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

NCT02843646 | Unknown

• 1 other identifier: Walk_Aide
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

gait training; stepping

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Pain scale

  Each day of therapy, from date of randomization until up to six weeks after date of randomization

Study Arms (2)

Walk Aide training

EXPERIMENTAL

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

Delayed Walk Aide training

PLACEBO COMPARATOR

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

Interventions

Walk Aide training DEVICE

Delayed Walk Aide training; Walk Aide training

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Blythedale Children's Hospital: lead

Study Sites (1)

Blythedale Children's Hospital

Valhalla, New York, 10595, United States

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2016
• First Posted: July 26, 2016
• Study Start: July 1, 2016
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: January 10, 2022

Record last verified: 2022-01

Locations

US (1)