Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Investigating the Use of the WalkAide on a Child's Ability to Ascend/Descend Stairs and Curbs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02843646
Recruitment Status : Recruiting
First Posted : July 26, 2016
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
Blythedale Children's Hospital

Brief Summary:
The purpose of this study is to investigate 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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Device: Walk Aide training Not Applicable

Detailed Description:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ability to ambulate independently with or without an assistive device and/or lower extremity orthoses.
  • Ability to follow and understand experimental procedures.

Exclusion Criteria:

  • Seizure history interfering with use of functional electrical stimulation as verified by their MD.
  • Inability to be able to complete the assessment tests to gain a baseline score.
  • Skin irritation/skin intact.
  • Uncorrected vision impairments.

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, New York
Blythedale Children's Hospital Recruiting
Valhalla, New York, United States, 10595
Contact: Linda Fieback, PT    914-592-7138    lindaf@blythedale.org   
Sub-Investigator: Mark Felsenfeld, PT         
Sub-Investigator: Teresa Smith, PT         
Sponsors and Collaborators
Blythedale Children's Hospital
Layout table for additonal information
Responsible Party: Blythedale Children's Hospital
ClinicalTrials.gov Identifier: NCT02843646    
Other Study ID Numbers: Walk_Aide
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Blythedale Children's Hospital:
gait training
stepping
Additional relevant MeSH terms:
Layout table for MeSH terms
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases