Upper Extremity DysfunctionNCT01959581
Movement Enhancing Device for Children
A study testing Movement Enhancing Device in people with Upper Extremity Dysfunction, run by University of Delaware at 3 sites in United States.
Trial summary
The purpose of this study is to assess: 1) how infants move their bodies to explore, play, and solve problems, 2) if this is different in a high-risk group of infants, and 3) if these abilities can be advanced in a high-risk group through the use of a movement assisting device. Read more about this study
- Who is it for?
- Ages 1 month to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Extremity Dysfunction
- What is being tested?
- Movement Enhancing Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2014to Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 month to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants will be invited to participate if they are between 1 month and 6 years and:
- Were born < 36 weeks of gestational age with periventricular leukomalacia or grade III or IV intraventricular hemorrhage
- Were born > 36 weeks of gestational age with encephalopathy related to perinatal asphyxia
- Have the diagnosis of neonatal stroke or intracranial hemorrhage
- Have brachial plexus palsy
- Have arthrogryposis multiplex congenital
- Have Down syndrome
- Have congenital hypotonia
Who cannot join
- blindness or severe sensory motor impairments that would prohibit the child from completing the study assessment.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Christiana Care Health Services
Newark, Delaware, 19713
University of Delaware
Newark, Delaware, 19716
Nemours Foundation
Wilmington, Delaware, 19803
About this study
Official title: An Innovative Device for Intervention in Infants With Nervous System Injury
The purpose of this study is to assess: 1) how infants move their bodies to explore, play, and solve problems, 2) if this is different in a high-risk group of infants, and 3) if these abilities can be advanced in a high-risk group through the use of a movement assisting device.
Read the detailed description
Certain conditions or diagnoses identified soon after birth are known to put infants at risk for having problems with their motor (movement) development as they get older. Infants with these diagnoses are at risk for additional developmental problems due to their inability to move their bodies to explore, learn, and play. This study tests how a device that assists movement can help exploration, learning, and play in children. The information gathered in this study will help us better understand how early learning happens and how we can help individuals become better movers, learners, and problem-solvers so they can increase their participation in everyday play activities.
- Conditions
- Upper Extremity Dysfunction
- Being tested
- Movement Enhancing Device
- Keywords
- Wilmington Robotic Exoskeleton, Reaching, Upper extremity function, Preterm Infants, Brain injury, Pediatrics, Early Intervention, Arthrogryposis
- Medical subject headings
- Brain Injuries, Arthrogryposis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Movement Enhancing DeviceDevice
Also called WREX (Wilmington Robotic Exoskeleton)
Naturalistic play activities using the hands while wearing the movement enhancing device.
| Study group | Role | What they receive |
|---|---|---|
| Movement enhancing device | Other | Guided play while wearing a movement assisting device Receives: Device: Movement Enhancing Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Time Contacting Objects
Percent of the assessment time participants are able to contact objects across different locations. Change within each session with versus without the exoskeleton donned. Slope of change across time in the intervention phase relative to in the baseline phase.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2013 (estimated)
- Study startMay 2014
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Upper Extremity DysfunctionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Collaborators
- Christiana Care Health Services, Alfred I. duPont Hospital for Children
- Responsible party
- Sponsor
- Investigators
- Michele A Lobo, PT, PhD, Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01959581
- Sponsor's protocol ID
- 1R21HD076092-01A1
- Status last verified
- Jun 2017
- First submitted
- 8 Oct 2013
- Last updated
- 6 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Innovative Device for Intervention in Infants With Nervous System Injury
- ClinicalTrials.gov ID
- NCT01959581
- Acronym / sponsor ID
- 1R21HD076092-01A1
- Conditions
- Upper Extremity Dysfunction
- Keywords
- Wilmington Robotic Exoskeleton, Reaching, Upper extremity function, Preterm Infants, Brain injury, Pediatrics, Early Intervention, Arthrogryposis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Collaborators
- Christiana Care Health Services, Alfred I. duPont Hospital for Children
- Study start
- May 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 10 Oct 2013 (estimated)
- Results
- Posted 6 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess: 1) how infants move their bodies to explore, play, and solve problems, 2) if this is different in a high-risk group of infants, and 3) if these abilities can be advanced in a high-risk group through the use of a movement assisting device.
Detailed description
Certain conditions or diagnoses identified soon after birth are known to put infants at risk for having problems with their motor (movement) development as they get older. Infants with these diagnoses are at risk for additional developmental problems due to their inability to move their bodies to explore, learn, and play. This study tests how a device that assists movement can help exploration, learning, and play in children. The information gathered in this study will help us better understand how early learning happens and how we can help individuals become better movers, learners, and problem-solvers so they can increase their participation in everyday play activities.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Movement enhancing device | Other | Device: Movement Enhancing DeviceGuided play while wearing a movement assisting device |
Who may qualify
- Ages
- 1 month to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Infants will be invited to participate if they are between 1 month and 6 years and:
- Were born < 36 weeks of gestational age with periventricular leukomalacia or grade III or IV intraventricular hemorrhage
- Were born > 36 weeks of gestational age with encephalopathy related to perinatal asphyxia
- Have the diagnosis of neonatal stroke or intracranial hemorrhage
- Have brachial plexus palsy
Key exclusion criteria (1 listed)
- blindness or severe sensory motor impairments that would prohibit the child from completing the study assessment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Movement Enhancing DeviceAlso: WREX (Wilmington Robotic Exoskeleton)Naturalistic play activities using the hands while wearing the movement enhancing device. | Device | Movement enhancing device |
Primary outcome
Change in Time Contacting Objects
Time frame: 7 months
Percent of the assessment time participants are able to contact objects across different locations. Change within each session with versus without the exoskeleton donned. Slope of change across time in the intervention phase relative to in the baseline phase.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Michele A Lobo, PT, PhD principal investigator
University of Delaware
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Movement Enhancing Device in people with Upper Extremity Dysfunction, run by University of Delaware at 3 sites in United States.
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 8 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 6 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Yes. Results are posted in the registry (first posted 6 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Time Contacting Objects (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jul 2017.