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Sensorimotor Control During Postural Transitions in CP

Primary Purpose

Cerebral Palsy

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Stochastic Resonance Electric Stimulation

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Balance Control, Stochastic Resonance, Postural Transitions

Eligibility Criteria

8 Years - 24 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of DelawareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Stochastic Resonance stimulation

No Stochastic Resonance stimulation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in COM

Change in the Center of Mass (COM) trajectories while performing various activities.

Change in COP

Change in the Center of Pressure (COP) trajectories while performing various activities.

Total time

Time taken to complete the task.

Secondary Outcome Measures

Full Information

NCT ID

NCT05384990

First Posted

May 11, 2022

Last Updated

May 17, 2022

Sponsor

University of Delaware

1. Study Identification

Unique Protocol Identification Number

NCT05384990

Brief Title

Sensorimotor Control During Postural Transitions in CP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 22, 2021 (Actual)

Primary Completion Date

May 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Delaware

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Palsy

Keywords

Balance Control, Stochastic Resonance, Postural Transitions

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

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

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.

Allocation

Randomized

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Stochastic Resonance stimulation

Arm Type

Experimental

Arm Description

Arm Title

No Stochastic Resonance stimulation

Arm Type

No Intervention

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Stochastic Resonance Electric Stimulation

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in COM

Description

Change in the Center of Mass (COM) trajectories while performing various activities.

Time Frame

2 assessment points: Baseline - pre stimulation COM, and at the end of the session with stimulation (Day 1)- Post stimulation COM

Title

Change in COP

Description

Change in the Center of Pressure (COP) trajectories while performing various activities.

Time Frame

2 assessment points: Baseline - pre stimulation COP, and at the end of the session with stimulation (Day 1)- Post stimulation COP

Title

Total time

Description

Time taken to complete the task.

Time Frame

Baseline, Post Stimulation (Day 1)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

24 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Samuel CK Lee, PT, PhD

Phone

302-831-2450

slee@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Khushboo Verma, PT

Phone

3028317611

vkhush@udel.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Samuel Lee, PT, PhD

Organizational Affiliation

University of Dealware

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Delaware

City

Newark

State/Province

Delaware

ZIP/Postal Code

19713

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Samuel CK Lee, PT. PhD

Phone

302-831-2450

slee@udel.edu

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Sensorimotor Control During Postural Transitions in CP

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