Photovoice for Spinal Cord Injury to Prevent Falls

Spinal Cord Injuries Clinical Trial

Official title:

Through the Lens of People With Spinal Cord Injury: Using Photovoice to Prevent Falls

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04864262
• Other study ID #: 20-6312
• Status: Completed
• Phase: N/A
• Start date: September 27, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: May 2024
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Other:
• Photovoice
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.

Locations

Country	Name	City	State
Canada	KITE-Toronto Rehabilitation Institute, UHN	Toronto

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Final Interview	A semi-structured interview will be conducted to explore participants' perceptions of the photovoice intervention following a qualitative descriptive design.	At study completion, 7.5 months.
Primary	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.	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
Primary	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.	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
Primary	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	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
Primary	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.	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	Tracking falls	Counting the number of falls experienced by participants	For 12 weeks after of the photovoice intervention
Secondary	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.	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	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.	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	Life Satisfaction Questionnaire 9	The LiSAT-9 Is a self-report measure assessing quality of life.	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