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Neuroprosthetic Device

Walk Aide training for Cerebral Palsy

N/A
Waitlist Available
Research Sponsored by Blythedale Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 of intervention up to 5 days after the last day of intervention
Awards & highlights

Study Summary

This trial is testing whether the WalkAide, a device that helps with ankle control, can help a child with walking up and down stairs and curbs. It is expected that using the WalkAide will help the child be faster, more symmetrical, and more independent.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 of intervention and up to 5 days after the last day of intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 of intervention and up to 5 days after the last day of intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in the Step-Up-and-Over measure
Change in the Timed-Up-and-Down-Stairs (TUDS) measure
Secondary outcome measures
Pain scale

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Walk Aide trainingExperimental Treatment1 Intervention
This group of children will receive six weeks of Walk Aide training. During training, children will wear the Walk Aide. This device triggers ankle dorsiflexion, and controls the timing and duration of personal nerve stimulation during the swing phase of gait. The duration of the stimulus is gradually increased along with the wearing of the Walkaide. Subjects will begin by wearing the prosthesis for 30 minutes. The wearing time will be increased to waking hours of the subject, depending on their age. The electrodes will be placed on the client before the session is to begin, and taken off immediately after WalkAide usage. The skin will be checked before and after WalkAide electrode usage. The skin will be cleaned with an alcohol wipe before the electrodes are applied.
Group II: Delayed Walk Aide trainingPlacebo Group1 Intervention
This group of children will not receive Walk Aide training during the first six weeks of enrollment. This group will serve as a comparator group to Arm 1. After six weeks, children in this group will be given the option to complete the 6-week Walk Aide training protocol that is given in Arm 1.

Find a Location

Who is running the clinical trial?

Blythedale Children's HospitalLead Sponsor
5 Previous Clinical Trials
210 Total Patients Enrolled
5 Trials studying Cerebral Palsy
210 Patients Enrolled for Cerebral Palsy

Frequently Asked Questions

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

Does the study permit those below 35 years of age to participate?

"The clinical trial protocol states that the ideal participants are aged 8-17. Additionally, there are 140 trials conducted for minors and 26 studies targeting people over 65 years old."

Answered by AI

How many participants are enrolled in this research endeavor?

"Affirmative, the research study is presently gathering participants. It was first advertised on July 1st 2016 and has recently been updated on January 5th 2022. The trial hopes to enroll a dozen individuals at one medical site."

Answered by AI

Are there vacancies available for those wishing to take part in the research?

"Affirmative. According to clinicaltrials.gov, this research endeavour is currently looking for volunteers. It was first announced on July 1st 2016 and was most recently updated on January 5th 2022. The study needs 12 individuals from one location to participate in the trial."

Answered by AI

Are there any particular prerequisites for joining this research experiment?

"To qualify for this research project, participants must possess a diagnosis of cerebral palsy and should be between 8-17 years old. The planned recruitment is around 12 individuals."

Answered by AI

Who else is applying?

What site did they apply to?
Blythedale Children's Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
~1 spots leftby Apr 2025