- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05384990
Sensorimotor Control During Postural Transitions in CP
May 17, 2022 updated by: Samuel Lee, University of Delaware
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
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Samuel CK Lee, PT, PhD
- Phone Number: 302-831-2450
- Email: slee@gmail.com
Study Contact Backup
- Name: Khushboo Verma, PT
- Phone Number: 3028317611
- Email: vkhush@udel.edu
Study Locations
-
-
Delaware
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Newark, Delaware, United States, 19713
- Recruiting
- University of Delaware
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Contact:
- Samuel CK Lee, PT. PhD
- Phone Number: 302-831-2450
- Email: slee@udel.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 24 years (ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria for individuals with CP:
- Age 8-24
- 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
Exclusion Criteria for individuals with CP:
- 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.
Inclusionary criteria for typically developing volunteers:
- Aged 8-24 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
- Has not been diagnosed with any neurological or balance disorders
- Seizure-free
Exclusionary criteria for typically developing volunteers:
- Diagnosis of CP
- Significant scoliosis with primary curve > 40°
- Lower extremity surgery or fractures in the year prior testing
- Joint instability or dislocation in the lower extremities
- Severe tactile hypersensitivity
- A history of selective dorsal root rhizotomy
- Botulinum toxin injections in the lower extremities within the past 6 months
- Marked visual or hearing deficits
- Any embedded metal that may be contraindicated with application of SR
- Severe spasticity of the lower extremity muscles (eg. a score of 4 on the Modified Ashworth)
- Pregnancy (self-reported)
- Severely limited joint range of motion/ irreversible muscle contractures that would not be candidates for soft-tissue surgery
- Learning disabilities
- History of neurological disorders
- Balance and/or postural impairment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
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.
|
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.
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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
Time Frame: 2 assessment points: Baseline - pre stimulation COM, and at the end of the session with stimulation (Day 1)- Post stimulation COM
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Change in the Center of Mass (COM) trajectories while performing various activities.
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2 assessment points: Baseline - pre stimulation COM, and at the end of the session with stimulation (Day 1)- Post stimulation COM
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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.
|
2 assessment points: Baseline - pre stimulation COP, and at the end of the session with stimulation (Day 1)- Post stimulation COP
|
Total time
Time Frame: Baseline, Post Stimulation (Day 1)
|
Time taken to complete the task.
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Baseline, Post Stimulation (Day 1)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Samuel Lee, PT, PhD, University of Dealware
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 22, 2021
Primary Completion (ANTICIPATED)
May 1, 2023
Study Completion (ANTICIPATED)
December 1, 2023
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 (ACTUAL)
May 23, 2022
Last Update Submitted That Met QC Criteria
May 17, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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