Balance Control in Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

Sensor Fusion for Balance Control in Children With Cerebral Palsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02456376
• Other study ID #: 71002-PHI-14
• Secondary ID: 22173
• Status: Recruiting
• Phase: N/A
• First received: May 26, 2015
• Last updated: May 26, 2015
• Start date: May 2014
• Est. completion date: December 2016

Study information

• Verified date: May 2015
• Source: Temple University
• Contact: Anastasia Zarkou, PT, MS
• Email: azarkou[@]udel.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 18 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Procedure:
• Sensory Integration Testing
Investigate how sensory information are integrated during upright stance when visual and body senses are challenged in a virtual reality environment
• SR stimulation & Sensory integration testing
Use SR stimulation to improve sensory integration when visual and body senses are challenged in a virtual reality environment

Locations

Country	Name	City	State
United States	Shriners Hospital for Children	Philadelphia	Pennsylvania
United States	Temple University	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Temple University	Shriners Hospitals for Children, University of Delaware

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No