Balance Control in Children With Cerebral Palsy

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Sensor Fusion for Balance Control in Children With Cerebral Palsy

Conditions
-----------------
Cerebral Palsy

Intervention / Treatment
-----------------
* Procedure: Sensory Integration Testing
* Procedure: SR stimulation & Sensory integration testing


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Children with Cerebral palsy<br>Sensory integration testing SR stimulation and Sensory integration testing | Procedure: Sensory Integration Testing<br>* Investigate how sensory information are integrated during upright stance when visual and body senses are challenged in a virtual reality environment<br>* Other names: Sensor Fusion paradigm;Procedure: SR stimulation & Sensory integration testing<br>* Use SR stimulation to improve sensory integration when visual and body senses are challenged in a virtual reality environment<br>|
| Active Comparator: Children with Typical Development<br>Sensory integration testing SR stimulation and Sensory integration testing | Procedure: Sensory Integration Testing<br>* Investigate how sensory information are integrated during upright stance when visual and body senses are challenged in a virtual reality environment<br>* Other names: Sensor Fusion paradigm;Procedure: SR stimulation & Sensory integration testing<br>* Use SR stimulation to improve sensory integration when visual and body senses are challenged in a virtual reality environment<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gain response | For both the sensory reweighting testing, the visual signal will be displayed as a visual flow with translation in anterior-posterior (AP) direction (i.e., sagittal plane) and presented at different amplitudes (0.25 and 0.5 cm) at 0.2 Hz to measure: the change in gain (weighting) to vision (intramodal effect); and a change in gain to vibration and galvanic stimulation (intermodal effects). Gain for each modality relative to both the leg segment AP translation and trunk segment AP translation will be measured. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gain response | For the sensory reweighting with the addition of SR stimulation testing, the visual signal will be displayed as a visual flow with translation in anterior-posterior (AP) direction (i.e., sagittal plane) and presented at different amplitudes (0.25 and 0.5 cm) at 0.2 Hz to measure: the change in gain (weighting) to vision (intramodal effect); and a change in gain to vibration and galvanic stimulation (intermodal effects). Gain for each modality relative to both the leg segment AP translation and trunk segment AP translation will be measured. | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sensor Fusion, Stochastic Resonance Stimulation, Sensory deficits, Postural Control