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

Sponsor

University of Illinois at Urbana-Champaign (Other)

Overall Status

Unknown status

CT.gov ID

NCT03744884

Collaborator

OSF Healthcare System (Other), University of Illinois College of Medicine at Peoria (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.	N/A

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 Design

Study Type:

Interventional

Anticipated 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.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

Actual Study Start Date :

Dec 1, 2018

Anticipated Primary Completion Date :

Jan 1, 2021

Anticipated Study Completion Date :

Jan 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

Smoothness Index [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

Surface electromyography [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.
Forces and torques against force sensor during gampeplay and in robotic zero-force channel [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.
Montreal Spasticity Rating Test (MSRT) [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
Dyskinesia Impairment Scale (DIS) [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.
Selective Control of the Upper Extremity Scale (SCUES) [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.
Quality of Upper Extremity Skills Test (QUEST) [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.
Tardieu scale [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.
World Health Organization Disability Assessment Schedule 2 Children and Youth (WHODAS II - CY) [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.
Qualitative Feedback Module [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Illinois at Urbana-Champaign	Urbana	Illinois	United States	61801

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Citlali Lopez-Ortiz, Assistant Professor, University of Illinois at Urbana-Champaign

ClinicalTrials.gov Identifier:

NCT03744884

Other Study ID Numbers:

18476

First Posted:

Nov 16, 2018

Last Update Posted:

Jan 3, 2020

Last Verified:

Dec 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Citlali Lopez-Ortiz, Assistant Professor, University of Illinois at Urbana-Champaign

Virtual reality

Haptic feedback

Robotic

Additional relevant MeSH terms:

Muscle Spasticity

Paralysis

Cerebral Palsy

Study Results

No Results Posted as of Jan 3, 2020