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

University of Illinois at Urbana-Champaign

Status: Unknown

Conditions: Cerebral Palsy, Mixed; Cerebral Palsy, Spastic

Treatments: Behavioral: Force efforts with haptic feedback in virtual reality.

Study type: Interventional

Funder types: Other

Identifiers

NCT03744884

18476

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 estimated patients

Sex: All

Ages: 7 to 17 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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68 participants in 4 patient groups

CP intervention group

Experimental group

Description:

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

Treatment:

Behavioral: Force efforts with haptic feedback in virtual reality.

CP control group

No Intervention group

Description:

Regular activity control group, for participants with CP.

TD intervention group

Experimental group

Description:

Force efforts haptic feedback in virtual reality. The intervention will be the same as the CP intervention group but for typically developing participants.

Treatment:

Behavioral: Force efforts with haptic feedback in virtual reality.

TD control group

No Intervention group

Description:

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