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

NCT03744884 | Unknown

• 1 other identifier: 18476
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Keywords

Virtual reality; Haptic feedback; Robotic

Outcome Measures

Primary Outcomes (1)

• 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.

  Tested during the assessment sessions spanning over a 6 to 7 week period.

Secondary Outcomes (9)

• Surface electromyography

  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

  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)

  Tested during the assessment sessions spanning over a 6 to 7 week period.

• Dyskinesia Impairment Scale (DIS)

  Tested during the assessment sessions spanning over a 6 to 7 week period.

• Selective Control of the Upper Extremity Scale (SCUES)

  Tested during the assessment sessions spanning over a 6 to 7 week period.

Study Arms (4)

CP intervention group

EXPERIMENTAL

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

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.

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.

Interventions

Force efforts with haptic feedback in virtual reality. BEHAVIORAL

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.

CP intervention group; TD intervention group

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead
• OSF Healthcare System: collaborator
• University of Illinois College of Medicine at Peoria: collaborator

Study Sites (1)

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

RECRUITING

Related Publications (54)

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• McNish RN, Chembrammel P, Speidel NC, Lin JJ, Lopez-Ortiz C. Rehabilitation for Children With Dystonic Cerebral Palsy Using Haptic Feedback in Virtual Reality: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Jan 14;8(1):e11470. doi: 10.2196/11470.

  PMID: 31344678 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Citlali Lopez-Ortiz

  University of Illinois at Urbana-Champaign

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Citlali Lopez-Ortiz, PhD

CONTACT

217-300-1022; lopezort@illinois.edu

Reika McNish, BA

CONTACT

217-244-9336; rmcnish2@illinois.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: November 16, 2018
• Study Start: December 1, 2018
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: January 3, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)