Sensorimotor Control During Postural Transitions in CP

NCT ID: NCT05384990

Last Updated: 2025-11-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-12-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Stochastic Resonance Electric Stimulation

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Delaware

OTHER

Sponsor Role: lead

Responsible Party

Samuel Lee

Director and Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Samuel Lee, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Dealware

Locations

University of Delaware

Newark, Delaware, United States

Countries

United States

Other Identifiers

1759703

Identifier Type: -

Identifier Source: org_study_id