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Robotic Ankle Assist Device for Cerebral Palsy
Study Summary
This trial is testing a robotic device that helps with ankle movement to see if it can improve mobility for children with cerebral palsy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- I can move my ankle downwards at least 20 degrees.I am between 8 and 18 years old.I had orthopedic surgery within the last year.My height, weight, and BMI are within the typical range for children with CP.I can do 5 heel raises with little help for balance.I have been diagnosed with cerebral palsy.My background or identity does not limit my participation.I can walk for 6 minutes, with or without help.I don't have any health issues besides CP that would make it unsafe for me to join.I can walk with or without limitations.My knee or ankle cannot fully straighten, bending more than 15 degrees.
- Group 1: Assistance training
- Group 2: Parent supervised resistance training
- Group 3: Therapist-guided training
- Group 4: User testing
- Group 5: Therapist supervised resistance training
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What are the researchers investigating with this study?
"The sponsor of this clinical trial, BiOMOTUM, Inc., is measuring the primary outcome—Change in lower extremity muscle activity similarity to the average unimpaired activity pattern—over a 30-minute session. Additionally, this study will assess secondary outcomes including Ankle muscle co-contraction (defined as Number of steps with mean stance phase ankle co-contraction below pre-session baseline), Qualitative therapist assessment of session quality, participant movement, and device usability via questionnaire (defined as Qualitative therapist assessment of session quality, participant movement quality, and device usability via questionnaire), and Minimum age and function level required to"
Is the age limit for this clinical trial set at 25 years or older?
"This trial is only for children aged 8-18, as that is the age range specified in the inclusion criteria."
For whom is this clinical trial designed?
"This trial is for children and adolescents with cerebral palsy aged 8-18. The primary enrolment criterion is the ability to complete 5 heel raises unassisted (for balance only). Other inclusion requirements are as follows: the understanding and following of simple directions, a diagnosis of cerebral palsy, any sex, race, ethnicity or socioeconomic status, GMFCS level I, II or III, the ability to walk unassisted or with assistance for at least 6 minutes, and age between 8-18 years old. Lastly, patients must fall within the 5th - 95th percentile height/weight/BMI range for children with CP."
Are there any current openings in this trial for new participants?
"The listed clinical trial on clinicaltrials.gov is recruiting patients, with the posting date being November 1st 2020 and the last edit on May 7th 2021."
What are the risks associated with using RAAD devices?
"The Robotic Ankle Assist Device (RAAD) is still in early stages of testing, so it only received a score of 1 for safety."
How many people are included in this experimental treatment program?
"Yes, that is accurate. This clinical trial is seeking 48 participants from 1 location and the listing on clinicaltrials.gov says it is still recruiting patients. The initial posting was on November 1st, 2020 with the most recent update being on May 7th, 2021."
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