Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2025-12-26 @ 12:18 PM
Study NCT ID:
NCT06159400
Status:
COMPLETED
Last Update Posted:
2025-02-25
First Post:
2023-11-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Power-assisted Mobility for Children
Sponsor:
University of Manitoba
Organization:
Study Overview
Official Title:
Power-assisted Mobility for Children
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: