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

Primary Purpose

Cerebral Palsy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Walk Aide training
Sponsored by
Blythedale Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring gait training, stepping

Eligibility Criteria

8 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Blythedale Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Walk Aide training

Delayed Walk Aide training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in the Timed-Up-and-Down-Stairs (TUDS) measure
Measures the ability of a child to negotiate stairs
Change in the Step-Up-and-Over measure
Measures the ability of a child to step up and over a curb

Secondary Outcome Measures

Pain scale
Children will be asked to rate pain caused by the Walk Aide on each day of therapy (day of therapy only)

Full Information

First Posted
July 19, 2016
Last Updated
January 5, 2022
Sponsor
Blythedale Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02843646
Brief Title
Investigating the Use of the WalkAide on a Child's Ability to Ascend/Descend Stairs and Curbs
Official Title
Investigating the Use of the WalkAide on a Child's Ability to Ascend/Descend Stairs and Curbs
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 2016 (undefined)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Blythedale Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
gait training, stepping

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Walk Aide training
Arm Type
Experimental
Arm Description
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.
Arm Title
Delayed Walk Aide training
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Walk Aide training
Primary Outcome Measure Information:
Title
Change in the Timed-Up-and-Down-Stairs (TUDS) measure
Description
Measures the ability of a child to negotiate stairs
Time Frame
Day 1 of intervention and up to 5 days after the last day of intervention
Title
Change in the Step-Up-and-Over measure
Description
Measures the ability of a child to step up and over a curb
Time Frame
Day 1 of intervention up to 5 days after the last day of intervention
Secondary Outcome Measure Information:
Title
Pain scale
Description
Children will be asked to rate pain caused by the Walk Aide on each day of therapy (day of therapy only)
Time Frame
Each day of therapy, from date of randomization until up to six weeks after date of randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Blythedale Children's Hospital
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Fieback, PT
Phone
914-592-7138
Email
lindaf@blythedale.org
First Name & Middle Initial & Last Name & Degree
Mark Felsenfeld, PT
First Name & Middle Initial & Last Name & Degree
Teresa Smith, PT

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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