Movement Characterization in Spastic/Dystonic Cerebral Palsy Using Haptic Feedback in Virtual Reality
NCT ID: NCT03744884
Last Updated: 2020-01-03
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
68 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-12-01
Study Completion Date
2021-01-01
Brief Summary
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This game-like intervention using virtual reality will provide an objective and quantitative characterization of dystonia and spasticity presentations in cerebral palsy, even if combined, through the process of motor learning. This intervention could have a therapeutic benefit in the rehabilitation of children with cerebral palsy.
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Detailed Description
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Cerebral palsy is the most common developmental motor disorder in children. Individuals with cerebral palsy demonstrate abnormal muscle tone and motor control. Within the population of children with cerebral palsy, between 4% and 17% present dystonic symptoms and between 80% to 95% of cases present spasticity. In many cases spasticity and dystonia are present in the same child and accurate diagnosis may be challenging.
This study consists of a randomized controlled trial that uses a virtual reality game-based intervention incorporating fully-automated robotic haptic feedback to aid the the objective, quantitative diagnosis of spasticity and dystonia u=in CP. The study consists of face-to-face assessments of movement before, after, and one-month following the completion of the six-session game-based intervention. Children with spastic/dystonic cerebral palsy and typically developing children between the ages of 7 and 17 will be recruited for this study. The investigators anticipate to recruit a total of 68 participants, 34 with cerebral palsy and 34 typically developing. Both groups of children will be randomly allocated into an intervention or control group using a blocked randomization method. Movement outcomes will be examined for changes in quantitative and clinical measures in children with spastic/dystonic cerebral palsy and typically developing children to aid on the classification of movement disorders. Pair t-tests will be conducted on movement outcomes for both groups of children independently. Positive and negative results will be reported and addressed.
This study consists of a randomized controlled trial that uses a virtual reality game-based intervention incorporating fully-automated robotic haptic feedback to aid the the objective, quantitative diagnosis of spasticity and dystonia u=in CP. The study consists of face-to-face assessments of movement before, after, and one-month following the completion of the six-session game-based intervention. Children with spastic/dystonic cerebral palsy and typically developing children between the ages of 7 and 17 will be recruited for this study. The investigators anticipate to recruit a total of 68 participants, 34 with cerebral palsy and 34 typically developing. Both groups of children will be randomly allocated into an intervention or control group using a blocked randomization method. Movement outcomes will be examined for changes in quantitative and clinical measures in children with spastic/dystonic cerebral palsy and typically developing children to aid on the classification of movement disorders. Pair t-tests will be conducted on movement outcomes for both groups of children independently. Positive and negative results will be reported and addressed.
Conditions
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Cerebral Palsy, Mixed
Cerebral Palsy, Spastic
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
A group of children with dystonic or spastic/dystonic cerebral palsy and a group of typical developing children will be randomly assigned to an intervention or control group. The control group will only attend assessment sessions whereas the intervention group will attend both the assessment and intervention sessions.
Primary Study Purpose
DIAGNOSTIC
Blinding Strategy
SINGLE
Outcome Assessors
Research team members administering clinical assessments will be blinded from participant allocation. Participant's allocation will not be revealed during the course of the study.
Study Groups
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CP intervention group
Force efforts with haptic feedback in virtual reality for participants with CP.
Group Type
EXPERIMENTAL
Force efforts with haptic feedback in virtual reality.
Intervention Type
BEHAVIORAL
A virtual reality game-based intervention incorporating fully-automated robotic haptic feedback. The study consists of face-to-face assessments of movement before, after, and one-month following the completion of the six-session game-based intervention. Children with spastic/dystonic cerebral palsy between the ages of 7 and 17 will be recruited for this study along with a group of typically developing children in the same age range. Both groups of children will be randomly allocated into an intervention or control group using a blocked randomization method.
CP control group
Regular activity control group, for participants with CP.
Group Type
NO_INTERVENTION
No interventions assigned to this group
TD intervention group
Force efforts haptic feedback in virtual reality. The intervention will be the same as the CP intervention group but for typically developing participants.
Group Type
EXPERIMENTAL
Force efforts with haptic feedback in virtual reality.
Intervention Type
BEHAVIORAL
A virtual reality game-based intervention incorporating fully-automated robotic haptic feedback. The study consists of face-to-face assessments of movement before, after, and one-month following the completion of the six-session game-based intervention. Children with spastic/dystonic cerebral palsy between the ages of 7 and 17 will be recruited for this study along with a group of typically developing children in the same age range. Both groups of children will be randomly allocated into an intervention or control group using a blocked randomization method.
TD control group
Regular activity control group, same as CP no intervention group, but for typically developing participants.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Force efforts with haptic feedback in virtual reality.
A virtual reality game-based intervention incorporating fully-automated robotic haptic feedback. The study consists of face-to-face assessments of movement before, after, and one-month following the completion of the six-session game-based intervention. Children with spastic/dystonic cerebral palsy between the ages of 7 and 17 will be recruited for this study along with a group of typically developing children in the same age range. Both groups of children will be randomly allocated into an intervention or control group using a blocked randomization method.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
* Between ages 7 and 17
* Have been diagnosed with dystonic or spastic/dystonic cerebral palsy, for the cerebral palsy groups, or have no neuromuscular conditions, for typically developing groups
* Have mild to no difficulty understanding conversations compared to others of the same age
* Communicates age appropriately or with some difficulty but a new listener can understand
* Have no uncorrected vision
* Have hearing without the need of a hearing aid
* Have no other neural, neuromuscular, or musculoskeletal conditions
* Participation in stable school and/or private physical or occupational therapy with a frequency no greater than two sessions per week, for cerebral palsy groups
* Have no changes in medication for the six months previous to enrollment in the study
* Be medically stable
* Have no other concurrent illness
* Have not received any Botox treatment within three months previous to the initiation of the study
* No use of cardiac pacemakers, hearing aids, or another electronic implanted device
* Absence of allergy to silver or skin adhesives
* Have never had seizures
* Have Manual Ability Classification System (MACS) score I-III
* Have been diagnosed with dystonic or spastic/dystonic cerebral palsy, for the cerebral palsy groups, or have no neuromuscular conditions, for typically developing groups
* Have mild to no difficulty understanding conversations compared to others of the same age
* Communicates age appropriately or with some difficulty but a new listener can understand
* Have no uncorrected vision
* Have hearing without the need of a hearing aid
* Have no other neural, neuromuscular, or musculoskeletal conditions
* Participation in stable school and/or private physical or occupational therapy with a frequency no greater than two sessions per week, for cerebral palsy groups
* Have no changes in medication for the six months previous to enrollment in the study
* Be medically stable
* Have no other concurrent illness
* Have not received any Botox treatment within three months previous to the initiation of the study
* No use of cardiac pacemakers, hearing aids, or another electronic implanted device
* Absence of allergy to silver or skin adhesives
* Have never had seizures
* Have Manual Ability Classification System (MACS) score I-III
Minimum Eligible Age
7 Years
Maximum Eligible Age
17 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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OSF Healthcare System
OTHER
Sponsor Role
collaborator
University of Illinois College of Medicine at Peoria
OTHER
Sponsor Role
collaborator
University of Illinois at Urbana-Champaign
OTHER
Sponsor Role
lead
Responsible Party
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Citlali Lopez-Ortiz
Assistant Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Citlali Lopez-Ortiz
Role: PRINCIPAL_INVESTIGATOR
University of Illinois at Urbana-Champaign
Locations
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University of Illinois at Urbana-Champaign
Urbana, Illinois, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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References
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McNish RN, Chembrammel P, Speidel NC, Lin JJ, Lopez-Ortiz C. Rehabilitation for Children With Dystonic Cerebral Palsy Using Haptic Feedback in Virtual Reality: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Jan 14;8(1):e11470. doi: 10.2196/11470.
Reference Type
DERIVED
Other Identifiers
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18476
Identifier Type: -
Identifier Source: org_study_id
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RECRUITING
NA
Home-based Virtual Reality Rehabilitation for Children With Cerebral Palsy
NCT06478082
COMPLETED
NA
Investigating New Methods to Study Movement in Children and Young Adults With Movement Disorders.
NCT06498596
RECRUITING
Noninvasive Spinal Neuromodulation Enables Locomotor Recovery in Individuals With Cerebral Palsy
NCT04882592
UNKNOWN
PHASE1
Effects of Virtual Reality on Cerebral Palsy
NCT04768374
COMPLETED
NA
Exploring Hypertonia in Children With Cerebral Palsy
NCT01744158
UNKNOWN
Activities-based Locomotor Training in Children With Cerebral Palsy
NCT07184411
RECRUITING
NA
Locomotor Learning in Infants at High Risk for Cerebral Palsy
NCT04561232
COMPLETED
NA
Spastic Myopathy in Adults With Cerebral Palsy
NCT07293988
RECRUITING
NA
Efficacy Study of an Interactive Robot for the Rehabilitation of the Upper Limb in Children With Cerebral Palsy
NCT01700153
COMPLETED
NA
Motor Training for Infants With Cerebral Palsy
NCT04886895
RECRUITING
NA