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

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy
• Intervention / Treatment: Device: Walk Aide training

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.

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Valhalla, New York, United States, 10595
      • Recruiting
      • Blythedale Children's Hospital
      • Contact: Linda Fieback, PT; Phone Number: 914-592-7138; Email: lindaf@blythedale.org
      • Sub-Investigator: Mark Felsenfeld, PT
      • Sub-Investigator: Teresa Smith, PT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Timed-Up-and-Down-Stairs (TUDS) measure	Measures the ability of a child to negotiate stairs	Day 1 of intervention and up to 5 days after the last day of intervention
Change in the Step-Up-and-Over measure	Measures the ability of a child to step up and over a curb	Day 1 of intervention up to 5 days after the last day of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scale	Children will be asked to rate pain caused by the Walk Aide on each day of therapy (day of therapy only)	Each day of therapy, from date of randomization until up to six weeks after date of randomization

Collaborators and Investigators

• Sponsor: Blythedale Children's Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: July 19, 2016
• First Submitted That Met QC Criteria: July 21, 2016
• First Posted (Estimate): July 26, 2016

Study Record Updates

• Last Update Posted (Actual): January 10, 2022
• Last Update Submitted That Met QC Criteria: January 5, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: gait training; stepping
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: Walk_Aide

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided