Sensorimotor Control During Postural Transitions in CP

Neuromotor Control During Postural Transitions in Children and Young Adults With Cerebral Palsy

Sponsors

Lead Sponsor: University of Delaware

Source University of Delaware
Brief Summary

The purpose of this study is to investigate whether a light electrical stimulation to leg muscles and joints can help people with Cerebral Palsy (CP) maintain balance during everyday tasks such as getting up from a chair and walking. Children and young adults with CP can have trouble with daily tasks such as standing up, sitting down on the chair and turning. The difficulty in maintaining balance sometimes lead to falls. This raises risk of disability in CP as children age into teens and adults. Current treatments are not very effective. In this study, children and young adults will be asked to stand up from a stool, walk in a straight line, turn, walk back and sit down on the stool. Participants will receive electrical stimulation at a very low intensity that cannot be felt to help increase their sensory perception. The investigators will evaluate treatment by testing balance, and other functional measures.

Overall Status Recruiting
Start Date 2021-11-22
Completion Date 2023-12-01
Primary Completion Date 2023-05-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in COM 2 assessment points: Baseline - pre stimulation COM, and at the end of the session with stimulation (Day 1)- Post stimulation COM
Change in COP 2 assessment points: Baseline - pre stimulation COP, and at the end of the session with stimulation (Day 1)- Post stimulation COP
Total time Baseline, Post Stimulation (Day 1)
Enrollment 36
Condition
Intervention

Intervention Type: Device

Intervention Name: Stochastic Resonance Electric Stimulation

Description: Subjects will be asked to perform postural transitions like sit to stand, gait initiation, sit to walk and Timed up and the Go (TUG) functional test. This will entail a subsensory electrical signal with a white noise frequency distribution. Proprioceptive SR electrical stimulation will be delivered by BIOPAC Systems, Inc. stimulators that are current limited to deliver less than 10 milli ampere of current. Electrical stimulation will be delivered to muscles and joints along the legs and hips. The stimulation intensity will be very low, below the sensory threshold of the participant.

Arm Group Label: Stochastic Resonance stimulation

Eligibility

Criteria:

Inclusion Criteria for individuals with CP: 1. Age 8-24 2. Diagnosis of CP 3. GMFCS level I-II 4. Ability to stand up from a chair and start walking. 5. Migration index of proximal hip (MIGR) < 40% femoral head covering in acetabulum 6. At least 0° passive dorsiflexion range of motion (ROM) 7. Sufficient visuoperceptual, cognitive and communication skills 8. Seizure-free or well-controlled seizures 9. No other neurological or musculoskeletal disorders (e.g. dystonia, severe scoliosis, hip instability 10. Ability to communicate pain or discomfort 11. Ability to assent/consent or obtain parent/guardian consent Exclusion Criteria for individuals with CP: 1. Scoliosis with primary curve > 40% 2. Spinal fusions extending into pelvis 3. Lower Extremity joint instability or dislocation 4. Severe tactile hypersensitivity 5. Lower extremity botulinum injections in the past 6 months 6. Implanted medical device or metal contraindicative of the application of SR 7. Pregnancy (self-reported) 8. Severe lower extremity spasticity (Modified Ashworth Scale score of 4 or greater) 9. History of pulmonary disease limiting exercise tolerance (Asthma Control Test screen) 10. History of cardiac disease (American Heart Association screen) 11. Severely limited range of joint motion/ irreversible muscle contractures 12. Lower extremity surgery or significant injury within last 1 yr. Inclusionary criteria for typically developing volunteers: 1. Aged 8-24 years old 2. Ability to stand up from a chair and start walking without an assistive device or orthoses 3. Able to communicate discomfort during testing and can follow multi-step directions 4. Has not been diagnosed with any neurological or balance disorders 5. Seizure-free Exclusionary criteria for typically developing volunteers: 1. Diagnosis of CP 2. Significant scoliosis with primary curve > 40° 3. Lower extremity surgery or fractures in the year prior testing 4. Joint instability or dislocation in the lower extremities 5. Severe tactile hypersensitivity 6. A history of selective dorsal root rhizotomy 7. Botulinum toxin injections in the lower extremities within the past 6 months 8. Marked visual or hearing deficits 9. Any embedded metal that may be contraindicated with application of SR 10. Severe spasticity of the lower extremity muscles (eg. a score of 4 on the Modified Ashworth) 11. Pregnancy (self-reported) 12. Severely limited joint range of motion/ irreversible muscle contractures that would not be candidates for soft-tissue surgery 13. Learning disabilities 14. History of neurological disorders 15. Balance and/or postural impairment

Gender:

All

Minimum Age:

8 Years

Maximum Age:

24 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Samuel Lee, PT, PhD Principal Investigator University of Dealware
Overall Contact

Last Name: Samuel CK Lee, PT, PhD

Phone: 302-831-2450

Email: [email protected]

Location
Facility: Status: Contact: University of Delaware Samuel CK Lee, PT. PhD 302-831-2450 [email protected]
Location Countries

United States

Verification Date

2022-05-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Delaware

Investigator Full Name: Samuel Lee

Investigator Title: Director and Associate Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Stochastic Resonance stimulation

Type: Experimental

Description: During this condition, participants will perform postural transitions like sit to stand, gait initiation, sit to walk and Timed Up and Go test while receiving stochastic resonance stimulation on legs and hip.

Label: No Stochastic Resonance stimulation

Type: No Intervention

Description: During this condition, participants will perform postural transitions like sit to stand, gait initiation, sit to walk and Timed Up and Go test without receiving any electrical stimulation.

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Intervention Model Description: Cross sectional study in children with CP and age matched TD (typical developing). Each group will undergo two stimulation conditions, stochastic resonance (SR) stimulation and a no stochastic resonance (noSR) condition while performing postural Transitions.

Primary Purpose: Treatment

Masking: Single (Participant)

Masking Description: The SR stimulation will be provided to the participant in a randomized order using a computer based program. Participants will be unaware of the test condition.

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