NCT04864262

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 28, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

September 27, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

May 9, 2024

Status Verified

May 1, 2024

Enrollment Period

2 years

First QC Date

April 26, 2021

Last Update Submit

May 8, 2024

Conditions

Keywords

FallsBalancePhotovoice

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (4)

  • Tracking falls

    For 12 weeks after of the photovoice intervention

  • Survey of Activities and Fear of Falling in the Elderly

    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

    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

    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 Outcomes (1)

  • Final Interview

    At study completion, 7.5 months.

Study Arms (1)

Photovoice

EXPERIMENTAL
Other: Photovoice

Interventions

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.

Photovoice

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KITE-Toronto Rehabilitation Institute, UHN

Toronto, Canada

Location

Related Publications (2)

  • 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. 2025 Dec 18:1-14. doi: 10.1080/10790268.2025.2593079. Online ahead of print.

  • Sessford 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.

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 26, 2021

First Posted

April 28, 2021

Study Start

September 27, 2021

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

May 9, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share

IPD is available upon request to the UHN REB for approval to access research participant data.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR

Locations