Clinical trial NCT06159400: Power-assisted Mobility for Children
Official title: Power-assisted Mobility for Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Power Assisted Device
Children, Only
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2023-12-06
Enrollment: 2
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children who are current clients at the Rehabilitation Centre for Children

Brief summary: In this project, we intend to explore the experience of children who use a manual wheelchair (MWC), their parent/guardian, and their prescribing therapist after the child is exposed to a power-assist device (PAD) attached to their MWC as a potential mobility alternative. The specific objectives are 1) to explore the children's experience and impressions of using the PAD; 2) To explore the parent/guardians' perspectives on potential application of the PAD for their child, and 3) To explore occupational/physical therapists' perspectives on potential recommendation of, and training with, a PAD for children.

Detailed description: There are currently no published evidence on the benefits of PADs for children; perceptions of appropriateness among children/parents/clinicians; or information on how PAD introduction and training might be best implemented. Given this paucity of evidence, this study intends to create some foundational knowledge and evidence about PAD use among children.

Research Purpose

In this project, we intend to explore the experience of children who use a MWC, their parent/guardian, and their prescribing therapist after they are exposed to a PAD as a potential mobility alternative. The specific objectives are:

* To explore the children's experience and impressions of using the PAD
* To explore the parent/guardians' perspectives on potential application of the PAD for their child
* To explore occupational/physical therapists' perspectives on potential recommendation of, and training with, a PAD for children We will schedule 2 to 3 sessions, between 30 and 60 minutes long, where the child will have an opportunity to try a PAD with their MWC. The sessions will be held at the Rehabilitation Centre for Children (RCC). We will attach a PAD to the child's MWC using a small bracket on the crossbar of the frame; no change or modification to the MWC is required. A physical or occupational therapist will lead the sessions; they will begin with an explanation and introduction to the PAD and then allow the child to practice using the PAD, providing instruction and ensuring safe operation. The sessions will be video recorded so we can review the sessions later when we are analyzing the interview responses; once the study is complete the video recordings will be destroyed.

After the last session, the parent and child will each be asked to participate in a semi-structured interview. The interviews will last about 30 minutes. We anticipate the interviews will be conducted in a private space at RCC immediately following the last session; however, we can also conduct the interviews at a later time and in a location convenient to you (e.g., at your home; a community location; online).

At the interview, parents will be asked about your perspective on your child's experience with using a PAD on their MWC. Parents will be asked questions about the training process and the potential benefits and drawbacks of using and learning to use a PAD. Sample questions include: Tell me about your child's use of a wheelchair; Tell me what you think of the PAD; Do you think you would want your child to use a PAD? The child will also be interviewed and parents can be present at the interview session with the child if they choose. Sample questions include: Tell me what you think of the PAD; How difficult was it to get the hang of the PAD; Would you want to use a PAD.

Eligibility criteria: Inclusion Criteria:

* Children (\>18 years) among current Rehabilitation Centre for Children clients who use a manual wheelchair
* parents express a willingness or interest to pursue power assisted device use for their child

Exclusion Criteria:

* have insufficient motor, cognitive and development skills to learn to use a power assisted device

Primary outcomes:
measure: Child's experience
timeFrame: The semi-structured interview will be conducted after the final (3rd) session of the child being exposed to the power-assisted device.Interviews will last approximately 30 minutes each.
measure: Parent/Guardian's experience
timeFrame: The semi-structured interview will be conducted after the final (3rd) session of the child being exposed to the power-assisted device.Interviews will last approximately 30 minutes each.
measure: Therapist's experience
timeFrame: The semi-structured interview will be conducted after the final (3rd) session of the child being exposed to the power-assisted device. Interviews will last approximately 30 minutes each.
Secondary outcomes:
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Ed Giesbrecht, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kenyon LK, Blank K, Meengs J, Schultz AM. "Make it fun": a qualitative study exploring key aspects of power mobility interventions for children. Disabil Rehabil Assist Technol. 2023 Apr;18(3):304-312. doi: 10.1080/17483107.2020.1849431. Epub 2020 Dec 1.
citation: Ross T, Buliung R. A systematic review of disability's treatment in the active school travel and children's independent mobility literatures. Transport reviews. 2018;38(3):349-371.