Photovoice for Spinal Cord Injury to Prevent Falls
Primary Purpose
Spinal Cord Injuries
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Photovoice
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Falls, Balance, Photovoice
Eligibility Criteria
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
Sites / Locations
- KITE-Toronto Rehabilitation Institute, UHN
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Photovoice
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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
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.
Secondary Outcome Measures
Tracking falls
Counting the number of falls experienced by participants
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.
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.
Life Satisfaction Questionnaire 9
The LiSAT-9 Is a self-report measure assessing quality of life.
Full Information
NCT ID
NCT04864262
First Posted
April 26, 2021
Last Updated
April 19, 2023
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT04864262
Brief Title
Photovoice for Spinal Cord Injury to Prevent Falls
Official Title
Through the Lens of People With Spinal Cord Injury: Using Photovoice to Prevent Falls
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 27, 2021 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Falls, Balance, Photovoice
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Photovoice
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Photovoice
Intervention Description
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.
Primary Outcome Measure Information:
Title
Falls Efficacy Scale - International
Description
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.
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
Title
Activities-specific Balance Confidence Scale
Description
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.
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
Title
Spinal Cord Injury Falls Concern Scale
Description
The SCI-FCS is designed to assess falls self-efficacy during daily activities among individuals who are dependent upon a wheelchair for mobility
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
Title
Wheelchair Use Confidence Scale v.3
Description
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.
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
Secondary Outcome Measure Information:
Title
Tracking falls
Description
Counting the number of falls experienced by participants
Time Frame
For 12 weeks after of the photovoice intervention
Title
Survey of Activities and Fear of Falling in the Elderly
Description
The SAFE is a measures of the impact of fear of falling on restriction of activity.
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
Title
Impact on Participation and Autonomy Questionnaire
Description
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.
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
Title
Life Satisfaction Questionnaire 9
Description
The LiSAT-9 Is a self-report measure assessing quality of life.
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
Other Pre-specified Outcome Measures:
Title
Final Interview
Description
A semi-structured interview will be conducted to explore participants' perceptions of the photovoice intervention following a qualitative descriptive design.
Time Frame
At study completion, 7.5 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
KITE-Toronto Rehabilitation Institute, UHN
City
Toronto
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD is available upon request to the UHN REB for approval to access research participant data.
Learn more about this trial
Photovoice for Spinal Cord Injury to Prevent Falls
We'll reach out to this number within 24 hrs