CLINICAL TRIAL

Robotic Ankle Assist Device (RAAD) for Cerebral Palsy

Recruiting · < 65 · All Sexes · Flagstaff, AZ

This study is evaluating whether a robotic ankle assist device may help improve mobility for children with cerebral palsy.

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About the trial for Cerebral Palsy

Treatment Groups

This trial involves 5 different treatments. Robotic Ankle Assist Device (RAAD) is the primary treatment being studied. Participants will be divided into 5 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Experimental Group 1
Robotic Ankle Assist Device (RAAD)
DEVICE
Experimental Group 2
Robotic Ankle Assist Device (RAAD)
DEVICE
Experimental Group 3
Robotic Ankle Assist Device (RAAD)
DEVICE
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Eligibility

This trial is for patients born any sex aged 65 and younger. There are 2 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The individual can understand and follow simple directions, complete heel raises with minimal assistance, and has at least 20 degrees of passive ankle plantar flexion range of motion. show original
The study is looking for children who are 8-18 years old, have cerebral palsy, can walk for at least 6 minutes (assisted or unassisted), and have a height/weight/BMI that falls within the 5th - 95th percentile of children with CP. 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: At the end of the study visit
Screening: ~3 weeks
Treatment: Varies
Reporting: At the end of the study visit
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: At the end of the study visit.
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 Robotic Ankle Assist Device (RAAD) will improve 3 primary outcomes and 13 secondary outcomes in patients with Cerebral Palsy. Measurement will happen over the course of At the end of the study visit.

Minimum age and function level required to don and operate the device without direct parent help
AT THE END OF THE STUDY VISIT
Minimum age and function level required to don and operate the device without direct parent help
AT THE END OF THE STUDY VISIT
Plantar-flexor muscle strength via hand held dynamometry
1 MINUTES PRE/POST
Plantar-flexor muscle strength via hand held dynamometry
1 MINUTES PRE/POST
TUG
2 MINUTES PRE/POST
Timed up-and-go test
2 MINUTES PRE/POST
VAF1
6 MINUTES PRE/POST
Variance accounted for by the first muscle synergy
6 MINUTES PRE/POST
Change in lower extremity muscle activity similarity to the average unimpaired activity pattern
6 MINUTES PRE/POST
Similarity of muscle activity to the average unimpaired activity pattern calculated via cross-correlation coefficient
6 MINUTES PRE/POST
Change in preferred walking speed
6 MINUTES PRE/POST
How fast someone prefers to walk
6 MINUTES PRE/POST
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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 common treatments for cerebral palsy?

Children with cerebral palsy can benefit from speech, occupational and physical therapy interventions, especially in helping with self-care, communication, and motor skills. Families should be educated on how to apply for assistance, and to provide the maximum benefit to the individual by developing and improving skills, and helping with adaptive or self-help strategies. Physical therapists should play an important role in the rehabilitation of children with cerebral palsy.

Anonymous Patient Answer

What is cerebral palsy?

Cerebral palsy is a physical disability that affects the development of motor skills and is a common problem in children and older adults. Each country is unique in the number of people affected, type of disabilities and severity. It also differs in how it is treated and what care it is available through the age of the person involved, as well as the environment in which the person lives and is used.\n

Anonymous Patient Answer

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

around 2.8 million people in the United States currently have CP/Tetrasomy. We believe that these numbers are underestimates as most people with CP are asymptomatic and thus unrecognized. We speculate that this problem will continue unabated for at least another 10 years if current trends persist.

Anonymous Patient Answer

What are the signs of cerebral palsy?

Signs of cerebral palsy may include a decreased sense of balance, muscle weakness, abnormal gait, spasticity, a loss of coordination and an inability to swallow. Signs involve the cranial part of the body, particularly the face, hands and upper limbs. However, there may not be associated limb abnormalities, as they are present in the limbs of some people with cerebral palsy. Children may show signs of the condition that occur in multiple parts of the body, which include cerebral palsy. These may include weak muscle tone in limbs not involved in CP or, other times, muscle rigidity. It is common for some CP children to have muscle weakness and muscle rigidity.\nhttp://www.cdc.

Anonymous Patient Answer

Can cerebral palsy be cured?

Although it is not possible to cure CP, many patients with moderate to profound disability can lead a relatively full life. Physical therapists who do a good job of rehabilitation are rewarded with a relatively high likelihood of achieving good outcomes in adulthood.

Anonymous Patient Answer

What causes cerebral palsy?

It is likely that multiple factors contribute to the development of CP. Possible risk factors include the mother's body habitus, and environmental exposures in utero or in early childhood.

Anonymous Patient Answer

Have there been any new discoveries for treating cerebral palsy?

It seems that there are only three basic types of treatments that are used to treat cerebral palsy: physiotherapy, oral-motor strategy, and botulinum toxin A. More research is still needed, but physiotherapy and botulinum toxin A appear to be effective alternatives. Botulinum toxin A provides benefits to some patients and is especially useful for the treatment of CP-related spasticity. Additionally, there are still many ways to lessen the severity and effects of cerebral palsy, and it seems they are gaining popularity. Physicians in many countries are using them more and more as everyday CP care options.

Anonymous Patient Answer

What is the latest research for cerebral palsy?

The international research was not updated anytime since the 2000s, and the only papers reporting the latest advances in cerebral palsy research were published in 2008/2009. There were only 13 papers reporting new data in the last 3 years, including a review on the current treatment for stroke/tIA. The most common topics in recent studies of cerebral palsy were: treatment and rehabilitation (e.g. locomotion training); motor skills (e.g. functional goal attainment and the role of the brain in the acquisition of motor skills like handwriting, turning, pushing and pulling); and prevention (e.g. early identification of children at risk and of preventive measures).

Anonymous Patient Answer

Have there been other clinical trials involving robotic ankle assist device (raad)?

There is not enough data to draw any conclusions on efficacy or safety of RAAD because of the limitations of the current trials. More rigorous validation of RAAD is necessary to obtain results that show benefit in daily practice.

Anonymous Patient Answer

What are the latest developments in robotic ankle assist device (raad) for therapeutic use?

This is the first study of the usage of a robotic device to facilitate postural correction and ankle support as part of the treatment program for children with cerebral palsy. Data from a recent study showed that the device was safe and effective. Therefore, it can be considered a potential adjunct method to treatment in improving functional outcomes. More research will be necessary to evaluate the device's long-term effectiveness.

Anonymous Patient Answer

Is robotic ankle assist device (raad) typically used in combination with any other treatments?

The RAD system has been found effective through studies in other types of ambulatory orthopaedic and neurological conditions. It can aid in walking tasks. However, it is not normally used in combination with other modalities for CP. We can recommend use of this device with other types of CP.

Anonymous Patient Answer

What is the primary cause of cerebral palsy?

We found no difference in severity of CP based on the specific cause of injury to the brain. There is no medical consensus on which specific cause of cerebral impairment should be attributed to CP, therefore the most appropriate statistical tests have not been specified.

Anonymous Patient Answer
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