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

Primary Purpose

Gait, Hemiplegic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ankle Orthotic
Sponsored by
University of Delaware
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Gait, Hemiplegic

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  • 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.

Sites / Locations

  • University of Delaware STAR Campus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ankle Orthotic

Arm Description

The participant will wear two different ankle orthotics, their currently prescribed orthotic and the experimental orthotic.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 23, 2020
Last Updated
September 13, 2023
Sponsor
University of Delaware
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1. Study Identification

Unique Protocol Identification Number
NCT04619043
Brief Title
Understanding the Effects of Quantitatively-Prescribing Passive-Dynamic Ankle-Foot Orthosis Bending Stiffness for Individuals Post-Stroke
Official Title
Evaluation of a Prescription Model to Customize Passive-Dynamic Ankle-Foot Orthoses for Persons Post-Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
June 2023 (Actual)
Study Completion Date
June 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Delaware

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gait, Hemiplegic

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ankle Orthotic
Arm Type
Experimental
Arm Description
The participant will wear two different ankle orthotics, their currently prescribed orthotic and the experimental orthotic.
Intervention Type
Device
Intervention Name(s)
Ankle Orthotic
Primary Outcome Measure Information:
Title
Peak Plantar Flexion Moment
Description
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.
Time Frame
4 weeks
Title
Step Length
Description
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.
Time Frame
4 weeks
Title
Step Ratio
Description
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.
Time Frame
4 weeks
Title
Propulsion Impulse Ratio
Description
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.
Time Frame
4 weeks
Title
Ankle Power
Description
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.
Time Frame
4 weeks
Title
Propulsion Force
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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 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.
Facility Information:
Facility Name
University of Delaware STAR Campus
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
8066114
Citation
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.
Results Reference
background
PubMed Identifier
10619100
Citation
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, Avon). 1999 Feb;14(2):125-35. doi: 10.1016/s0268-0033(98)00062-x.
Results Reference
background
Citation
Olney SJ, Richards C. Hemiparetic gait following stroke. Part i: Characteristics. Gait Posture 4:136-148, 1996
Results Reference
background
PubMed Identifier
21605927
Citation
Peterson CL, Kautz SA, Neptune RR. Muscle work is increased in pre-swing during hemiparetic walking. Clin Biomech (Bristol, Avon). 2011 Oct;26(8):859-66. doi: 10.1016/j.clinbiomech.2011.04.010. Epub 2011 May 24.
Results Reference
background
PubMed Identifier
20466377
Citation
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.
Results Reference
background
PubMed Identifier
12855307
Citation
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.
Results Reference
background
PubMed Identifier
22806377
Citation
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.
Results Reference
background
PubMed Identifier
33840749
Citation
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.
Results Reference
derived

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

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