CLINICAL TRIAL

Balance training for Hemiplegic Cerebral Palsy

Recruiting · < 18 · All Sexes · Greenville, NC

Remote Ischemic Conditioning, Bimanual Skill Learning, and Corticospinal Excitability

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About the trial for Hemiplegic Cerebral Palsy

Eligible Conditions
Hemiplegic Cerebral Palsy · Paralysis · Remote Ischemic Conditioning · Unilateral Cerebral Palsy · Ischemia · Cerebral Palsy

Treatment Groups

This trial involves 2 different treatments. Balance Training is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Balance training
BEHAVIORAL
Remote Ischemic Conditioning (RIC)
BEHAVIORAL
Bimanual Cup Stacking Training
BEHAVIORAL
Hand Arm Bimanual Intensive Therapy (HABIT)
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Sham conditioning
BEHAVIORAL
Balance training
BEHAVIORAL
Bimanual Cup Stacking Training
BEHAVIORAL
Hand Arm Bimanual Intensive Therapy (HABIT)
BEHAVIORAL

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Balance training
2014
Completed Phase 1
~580
Remote Ischemic Conditioning (RIC)
2015
Completed Phase 3
~410

Eligibility

This trial is for patients born any sex aged 18 and younger. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Children diagnosed with unilateral cerebral palsy, ages 6-16 years
Manual Ability Classification System (MACS) levels I-III
Ability to complete a stack of 3 cups in 2 minutes
Mainstream in school and has sufficient cognition to follow the experiment instructions
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Baseline and 1 week
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline and 1 week.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Balance training will improve 5 primary outcomes and 8 secondary outcomes in patients with Hemiplegic Cerebral Palsy. Measurement will happen over the course of Baseline and 1 week.

Change in Assisting Hand Assessment
BASELINE AND 1 WEEK
Assisting Hand Assessment assesses bimanual coordination and affected hand function. A 5-point change from pre- to post-intervention is considered a clinically meaningful improvement.
Change in accelerometry derived variables
BASELINE AND 1 WEEK
Number of movements, use ratio, magnitude ratio, bilateral magnitude, and acceleration variability will be quantified using wrist worn accelerometers. Greater values indicate better bimanual performance.
Change in Short-Interval Intracortical Inhibition (SICI)
BASELINE AND 1 WEEK
For SICI, a subthreshold (80% RMT) conditioning pulse to the motor hotspot will be applied followed by a suprathreshold (120% RMT) test pulse 3 milliseconds later. Reduction in SICI indicates intracortical facilitation.
Change in Stimulus-response curves
BASELINE AND 1 WEEK
Suprathreshold intensities of 110%, 120%, 130%, 140%, and 150% of resting motor threshold will be administered randomly on the lesioned and non-lesioned cortex. Greater motor evoked potential response at each of these intensities indicate greater corticospinal excitability.
Change in Balance performance
BASELINE AND 1 WEEK
The average amount of time in seconds that a participant maintains the stability platform within ±5° of horizontal position during 15 trials of 30 seconds each. The total score will range between 0-30 seconds. Higher balance score indicates better balance performance. Greater average balance time indicates better balance performance.
Change in Intracortical Facilitation (ICF)
BASELINE AND 1 WEEK
For ICF, the interstimulus interval will increase to 12 milliseconds. Greater ICF indicates greater intracortical facilitation.
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Who is running the study

Principal Investigator
S. M. S.
Prof. Swati Manoharrao Surkar, Assistant Professor
East Carolina University

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes hemiplegic cerebral palsy?

At a higher level, hemiplegic cerebral palsy results from the brain being starved and not getting enough blood to develop properly; therefore, the brain cell can no longer do its job, so the effect of the brain is reduced.

Anonymous Patient Answer

What is hemiplegic cerebral palsy?

The diagnosis of hemiplegic cerebral palsy is often delayed, possibly because it is difficult to identify, and to define its severity. It usually follows an insidious course leading to severe deterioration of function and disability.

Anonymous Patient Answer

What are the signs of hemiplegic cerebral palsy?

Motor and sensory impairments are main features of hemiplegic cerebral palsy. Sensory impairment can give rise to a loss in function affecting the use of bodily functions. For this reason, an impairment in sensory abilities and the ability to control the extremities are indicative of hemiplegic cerebral palsy.

Anonymous Patient Answer

How many people get hemiplegic cerebral palsy a year in the United States?

In 2009, there are an estimated 2.07 million Americans aged 18 years and over who have hemiplegic cerebral palsy. Approximately 1.4 million of these have no mobility of the upper limbs. Thus, the 1 in 50 lifetime incidence of the disease suggests approximately 1.6 percent of each year. Approximately 1 in 380 infants born in the United States will develop the disorder. Children from low-income families and African Americans are most likely to be afflicted.

Anonymous Patient Answer

Can hemiplegic cerebral palsy be cured?

HCP is difficult to cure. Treatment that focuses on addressing the physical and social aspects of the disease only is not sufficient. The importance of multidisciplinary approach can allow many patients to live normal and active lives while having a moderate disability.

Anonymous Patient Answer

What are common treatments for hemiplegic cerebral palsy?

Cerebral palsy children and adolescents can benefit from a range of interventions including physical, occupational, speech, music and sensory therapy, as well as occupational therapy to promote functional independence and participation. Other interventions often used with children with cerebral palsy and adolescents include walking aids and splints, crutches and mobility aids, orthopaedic and non-surgical treatments for deformities. Children and young adolescents with mild to moderate cerebral palsy often do not develop adequate use of their trunk musculature, resulting in low mobility and functional limitation. Children with moderate to severe cerebral palsy may have problems with endurance walking and may have problems with gait.

Anonymous Patient Answer

Who should consider clinical trials for hemiplegic cerebral palsy?

Clinical trials for hemiplegic cerebral palsy of children should focus on children with an IQ above 50%; children with hemiplegic cerebral palsy with both lower extremities in a downward orientation need to be the center of attention. The authors recommend that a neurologist, pediatric neurologist, or neuroprotective approach should be offered to patients with hemiplegic cerebral palsy.

Anonymous Patient Answer

Is bimanual cup stacking training typically used in combination with any other treatments?

Bimanual cup stacking training is typically used in conjunction with other treatment modalities for patients who have hemiplegia and upper extremity function. This treatment tends to be effective for both spasticity and passive range of motion.

Anonymous Patient Answer

How does bimanual cup stacking training work?

Findings from a recent study of this study indicate that this protocol may be useful in developing bimanual training and bimanual coordination for use with hemiplegic CP children.

Anonymous Patient Answer

Does hemiplegic cerebral palsy run in families?

In a recent study, findings was not able to detect any significant differences from the expected level in the level of siblingship among families with hemiplegic CP. However, parents were found to be more anxious and anxious and to have a lower level of acceptance on their children's disability due to hemiplegic CP.

Anonymous Patient Answer

How serious can hemiplegic cerebral palsy be?

Hemiplegic cerebral palsy can lead to long-term impairments. These impairments can affect the physical functioning, occupational performance and social interaction of patients with hemiplegic cerebral palsy. It’s important to educate people on the impact hemiplegic cerebral palsy can have, and help to prevent these impairments from developing.

Anonymous Patient Answer

What is the latest research for hemiplegic cerebral palsy?

The most recent research was written by a group of pediatric neurologists, nurses, and physical therapists. It has been shown that for children with hemiplegic cerebral palsy, the use of the FIM to assess activity can be used to measure the daily activities of their caretaker.

Anonymous Patient Answer
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