CLINICAL TRIAL

PlayGait for Cerebral Palsy

Recruiting · < 18 · All Sexes · Edmonds, WA

PlayGait: A Dynamic Exoskeleton

See full description

About the trial for Cerebral Palsy

Treatment Groups

This trial involves 2 different treatments. PlayGait 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.
PlayGait
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Baseline
OTHER

Eligibility

This trial is for patients born any sex aged 18 and younger. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
You are 3 to 4 years old. show original
Hemiplegic cerebral palsy
Parent/caregiver is willing to have the child stop wearing their prescribed AFO during data collections (lab sessions and two 7-day periods at home). show original
You are able to walk at least 10 meters without the use of assistive devices or AFOs. show original
You have the ability to walk without the use of assistive devices or AFOs. show original
You have a stiff knee gait with less than normal knee flexion during swing phase. show original
You have less than 20 degrees of hip flexion contracture. show original
You have a level I or II gross motor function classification. show original
The Modified Ashworth Scale (MAS) is a validated tool for measuring muscle strength in older adults. show original
You have family to attend all study sessions. show original
View All
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
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 1st lab session (baseline); 3rd lab session with PlayGait after 7 days of wearing PlayGait
Screening: ~3 weeks
Treatment: Varies
Reporting: 1st lab session (baseline); 3rd lab session with PlayGait after 7 days of wearing PlayGait
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 1st lab session (baseline); 3rd lab session with PlayGait after 7 days of wearing PlayGait.
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 PlayGait will improve 2 primary outcomes and 5 secondary outcomes in patients with Cerebral Palsy. Measurement will happen over the course of PlayGait condition: 7 days in the community with PlayGait.

Time of PlayGait use
PLAYGAIT CONDITION: 7 DAYS IN THE COMMUNITY WITH PLAYGAIT
Amount of time each day that PlayGait is worn
PLAYGAIT CONDITION: 7 DAYS IN THE COMMUNITY WITH PLAYGAIT
Average steps per day
BASELINE CONDITION: 7 DAYS IN THE COMMUNITY WITHOUT PLAYGAIT (NO LOWER-LIMB ASSISTIVE DEVICES); PLAYGAIT CONDITION: 7 DAYS WITH PLAYGAIT
Step count per day
BASELINE CONDITION: 7 DAYS IN THE COMMUNITY WITHOUT PLAYGAIT (NO LOWER-LIMB ASSISTIVE DEVICES); PLAYGAIT CONDITION: 7 DAYS WITH PLAYGAIT
Cadence
7 DAYS WITH BASELINE CONDITION; 7 DAYS WITH PLAYGAIT CONDITION
Low, medium, and high activity rate
7 DAYS WITH BASELINE CONDITION; 7 DAYS WITH PLAYGAIT CONDITION
Shifts in cadence
7 DAYS WITH BASELINE CONDITION; 7 DAYS WITH PLAYGAIT CONDITION
Shifts from low to medium cadence and shifts from medium to high cadence
7 DAYS WITH BASELINE CONDITION; 7 DAYS WITH PLAYGAIT CONDITION
Pediatric Balance Scale
1ST LAB SESSION (BASELINE); 3RD LAB SESSION WITH PLAYGAIT AFTER 7 DAYS OF WEARING PLAYGAIT
Participant completes 14 activity items that measure pediatric balance
1ST LAB SESSION (BASELINE); 3RD LAB SESSION WITH PLAYGAIT AFTER 7 DAYS OF WEARING PLAYGAIT
10 meter walk test
1ST LAB SESSION (BASELINE); 3RD LAB SESSION WITH PLAYGAIT AFTER 7 DAYS OF WEARING PLAYGAIT
The time it takes to walk 10 meters
1ST LAB SESSION (BASELINE); 3RD LAB SESSION WITH PLAYGAIT AFTER 7 DAYS OF WEARING PLAYGAIT
See More

Who is running the study

Principal Investigator
J. Z.
Jessica Zistatsis, Project Manager
Orthocare Innovations, LLC

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 are the signs of cerebral palsy?

It is not uncommon for the signs of cerebral palsy to be misdiagnosed as psychosis or dementia. It is important for parents to inform health practitioners of the signs of cerebral palsy. This will enable health practitioners to identify cerebral palsy and initiate appropriate assessments and treatment planning.

Anonymous Patient Answer

What are common treatments for cerebral palsy?

The most common treatments for cerebral palsy are orthopaedic procedures, physiotherapy, occupational therapy, and speech therapy. Children with moderate or severe impairment might benefit from early mobility training beginning at age 2, or some children with severe motor impairment might benefit from occupational therapy to improve function and participation in daily activities.

Anonymous Patient Answer

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

For children under one year old, the rate of cerebral palsy is 6.1 per 1,000 live births The rate for children aged one year and over reaches 13.7 per 1,000 live births. The relative rates of cerebral palsy vary from province to province in Canada. Rates range from 4.3 per 10,000 live births in Nunavut to 25.9 per 10,000 in Saskatchewan.

Anonymous Patient Answer

Can cerebral palsy be cured?

There is no evidence of a cure in anyone with cerebral palsy. We have the strongest evidence against curing anyone with severe motor impairments, or people who have progressive impairments. There is weak evidence of harm from intervention.

Anonymous Patient Answer

What causes cerebral palsy?

Different genes or multiple rare genetic mutations (or combinations of rare mutations) may be involved, and this is one of the many possible causes of cerebral palsy. In the case of hemispheric cerebral palsy, such genetic abnormalities manifest early in development of the brain, and the resulting abnormalities in the brain development cause a specific type of cerebral palsy. The genetic abnormality may be the consequence of an infection, prenatal exposure to an environmental chemical, or other factor, but it is not, in itself, the cause. However, many children affected by cerebral palsy have a combination of genetic factors, and these combined genetic abnormalities are sufficient to cause the most severe forms of the disease, and account for about 40 percent of affected children.

Anonymous Patient Answer

What is cerebral palsy?

Cerebral palsy is a major neurological problem affecting about 3.3 million people in the United States each year and is the result of damage to, or impairment in, brain function.

Anonymous Patient Answer

What is the latest research for cerebral palsy?

Although the research area of cerebral palsy has expanded widely, there have been few advances in this field over the last 15 years. It is not clear why advances have been slow to be made. One theory is that the problem is that of insufficient funding.

Anonymous Patient Answer

Does cerebral palsy run in families?

Results from a recent clinical trial illustrate the difficulty faced by clinicians and researchers regarding the problem of designing and examining research on inheritance of CP. If an individual has CP, it is not always the same in all relatives or even when all relatives have the condition. Since a genetic connection to CP cannot be determined from these studies, the problem of researching CP is more complicated.

Anonymous Patient Answer

Has playgait proven to be more effective than a placebo?

The authors concluded, “Children aged 3 to 5 years with [cerebral palsy](https://www.withpower.com/clinical-trials/cerebral-palsy) showed positive results with a new and simple training programme, involving playgait. Such exercise programme is feasible and can become part of the physiotherapeutic treatment in the standard practice of children with cerebral palsy.” In addition, the playgait training has been used to provide an effective treatment for children with CP aged 5 to 8 years old. There have also been no negative side effects, for which this programme had been recommended for use. Nevertheless, this programme is relatively new and further study is needed to confirm whether it is effective in children with cerebral palsy.

Anonymous Patient Answer

What is the primary cause of cerebral palsy?

When a person was conceived, a congenital lesion was present from day one of life. The lesion caused the inability of the child to do things that are essential to live. In fact, the child was born with the inability to walk, chew and communicate. Sometimes, the brain never recovers. If the lesion occurs in utero, it causes irreversible brain damage before birth. If it occurs in the first 24 hours of life and causes injury and damage to the brain, it can lead to chronic brain deterioration. A sudden lesion that occurs while the infant is still in the womb, a stroke, can also cause cerebral palsy.

Anonymous Patient Answer

Does playgait improve quality of life for those with cerebral palsy?

While this small study is preliminary, it highlights the value of playgait as a rehabilitation intervention for children with CP. Findings from a recent study provides an entry point to examine the impact of playgait on physical disability, leisure-time physical activity, self-efficacy and quality of life.

Anonymous Patient Answer

What does playgait usually treat?

There are many diagnoses that can be missed in children with CP. The initial diagnosis is crucial to treatment, but often a child is misdiagnosed due to inconsistent speech patterns, unsteadiness, or ataxia, which can lead to the use of medications that are often insufficient. We do not use medications for the treatment of ‘normal’ people, but we use them for people with disabilities in order to treat the underlying condition. We use gait training to improve function in those children who are not able to walk independently, and in cases of developmental delay due to a CP-like condition.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Cerebral Palsy by sharing your contact details with the study coordinator.