Investigating the Use of the WalkAide on a Child's Ability to Ascend/Descend Stairs and Curbs
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|ClinicalTrials.gov Identifier: NCT02843646|
Recruitment Status : Recruiting
First Posted : July 26, 2016
Last Update Posted : October 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Palsy||Device: Walk Aide training||Not Applicable|
The investigators will examine the use of the WalkAide, a Neuroprosthetic device, on a child's ability to ascend/descend stairs and curbs. It is hypothesized that with WalkAide use, the improved ankle control achieved, will affect the speed, symmetry, and independence of completing the task.
Study subjects will be fitted with the WalkAide by Physical Therapists trained in this procedure. Subjects will build tolerance to the device over a two-week period, and use as able for the next six weeks. The children (participants/subjects) in the study will go through a desensitization process to familiarize them with the electrical stimulation.
The children will begin with no stimulation, wearing the Walkaide to introduce the sensation of the cuff on their leg prior to beginning the stimulation. Once familiar with the feel of the Walkaide, the electrical stimulation will be introduced slowly and gradually. The child's face and verbal responses will be monitored while the stimulation is introduced and turned up to the desired response threshold.
An age and cognitively appropriate pain scale will be available if applicable to the child and situation.
The children will be assured that if they do not want to continue or if they feel uncomfortable, then the electrical stimulation will be turned off immediately. The minimum stimulus intensity is determined in collaboration with each subject. The children are asked to identify when they first begin to feel the stimulus, and the number on the intensity knob is noted. 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. It is normal to observe somewhat reddened areas under the electrode placement following usage. However, the redness should disappear within an hour. With signs of irradiation or maintained redness, small pimple like lesions or blisters, the WalkAide usage will be discontinued at that time, and the patient will be brought to the medical staff. The skin will be re-evaluated an hour later following the electrode usage. The Pediatrician for that patient will be immediately notified, and the WalkAide usage discontinued until the problem is resolved.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Investigating the Use of the WalkAide on a Child's Ability to Ascend/Descend Stairs and Curbs|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||July 2022|
|Estimated Study Completion Date :||July 2022|
Experimental: Walk Aide training
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.
Device: Walk Aide training
Placebo Comparator: Delayed Walk Aide training
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.
Device: Walk Aide training
- Change in the Timed-Up-and-Down-Stairs (TUDS) measure [ Time Frame: Day 1 of intervention and up to 5 days after the last day of intervention ]Measures the ability of a child to negotiate stairs
- Change in the Step-Up-and-Over measure [ Time Frame: Day 1 of intervention up to 5 days after the last day of intervention ]Measures the ability of a child to step up and over a curb
- Pain scale [ Time Frame: Each day of therapy, from date of randomization until up to six weeks after date of randomization ]Children will be asked to rate pain caused by the Walk Aide on each day of therapy (day of therapy only)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02843646
|United States, New York|
|Blythedale Children's Hospital||Recruiting|
|Valhalla, New York, United States, 10595|
|Contact: Linda Fieback, PT 914-592-7138 email@example.com|
|Sub-Investigator: Mark Felsenfeld, PT|
|Sub-Investigator: Teresa Smith, PT|