Trial Outcomes & Findings for Human Factor Validation of Pediatric Mobility Device (NCT NCT03714256)

NCT ID: NCT03714256

Last Updated: 2021-01-14

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 33 participants
• Primary outcome timeframe: One day
• Results posted on: 2021-01-14

Participant Flow

Participant milestones

Measure	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	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
Overall Study STARTED	14	19
Overall Study COMPLETED	14	19
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Children 6-17 Months n=14 Participants 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	Children 18 - 36 Months n=19 Participants 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	Total n=33 Participants Total of all reporting groups
Age, Categorical <=18 years	14 Participants n=14 Participants	19 Participants n=19 Participants	33 Participants n=33 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=14 Participants	0 Participants n=19 Participants	0 Participants n=33 Participants
Age, Categorical >=65 years	0 Participants n=14 Participants	0 Participants n=19 Participants	0 Participants n=33 Participants
Sex: Female, Male Female	7 Participants n=14 Participants	10 Participants n=19 Participants	17 Participants n=33 Participants
Sex: Female, Male Male	7 Participants n=14 Participants	9 Participants n=19 Participants	16 Participants n=33 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	14 participants n=14 Participants	19 participants n=19 Participants	33 participants n=33 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Children 6-17 Months n=14 Participants 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	Children 18 - 36 Months n=19 Participants 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
Cumulative Number of Use Errors Associated With the Usage of the Device According to Labelling	4 Errors	2 Errors

Adverse Events

Children 6-17 Months

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Children 18 - 36 Months

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vice President of Research and Innovation

Permobil

Phone: +46703836763

Email: karin.leire@permobil.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60