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Photovoice for Spinal Cord Injury to Prevent Falls

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ClinicalTrials.gov Identifier: NCT04864262
Recruitment Status : Recruiting
First Posted : April 28, 2021
Last Update Posted : October 5, 2021
Sponsor:
Information provided by (Responsible Party):
Kristin Musselman, University Health Network, Toronto

Study Description
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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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Other: Photovoice Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Through the Lens of People With Spinal Cord Injury: Using Photovoice to Prevent Falls
Actual Study Start Date : September 27, 2021
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Photovoice 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.


Outcome Measures
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Primary Outcome Measures :
  1. Tracking falls [ Time Frame: For 12 weeks before the photovoice intervention ]
    Counting the number of falls experienced by participants

  2. Tracking falls [ Time Frame: For 12 weeks after of the photovoice intervention ]
    Counting the number of falls experienced by participants

  3. Falls Efficacy Scale - International [ Time Frame: 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.

  4. Activities-specific Balance Confidence Scale [ Time Frame: 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.

  5. Spinal Cord Injury Falls Concern Scale [ Time Frame: 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

  6. Wheelchair Use Confidence Scale v.3 [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1) traumatic 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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04864262


Contacts
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Contact: Research Coordinator 4165973422 ext 6199 katherine.chan@uhn.ca
Contact: Kristin Musselman 4165973422 ext 6190 kristin.musselman@uhn.ca

Locations
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Canada
KITE-Toronto Rehabilitation Institute, UHN Recruiting
Toronto, Canada
Contact: Katherine Chan       katherine.chan@uhn.ca   
Sponsors and Collaborators
University Health Network, Toronto
More Information
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Responsible Party: Kristin Musselman, Principal Investigator, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT04864262    
Other Study ID Numbers: 20-6312
First Posted: April 28, 2021    Key Record Dates
Last Update Posted: October 5, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kristin Musselman, University Health Network, Toronto:
Falls
Balance
Photovoice
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System