Characterization and Clinical Trial of a Variable Friction Shoe

Official title

Characterization and Clinical Trial of a Variable Friction Shoe, a New Paradigm of Reduced-constraint Locomotor Therapy for People Exhibiting Foot Drop Due to Stroke

Overview

More than one million Americans present with foot drop after stroke. As the aging population grows in the United States and across the world, incidence of stroke will grow as age is a key risk factor, thus there will be a need for low-cost, easy-to-use, and scalable solutions to administer proper therapy to promote recovery. This study will evaluate a Variable Friction shoe (VF shoe), a new low-cost medical device, for foot drop in an at-home setting.

Detailed description

The investigators propose an alternative strategy that addresses the hazard of tripping even while allowing full volitional control of the ankle: an inexpensive Variable Friction (VF) shoe. Its outsole is high-friction during the stance phase of gait and low friction during swing; further, it produces a "click" when a scuff occurs.

The investigator's central hypothesis is that allowing volitional motion of the ankle while mitigating the hazard of tripping coupled with gait-phased auditory biofeedback will result in improved gait for subjects with drop foot. Specifically, the investigators hypothesize that the VF shoe will show significantly greater therapeutic effects than an AFO, yet maintain the desirable orthotic effect of the AFO. The study is arranged in two Aims.

Exploratory Aim: Identify a systematic, methodical approach to device fitting, in-clinic and at-home training with the VF shoe and optimization of collecting outcome measures as assessments. For example, up to 10 participants will be enrolled for up to 8 visits over 12 weeks to determine the optimal data collection methods, fitting and training of use of VF shoes, and order of assessments, etc.

Specific Aim 1: Characterize the scuff-force reduction of the VF shoe over the lifetime of use. Critical to understanding the effects of the VF shoe is a characterization of the level of scuff-force reduction.

Specific Aim 2: Evaluate the effects of the VF shoe on gait in individuals with chronic stroke and drop foot. During each 12-week phase of an AB-BA clinical trial, participants will walk for at least 30-45 minutes per day for at least 5 days per week at home.

Interventions

• Device Variable Friction Shoe Training
  The experimental group (A) will be given a pair of VF shoes and instructed to use shoes on both feet. This group will be instructed to walk on hard surfaces to engage auditory feedback of the VF shoes. This group group will be monitored daily using actigraphy and will receive weekly check-up telephone calls by a member of the research team to record number of steps, walking time, a scale for self-identified effort and perceived safety levels.
• Device Ankle Foot Orthosis (AFO) Training
  The control group (B) will be provided an AFO to use on the paretic limb. This group will be instructed to walk on hard surfaces. This group group will be monitored daily using actigraphy and will receive weekly check-up telephone calls by a member of the research team to record number of steps, walking time, a scale for self-identified effort and perceived safety levels.

Primary outcome measures

• Walking Speed (Device Off) [Time frame: 26 weeks]

Secondary outcome measures (3)

• Berg Balance Scale [Time frame: 26 weeks]
• 6 Minute Walk Test [Time frame: 26 weeks]
• Stroke Impact Scale [Time frame: 26 weeks]

Eligibility criteria

Inclusion criteria

• At least 3 months poststroke
• Age 18 or older
• Possess a prescribed AFO or be a potential candidate for use of an AFO
• Can ambulate at least 10m with or without an assistive device such as a cane or walker
• Medically stable as determined by physician medical clearance
• No expected change in medications for at least 3 months
• Adequate stability at the ankle during stance
• Ability to hear clicking noise made by the VF shoe
• Physician approval
• Ability to give informed consent
• Able to sit unsupported and be able to follow a three-step command
• No unhealed/unresolved orthopedic injury to either upper or lower extremity and no history of severe back pain
• English speaking
• Willing to follow an exercise program with both devices for at least 30 minutes per day, at least 5 days per week for the full length of the program (6 months)

Exclusion criteria

• History of falling more than once a week prior to the stroke
• Gait speed: self-selected velocity (SSV) greater than 1.2 m/s
• Inability to operate in the devices safely and no caregiver assistance available
• Morbid obesity (body mass index >40 kg/m2)
• Preexisting conditions such as serious cardiac conditions, myocardial infarction, congestive heart failure, demand pacemaker, seizures, excessive dysesthetic pain, and severe lower extremity pathology that would interfere with fit or use of the shoe.
• Severe deficits in cognition or communication
• Pregnant women (status determined by self-reporting).
• Co-morbidity that interferes with the study (e.g. significant arthritis or joint problems, history of back injury, neuromuscular disorders, epilepsy, etc.).
• Severe Osteoporosis (status determined by self-reporting).
• Prisoners
• Not currently receiving botox to the lower extremities.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Shirley Ryan AbilityLab — Chicago

Publications

• Burridge JH, Taylor PN, Hagan SA, Wood DE, Swain ID. The effects of common peroneal stimulation on the effort and speed of walking: a randomized controlled trial with chronic hemiplegic patients. Clin Rehabil. 1997 Aug;11(3):201-10. doi: 10.1177/026921559701100303. PMID 9360032
• Bulley C, Mercer TH, Hooper JE, Cowan P, Scott S, van der Linden ML. Experiences of functional electrical stimulation (FES) and ankle foot orthoses (AFOs) for foot-drop in people with multiple sclerosis. Disabil Rehabil Assist Technol. 2015 Nov;10(6):458-467. doi: 10.3109/17483107.2014.913713. Epub 2014 May 6. PMID 24796365
• Lee YS, Wang PY. Foot drop caused by a brain tumor: a case report. Acta Neurol Taiwan. 2009 Jun;18(2):130-1. PMID 19673367
• Stewart JD. Foot drop: where, why and what to do? Pract Neurol. 2008 Jun;8(3):158-69. doi: 10.1136/jnnp.2008.149393. PMID 18502948
• Benjamin EJ, Virani SS, Callaway CW, Chamberlain AM, Chang AR, Cheng S, Chiuve SE, Cushman M, Delling FN, Deo R, de Ferranti SD, Ferguson JF, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Lutsey PL, Mackey JS, Matchar DB, Matsushita K, Mussolino ME, Nasir K, O'Flaherty M, Palaniappan LP, Pandey A, Pandey DK, Reeves MJ, PMID 29386200
• Lawrence ES, Coshall C, Dundas R, Stewart J, Rudd AG, Howard R, Wolfe CD. Estimates of the prevalence of acute stroke impairments and disability in a multiethnic population. Stroke. 2001 Jun;32(6):1279-84. doi: 10.1161/01.str.32.6.1279. PMID 11387487
• Barker WH, Mullooly JP. Stroke in a defined elderly population, 1967-1985. A less lethal and disabling but no less common disease. Stroke. 1997 Feb;28(2):284-90. doi: 10.1161/01.str.28.2.284. PMID 9040676
• Watkins CL, Leathley MJ, Gregson JM, Moore AP, Smith TL, Sharma AK. Prevalence of spasticity post stroke. Clin Rehabil. 2002 Aug;16(5):515-22. doi: 10.1191/0269215502cr512oa. PMID 12194622

Identifiers

NCT: NCT06234124 · STU00219400 · 1R01HD112475-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗