CLINICAL TRIAL

Pediatric Constrained Induced Movement Therapy for Hemiplegic Cerebral Palsy

Recruiting · < 18 · All Sexes · Columbus, OH

Feasibility of Pediatric CIMT by Televideo

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About the trial for Hemiplegic Cerebral Palsy

Eligible Conditions
Hemiplegic Cerebral Palsy · Cerebral Palsy

Treatment Groups

This trial involves 2 different treatments. Pediatric Constrained Induced Movement Therapy is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Pediatric Constrained Induced Movement Therapy
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and younger. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
ages 1 - 10 years old at enrollment;
The diagnosis of hemiplegic CP is supported by the report of a parent. show original
You are able to participate in therapy 3 hours/day x 5 days/week x 4 weeks. show original
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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: Within 1 week following intervention
Screening: ~3 weeks
Treatment: Varies
Reporting: Within 1 week following intervention
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Within 1 week following intervention.
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 Pediatric Constrained Induced Movement Therapy will improve 5 primary outcomes, 2 secondary outcomes, and 4 other outcomes in patients with Hemiplegic Cerebral Palsy. Measurement will happen over the course of Within 2 weeks of intervention completion.

Acceptability of Intervention Measure (AIM)
WITHIN 2 WEEKS OF INTERVENTION COMPLETION
Acceptability of Intervention will be assessed through a four-item measure (AIM). The measure includes four statements about the appeal of the intervention (e.g. I like the intervention; I welcome the intervention; the intervention meets my approval; the intervention is appealing to me). Individuals rate the extent to which the agree with each statement on a five-level scale (completely disagree, disagree, neither agree or disagree, agree, completely agree).
WITHIN 2 WEEKS OF INTERVENTION COMPLETION
Fidelity of Intervention Assessment
ONCE PER WEEK DURING 4-WEEK INTERVENTION PERIOD
This instrument assesses the extent to which the therapist adhered to fifteen core constructs of the intervention protocol. Evidence of adherence to high quality pediatric rehabilitation elements includes 6 constructs that are scored as Present (present-some and present-strong) or Absent. Includes items such as "collaboration between parent and therapist" and "aligning therapy with child's goals". Evidence of core components of pediatric constraint induced movement therapy is scored as Present or Absent. Includes items such as "high intensity of intervention" and occurs in "natural environment". Total score is number of core components present.
ONCE PER WEEK DURING 4-WEEK INTERVENTION PERIOD
Structured Activity Session
WITHIN 2 WEEKS PRIOR TO START OF INTERVENTION AND WITHIN 1 WEEK FOLLOWING INTERVENTION
The Structured Activity Session identifies a variety of age-appropriate activities and behaviors that can be coded for quality and frequency of movement, as well as the number of activities and behaviors completed. The activity session will include a 1. dressing activity (e.g. donning and doffing and zippered sweatshirt), 2. a snack activity (e.g. opening a beverage container, opening and eating a snack with small food items like goldfish, and opening and eating a snack with a utensil like applesauce or pudding), and gross motor activities (like catching a ball, jumping).
WITHIN 2 WEEKS PRIOR TO START OF INTERVENTION AND WITHIN 1 WEEK FOLLOWING INTERVENTION
Abilhand-kids
WITHIN 2 WEEKS PRIOR TO START OF INTERVENTION AND WITHIN 1 WEEK FOLLOWING INTERVENTION
ABILHAND-kids is a parent reported measure of manual ability in children with Cerebral Palsy. Parents estimate their child's ease/difficulty with performing 21 selected activities of daily living. Parents rate their child's difficulty on a three-level scale: "Impossible", "Difficult", or "Easy".
WITHIN 2 WEEKS PRIOR TO START OF INTERVENTION AND WITHIN 1 WEEK FOLLOWING INTERVENTION
Box and Block
WITHIN 2 WEEKS PRIOR TO START OF INTERVENTION AND WITHIN 1 WEEK FOLLOWING INTERVENTION
The Box and Block assesses manual dexterity. It has strong psychometric properties. The child is instructed to move 1-inch square blocks from one side of a wooden box over a partition to the other side. The scoring is based on the number of blocks moved over within 60 seconds.
WITHIN 2 WEEKS PRIOR TO START OF INTERVENTION AND WITHIN 1 WEEK FOLLOWING INTERVENTION
Usefulness, Usability and Desirability Assessment (UUD)
WITHIN 2 WEEKS OF INTERVENTION COMPLETION
The Usability of the remote delivery system (use of the iPad, Kubi robot; video upload) will be assessed with the UUD assessment. Usability includes three major components: usefulness, desirability, and usability. The UUD gathers data on usability (ease of use of the telehealth technology) (9 items), usefulness (value, relevance, and applicability of the telehealth technology) (10 items), and desirability (overall appeal or interest of the telehealth technology) (4 items). Items are rated a five-point Likert-type scale.
WITHIN 2 WEEKS OF INTERVENTION COMPLETION
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Who is running the study

Principal Investigator
A. D.
Amy Darragh, Director of the Occupational Therapy Division in the School of Health and Rehabilitation Sciences in the College of Medicine
Ohio State 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.

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

Nearly 500,000 children in the United States are diagnosed with hemiplegic [cerebral palsy](https://www.withpower.com/clinical-trials/cerebral-palsy) annually, making it a leading cause of severely disabling childhood disability. The rate of hemiplegic cerebral palsy increases with the increasing frequency of perinatal asphyxia and preeclampsia; this rate may further increase as the perinatal screening and treatment of the disease has become more effective.

Anonymous Patient Answer

What causes hemiplegic cerebral palsy?

Recent findings is the first time, in our opinion, to explore the association between risk factors for hemiplegic CP and environmental exposures in the setting of a specific population. Exposure to environmental risk factors at certain times during the gestational period is associated with worse outcomes for infants with hemiplegic CP at age 1 year. Birth at term was protective of both infant and child outcomes.

Anonymous Patient Answer

What is hemiplegic cerebral palsy?

HCP is a disease with frequent and variable sequelae that can be traced back to lesions in the embryonic brain that impair growth. Children with HCP have multiple disabling conditions along with intellectual disability, motor impairment and sensory dysfunction. They require a multidisciplinary approach to healthcare with physical therapists, speech therapists and social workers leading the treatment team, working along with a multidisciplinary team including paediatric psychiatrists to assess and manage mental health issues.

Anonymous Patient Answer

What are the signs of hemiplegic cerebral palsy?

Hemiplegic cerebral palsy can present clinically as mild motor deficits and psychomotor problems (particularly in older children), but it is possible that subtle motor disturbances may be missed in young children. The degree of hemiplegia is correlated with functional deficits in the paretic (weak or paralyzed side of the body); the use of non-paretic limbs is possible, but may result in altered movement patterns. The hemiparesis and ataxia in children might be indicative of subcortical injury.

Anonymous Patient Answer

What are common treatments for hemiplegic cerebral palsy?

Children with hemiplegic [cerebral palsy](https://www.withpower.com/clinical-trials/cerebral-palsy) may have moderate to severe motor and/or intellectual disability. As the severity of their disabilities increases, the range of treatment options increases as well. Children with hemiplegic cerebral palsy may be treated in the same way as healthy children with hemiplegic cerebral palsy. However, hemiplegic cerebral palsy children may have more serious medical issues, which puts them at a higher risk for non-essential medical costs. If not treated, many hemiplegic cerebral palsy children will eventually suffer from spastic quadriplegia, and the most common cause of medical-related death in hemiplegic cerebral palsy children is cancer.

Anonymous Patient Answer

Can hemiplegic cerebral palsy be cured?

Data from a recent study show that, despite rigorous rehabilitation, significant cerebral palsy symptoms are still present two years after the initial stroke, and that residual symptoms are likely to be progressive.

Anonymous Patient Answer

Does hemiplegic cerebral palsy run in families?

There appears to be little genetic contribution to the early development of CCSP by the traditional criteria of consanguinity and family history. However, given that familiality is higher than 5%, we cannot exclude a role for genes in the etiology of CCSP if familial cases would also be included.

Anonymous Patient Answer

What is the average age someone gets hemiplegic cerebral palsy?

Children aged 5–6 years accounted for the largest proportion of children with hemiplegic cerebral palsy, followed by children aged 7–13 years. Children aged 10–14 years were the only age group with disproportionately low numbers compared with the number of children with hemiplegic cerebral palsy of other ages.

Anonymous Patient Answer

How does pediatric constrained induced movement therapy work?

Data from a recent study of this study, particularly the significant effect in the paretic lower limb, suggest the effectiveness of constraining induced movements therapy. A systematic review of research in this area is encouraged to expand the knowledge on the treatment of pediatric hemiplegic cerebral palsy.

Anonymous Patient Answer

How serious can hemiplegic cerebral palsy be?

Hemiplegic cerebral palsy is a condition that many children with cerebral palsy encounter when they reach the age of 4 to 5 years. The neurological and cognitive consequences of this condition for children, especially the [spastic children, are serious (Cerebral Palsy Association (2011). I-II)]. Cerebral palsy was more prevalent in this [study population]] than in the UK population (13.5% [CVA (11.9% to 14.7%], CVA; (2012) 14–16.3% [CVA (14% to 17%]) and Canada [CVA (2.1% to 4.2%], Canada 11.

Anonymous Patient Answer

What is the latest research for hemiplegic cerebral palsy?

Based on the authors' survey of recent literature, there is little evidence to support any evidence-based practices to treatment of hemiplegic CP, and the existing literature has mostly concentrated on the basic neurological, medical, and nursing features of hemiplegic CP. Although the quality of research on the effectiveness of specific treatment approaches (e.g., exercise) has increased lately, the evidence base is still of low quality and warrants further investigation.

Anonymous Patient Answer

Has pediatric constrained induced movement therapy proven to be more effective than a placebo?

This systematic review concludes that CCIMT, administered three times per week for 11 to 20 weeks, is not efficacious in children with hemiplegic CP. However, future research using this technique should continue to address whether there are subgroups of children with hemiplegic CP who benefit from this therapy to no greater than a placebo.

Anonymous Patient Answer
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