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

Gait, Hemiplegic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04619043
• Other study ID #: 395018-16
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: June 2023

Study information

• Verified date: September 2023
• Source: University of Delaware
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Gait, Hemiplegic

Intervention

Device:
• Ankle Orthotic

Locations

Country	Name	City	State
United States	University of Delaware STAR Campus	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
University of Delaware

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View Citation

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

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks
Primary	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.	4 weeks
Primary	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.	4 weeks
Primary	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.	4 weeks
Primary	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.	4 weeks
Primary	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.	4 weeks