Characterization and Clinical Trial of a Variable Friction Shoe

Stroke Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06234124
• Other study ID #: STU00219400
• Secondary ID: 1R01HD112475-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: June 2027

Study information

• Verified date: January 2024
• Source: Shirley Ryan AbilityLab
• Contact: Joe Harris, DPT
• Phone: 312-238-8425
• Email: jharris2[@]sralab.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 3 months - 1-year poststroke (the period in which patients would typically be fitted with a device for foot drop)

2. Age 18 or older

3. Possess a prescribed AFO or be a potential candidate for use of an AFO

4. Can ambulate at least 10m with or without an assistive device such as a cane or walker

5. Medically stable as determined by physician medical clearance

6. No expected change in medications for at least 3 months

7. Adequate stability at the ankle during stance

8. Ability to hear clicking noise made by the VF shoe

9. Physician approval

10. Ability to give informed consent

11. Able to sit unsupported and be able to follow a three-step command

12. No unhealed/unresolved orthopedic injury to either upper or lower extremity and no history of severe back pain

13. English speaking

14. 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:

1. History of falling more than once a week prior to the stroke

2. Gait speed: self-selected velocity (SSV) greater than 1.2 m/s

3. Inability to operate in the devices safely and no caregiver assistance available

4. Morbid obesity (body mass index >40 kg/m2)

5. 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.

6. Severe deficits in cognition or communication

7. Pregnant women (status determined by self-reporting).

8. Co-morbidity that interferes with the study (e.g. significant arthritis or joint problems, history of back injury, neuromuscular disorders, epilepsy, etc.).

9. Severe Osteoporosis (status determined by self-reporting).

10. Prisoners

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Shirley Ryan AbilityLab	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of California, Santa Barbara

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* Note: There are 77 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Walking Speed (Device Off)	10 meter walk test (meters/second)	26 weeks
Secondary	Berg Balance Scale	14 item objective measure designed to assess static balance and fall risk in adult populations. Items assessed include siting and standing balance during transfers, altered base of support, reaching, turning, eyes open and closed. Each item is scored 0 to 4 points for a maximum of 56 points.	26 weeks
Secondary	6 Minute Walk Test	The 6MWT measures the distance a subject can walk indoors on a flat, hard surface in a period of 6 minutes, using assistive devices, as necessary.	26 weeks
Secondary	Stroke Impact Scale	The SIS is a validated measure of the impact of stroke on overall physical and cognitive function. This 59-item patient-based questionnaire assesses eight domains of stroke recovery: strength, mobility, communication, emotion, memory and thinking, participation, activities of daily living/instrumental activities of daily living (ADL/IADL) and hand function. An additional question requires the patient to rate their stroke recovery on a scale from 0 to 100. This measure instructs subjects to answer the question based on the period of time twofour weeks prior to the questionnaire	26 weeks