Recruiting

Haptic Feedback

Sponsor:

University of Illinois at Urbana-Champaign

Code:

NCT03744884

Conditions

Cerebral Palsy, Mixed

Cerebral Palsy, Spastic

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Accepted

Interventions

Force efforts with haptic feedback in virtual reality.

Study Details

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.

Conditions

Cerebral Palsy, Mixed

Cerebral Palsy, Spastic

Study ID

NCT03744884

Start date

Dec 1, 2018

Status verified date

Dec, 2019

Completion date

Jan 1, 2021

Anticipated

Primary completion date

Jan 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Accepted

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

Study Design

Enrollment

68 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: CP intervention group

Force efforts with haptic feedback in virtual reality for participants with CP.

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.

no intervention: TD control group

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

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Citlali Lopez-Ortiz, PhD

217-300-1022lopezort@illinois.edu

Reika McNish, BA

217-244-9336rmcnish2@illinois.edu

Locations

University of Illinois at Urbana-Champaign

Recruiting

Urbana, Illinois, United States, 61801

Contacts

Citlali Lopez-Ortiz, MA. PhD

217-300-1022lopezort@illinois.edu

More Information

Sponsor

University of Illinois at Urbana-Champaign

Last update posted

Jan 3, 2020

Last verified

Dec, 2019

Keywords

  • Virtual reality
  • Haptic feedback
  • Robotic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Illinois at Urbana-Champaign on 2020-01-03.