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Gait, HemiplegicNCT04619043

Understanding the Effects of Quantitatively-Prescribing Passive-Dynamic Ankle-Foot Orthosis Bending Stiffness for Individuals Post-Stroke

A study testing Ankle Orthotic in people with Gait, Hemiplegic, run by University of Delaware at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

When people walk, their ankle joints help to hold them upright and move them forward. Ankle braces are often given to people who have had a stroke to help their ankle joints work properly. Read more about this study

Who is it for?
Any age
Conditions the study is for
Gait, Hemiplegic
What is being tested?
Ankle Orthotic
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
Jan 2016to Jun 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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 21-85 years of age
  • chronic hemiparesis stroke (> 6 months post stroke)
  • prescribed an AFO by a clinician
  • able to walk for at least two minutes without assistance from another person
  • adequate paretic dorsiflexion range-of-motion (RoM ≥ 12°)
  • plantar flexor strength deficits (peak paretic plantar flexion moment in gait at least 0.15 Nm/kg lower than the mean speed-matched, height normalized value from our normative database)

Who cannot join

  • cerebellar signs (ataxic ("drunken") gait or decreased coordination during rapid alternating hand or foot movements)
  • neurologic conditions other than stroke
  • more than one stroke
  • sensorimotor neglect
  • intermittent claudication
  • inability to walk outside the home prior to the stroke
Show all 12Show fewer
  • total joint replacement and orthopedic problems in the lower limbs or spine that limit walking
  • coronary artery bypass graft or myocardial infarction within past 3 months
  • unexplained dizziness in last 6 months
  • cannot understand spoken instruction, communicate with the investigators
  • walk for 2 minutes at a self-selected speed without assistance from another person (assistive device allowed)
  • must have a resting heart rate between 40-100 beats per minute and a resting blood pressure between 90/60 to 170/90.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Delaware STAR Campus

    Newark, Delaware, 19713

Other trials in United States

About this study

Official title: Evaluation of a Prescription Model to Customize Passive-Dynamic Ankle-Foot Orthoses for Persons Post-Stroke

When people walk, their ankle joints help to hold them upright and move them forward. Ankle braces are often given to people who have had a stroke to help their ankle joints work properly. The investigators have developed a method to design and make a special type of ankle brace that allows the investigators to control every characteristic of the ankle brace, allowing the investigators to customize the ankle brace to fit and function just the way the investigators want it to. The investigators think that ankle braces customized to meet the needs of each individual person will help the participants walk better. The investigators have also developed a prescription model that tells the investigators how to customize these ankle braces to address different levels of two common impairments experienced by people post stroke -decreased ability to move the ankle joint and weakened calf muscles. The purpose of this study is to test the prescription model to see if wearing the ankle brace customized based on the prescription model improves people's ability to walk. To accomplish this goal, the investigators will first measure each person's ability to move his/her ankle joint and the strength of his/her calf muscles. The investigators will put this information in to the prescription model to determine how to customize the ankle brace for each person. The investigators will then use the method developed to make the customized ankle brace. Finally, the investigators will measure how each person walks in the ankle brace customized just for the participants. This study will allow the investigators to validate and/or refine the prescription model and teach the investigators how persons post-stroke adapt to walking in ankle braces with different characteristics.

Being tested
Ankle Orthotic
Medical subject headings
Gait Disorders, Neurologic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ankle OrthoticDevice

Study groups in NCT04619043
Study groupRoleWhat they receive
Ankle OrthoticExperimentalThe participant will wear two different ankle orthotics, their currently prescribed orthotic and the experimental orthotic.
Receives: Device: Ankle Orthotic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peak Plantar Flexion Moment

    The peak plantar flexion moment (Newton - meters per degree) will be measured at 0, 2, and 4 weeks via an instrumented gait analysis while the participant walks at their self-selected walking speed wearing their ankle brace.

    Measured: 4 weeks

  2. Step Length

    Step Length (meters) will be measured via an instrumented gait analysis 0, 2, and 4 weeks while the participant walks at their self-selected walking speed wearing their ankle brace.

    Measured: 4 weeks

  3. Step Ratio

    Step ratio (unitless) will be measured via an instrumented gait analysis 0, 2, and 4 weeks while the participant walks at their self-selected walking speed wearing their ankle brace.

    Measured: 4 weeks

  4. Propulsion Impulse Ratio

    Propulsion Impulse Ratio (unitless) will be measured via an instrumented gait analysis 0, 2, and 4 weeks while the participant walks at their self-selected walking speed wearing their ankle brace.

    Measured: 4 weeks

  5. Ankle Power

    Ankle Power (Work) will be measured via an instrumented gait analysis 0, 2, and 4 weeks while the participant walks at their self-selected walking speed wearing their ankle brace.

    Measured: 4 weeks

  6. Propulsion Force

    Propulsion Force (Newtons) will be measured via an instrumented gait analysis 0, 2, and 4 weeks while the participant walks at their self-selected walking speed wearing their ankle brace.

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2020
  2. Study startJan 2016
  3. Primary completionJun 2023
  4. Study completionJun 2023

Resources

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
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04619043
Sponsor's protocol ID
395018-16
Status last verified
Sep 2023
First submitted
23 Oct 2020
Last updated
15 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Olney SJ, Griffin MP, McBride ID. Temporal, kinematic, and kinetic variables related to gait speed in subjects with hemiplegia: a regression approach. Phys Ther. 1994 Sep;74(9):872-85. doi: 10.1093/ptj/74.9.872.

    PubMed 8066114

  • Nadeau S, Gravel D, Arsenault AB, Bourbonnais D. Plantarflexor weakness as a limiting factor of gait speed in stroke subjects and the compensating role of hip flexors. Clin Biomech (Bristol). 1999 Feb;14(2):125-35. doi: 10.1016/s0268-0033(98)00062-x.

    PubMed 10619100

  • Olney SJ, Richards C. Hemiparetic gait following stroke. Part i: Characteristics. Gait Posture 4:136-148, 1996

  • Peterson CL, Kautz SA, Neptune RR. Muscle work is increased in pre-swing during hemiparetic walking. Clin Biomech (Bristol). 2011 Oct;26(8):859-66. doi: 10.1016/j.clinbiomech.2011.04.010. Epub 2011 May 24.

    PubMed 21605927

  • Peterson CL, Hall AL, Kautz SA, Neptune RR. Pre-swing deficits in forward propulsion, swing initiation and power generation by individual muscles during hemiparetic walking. J Biomech. 2010 Aug 26;43(12):2348-55. doi: 10.1016/j.jbiomech.2010.04.027. Epub 2010 May 13.

    PubMed 20466377

  • Mulroy S, Gronley J, Weiss W, Newsam C, Perry J. Use of cluster analysis for gait pattern classification of patients in the early and late recovery phases following stroke. Gait Posture. 2003 Aug;18(1):114-25. doi: 10.1016/s0966-6362(02)00165-0.

    PubMed 12855307

  • Knarr BA, Higginson JS, Binder-Macleod SA. Validation of an adjustment equation for the burst superimposition technique in subjects post-stroke. Muscle Nerve. 2012 Aug;46(2):267-9. doi: 10.1002/mus.23431.

    PubMed 22806377

  • Skigen JT, Koller CA, Nigro L, Reisman DS, McKee Z, Pinhey SR, Henderson A, Wilken JM, Arch ES. Customized passive-dynamic ankle-foot orthoses can improve walking economy and speed for many individuals post-stroke. J Neuroeng Rehabil. 2024 Jul 29;21(1):126. doi: 10.1186/s12984-024-01425-7.

    PubMed 39069629

  • Koller C, Reisman D, Richards J, Arch E. Understanding the effects of quantitatively prescribing passive-dynamic ankle-foot orthosis bending stiffness for individuals after stroke. Prosthet Orthot Int. 2021 Aug 1;45(4):313-321. doi: 10.1097/PXR.0000000000000012.

    PubMed 33840749

Questions about this trial

What is this clinical trial studying?

A study testing Ankle Orthotic in people with Gait, Hemiplegic, run by University of Delaware 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 6 inclusion and 12 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: finished, as of the sponsor's last update on 15 Sep 2023. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak Plantar Flexion Moment (time frame: 4 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04619043, which also lists 9 linked publications.

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 15 Sep 2023.

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