Sensorimotor Control During Postural Transitions in CP

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cerebral Palsy
• Intervention / Treatment: Device: Stochastic Resonance Electric Stimulation

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Newark, Delaware, United States, 19713
      • University of Delaware

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria for individuals with CP:

1. Age 10-21
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 10-21 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stochastic Resonance stimulation; 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.	Device: Stochastic Resonance Electric Stimulation; 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.
No Intervention: No Stochastic Resonance stimulation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in COM	Change in the Center of Mass (COM) trajectories while performing various activities.	2 assessment points: Baseline - pre stimulation COM, and at the end of the session with stimulation (Day 1)- Post stimulation COM
Change in COP	Change in the Center of Pressure (COP) trajectories while performing various activities.	2 assessment points: Baseline - pre stimulation COP, and at the end of the session with stimulation (Day 1)- Post stimulation COP
Total time	Time taken to complete the task.	Baseline, Post Stimulation (Day 1)

Collaborators and Investigators

• Sponsor: University of Delaware
• Investigators: Principal Investigator: Samuel Lee, PT, PhD, University of Dealware

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): May 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: May 11, 2022
• First Submitted That Met QC Criteria: May 17, 2022
• First Posted (Actual): May 23, 2022

Study Record Updates

• Last Update Posted (Estimated): November 14, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Balance Control; Stochastic Resonance; Postural Transitions
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 1759703

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No