Sensorimotor Control During Postural Transitions in CP

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05384990
• Other study ID #: 1759703
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: May 2025

Study information

• Verified date: May 2024
• Source: University of Delaware
• Contact: Samuel CK Lee, PT, PhD
• Phone: 302-831-2450
• Email: slee[@]udel.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

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.

Locations

Country	Name	City	State
United States	University of Delaware	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
University of Delaware

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Total time	Time taken to complete the task.	Baseline, Post Stimulation (Day 1)