Sensorimotor Control During Postural Transitions in CP

• ClinicalTrials.gov Identifier: NCT05384990
• Recruitment Status: Recruiting
• First Posted: May 23, 2022
• Last Update Posted: May 23, 2022
• Sponsor: University of Delaware
• Information provided by (Responsible Party): Samuel Lee, University of Delaware

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cerebral Palsy	Device: Stochastic Resonance Electric Stimulation	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 36 participants
• 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.
• 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.
• Primary Purpose: Treatment
• Official Title: Neuromotor Control During Postural Transitions in Children and Young Adults With Cerebral Palsy
• Actual Study Start Date: November 22, 2021
• Estimated Primary Completion Date: May 2023
• Estimated Study Completion Date: December 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

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

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

Contacts and Locations

Contacts

Contact: Samuel CK Lee, PT, PhD; 302-831-2450; slee@gmail.com

Contact: Khushboo Verma, PT; 3028317611; vkhush@udel.edu

Locations

United States, Delaware

University of Delaware; Recruiting

Newark, Delaware, United States, 19713

Contact: Samuel CK Lee, PT. PhD 302-831-2450 slee@udel.edu

Sponsors and Collaborators

University of Delaware

Investigators

• Principal Investigator: Samuel Lee, PT, PhD; University of Dealware

More Information

• Responsible Party: Samuel Lee, Director and Associate Professor, University of Delaware
• ClinicalTrials.gov Identifier: NCT05384990
• Other Study ID Numbers: 1759703
• First Posted: May 23, 2022
• Last Update Posted: May 23, 2022
• Last Verified: May 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Samuel Lee, University of Delaware:

Balance Control; Stochastic Resonance; Postural Transitions

Additional relevant MeSH terms:

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