Power Assisted DeviceNCT06159400
Power-assisted Mobility for Children
An observational study of Power Assisted Device and Children, Only, run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Power Assisted Device, Children, Only
- How many people
- 2 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2024to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children who are current clients at the Rehabilitation Centre for Children
Who may be able to join
- 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
Who cannot join
- have insufficient motor, cognitive and development skills to learn to use a power assisted device
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Power Assisted Device, Children, Only
What is being measured
The primary outcome is the main question the study is designed to answer.
Child's experience
A semi-structured interview will be used to gain insight into children's experience using a power-assisted device. After a brief introduction, the child will be asked about their own wheelchair (how long they have used it, how often they use it, what do they do with their wheelchair, do they find it difficult or easy, any challenges). They will then be asked about the power assisted device (what did you think about it, how difficult was it to use, did your therapist do anything to help you with the power assisted device, did you get used to using it, what did you like most, what did you like least). They will then be asked if they would want a power assisted device if it was possible to get one. The interview will then be concluded.
Measured: 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.
Parent/Guardian's experience
A semi-structured interview will be used to gain insight into parent or guardian's experience with their child using a power-assisted device (PAD). After a brief introduction, the parent/guardian will be asked to tell the interviewers about their child's use of a manual wheelchair (MWC) (how long they have used it, how much time do they use their MWC for mobility, difficulties or challenges with the MWC). They will then be asked about the use of the PAD (what did you think the first time you saw it, how do you think your child found using the PAD the first time and did this change, do you think it was any different than their MWC, how difficult do you think it was for your child to learn to use the PAD, how confident would you be with your child's use of the PAD now, what impact did the PAD have on your child's confidence). They would then be asked if they could, hypothetically, get a PAD for their child, if they would want one. The interview will then be concluded.
Measured: 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.
Therapist's experience
A semi-structured interview will be used to gain insight into therapist's experience with the child using a power-assisted device (PAD). After a short introduction, the therapist will be asked to tell the interviewer about their pervious experience using a PAD (how familiar they are and how easy it was to learn). They will then be asked how easy (or difficult) they found teaching a child to use the PAD (what made teaching difficult, what concerns did you have about a child using a PAD, what activities do you think are most important to address in training a child to use a PAD, was there enough time (2 or 3 sessions) to get a sense of whether a PAD might be appropriate (safe/competent) for a child). The therapist will then be asked what potential applications do they see for this child using a PAD? The therapist will be asked if they see a potential application for using PAD with other children. The interview will then be concluded.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start1 Mar 2024
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Power Assisted DeviceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ed Giesbrecht, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159400
- Sponsor's protocol ID
- HS26207 (H2023:321)
- Status last verified
- Nov 2023
- First submitted
- 28 Nov 2023
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33259252Ross 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Power-assisted Mobility for Children
- ClinicalTrials.gov ID
- NCT06159400
- Acronym / sponsor ID
- HS26207 (H2023:321)
- Conditions
- Power Assisted Device, Children, Only
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 6 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children who are current clients at the Rehabilitation Centre for Children
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- have insufficient motor, cognitive and development skills to learn to use a power assisted device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Child's experience
Time frame: 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.
A semi-structured interview will be used to gain insight into children's experience using a power-assisted device. After a brief introduction, the child will be asked about their own wheelchair (how long they have used it, how often they use it, what do they do with their wheelchair, do they find it difficult or easy, any challenges). They will then be asked about the power assisted device (what did you think about it, how difficult was it to use, did your therapist do anything to help you with the power assisted device, did you get used to using it, what did you like most, what did you like least). They will then be asked if they would want a power assisted device if it was possible to get one. The interview will then be concluded.
Parent/Guardian's experience
Time frame: 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.
A semi-structured interview will be used to gain insight into parent or guardian's experience with their child using a power-assisted device (PAD). After a brief introduction, the parent/guardian will be asked to tell the interviewers about their child's use of a manual wheelchair (MWC) (how long they have used it, how much time do they use their MWC for mobility, difficulties or challenges with the MWC). They will then be asked about the use of the PAD (what did you think the first time you saw it, how do you think your child found using the PAD the first time and did this change, do you think it was any different than their MWC, how difficult do you think it was for your child to learn to use the PAD, how confident would you be with your child's use of the PAD now, what impact did the PAD have on your child's confidence). They would then be asked if they could, hypothetically, get a PAD for their child, if they would want one. The interview will then be concluded.
Therapist's experience
Time frame: 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.
A semi-structured interview will be used to gain insight into therapist's experience with the child using a power-assisted device (PAD). After a short introduction, the therapist will be asked to tell the interviewer about their pervious experience using a PAD (how familiar they are and how easy it was to learn). They will then be asked how easy (or difficult) they found teaching a child to use the PAD (what made teaching difficult, what concerns did you have about a child using a PAD, what activities do you think are most important to address in training a child to use a PAD, was there enough time (2 or 3 sessions) to get a sense of whether a PAD might be appropriate (safe/competent) for a child). The therapist will then be asked what potential applications do they see for this child using a PAD? The therapist will be asked if they see a potential application for using PAD with other children. The interview will then be concluded.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Background: PubMed 33259252Kenyon 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.
- BackgroundRoss 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.
Related trials for Power Assisted Device
Recruiting
Feasibility Study of the Flash-Sole: A Wearable Midsole With Soft Actuators for Walking Assistance
Motor Function
Enrolling by invitation
Powered Assist Hip Exoskeleton to Improve Ambulation in Severe Lung Disease
Lung Disease Chronic
Recruiting
Effects of Mobilization Using a Powered Lower-limb Exoskeleton With Prolonged Mechanical Ventilation
Prolonged Mechanical Ventilation, Ventilator Weaning
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ed Giesbrecht, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Power Assisted Device and Children, Only, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child's experience (time frame: 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06159400, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.