Cerebral PalsyNCT02843646
Investigating the Use of the WalkAide on a Child's Ability to Ascend/Descend Stairs and Curbs
A study testing Walk Aide training in people with Cerebral Palsy, run by Blythedale Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Walk Aide training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ability to ambulate independently with or without an assistive device and/or lower extremity orthoses.
- Ability to follow and understand experimental procedures.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Blythedale Children's Hospital
Valhalla, New York, 10595
Linda Fieback, PT, 914-592-7138, lindaf@blythedale.org
Mark Felsenfeld, PT
About this study
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.
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- Walk Aide training
- Keywords
- gait training, stepping
- Medical subject headings
- Cerebral Palsy, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walk Aide trainingDevice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Walk Aide training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Timed-Up-and-Down-Stairs (TUDS) measure
Measures the ability of a child to negotiate stairs
Measured: 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
Measured: Day 1 of intervention up to 5 days after the last day of intervention
Secondary outcomes (1)
Pain scale
Children will be asked to rate pain caused by the Walk Aide on each day of therapy (day of therapy only)
Measured: Each day of therapy, from date of randomization until up to six weeks after date of randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Blythedale Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02843646
- Sponsor's protocol ID
- Walk_Aide
- Status last verified
- Jan 2022
- First submitted
- 19 Jul 2016
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Use of the WalkAide on a Child's Ability to Ascend/Descend Stairs and Curbs
- ClinicalTrials.gov ID
- NCT02843646
- Acronym / sponsor ID
- Walk_Aide
- Conditions
- Cerebral Palsy
- Keywords
- gait training, stepping
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Blythedale Children's HospitalUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 26 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Walk Aide training | Experimental | Device: Walk Aide trainingThis 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. |
| Delayed Walk Aide training | Placebo comparator | Device: Walk Aide trainingThis 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. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Ability to ambulate independently with or without an assistive device and/or lower extremity orthoses.
- Ability to follow and understand experimental procedures.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walk Aide training | Device | Delayed Walk Aide training, Walk Aide training |
Primary outcome
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
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
1 secondary outcome
Pain scale
Time frame: Each day of therapy, from date of randomization until up to six weeks after date of randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walk Aide training in people with Cerebral Palsy, run by Blythedale Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2022.