Balance Control in Children With Cerebral Palsy

Temple University

Status: Unknown

Conditions: Cerebral Palsy

Treatments: Procedure: SR stimulation & Sensory integration testing; Procedure: Sensory Integration Testing

Study type: Interventional

Funder types: Other

Identifiers

NCT02456376

22173 (Other Identifier)

71002-PHI-14

Details and patient eligibility

About

The purpose of this study is to investigate how sensory information processing affects balance ability in children with cerebral palsy (CP). An additional goal is to determine if a subsensory electrical stimulation called Stochastic Resonance (SR) Stimulation, can improve balance in children with CP. Children with CP and children with typical development will participate and complete a series of clinical and balance assessments. They will also be tested in a sensor fusion paradigm to investigate potential deficits in the dynamic integration of visual, vestibular and proprioceptive information during upright stance. SR stimulation will then be used to potentially improve these deficits and subsequently their balance ability.

Enrollment: 20 estimated patients

Sex: All

Ages: 8 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Diagnosis of spastic diplegia CP (GMFCS I- III)*
• Ability to stand independently for approximately 2 min

Exclusion criteria

• Lower extremity surgery or fractures in the year prior testing

• Joint instability or dislocation in the lower extremities

• Botulinum toxin injections in the lower extremities within the past 6 months*

• Marked visual or hearing deficits

• Uncontrolled seizure disorder

• Implanted medical device that may be contraindicated with application of SR stimulation

  • Asterisk indicates the eligibility criteria that should be met only by children with CP

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Children with Cerebral palsy

Experimental group

Description:

Sensory integration testing SR stimulation and Sensory integration testing

Treatment:

Procedure: Sensory Integration Testing

Procedure: SR stimulation & Sensory integration testing

Children with Typical Development

Active Comparator group

Description:

Sensory integration testing SR stimulation and Sensory integration testing

Treatment:

Procedure: Sensory Integration Testing

Procedure: SR stimulation & Sensory integration testing