Clinical trial NCT03744884: Movement Characterization in Spastic/Dystonic Cerebral Palsy Using Haptic Feedback in Virtual Reality
Official title: Movement Impairment Characterization and Rehabilitation for Spastic/Dystonic Cerebral Palsy Using Robotic Haptic Feedback in Virtual Reality
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy, Mixed
Cerebral Palsy, Spastic
Keywords: Virtual reality
Haptic feedback
Robotic
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
Collaborators: name: OSF Healthcare System
name: University of Illinois College of Medicine at Peoria
First posted: 2018-11-16
Enrollment: 68
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Exclusion Criteria:

* Not meeting ALL inclusion criteria

Primary outcomes:
measure: Smoothness Index
timeFrame: Tested during the assessment sessions spanning over a 6 to 7 week period.
Secondary outcomes:
measure: Surface electromyography
timeFrame: Tested during the assessment sessions and on the first and last day of gameplay spanning over a 6 to 7 week period.
measure: Forces and torques against force sensor during gampeplay and in robotic zero-force channel
timeFrame: Tested during the assessment sessions and on the first and last day of gameplay spanning over a 6 to 7 week period.
measure: Montreal Spasticity Rating Test (MSRT)
timeFrame: Tested during the assessment sessions spanning over a 6 to 7 week period.
measure: Dyskinesia Impairment Scale (DIS)
timeFrame: Tested during the assessment sessions spanning over a 6 to 7 week period.
measure: Selective Control of the Upper Extremity Scale (SCUES)
timeFrame: Tested during the assessment sessions spanning over a 6 to 7 week period.
measure: Quality of Upper Extremity Skills Test (QUEST)
timeFrame: Tested during the assessment sessions spanning over a 6 to 7 week period.
measure: Tardieu scale
timeFrame: Tested during the assessment sessions spanning over a 6 to 7 week period.
measure: World Health Organization Disability Assessment Schedule 2 Children and Youth (WHODAS II - CY)
timeFrame: Tested during the assessment sessions spanning over a 6 to 7 week period.
measure: Qualitative Feedback Module
timeFrame: Tested during the assessment sessions spanning over a 6 to 7 week period.
Other outcomes:
Locations:
city: Urbana
country: United States
facility: University of Illinois at Urbana-Champaign
state: Illinois
Study officials:
affiliation: University of Illinois at Urbana-Champaign
name: Citlali Lopez-Ortiz
role: PRINCIPAL_INVESTIGATOR
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