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Movement Characterization in Spastic/Dystonic Cerebral Palsy Using Haptic Feedback in Virtual Reality

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ClinicalTrials.gov Identifier: NCT03744884
Recruitment Status : Not yet recruiting
First Posted : November 16, 2018
Last Update Posted : November 16, 2018
Sponsor:
Collaborators:
OSF Healthcare System
University of Illinois College of Medicine at Peoria
Information provided by (Responsible Party):
Citlali Lopez-Ortiz, University of Illinois at Urbana-Champaign

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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy, Mixed Cerebral Palsy, Spastic Behavioral: Force efforts with haptic feedback in virtual reality. Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Diagnostic
Official Title: Movement Impairment Characterization and Rehabilitation for Spastic/Dystonic Cerebral Palsy Using Robotic Haptic Feedback in Virtual Reality
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CP intervention group
Force efforts with haptic feedback in virtual reality for participants with CP.
Behavioral: 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.

No Intervention: CP control group
Regular activity control group, for participants with CP.
Experimental: 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.
Behavioral: 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.

No Intervention: TD control group
Regular activity control group, same as CP no intervention group, but for typically developing participants.



Primary Outcome Measures :
  1. Smoothness Index [ Time Frame: Tested during the assessment sessions spanning over a 6 to 7 week period. ]

    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.



Secondary Outcome Measures :
  1. Surface electromyography [ Time Frame: Tested during the assessment sessions and on the first and last day of gameplay spanning over a 6 to 7 week period. ]
    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.

  2. Forces and torques against force sensor during gampeplay and in robotic zero-force channel [ Time Frame: Tested during the assessment sessions and on the first and last day of gameplay spanning over a 6 to 7 week period. ]
    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.

  3. Montreal Spasticity Rating Test (MSRT) [ Time Frame: Tested during the assessment sessions spanning over a 6 to 7 week period. ]
    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

  4. Dyskinesia Impairment Scale (DIS) [ Time Frame: Tested during the assessment sessions spanning over a 6 to 7 week period. ]
    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.

  5. Selective Control of the Upper Extremity Scale (SCUES) [ Time Frame: Tested during the assessment sessions spanning over a 6 to 7 week period. ]
    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.

  6. Quality of Upper Extremity Skills Test (QUEST) [ Time Frame: Tested during the assessment sessions spanning over a 6 to 7 week period. ]

    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.


  7. Tardieu scale [ Time Frame: Tested during the assessment sessions spanning over a 6 to 7 week period. ]

    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.


  8. World Health Organization Disability Assessment Schedule 2 Children and Youth (WHODAS II - CY) [ Time Frame: Tested during the assessment sessions spanning over a 6 to 7 week period. ]

    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.


  9. Qualitative Feedback Module [ Time Frame: Tested during the assessment sessions spanning over a 6 to 7 week period. ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03744884


Contacts
Contact: Citlali Lopez-Ortiz, PhD 217-300-1022 lopezort@illinois.edu
Contact: Reika McNish, BA 217-244-9336 rmcnish2@illinois.edu

Sponsors and Collaborators
University of Illinois at Urbana-Champaign
OSF Healthcare System
University of Illinois College of Medicine at Peoria
Investigators
Principal Investigator: Citlali Lopez-Ortiz University of Illinois at Urbana-Champaign

Publications:

Responsible Party: Citlali Lopez-Ortiz, Assistant Professor, University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier: NCT03744884     History of Changes
Other Study ID Numbers: 18476
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Citlali Lopez-Ortiz, University of Illinois at Urbana-Champaign:
Virtual reality
Haptic feedback
Robotic

Additional relevant MeSH terms:
Paralysis
Cerebral Palsy
Muscle Spasticity
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations