain with 12-items. Participants will be asked to complete the scale for the exercise and sport domains only, for a total 24 items. Participants respond using a 7-point Likert type scale ranging from 1 (strongly disagree) and 7 (strongly agree).
Measured: Change in Quality of Physical Activity Participation will be assessed at three time points: Baseline, Week 4, and Week 8
Employment - The Short Form Craig Handicap Assessment and Reporting
Employment will be assessed using the Craig Handicap Assessment and Reporting Technique - Short Form (CHART-SF).The CHART-SF will be modified to 2-items for the current study to only assess employment hours and financial earnings.
Measured: Change in Employment will be assessed at three time points: Baseline, Week 4, and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start29 Jul 2021
- Primary completion1 Oct 2021
- Study completion1 Dec 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 Spinal Cord InjuriesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to either a wait-list control or intervention group. The wait-list control group will be instructed to maintain their current health habits and not to engage in any new physical activity or health programs for the next 8-weeks. The wait-list control group will be invited to access the intervention after 8-weeks.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Curatio Networks Inc.
- Responsible party
- Principal investigator, Kathleen Martin Ginis, University of British Columbia
- Investigators
- Kathleen A Martin Ginis, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05063617
- Sponsor's protocol ID
- SCIStepTogether
- Other IDs
- H21-01279
- Status last verified
- May 2022
- First submitted
- 10 Aug 2021
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing individual participant data is not part of our ethical approval.
Publications
Lawrason SVC, Brown-Ganzert L, Campeau L, MacInnes M, Wilkins CJ, Martin Ginis KA. mHealth Physical Activity Intervention for Individuals With Spinal Cord Injury: Planning and Development Processes. JMIR Form Res. 2022 Aug 19;6(8):e34303. doi: 10.2196/34303.
PubMed 35984695
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Acceptability and Feasibility of an mHealth App to Increase the Quantity and Quality of Physical Activity Experiences Among Individuals With Spinal Cord Injury Who Ambulate
- ClinicalTrials.gov ID
- NCT05063617
- Acronym / sponsor ID
- SCIStepTogether
- Conditions
- Spinal Cord Injuries
- Keywords
- exercise, health promotion, smartphone, telemedicine, recreation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Curatio Networks Inc.
- Study start
- 29 Jul 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 1 Oct 2021 (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 project aims to test the feasibility of a new digital (mHealth) physical activity support program, delivered through an innovative mHealth platform (Curatio) for individuals living with spinal cord injury (SCI) who walk. The rationale for this project is to understand whether a mHealth intervention for increasing the amount and quality of physical activity is feasible for individuals with SCI who walk. The plan is to assess engagement, acceptability and feasibility in addition to primary outcomes related to physical activity behaviour. The investigators hypothesize that the intervention will be feasible and acceptable to deliver to individuals with SCI who walk. The investigators also hypothesize that the intervention will be engaging but recommendations will be made by participants following the study. Finally, it is hypothesized that compared with individuals in the wait-list control group, individuals in the intervention group will experience the following improvements related to exercise after 8-weeks: fulfillment of basic psychological needs, greater autonomous motivation, have enhanced social support, better action control, improved facilitators for behaviour change, more leisure-time physical activity, better quality participation, and enhanced employment.
Detailed description
This randomized controlled trial will examine the feasibility and acceptability of a mobile health (mHealth) application called Stronger Together. Stronger Together is an app that hosts programs for individuals with chronic illnesses and disabilities. In this study, the investigators are developing and testing the Stronger Together program that aims to improve the quantity and quality of physical activity among ambulators with SCI. Furthermore, the study will also collect pilot data on the magnitude of the effects on physical activity participation (quality and quantity) and psychosocial influences on physical activity. Individuals living with SCI who walk and live in Canada or the United States will be recruited for this study and will be assigned to either a wait-list control or intervention group. The wait-list control group will be instructed to maintain current health habits and not to engage in any new physical activity or health programs for the next 8-weeks. The wait-list control group will be invited to access the intervention after 8-weeks.
Potential participants will be immediately directed to complete the consent forms/baseline measures in Qualtrics. Once consent and baseline measures are completed, participants will be randomized into either the wait-list control or intervention condition. The investigators will aim to recruit at least 8-10 participants with consent and baseline measures completed before randomization into conditions in order for there to be enough participants in the program at the same time for peer support. After the first 8-10 participants, individuals will be randomized immediately after baseline testing so that participants randomized to the intervention group can join others in the app right away. Randomization will be done by the investigators using a random numbers generator in blocks of 2 and 4 with even groups in each condition (i.e., n=10 per condition). Waitlist-control participants will be directed to continue normal daily activity. Intervention participants will be directed to the App store to download the Stronger Together app to proceed with app registration. Participants will then be connected with the community coach who is a 'real live person' who monitors in-app activity. Other in-app features include peer discussion groups, behavioural support, and educational modules to support strategies to increase the quantity and quality of physical activity.
The 8-week program features weekly blocks of content. Each week builds from the previous week and targets specific components related to the three basic psychological needs (autonomy, relatedness, competence). The overall cadence of each weekly block is maintained throughout. For example, each week contains: 1) education modules 2) a worksheet or guided practice 3) behavioural support from the community coach and 4) peer support from the discussion group. Participants in the intervention group will be encouraged to use the app as often as needed (but at least once per week) and actively participate in the programming. The community coach (SL) will prompt participants who have not engaged in the app in a week to remind participants to complete weekly modules. In-app data, including user metrics will be collected and analyzed for descriptive patterns and assess correlations with the outcome measures (e.g., is the amount of time spent in-app correlated with changes in behaviour).
Participants in both the intervention and control groups will be asked to participate in eight online questionnaires provided through the survey platform Qualtrics at three different time points (baseline/onboarding, 4- and 8-weeks of using the Stronger Together program). A link to these questionnaires which will be hosted on Qualtrics will be emailed to all participants.
After completing the final online survey (at 8-weeks), participants in the intervention group will be invited to participate in an interview to further explore their experiences and to increase understanding of factors that influence acceptability and satisfaction of the Stronger Together program. The interview will be structured whereby the participant will go through the application with the interviewer to discuss preferred components. This will provide a greater understanding of user engagement.
Additionally, feasibility metrics will be kept and recorded throughout the duration of the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be assigned to either a wait-list control or intervention group. The wait-list control group will be instructed to maintain their current health habits and not to engage in any new physical activity or health programs for the next 8-weeks. The wait-list control group will be invited to access the intervention after 8-weeks.
| Arm | Type | Receives |
|---|---|---|
| Wait-List Control | No intervention | –The wait-list control group will be instructed to maintain their current health habits and not to engage in any new physical activity or health programs for the next 8-weeks. The wait-list control group will be invited to access the intervention after 8-weeks. |
| mHealth Intervention | Experimental | Device: SCI Step TogetherIntervention participants will be directed to the App store to download the Stronger Together app to proceed with app registration. Participants will then be connected with the community coach who is a 'real live person' who monitors in-app activity (this will be the program lead, SL). Other in-app features include peer discussion groups, behavioural support, and educational modules to support strategies to increase the quantity and quality of physical activity. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Can read and write in English
- Own a smartphone or tablet
- Are 19 years of age or older
- Are a Canadian or United States resident
- Have sustained a spinal cord injury
Key exclusion criteria (1 listed)
- Have a spinal cord injury but use a wheelchair as primary mode of mobility
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 |
|---|---|---|
| SCI Step TogetherThe 8-week program features weekly blocks of content. Each week builds from the previous week and targets specific components related to the three basic psychological needs (autonomy, relatedness, competence). The overall cadence of each weekly block is maintained throughout. For example, each week contains: 1) education modules 2) a worksheet or guided practice to apply the strategies in their own goals for that week along with embedded questions to discuss with their community coach 3) behavioural support from the community coach and 4) peer support from the discussion group. | Device | mHealth Intervention |
Primary outcome
Recruitment rate
Time frame: 8 weeks
Divide the total number of participants enrolled by the number of participants contacted
Eligibility rate
Time frame: 8 weeks
Number of potential participants excluded from the total number of interested participants
Retention rate
Time frame: 8 weeks
Number of participants who completed at least some part of the intervention from those who were randomized
Adherence rate
Time frame: 8 weeks
Number of participants who completed testing and follow-up measures
Costs
Time frame: 8 weeks
Cost of producing software and app, participant remuneration, and cost of health behaviour coach
Staff preparation time
Time frame: Feasibility metrics will be recorded throughout the study. Feasibility will be assessed at the end of the 8-weeks.
The number of hours it requires staff to recruit partners and participants, liaise participants, and enter participant data
Number of adverse events
Time frame: 8 weeks
Number of health problems reported over the course of the intervention
Compliance
Time frame: 8 weeks
The number of modules completed by each intervention participant in the app
Number of log ins
Time frame: 8 weeks
The number of times each intervention group participant logs into the app on a weekly basis
Duration of log ins
Time frame: 8 weeks
The duration of each log in for each intervention group participant on a weekly basis
Qualitative interview
Time frame: 8 weeks
A semi-structured interview with intervention group participants to explore the experiences with the app
Basic Psychological Needs - The Psychological Need Satisfaction in Exercise Scale.
Time frame: Change in Basic Psychological Needs will be assessed at three time points: Baseline, Week 4, and Week 8
Basic Psychological Needs will be assessed using the The Psychological Need Satisfaction in Exercise Scale (Wilson et al., 2006). This 18-item scale assesses the satisfaction of the psychological needs for exercise using a 6-point Likert scale ranging from 1 (false) to 6 (true) (Wilson et al., 2006). A mean can be calculated for each psychological need (6-items each for autonomy, competence, and relatedness) with a higher score representing greater satisfaction of that need.
Social Support - Sallis' social support questionnaire
Time frame: Change in Social Support will be assessed at three time points: Baseline, Week 4, and Week 8
Social support will be measured using a modified version of Sallis' social support questionnaire (Sallis et al., 1987). The 7-item survey uses a 6-point Likert-type scale and assesses emotional support (3 items) and practical support (4 items). A higher score means individuals feel a greater sense of social support.
Autonomous and Controlled Motivation - The Treatment Self-Regulation for Exercise Scale
Time frame: Change in Motivation will be assessed at three time points: Baseline, Week 4, and Week 8
Motivation will be assessed by the The Treatment Self-Regulation for Exercise Scale. The 15-item scale uses a 7-point Likert scale ranging from 1 (not at all true) to 7 (very true) to assess why one would engage in exercise activities (Levesque et al., 2007). A higher score is more autonomous motivation.
Behaviour Change Factors - The Determinants of Physical Activity Questionnaire
Time frame: Change in Behaviour Change Factors will be assessed at three time points: Baseline, Week 4, and Week 8
Behaviour change factors will be assessed using the The Determinants of Physical Activity Questionnaire. A modified version will be used to assess the following domains targeted in the intervention: Knowledge, Beliefs about Capabilities, Skills, Social Influences, Beliefs about Consequences, Action Planning, Coping Planning, and Goal Conflict (24-items). The questionnaire uses a scale from 1 to 7 with 1 being strongly disagree, and 7 being strongly agree.
Action Control - The Action Control Scale (Sniehotta et al., 2005).
Time frame: Change in Action Control will be assessed at three time points: Baseline, Week 4, and Week 8
Action control will be assessed with 6 items that ask participants to indicate the extent to which they self-monitor their physical activity (1 = definitely false; 7 = definitely true). (Sniehotta et al., 2005).
3 secondary outcomes
Leisure-Time Physical Activity - The Leisure-Time Physical Activity Questionnaire
Time frame: Change in Leisure-Time Physical Activity will be assessed at three time points: Baseline, Week 4, and Week 8
Quality of Physical Activity Participation - Measure of Experiential Aspects of Participation
Time frame: Change in Quality of Physical Activity Participation will be assessed at three time points: Baseline, Week 4, and Week 8
Employment - The Short Form Craig Handicap Assessment and Reporting
Time frame: Change in Employment will be assessed at three time points: Baseline, Week 4, and Week 8
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 18 May 2022.
- Derived from this study: PubMed 35984695Lawrason SVC, Brown-Ganzert L, Campeau L, MacInnes M, Wilkins CJ, Martin Ginis KA. mHealth Physical Activity Intervention for Individuals With Spinal Cord Injury: Planning and Development Processes. JMIR Form Res. 2022 Aug 19;6(8):e34303. doi: 10.2196/34303.
- Individual participant dataSharing planned: No. Sharing individual participant data is not part of our ethical approval.
Related trials for Spinal Cord Injuries
Recruiting
Understanding and Enhancing Human Health and Movement
Spinal Cord Injury, Stroke (CVA) or Transient Ischemic Attack
Not yet recruiting
Influence of Transcranial Electrical Stimulation on Arm and Hand Function After Cervical Spinal Cord Injury
Spinal Cord Injury
Recruiting
Effect of TMS on Neuropathic Pain for Patients With Spinal Cord Injury
Spinal Cord Injury, Neuropathic Pain
Not yet recruiting
Implementation Study on Hospital-to-home Advanced Rehabilitation Technologies (ART)
Brain Injuries
Recruiting
tSCS Combined With Rehabilitation Training in Treating Paraplegic Patients After SCI
Spinal Cord Injury, Paraplegia, Spinal
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.
Kathleen A Martin Ginis, 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 SCI Step Together in people with Spinal Cord Injuries, 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 6 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 18 May 2022. 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?
Recruitment rate (time frame: 8 weeks). The study lists 16 primary outcomes in all. 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 NCT05063617, 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 18 May 2022.