Cerebral Palsy, MixedNCT03744884
Movement Characterization in Spastic/Dystonic Cerebral Palsy Using Haptic Feedback in Virtual Reality
A study testing Force efforts with haptic feedback in virtual reality. in people with Cerebral Palsy, Mixed and Cerebral Palsy, Spastic, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Mixed, Cerebral Palsy, Spastic
- What is being tested?
- Force efforts with haptic feedback in virtual reality.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2018to 1 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- Not meeting ALL inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Illinois at Urbana-Champaign
Urbana, Illinois, 61801
Citlali Lopez-Ortiz, MA. PhD, 217-300-1022, lopezort@illinois.edu
About this study
Official title: Movement Impairment Characterization and Rehabilitation for Spastic/Dystonic Cerebral Palsy Using Robotic Haptic Feedback in Virtual Reality
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.
Read the 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.
- Conditions
- Cerebral Palsy, Mixed, Cerebral Palsy, Spastic
- Being tested
- Force efforts with haptic feedback in virtual reality.
- Keywords
- Virtual reality, Haptic feedback, Robotic
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Force efforts with haptic feedback in virtual reality.Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CP intervention group | Experimental | Force efforts with haptic feedback in virtual reality for participants with CP. Receives: Behavioral: Force efforts with haptic feedback in virtual reality. |
| CP control group | No intervention | Regular activity control group, for participants with CP. |
| TD intervention group | Experimental | Force efforts haptic feedback in virtual reality. The intervention will be the same as the CP intervention group but for typically developing participants. Receives: Behavioral: Force efforts with haptic feedback in virtual reality. |
| TD control group | No intervention | Regular activity control group, same as CP no intervention group, but for typically developing participants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Tested during the assessment sessions spanning over a 6 to 7 week period.
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Tested during the assessment sessions spanning over a 6 to 7 week period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start1 Dec 2018
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (54)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy, MixedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- OSF Healthcare System, University of Illinois College of Medicine at Peoria
- Responsible party
- Principal investigator, Citlali Lopez-Ortiz, University of Illinois at Urbana-Champaign
- Investigators
- Citlali Lopez-Ortiz, Principal investigator, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03744884
- Sponsor's protocol ID
- 18476
- Status last verified
- Dec 2019
- First submitted
- 26 Oct 2018
- Last updated
- 3 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Christensen D, Van Naarden Braun K, Doernberg NS, Maenner MJ, Arneson CL, Durkin MS, Benedict RE, Kirby RS, Wingate MS, Fitzgerald R, Yeargin-Allsopp M. Prevalence of cerebral palsy, co-occurring autism spectrum disorders, and motor functioning - Autism and Developmental Disabilities Monitoring Network, USA, 2008. Dev Med Child Neurol. 2014 Jan;56(1):59-65. doi: 10.1111/dmcn.12268. Epub 2013 Oct 1.
PubMed 24117446Paneth N. Establishing the diagnosis of cerebral palsy. Clin Obstet Gynecol. 2008 Dec;51(4):742-8. doi: 10.1097/GRF.0b013e318187081a.
PubMed 18981799Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.
PubMed 17370477Liptak GS. Health and well being of adults with cerebral palsy. Curr Opin Neurol. 2008 Apr;21(2):136-42. doi: 10.1097/WCO.0b013e3282f6a499.
PubMed 18317270Rice J, Skuza P, Baker F, Russo R, Fehlings D. Identification and measurement of dystonia in cerebral palsy. Dev Med Child Neurol. 2017 Dec;59(12):1249-1255. doi: 10.1111/dmcn.13502. Epub 2017 Aug 8.
PubMed 28786476Sanger TD, Delgado MR, Gaebler-Spira D, Hallett M, Mink JW; Task Force on Childhood Motor Disorders. Classification and definition of disorders causing hypertonia in childhood. Pediatrics. 2003 Jan;111(1):e89-97. doi: 10.1542/peds.111.1.e89.
PubMed 12509602Sanger TD. Arm trajectories in dyskinetic cerebral palsy have increased random variability. J Child Neurol. 2006 Jul;21(7):551-7. doi: 10.1177/08830738060210070201.
PubMed 16970842Sellier E, Platt MJ, Andersen GL, Krageloh-Mann I, De La Cruz J, Cans C; Surveillance of Cerebral Palsy Network. Decreasing prevalence in cerebral palsy: a multi-site European population-based study, 1980 to 2003. Dev Med Child Neurol. 2016 Jan;58(1):85-92. doi: 10.1111/dmcn.12865. Epub 2015 Aug 28.
PubMed 26330098Graham HK, Rosenbaum P, Paneth N, Dan B, Lin JP, Damiano DL, Becher JG, Gaebler-Spira D, Colver A, Reddihough DS, Crompton KE, Lieber RL. Cerebral palsy. Nat Rev Dis Primers. 2016 Jan 7;2:15082. doi: 10.1038/nrdp.2015.82.
PubMed 27188686Cramer SC, Sur M, Dobkin BH, O'Brien C, Sanger TD, Trojanowski JQ, Rumsey JM, Hicks R, Cameron J, Chen D, Chen WG, Cohen LG, deCharms C, Duffy CJ, Eden GF, Fetz EE, Filart R, Freund M, Grant SJ, Haber S, Kalivas PW, Kolb B, Kramer AF, Lynch M, Mayberg HS, McQuillen PS, Nitkin R, Pascual-Leone A, Reuter-Lorenz P, Schiff N, Sharma A, Shekim L, Stryker M, Sullivan EV, Vinogradov S. Harnessing neuroplasticity for clinical applications. Brain. 2011 Jun;134(Pt 6):1591-609. doi: 10.1093/brain/awr039. Epub 2011 Apr 10.
PubMed 21482550Sukal-Moulton T, Clancy T, Zhang LQ, Gaebler-Spira D. Clinical application of a robotic ankle training program for cerebral palsy compared to the research laboratory application: does it translate to practice? Arch Phys Med Rehabil. 2014 Aug;95(8):1433-40. doi: 10.1016/j.apmr.2014.04.010. Epub 2014 May 2.
PubMed 24792141Beveridge B, Feltracco D, Struyf J, Strauss E, Dang S, Phelan S, Wright FV, Gibson BE. "You gotta try it all": Parents' Experiences with Robotic Gait Training for their Children with Cerebral Palsy. Phys Occup Ther Pediatr. 2015;35(4):327-41. doi: 10.3109/01942638.2014.990547. Epub 2014 Dec 20.
PubMed 25529412Chen K, Ren Y, Gaebler-Spira D, Zhang LQ. Home-based tele-assisted robotic rehabilitation of joint impairments in children with cerebral palsy. Annu Int Conf IEEE Eng Med Biol Soc. 2014;2014:5288-91. doi: 10.1109/EMBC.2014.6944819.
PubMed 25571187Krebs HI, Fasoli SE, Dipietro L, Fragala-Pinkham M, Hughes R, Stein J, Hogan N. Motor learning characterizes habilitation of children with hemiplegic cerebral palsy. Neurorehabil Neural Repair. 2012 Sep;26(7):855-60. doi: 10.1177/1545968311433427. Epub 2012 Feb 13.
PubMed 22331211Fasoli SE, Fragala-Pinkham M, Hughes R, Krebs HI, Hogan N, Stein J. Robotic therapy and botulinum toxin type A: a novel intervention approach for cerebral palsy. Am J Phys Med Rehabil. 2008 Dec;87(12):1022-5. doi: 10.1097/PHM.0b013e31817fb346.
PubMed 18617860
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Movement Impairment Characterization and Rehabilitation for Spastic/Dystonic Cerebral Palsy Using Robotic Haptic Feedback in Virtual Reality
- ClinicalTrials.gov ID
- NCT03744884
- Acronym / sponsor ID
- 18476
- Conditions
- Cerebral Palsy, Mixed, Cerebral Palsy, Spastic
- Keywords
- Virtual reality, Haptic feedback, Robotic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- OSF Healthcare System, University of Illinois College of Medicine at Peoria
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 16 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| CP intervention group | Experimental | Behavioral: Force efforts with haptic feedback in virtual reality.Force efforts with haptic feedback in virtual reality for participants with CP. |
| CP control group | No intervention | –Regular activity control group, for participants with CP. |
| TD intervention group | Experimental | Behavioral: Force efforts with haptic feedback in virtual reality.Force efforts haptic feedback in virtual reality. The intervention will be the same as the CP intervention group but for typically developing participants. |
| TD control group | No intervention | –Regular activity control group, same as CP no intervention group, but for typically developing participants. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (1 listed)
- Not meeting ALL inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | CP intervention group, TD intervention group |
Primary outcome
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.
9 secondary outcomes
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.
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.
Montreal Spasticity Rating Test (MSRT)
Time frame: Tested during the assessment sessions spanning over a 6 to 7 week period.
Dyskinesia Impairment Scale (DIS)
Time frame: Tested during the assessment sessions spanning over a 6 to 7 week period.
Selective Control of the Upper Extremity Scale (SCUES)
Time frame: Tested during the assessment sessions spanning over a 6 to 7 week period.
Quality of Upper Extremity Skills Test (QUEST)
Time frame: Tested during the assessment sessions spanning over a 6 to 7 week period.
Tardieu scale
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)
Time frame: Tested during the assessment sessions spanning over a 6 to 7 week period.
Qualitative Feedback Module
Time frame: Tested during the assessment sessions spanning over a 6 to 7 week period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
- Background: PubMed 24117446Christensen D, Van Naarden Braun K, Doernberg NS, Maenner MJ, Arneson CL, Durkin MS, Benedict RE, Kirby RS, Wingate MS, Fitzgerald R, Yeargin-Allsopp M. Prevalence of cerebral palsy, co-occurring autism spectrum disorders, and motor functioning - Autism and Developmental Disabilities Monitoring Network, USA, 2008. Dev Med Child Neurol. 2014 Jan;56(1):59-65. doi: 10.1111/dmcn.12268. Epub 2013 Oct 1.
- Background: PubMed 18981799Paneth N. Establishing the diagnosis of cerebral palsy. Clin Obstet Gynecol. 2008 Dec;51(4):742-8. doi: 10.1097/GRF.0b013e318187081a.
- Background: PubMed 17370477Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.
- Background: PubMed 18317270Liptak GS. Health and well being of adults with cerebral palsy. Curr Opin Neurol. 2008 Apr;21(2):136-42. doi: 10.1097/WCO.0b013e3282f6a499.
- Background: PubMed 28786476Rice J, Skuza P, Baker F, Russo R, Fehlings D. Identification and measurement of dystonia in cerebral palsy. Dev Med Child Neurol. 2017 Dec;59(12):1249-1255. doi: 10.1111/dmcn.13502. Epub 2017 Aug 8.
- Background: PubMed 12509602Sanger TD, Delgado MR, Gaebler-Spira D, Hallett M, Mink JW; Task Force on Childhood Motor Disorders. Classification and definition of disorders causing hypertonia in childhood. Pediatrics. 2003 Jan;111(1):e89-97. doi: 10.1542/peds.111.1.e89.
- Background: PubMed 16970842Sanger TD. Arm trajectories in dyskinetic cerebral palsy have increased random variability. J Child Neurol. 2006 Jul;21(7):551-7. doi: 10.1177/08830738060210070201.
- Background: PubMed 26330098Sellier E, Platt MJ, Andersen GL, Krageloh-Mann I, De La Cruz J, Cans C; Surveillance of Cerebral Palsy Network. Decreasing prevalence in cerebral palsy: a multi-site European population-based study, 1980 to 2003. Dev Med Child Neurol. 2016 Jan;58(1):85-92. doi: 10.1111/dmcn.12865. Epub 2015 Aug 28.
- Background: PubMed 27188686Graham HK, Rosenbaum P, Paneth N, Dan B, Lin JP, Damiano DL, Becher JG, Gaebler-Spira D, Colver A, Reddihough DS, Crompton KE, Lieber RL. Cerebral palsy. Nat Rev Dis Primers. 2016 Jan 7;2:15082. doi: 10.1038/nrdp.2015.82.
- Background: PubMed 21482550Cramer SC, Sur M, Dobkin BH, O'Brien C, Sanger TD, Trojanowski JQ, Rumsey JM, Hicks R, Cameron J, Chen D, Chen WG, Cohen LG, deCharms C, Duffy CJ, Eden GF, Fetz EE, Filart R, Freund M, Grant SJ, Haber S, Kalivas PW, Kolb B, Kramer AF, Lynch M, Mayberg HS, McQuillen PS, Nitkin R, Pascual-Leone A, Reuter-Lorenz P, Schiff N, Sharma A, Shekim L, Stryker M, Sullivan EV, Vinogradov S. Harnessing neuroplasticity for clinical applications. Brain. 2011 Jun;134(Pt 6):1591-609. doi: 10.1093/brain/awr039. Epub 2011 Apr 10.
- Background: PubMed 24792141Sukal-Moulton T, Clancy T, Zhang LQ, Gaebler-Spira D. Clinical application of a robotic ankle training program for cerebral palsy compared to the research laboratory application: does it translate to practice? Arch Phys Med Rehabil. 2014 Aug;95(8):1433-40. doi: 10.1016/j.apmr.2014.04.010. Epub 2014 May 2.
- Background: PubMed 25529412Beveridge B, Feltracco D, Struyf J, Strauss E, Dang S, Phelan S, Wright FV, Gibson BE. "You gotta try it all": Parents' Experiences with Robotic Gait Training for their Children with Cerebral Palsy. Phys Occup Ther Pediatr. 2015;35(4):327-41. doi: 10.3109/01942638.2014.990547. Epub 2014 Dec 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Citlali Lopez-Ortiz principal investigator
University of Illinois at Urbana-Champaign
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Force efforts with haptic feedback in virtual reality. in people with Cerebral Palsy, Mixed and Cerebral Palsy, Spastic, run by University of Illinois at Urbana-Champaign at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Citlali Lopez-Ortiz, PhD (217-300-1022, lopezort@illinois.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoothness Index (time frame: Tested during the assessment sessions spanning over a 6 to 7 week period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03744884, which also lists 54 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2020.