Sensorimotor Control During Postural Transitions in CP

NCT05384990 | Active Not Recruiting

• 1 other identifier: 1759703
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

Balance Control; Stochastic Resonance; Postural Transitions

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (2)

Stochastic Resonance stimulation

EXPERIMENTAL

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

No Stochastic Resonance stimulation

NO INTERVENTION

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.

Interventions

Stochastic Resonance Electric Stimulation DEVICE

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.

Stochastic Resonance stimulation

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 10-21
• Diagnosis of CP
• GMFCS level I-II
• Ability to stand up from a chair and start walking.
• Migration index of proximal hip (MIGR) \< 40% femoral head covering in acetabulum
• At least 0° passive dorsiflexion range of motion (ROM)
• Sufficient visuoperceptual, cognitive and communication skills
• Seizure-free or well-controlled seizures
• No other neurological or musculoskeletal disorders (e.g. dystonia, severe scoliosis, hip instability
• Ability to communicate pain or discomfort
• Ability to assent/consent or obtain parent/guardian consent

You may not qualify if:

• Scoliosis with primary curve \> 40%
• Spinal fusions extending into pelvis
• Lower Extremity joint instability or dislocation
• Severe tactile hypersensitivity
• Lower extremity botulinum injections in the past 6 months
• Implanted medical device or metal contraindicative of the application of SR
• Pregnancy (self-reported)
• Severe lower extremity spasticity (Modified Ashworth Scale score of 4 or greater)
• History of pulmonary disease limiting exercise tolerance (Asthma Control Test screen)
• History of cardiac disease (American Heart Association screen)
• Severely limited range of joint motion/ irreversible muscle contractures
• Lower extremity surgery or significant injury within last 1 yr.
• Aged 10-21 years old
• Ability to stand up from a chair and start walking without an assistive device or orthoses
• Able to communicate discomfort during testing and can follow multi-step directions

Sponsors & Collaborators

• University of Delaware: lead

Study Sites (1)

University of Delaware

Newark, Delaware, 19713, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Samuel Lee, PT, PhD

  University of Dealware

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director and Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 23, 2022
• Study Start: April 1, 2024
• Primary Completion: May 30, 2025
• Study Completion: December 30, 2025
• Last Updated: November 14, 2025

Record last verified: 2025-11

Locations

US (1)