Spinal Cord InjuryNCT06040749
Virtual Sport for Adults ≥ 50 Years With Spinal Cord Injury
A study testing Virtual group-based handcycling in people with Spinal Cord Injury, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Sport is a physical activity that has many physical, psychological and social benefits for those with spinal cord injury (SCI). However, most sport research involves people with SCI who are <50 years old. This is a problem because many people are >50 years old when first injured. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Virtual group-based handcycling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- 5 May 2023to 30 Sep 2024
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sustained a traumatic or non-progressive, non-traumatic SCI,
- Chronic stage of recovery (i.e., ≥12 months post-SCI),
- ≥50 years old,
- Be a manual wheelchair user,
- Able to understand spoken English,
- Can attend two virtual handcycling sessions/week for 12 weeks and attend on-site assessments,
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- Does not intend to change usual physical activity routine throughout duration of the intervention,
- Be cleared to participate in exercise (determined through completion of the 2022 Physical Activity Readiness Questionnaire for Everyone (PAR-Q+)58),
- Able to secure hands on handlebars with or without assistance during at-home sessions,
- Has one emergency contact who can be promptly reached at any point during the intervention,
- Can independently perform easy-moderate revolutions of arm ergometry movement for ≥10 minutes, with or without adaptations to secure the hands on the handlebars, and
- Can independently bring up at least one hand to wave at shoulder level.
Who cannot join
- Present with significant shoulder pain that reduces use of upper limbs,
- Present with condition(s) other than SCI that affect ability to use upper limbs or follow English instructions,
- Have a pressure injury (>grade 2) on the pelvis, sacrum, or hand(s), or
- Experienced major trauma or surgery within the last 6 months
- Have a history of cardiovascular disease (myocardial infarction, stroke, hyperlipidemia or untreated hypertension) and do not receive physician clearance to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peer-facilitated Virtual Sport for Adults ≥ 50 Years With Spinal Cord Injury
Sport is a physical activity that has many physical, psychological and social benefits for those with spinal cord injury (SCI). However, most sport research involves people with SCI who are <50 years old. This is a problem because many people are >50 years old when first injured. Moreover, people with a SCI are now living longer lives, meaning they also experience more health challenges. Unfortunately, there is limited research studying the impact of sport for adults with SCI aged ≥50 years old.
Read the detailed description
Aim: To investigate the impact of sport for people with SCI who are ≥50 years old.
Sport Program: This program will be a trial of virtual handcycling. Fifteen male and five female volunteers who are ≥50 years old, ≥12 months post-SCI, wheelchair users, and medically cleared to exercise will be recruited. Five participants will complete the program at a time, as a group, on Microsoft Teams. The sport program will begin with a physiotherapist virtually leading 15 minutes of warm-up exercises. Next, a person living with SCI who is aged ≥50 years old will facilitate 45 minutes of virtual handcycling while screen sharing an indoor cycling application called Zwift, which will provide participants with visual cues and context for changes in exercise intensity. Participants will be provided a cycle ergometer so they can participate in their own homes, and with a smart watch so heart rate can be monitored. This program will run twice a week for three months.
Outcomes: Data will be collected on physical, psychological, and social health at (1) the start of the sport program, (2) immediately after, and (3) three months after the program ends. Any adverse events experienced will be recorded on a survey. Participants' feedback on the sport program and confidence in staying active will also be assessed using an interview at the end.
Conclusion: The knowledge gained will assist in creating future sport programs that may help address the challenges associated with aging and SCI.
- Conditions
- Spinal Cord Injury
- Being tested
- Virtual group-based handcycling
- Keywords
- Virtual sport, Sport
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual group-based handcyclingOther
Virtual group-based handcycling
| Study group | Role | What they receive |
|---|---|---|
| Virtual group-based handcycling | Experimental | Virtual group-based handcycling, twice per week for 12 weeks. Each 60-minute session of the intervention will begin with maximum 15 minutes of physiotherapist-led warm-up exercises. Next, a peer-facilitated handcycling session, lasting maximum 45 minutes, will proceed. The handcycling component involves the upper extremities cycling in tandem on a stationary exercise bike. The peer facilitator will be an individual with SCI aged >50 years, who will co-lead participants alongside the physiotherapist through brief group discussion, maximum 40 minutes of moderate-vigorous handcycling, and maximum 5 minutes of cool-down. Receives: Other: Virtual group-based handcycling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spinal Cord Independence Measure
A questionnaire that evaluates the functional abilities of individuals with spinal cord injury (SCI). This scale consists of three sub-scales that assess areas of function most relevant to SCI: self-care (scored from 0-20), respiration and sphincter management (scored from 0-40), and mobility (scored from 0-40). Final scores for the Spinal Cord Independence Measure (SCIM) range from 0-100, where a higher score indicates greater functional ability.
Measured: Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention
Positive Affect and Well-Being Scale of the Quality of Life in Neurological Disorders Measure (PAWB-Neuro-QoL)
A questionnaire that assesses affect and sense of well-being. Each statement is to be rated from 1 to 5 ("never" to "always"). The minimum score is 9 and the maximum score is 45. A higher score reflects a greater sense of well-being.
Measured: Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention
Multidimensional Scale of Perceived Social Support
A questionnaire that evaluates perceived help from a significant other, family, and friends. Each statement is to be rated from 1 to 7 ("very strongly disagree" to "very strongly agree"). The minimum score is 12 and the maximum score is 84. A higher score reflects greater perceived social support.
Measured: Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention
Moorong Self-Efficacy Scale
A questionnaire that assesses confidence in performing everyday activities. Each item is scored on a 7-point scale, for a total score out of 112, with a higher score indicating greater self-efficacy.
Measured: Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention
Spinal Cord Injury Exercise Self-Efficacy Scale
A questionnaire that assesses an individual's confidence in performing various physical activities and exercise. Each statement is scored on a 4-point Likert scale, for a total score out of 40, in which a higher score indicates greater perceived exercise self-efficacy.
Measured: Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention
6 Minute Push Test
A field-based assessment that assesses aerobic fitness in manual wheelchair users. During this test, participants will be instructed to propel their wheelchair for 6 minutes along a 30 meter loop while an assessor records the total distanced travelled.
Measured: Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention
Semi-structured Interview
This interview will explore participants' perspectives on a) whether the intervention affected their physical, psychological, and social health, and b) the delivery of the intervention itself (e.g., components, frequency, duration). A semi-structured interview guide informed by the Modified Health through Sport Conceptual Model will be used as a guide.
Measured: Within 12 weeks after the intervention
Secondary outcomes (1)
Adverse Events
Adverse events will be monitored throughout the 12-week intervention. Participants will be asked to complete a survey either online or on paper within 24 hours of experiencing an adverse event. The survey will consist of questions including type, location, and severity. The survey will consist of both closed- and open-ended questions about the circumstances surrounding the adverse event.
Measured: During the 12-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start5 May 2023
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Musselman, University Health Network, Toronto
- Investigators
- Kristin E Musselman, PhD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06040749
- Sponsor's protocol ID
- 23-5096
- Status last verified
- Nov 2024
- First submitted
- 29 May 2023
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer-facilitated Virtual Sport for Adults ≥ 50 Years With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT06040749
- Acronym / sponsor ID
- 23-5096
- Conditions
- Spinal Cord Injury
- Keywords
- Virtual sport, Sport
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 5 May 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 18 Sep 2023 (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.
Sport is a physical activity that has many physical, psychological and social benefits for those with spinal cord injury (SCI). However, most sport research involves people with SCI who are <50 years old. This is a problem because many people are >50 years old when first injured. Moreover, people with a SCI are now living longer lives, meaning they also experience more health challenges. Unfortunately, there is limited research studying the impact of sport for adults with SCI aged ≥50 years old.
Detailed description
Aim: To investigate the impact of sport for people with SCI who are ≥50 years old.
Sport Program: This program will be a trial of virtual handcycling. Fifteen male and five female volunteers who are ≥50 years old, ≥12 months post-SCI, wheelchair users, and medically cleared to exercise will be recruited. Five participants will complete the program at a time, as a group, on Microsoft Teams. The sport program will begin with a physiotherapist virtually leading 15 minutes of warm-up exercises. Next, a person living with SCI who is aged ≥50 years old will facilitate 45 minutes of virtual handcycling while screen sharing an indoor cycling application called Zwift, which will provide participants with visual cues and context for changes in exercise intensity. Participants will be provided a cycle ergometer so they can participate in their own homes, and with a smart watch so heart rate can be monitored. This program will run twice a week for three months.
Outcomes: Data will be collected on physical, psychological, and social health at (1) the start of the sport program, (2) immediately after, and (3) three months after the program ends. Any adverse events experienced will be recorded on a survey. Participants' feedback on the sport program and confidence in staying active will also be assessed using an interview at the end.
Conclusion: The knowledge gained will assist in creating future sport programs that may help address the challenges associated with aging and SCI.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual group-based handcycling | Experimental | Other: Virtual group-based handcyclingVirtual group-based handcycling, twice per week for 12 weeks. Each 60-minute session of the intervention will begin with maximum 15 minutes of physiotherapist-led warm-up exercises. Next, a peer-facilitated handcycling session, lasting maximum 45 minutes, will proceed. The handcycling component involves the upper extremities cycling in tandem on a stationary exercise bike. The peer facilitator will be an individual with SCI aged >50 years, who will co-lead participants alongside the physiotherapist through brief group discussion, maximum 40 minutes of moderate-vigorous handcycling, and maximum 5 minutes of cool-down. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Sustained a traumatic or non-progressive, non-traumatic SCI,
- Chronic stage of recovery (i.e., ≥12 months post-SCI),
- ≥50 years old,
- Be a manual wheelchair user,
- Able to understand spoken English,
Key exclusion criteria (5 listed)
- Present with significant shoulder pain that reduces use of upper limbs,
- Present with condition(s) other than SCI that affect ability to use upper limbs or follow English instructions,
- Have a pressure injury (>grade 2) on the pelvis, sacrum, or hand(s), or
- Experienced major trauma or surgery within the last 6 months
- Have a history of cardiovascular disease (myocardial infarction, stroke, hyperlipidemia or untreated hypertension) and do not receive physician clearance to participate.
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 |
|---|---|---|
| Virtual group-based handcyclingVirtual group-based handcycling | Other | Virtual group-based handcycling |
Primary outcome
Spinal Cord Independence Measure
Time frame: Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention
A questionnaire that evaluates the functional abilities of individuals with spinal cord injury (SCI). This scale consists of three sub-scales that assess areas of function most relevant to SCI: self-care (scored from 0-20), respiration and sphincter management (scored from 0-40), and mobility (scored from 0-40). Final scores for the Spinal Cord Independence Measure (SCIM) range from 0-100, where a higher score indicates greater functional ability.
Positive Affect and Well-Being Scale of the Quality of Life in Neurological Disorders Measure (PAWB-Neuro-QoL)
Time frame: Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention
A questionnaire that assesses affect and sense of well-being. Each statement is to be rated from 1 to 5 ("never" to "always"). The minimum score is 9 and the maximum score is 45. A higher score reflects a greater sense of well-being.
Multidimensional Scale of Perceived Social Support
Time frame: Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention
A questionnaire that evaluates perceived help from a significant other, family, and friends. Each statement is to be rated from 1 to 7 ("very strongly disagree" to "very strongly agree"). The minimum score is 12 and the maximum score is 84. A higher score reflects greater perceived social support.
Moorong Self-Efficacy Scale
Time frame: Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention
A questionnaire that assesses confidence in performing everyday activities. Each item is scored on a 7-point scale, for a total score out of 112, with a higher score indicating greater self-efficacy.
Spinal Cord Injury Exercise Self-Efficacy Scale
Time frame: Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention
A questionnaire that assesses an individual's confidence in performing various physical activities and exercise. Each statement is scored on a 4-point Likert scale, for a total score out of 40, in which a higher score indicates greater perceived exercise self-efficacy.
6 Minute Push Test
Time frame: Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention
A field-based assessment that assesses aerobic fitness in manual wheelchair users. During this test, participants will be instructed to propel their wheelchair for 6 minutes along a 30 meter loop while an assessor records the total distanced travelled.
Semi-structured Interview
Time frame: Within 12 weeks after the intervention
This interview will explore participants' perspectives on a) whether the intervention affected their physical, psychological, and social health, and b) the delivery of the intervention itself (e.g., components, frequency, duration). A semi-structured interview guide informed by the Modified Health through Sport Conceptual Model will be used as a guide.
1 secondary outcome
Adverse Events
Time frame: During the 12-week intervention
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 6 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
Kristin E Musselman, PhD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual group-based handcycling in people with Spinal Cord Injury, run by University Health Network, Toronto 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 12 inclusion and 5 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 6 Apr 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?
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?
Spinal Cord Independence Measure (time frame: Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention). The study lists 7 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 6 Apr 2025.