Recruiting

WalkAide

Sponsor:

Blythedale Children's Hospital

Code:

NCT02843646

Conditions

Cerebral Palsy

Eligibility Criteria

Sex: All

Age: 8 - 17

Healthy Volunteers: Not accepted

Interventions

Walk Aide training

Study Details

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

Study ID

NCT02843646

Start date

Jul, 2016

Status verified date

Jan, 2022

Completion date

Jul, 2023

Anticipated

Primary completion date

Jul, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 17

Healthy Volunteers: Not accepted

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 Design

Enrollment

12 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Walk Aide training

Primary outcome measure

  • 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 ]
  • Change in the Step-Up-and-Over measure [ Time Frame: Day 1 of intervention up to 5 days after the last day of intervention ]

Central Contacts and Locations

Locations

Blythedale Children's Hospital

Recruiting

Valhalla, New York, United States, 10595

Contacts

More Information

Sponsor

Blythedale Children's Hospital

Last update posted

Jan 10, 2022

Last verified

Jan, 2022

Keywords

  • gait training
  • stepping

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Blythedale Children's Hospital on 2022-01-10.