Disability Physical
Conditions
Keywords
Pediatric
Brief summary
The purpose of this study is to validate the user interface of a pediatric power mobility device by establishing that the product is safe and effective use for the intended users.
Detailed description
The purpose of this study is to validate the user interface of a pediatric power mobility device by establishing that the product is safe and effective use for the intended users. The human factors validation study will be conducted in children with mobility impairments as categorised by Hays (1987) in the age range of 6 months to 36 months under realistic use conditions.The study is an open label, un-blinded, non-randomized study which consists of one visit.
Interventions
DEVICEDevice, patient mobility, powered
Pediatric mobility device
Sponsors
Permobil, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 36 Months
Healthy volunteers
No
Inclusion criteria
Primary users: * Informed consent signed by parents or guardian * Aged 6-36 months * Unable to mobilize independently for exploratory play and peer interaction, as categorized by Hays (1987) * Adequate trunk and head control to remain upright in the device, including regain head control * Adequate hand/ arm (distal) control to reach for objects in front of them Secondary users: * Signed informed consent * Physiotherapist/Occupational Therapist or parent/guardian of the child included in the test
Exclusion criteria
* Primary users: * Weight \>16 kg/35 Ibs * Length \>100 cm/39 In * Children that lack head control in such a severe manner that they cannot regain control if it is lost * Children who do not show awareness of or respond to toys, objects, sounds and/or people in their environment * Any other reason, if in the opinion of the investigator, the individual user is not appropriate, or suitable for participation in the test. Secondary users: * Hearing/vision loss or limited cognitive skills impacting the ability to take instructions and perform the tasks of the test * Ability to understand oral and written English as product labelling will in this Human Factor validation test only be available in English * Any other reason, if in the opinion of the investigator, the individual user is not appropriate, or suitable for participation in the test
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Number of Use Errors Associated With the Usage of the Device According to Labelling | One day | The tasks in this Human factors validation test, that will be performed by the users are: charge battery and disconnect it, adjust seat and table height, adjust the speed, place the child in device, adjust cushion and other support. The summary of identified errors, captured through observation and interview, will be counted and define the primary outcome |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Children 6-17 Months Device, patient mobility, powered:
Usability of the pediatric mobility device by both parent/guardian and occupational/physiological therapist, performed according to instructions for use at a one time occasion.
Device, patient mobility, powered: Pediatric mobility device | 14 |
| Children 18 - 36 Months Device, patient mobility, powered:
Usability of the pediatric mobility device by both parent/guardian and occupational/physiological therapist, performed according to instructions for use at a one time occasion.
Device, patient mobility, powered: Pediatric mobility device | 19 |
| Total | 33 |
Baseline characteristics
| Characteristic | Children 18 - 36 Months | Total | Children 6-17 Months |
|---|---|---|---|
| Age, Categorical <=18 years | 19 Participants | 33 Participants | 14 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 19 participants | 33 participants | 14 participants |
| Sex: Female, Male Female | 10 Participants | 17 Participants | 7 Participants |
| Sex: Female, Male Male | 9 Participants | 16 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 19 |
| other Total, other adverse events | 0 / 14 | 0 / 19 |
| serious Total, serious adverse events | 0 / 14 | 0 / 19 |
Outcome results
Primary
Cumulative Number of Use Errors Associated With the Usage of the Device According to Labelling
The tasks in this Human factors validation test, that will be performed by the users are: charge battery and disconnect it, adjust seat and table height, adjust the speed, place the child in device, adjust cushion and other support. The summary of identified errors, captured through observation and interview, will be counted and define the primary outcome
Time frame: One day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Children 6-17 Months | Cumulative Number of Use Errors Associated With the Usage of the Device According to Labelling | 4 Errors |
| Children 18 - 36 Months | Cumulative Number of Use Errors Associated With the Usage of the Device According to Labelling | 2 Errors |