Spinal Cord InjuriesNCT04864262
Photovoice for Spinal Cord Injury to Prevent Falls
A study testing Photovoice in people with Spinal Cord Injuries, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Falls is a health crisis that costs health care systems billions of dollars each year. This crisis is especially relevant for people living with spinal cord injury (SCI) as most of these people will fall at least once per year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Photovoice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- 27 Sep 2021to 30 Sep 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) traumatic or non-traumatic, non-progressive SCI >12 months ago; 2) American Spinal Injury Association Impairment Scale (AIS) rating A-D; 3) ≥18 years old; 4) community-dwelling; 5) experienced >1 fall since sustaining a SCI; 6) free of other conditions besides SCI that affect balance (e.g., vestibular disorder); 7) understand spoken English; and 8) have access and ability to use the internet
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Through the Lens of People With Spinal Cord Injury: Using Photovoice to Prevent Falls
Falls is a health crisis that costs health care systems billions of dollars each year. This crisis is especially relevant for people living with spinal cord injury (SCI) as most of these people will fall at least once per year. Falls can cause injury and a fear of falling, which often causes people to restrict their mobility and daily activities. Despite its importance, fall prevention for people with SCI is understudied, and as a result, there is a lack of treatments to address their high fall risk. We will evaluate a new treatment for fall prevention. Photovoice is a method that uses photographs and dialogue to share experiences, understand an issue and promote positive change. Specifically, we aim to evaluate the effects of photovoice on confidence related to balance and falls, occurrence of falls, participation in daily activities and quality of life among people living with SCI. We also aim to understand participants' experiences with photovoice as a fall prevention program. To achieve these aims, 40 individuals living with SCI will participate in this study. Participants will complete a six-week photovoice program that involves photo assignments, individual interviews and group meetings. The program will be led by a person with SCI and a member of the research team with a background in physical or occupational therapy or kinesiology. Questionnaires will be used throughout the study to measure confidence, participation and quality of life. The occurrence of falls will be tracked for 12 weeks before and after the photovoice program. At the end of the study, each participant's experiences with photovoice will be collected through interviews. The proposed research will address a critical gap in SCI rehabilitation, namely effective fall prevention, to improve well-being after SCI. The research findings will inform the need for, and design of, a larger clinical trial, and has the potential to transform fall prevention after SCI.
The data sharing plan includes sharing study-related information with people living with spinal cord injury. Dissemination activities targeting this group will be developed with input from study participants (e.g., photos may be converted to printed and online art displays and shared through community SCI organizations). Dissemination initiatives will also target health care administrators and rehabilitation clinicians. Study information will be shared with the professional associations representing these groups. To reach researchers in the SCI rehabilitation field, study findings will be presented at academic conferences and in rehabilitation-focused journals.
- Conditions
- Spinal Cord Injuries
- Being tested
- Photovoice
- Keywords
- Falls, Balance, Photovoice
- 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.
PhotovoiceOther
Photovoice is a method that uses photographs and dialogue to share experiences, understand an issue and promote positive change. Group meetings will be held four times throughout the photovoice intervention. The goals of the group meetings are to share knowledge about falls and fall prevention, identify commonalities in the issues raised by the participants, and discuss ways in which these issues could be addressed, both at individual and societal levels. For two photo assignments, participants will be asked to take 4-6 pictures for an assigned question. The question for photo assignment #1 will be 'What decreases your likelihood of falling?' The question for photo assignment #2 will be 'How do you reduce the risk of falling so that you can participate in meaningful activities?' Following each photo assignment, participants will complete an individual semi-structured interview with the peer mentor and the research trainee, who will have a background in physical or occupational therapy.
| Study group | Role | What they receive |
|---|---|---|
| Photovoice | Experimental | Not described Receives: Other: Photovoice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Falls Efficacy Scale - International
The 16-item ordinal scale measures how concerned individuals are about falling when they perform both easy and difficult physical and social activities, such as getting dressed/undressed, preparing simple meals, and going out to a social event.
Measured: Up to 7.5 months; change from start of Baseline (Phase I) to pre-intervention (Phase II) to post-intervention (Phase III) to end of 12-week follow-up
Activities-specific Balance Confidence Scale
The ABC Scale asks participants to rate their confidence (from 0% to 100%) in their ability to maintain balance while performing 16 functional tasks in standing or while walking.
Measured: Up to 7.5 months; change from start of Baseline (Phase I) to pre-intervention (Phase II) to post-intervention (Phase III) to end of 12-week follow-up
Spinal Cord Injury Falls Concern Scale
The SCI-FCS is designed to assess falls self-efficacy during daily activities among individuals who are dependent upon a wheelchair for mobility
Measured: Up to 7.5 months; change from start of Baseline (Phase I) to pre-intervention (Phase II) to post-intervention (Phase III) to end of 12-week follow-up
Wheelchair Use Confidence Scale v.3
It is a measure of one's confidence in using a wheelchair according to six wheelchair-related topics: wheelchair activities, negotiating the physical environment, knowledge and problem-solving, advocacy, managing emotions and managing social situations.
Measured: Up to 7.5 months; change from start of Baseline (Phase I) to pre-intervention (Phase II) to post-intervention (Phase III) to end of 12-week follow-up
Secondary outcomes (4)
Tracking falls
Counting the number of falls experienced by participants
Measured: For 12 weeks after of the photovoice intervention
Survey of Activities and Fear of Falling in the Elderly
The SAFE is a measures of the impact of fear of falling on restriction of activity.
Measured: Up to 7.5 months; change from start of Baseline (Phase I) to pre-intervention (Phase II) to post-intervention (Phase III) to end of 12-week follow-up
Impact on Participation and Autonomy Questionnaire
The IPA is a measure of participation and autonomy across five subscales: autonomy indoors, autonomy outdoors, family roles, social relations, and paid work and education.
Measured: Up to 7.5 months; change from start of Baseline (Phase I) to pre-intervention (Phase II) to post-intervention (Phase III) to end of 12-week follow-up
Life Satisfaction Questionnaire 9
The LiSAT-9 Is a self-report measure assessing quality of life.
Measured: Up to 7.5 months; change from start of Baseline (Phase I) to pre-intervention (Phase II) to post-intervention (Phase III) to end of 12-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 posted28 Apr 2021
- Study start27 Sep 2021
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04864262
- Sponsor's protocol ID
- 20-6312
- Status last verified
- May 2024
- First submitted
- 26 Apr 2021
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD is available upon request to the UHN REB for approval to access research participant data.
Publications
Sessford J, Kaiser A, Chan K, Alavinia M, Al-Anizi O, Singh H, Munce S, Musselman KE. Impact of a photovoice intervention on fall-related psychological variables, participation levels and quality of life in chronic spinal cord injury. J Spinal Cord Med. 2026 Jul;49(4):785-798. doi: 10.1080/10790268.2025.2593079. Epub 2025 Dec 18.
PubMed 41412174Sessford JD, Chan K, Kaiser A, Singh H, Munce S, Alavinia M, Musselman KE. Protocol for a single group, mixed methods study investigating the efficacy of photovoice to improve self-efficacy related to balance and falls for spinal cord injury. BMJ Open. 2022 Dec 8;12(12):e065684. doi: 10.1136/bmjopen-2022-065684.
PubMed 36600385
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Through the Lens of People With Spinal Cord Injury: Using Photovoice to Prevent Falls
- ClinicalTrials.gov ID
- NCT04864262
- Acronym / sponsor ID
- 20-6312
- Conditions
- Spinal Cord Injuries
- Keywords
- Falls, Balance, Photovoice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 28 Apr 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.
Falls is a health crisis that costs health care systems billions of dollars each year. This crisis is especially relevant for people living with spinal cord injury (SCI) as most of these people will fall at least once per year. Falls can cause injury and a fear of falling, which often causes people to restrict their mobility and daily activities. Despite its importance, fall prevention for people with SCI is understudied, and as a result, there is a lack of treatments to address their high fall risk. We will evaluate a new treatment for fall prevention. Photovoice is a method that uses photographs and dialogue to share experiences, understand an issue and promote positive change. Specifically, we aim to evaluate the effects of photovoice on confidence related to balance and falls, occurrence of falls, participation in daily activities and quality of life among people living with SCI. We also aim to understand participants' experiences with photovoice as a fall prevention program. To achieve these aims, 40 individuals living with SCI will participate in this study. Participants will complete a six-week photovoice program that involves photo assignments, individual interviews and group meetings. The program will be led by a person with SCI and a member of the research team with a background in physical or occupational therapy or kinesiology. Questionnaires will be used throughout the study to measure confidence, participation and quality of life. The occurrence of falls will be tracked for 12 weeks before and after the photovoice program. At the end of the study, each participant's experiences with photovoice will be collected through interviews. The proposed research will address a critical gap in SCI rehabilitation, namely effective fall prevention, to improve well-being after SCI. The research findings will inform the need for, and design of, a larger clinical trial, and has the potential to transform fall prevention after SCI.
The data sharing plan includes sharing study-related information with people living with spinal cord injury. Dissemination activities targeting this group will be developed with input from study participants (e.g., photos may be converted to printed and online art displays and shared through community SCI organizations). Dissemination initiatives will also target health care administrators and rehabilitation clinicians. Study information will be shared with the professional associations representing these groups. To reach researchers in the SCI rehabilitation field, study findings will be presented at academic conferences and in rehabilitation-focused journals.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Photovoice | Experimental | Other: Photovoice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) traumatic or non-traumatic, non-progressive SCI >12 months ago; 2) American Spinal Injury Association Impairment Scale (AIS) rating A-D; 3) ≥18 years old; 4) community-dwelling; 5) experienced >1 fall since sustaining a SCI; 6) free of other conditions besides SCI that affect balance (e.g., vestibular disorder); 7) understand spoken English; and 8) have access and ability to use the internet
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| PhotovoicePhotovoice is a method that uses photographs and dialogue to share experiences, understand an issue and promote positive change. Group meetings will be held four times throughout the photovoice intervention. The goals of the group meetings are to share knowledge about falls and fall prevention, identify commonalities in the issues raised by the participants, and discuss ways in which these issues could be addressed, both at individual and societal levels. For two photo assignments, participants will be asked to take 4-6 pictures for an assigned question. The question for photo assignment #1 will be 'What decreases your likelihood of falling?' The question for photo assignment #2 will be 'How do you reduce the risk of falling so that you can participate in meaningful activities?' Following each photo assignment, participants will complete an individual semi-structured interview with the peer mentor and the research trainee, who will have a background in physical or occupational therapy. | Other | Photovoice |
Primary outcome
Falls Efficacy Scale - International
Time frame: Up to 7.5 months; change from start of Baseline (Phase I) to pre-intervention (Phase II) to post-intervention (Phase III) to end of 12-week follow-up
The 16-item ordinal scale measures how concerned individuals are about falling when they perform both easy and difficult physical and social activities, such as getting dressed/undressed, preparing simple meals, and going out to a social event.
Activities-specific Balance Confidence Scale
Time frame: Up to 7.5 months; change from start of Baseline (Phase I) to pre-intervention (Phase II) to post-intervention (Phase III) to end of 12-week follow-up
The ABC Scale asks participants to rate their confidence (from 0% to 100%) in their ability to maintain balance while performing 16 functional tasks in standing or while walking.
Spinal Cord Injury Falls Concern Scale
Time frame: Up to 7.5 months; change from start of Baseline (Phase I) to pre-intervention (Phase II) to post-intervention (Phase III) to end of 12-week follow-up
The SCI-FCS is designed to assess falls self-efficacy during daily activities among individuals who are dependent upon a wheelchair for mobility
Wheelchair Use Confidence Scale v.3
Time frame: Up to 7.5 months; change from start of Baseline (Phase I) to pre-intervention (Phase II) to post-intervention (Phase III) to end of 12-week follow-up
It is a measure of one's confidence in using a wheelchair according to six wheelchair-related topics: wheelchair activities, negotiating the physical environment, knowledge and problem-solving, advocacy, managing emotions and managing social situations.
4 secondary outcomes
Tracking falls
Time frame: For 12 weeks after of the photovoice intervention
Survey of Activities and Fear of Falling in the Elderly
Time frame: Up to 7.5 months; change from start of Baseline (Phase I) to pre-intervention (Phase II) to post-intervention (Phase III) to end of 12-week follow-up
Impact on Participation and Autonomy Questionnaire
Time frame: Up to 7.5 months; change from start of Baseline (Phase I) to pre-intervention (Phase II) to post-intervention (Phase III) to end of 12-week follow-up
Life Satisfaction Questionnaire 9
Time frame: Up to 7.5 months; change from start of Baseline (Phase I) to pre-intervention (Phase II) to post-intervention (Phase III) to end of 12-week follow-up
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 9 May 2024.
- Derived from this study: PubMed 41412174Sessford J, Kaiser A, Chan K, Alavinia M, Al-Anizi O, Singh H, Munce S, Musselman KE. Impact of a photovoice intervention on fall-related psychological variables, participation levels and quality of life in chronic spinal cord injury. J Spinal Cord Med. 2026 Jul;49(4):785-798. doi: 10.1080/10790268.2025.2593079. Epub 2025 Dec 18.
- Derived from this study: PubMed 36600385Sessford JD, Chan K, Kaiser A, Singh H, Munce S, Alavinia M, Musselman KE. Protocol for a single group, mixed methods study investigating the efficacy of photovoice to improve self-efficacy related to balance and falls for spinal cord injury. BMJ Open. 2022 Dec 8;12(12):e065684. doi: 10.1136/bmjopen-2022-065684.
- Individual participant dataSharing planned: Yes. IPD is available upon request to the UHN REB for approval to access research participant data.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photovoice in people with Spinal Cord Injuries, 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 1 inclusion and 0 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 9 May 2024. 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?
Falls Efficacy Scale - International (time frame: Up to 7.5 months; change from start of Baseline (Phase I) to pre-intervention (Phase II) to post-intervention (Phase III) to end of 12-week follow-up). The study lists 4 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 NCT04864262, which also lists 2 linked publications.
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 9 May 2024.