NCT03714256

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 21, 2018

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 22, 2018

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 19, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 19, 2018

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

January 14, 2021

Completed
Last Updated

January 14, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

October 11, 2018

Results QC Date

October 22, 2020

Last Update Submit

January 8, 2021

Conditions

Disability Physical

Keywords

Pediatric

Outcome Measures

Primary Outcomes (1)

  • 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

    One day

Study Arms (2)

Children 6-17 months

EXPERIMENTAL

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: Device, patient mobility, powered

Children 18 - 36 months

EXPERIMENTAL

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: Device, patient mobility, powered

Interventions

Device, patient mobility, poweredDEVICE

Pediatric mobility device

Children 18 - 36 monthsChildren 6-17 months

Eligibility Criteria

Age6 Months - 36 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Oregon State University

Corvallis, Oregon, 97331, United States

Location

Belmont University

Nashville, Tennessee, 37212, United States

Location

Results Point of Contact

Title
Vice President of Research and Innovation
Organization
Permobil
karin.leire@permobil.com
+46703836763

Study Officials

  • Karin Leire

    Permobil Group

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2018

First Posted

October 22, 2018

Study Start

September 21, 2018

Primary Completion

November 19, 2018

Study Completion

November 19, 2018

Last Updated

January 14, 2021

Results First Posted

January 14, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

US(3)