An interventional study of Force efforts with haptic feedback in virtual reality. in Cerebral Palsy, Mixed and Cerebral Palsy, Spastic, sponsored by University of Illinois at Urbana-Champaign. Status unknown at 1 site in United States. Open to participants aged 7 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-03.
Sponsored by University of Illinois at Urbana-Champaign · Not applicable, Interventional, and Diagnostic
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.
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.
704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.
This study's planned enrollment of 68 is above the median of 36 across 525 interventional studies indexed under Muscle Spasticity.
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Exclusion Criteria:
Force efforts with haptic feedback in virtual reality for participants with CP.
Behavioral: Force efforts with haptic feedback in virtual reality.
Regular activity control group, for participants with CP.
Force efforts haptic feedback in virtual reality. The intervention will be the same as the CP intervention group but for typically developing participants.
Behavioral: Force efforts with haptic feedback in virtual reality.
Regular activity control group, same as CP no intervention group, but for typically developing participants.
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.
Smoothness Index
The smoothness index will be measured by analyzing the the integrated accelerometry signals of sensors placed on the upper limbs. Accelerometry data will be integrated to calculate the smoothness index on the velocity profile of the trajectories. The maximum value is 0, being the greatest level of smoothness that can be measured, and the minimum is minus infinity. A value closer to 0 is desired.
Time frame: Tested during the assessment sessions spanning over a 6 to 7 week period.
Surface electromyography
Surface electromyography (sEMG) data will be collected during the execution of a first port de bras. The first port de bras will follow the format from the Royal Academy of Dance as demonstrated (Figure 1). Data will be analyzed changes in muscle activity patterns as a secondary outcome measure. The sEMG data will also be acquired during maximum voluntary efforts. For calibration of game-playing.
Time frame: Tested during the assessment sessions and on the first and last day of gameplay spanning over a 6 to 7 week period.
Forces and torques against force sensor during gampeplay and in robotic zero-force channel
This involves a force/torque sensor mounted in the end effector of the robot. A pre-determined zero-force path has been programmed by the research team to allow the robot to move through straight lines connected to five points on a vertical plane. The participants will hold a gripper mounted on the force transducer and attempt to move the end effector of the robot along the zero-force path. The force transducer will measure the forces exerted by the participant as they do so. Force and torque signals will be collected during all game-playing sessions. The calibration for game playing involves a maximum voluntary effort by the participant's dominant arm against the sensor mounted on a sturdy table. Participants will also be assessed with the force sensor in fourteen different directions at 30% ± 10% of the maximal voluntary effort across all directions.
Time frame: Tested during the assessment sessions and on the first and last day of gameplay spanning over a 6 to 7 week period.
Montreal Spasticity Rating Test (MSRT)
The MSRT is a quantitative measure the onset of the stretch reflex that that correlates with clinical spasticity and shows good test re-test reliability
Time frame: Tested during the assessment sessions spanning over a 6 to 7 week period.
Dyskinesia Impairment Scale (DIS)
The Dyskinesia Impairment Scale (DIS) measures the severity of dystonia and choreoathetosis when an individual is at rest or moving. It was found to show good to excellent reliability and validity. Scores range from 0 to 4 for both duration and amplitude of each criterion. A score of 0 most corresponds to movement of healthy people without movement disorders. The highest score possible score is 576 indicating the most server level of impairs,ent. There are two sub scales: Dystonia and Choreoathetosis that have a range of 0-288 each. The total score is obtained by addition of the two subscores.
Time frame: Tested during the assessment sessions spanning over a 6 to 7 week period.
Selective Control of the Upper Extremity Scale (SCUES)
The Selective Control of the Upper Extremity Scale (SCUES) is a video-based tool to measure selective control of upper limb tasks. Psychometric analysis shows "comparable validity to other accepted video-based clinical assessment tools for the upper extremity in children with CP " with content validity ratio values indicating substantial agreement for most items. Scores are assigned for each assessed joint and can be rated as M3, M2, M1, or M0 with M3 representing normal selective motor control and M0 representing no selective motor control.
Time frame: Tested during the assessment sessions spanning over a 6 to 7 week period.
Quality of Upper Extremity Skills Test (QUEST)
The QUEST is 36 items in length and measures upper limb movement, hand function, and cooperativeness in children with CP. It has been found to be reliable to assess children with CP between 18 months and 8 years of age, with increased reliability in children up to 12 years of age \[30\]. It has also been found to show adequate to excellent validity. Initial scores range from 50 to 100, which are then standardized to be between 0 and 100. The initial score is summed by scoring the ability to complete an item according to specification as 2 points, not being able to, not willing to, or not administerable as 1 point, and minus 1 point for abnormal movement in the posture section of the assessment. The standardized score is found by dividing the sum of scores for each section tested by the total number of sections tested.
Time frame: Tested during the assessment sessions spanning over a 6 to 7 week period.
Tardieu scale
The Tardieu scale examines spasticity with quantified measures of the responses of stretch reflexes. This scale shows high test retest and poor to moderate inter-rater reliability; the Tardieu scale performs better than other similar measures, indicating it may be more reliable. Scores of quality of muscle reaction range from 0 to 5 with 0 being no resistance throughout passive movement and 5 being an immobile joint.
Time frame: Tested during the assessment sessions spanning over a 6 to 7 week period.
World Health Organization Disability Assessment Schedule 2 Children and Youth (WHODAS II - CY)
The WHODAS II - CY is a self-report 36 item document that assesses daily issues surrounding health conditions such as illnesses, injuries, and problems with mental health. In a validity study, it was found to show good reliability; however, limitations regarding options for those without significant disabilities were present. Each item can be scored from 1 to 5, with 1 indicating none and 5 indicating extreme or cannot do. Each item is scored, summed within the domain it is in, and the average is taken for each domain. The averages are summed and converted to a metric ranging from 0 to 100 where 0 indicates no disability and 100 indicating severe disability.
Time frame: Tested during the assessment sessions spanning over a 6 to 7 week period.
Qualitative Feedback Module
Multiple choice patient satisfaction questionnaire. Scores range from 0 to 5 for each item similar to the Wong-Baker FACES Pain Rating Scale with 0 indicating highest satisfaction and 5 indicating highest dissatisfaction.
Time frame: Tested during the assessment sessions spanning over a 6 to 7 week period.
Plan to share: No
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University of Illinois at Urbana-Champaign