Biomechanical and Neural Mechanisms of Post-stroke Gait Training

NCT04380454 | Completed DMC FDA Device

• 2 other identifiers: IRB00109530R01HD095975
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

The study seeks to develop an understanding of how, why, and for whom fast treadmill walking (Fast) and Fast with functional electrical stimulation (FastFES) induce clinical benefits, allowing future development of cutting-edge, individually-tailored gait treatments that enhance both gait quality and gait function.

Conditions

Stroke

Keywords

Rehabilitation; Post-stroke; Neural mechanism; Biomechanical mechanism; Electrical stimulation; Gait Training

Outcome Measures

Primary Outcomes (9)

• Change in 10-Meter Walk Test at Self-selected Walking Speed

  The 10-Meter Walk Test is used to assess walking speed over a short distance. A 10 meter (m) walkway over solid flooring will be measured and marked at start (0 m), 2 m, 8 m, and finish (10 m). Participants will be asked to complete three trials of the 10 m walk at their comfortable self-selected walking speed. The time for the three trials for each speed will be averaged and gait speed converted to meters/second.

  Baseline, Week 1 (after 3 training sessions), Week 2 (after 6 training sessions), Week 4 (after 12 training sessions), 6 Weeks Post-Training

• Change in 10-Meter Walk Test at Fast Walking Speed

  The 10-Meter Walk Test is used to assess walking speed over a short distance. A 10 m walkway over solid flooring will be measured and marked at start (0 m), 2 m, 8 m, and finish (10 m). Participants will be asked to complete three trials of the 10 m walk at their fast walking speed. The time for the three trials for each speed will be averaged and gait speed converted to meters/second.

  Baseline, Week 1 (after 3 training sessions), Week 2 (after 6 training sessions), Week 4 (after 12 training sessions), 6 Weeks Post-Training

• Change in 6-Minute Walk Test

  The 6-Minute Walk Test is a sub-maximal exercise test used to assess walking endurance. A walkway of a minimum 12 m over solid flooring will be measured and marked with a turn-around marked at either end of the walkway. The turn-around points will be approximately 49 inches (124 cm) wide with clear markings. A chair will be placed at one end of the walkway to allow for seated rest breaks if necessary. Prior to administering the test, the participant will be seated in the chair resting. The participant will then be asked to walk as far as possible in 6 minutes along the walkway using scripted instruction (see below). The distance (in meters) will be calculated by multiplying the number of total laps by 12 meters and adding the distance of the partial lap completed at the time the test ended.

  Baseline, Week 1 (after 3 training sessions), Week 2 (after 6 training sessions), Week 4 (after 12 training sessions), 6 Weeks Post-Training

• Change in Timed Up and Go (TUG) Test

  The Timed Up and Go test assesses mobility, balance, walking ability, and fall risk in older adults. The participant will be asked to be seated in a standard height chair (seat height 46 cm, arm height 67 cm), placing his/her back against the chair and resting his/her arms on the chair's arms. The participant will be asked to get up from the chair, walk to a line 3 m from the edge of the chair, turn around at the line, walk back to the chair, and sit down. The test will be timed using a stopwatch from when the investigator says "Go" to when the participant's buttocks touches the chair upon return. Time of the test will be recorded.

  Baseline, Week 1 (after 3 training sessions), Week 4 (after 12 training sessions), 6 Weeks Post-Training

• Change in Fugl-Meyer Assessment - Lower Extremity (FMA-LE)

  The Fugl-Meyer assessment of motor recovery after stroke evaluates and measures recovery in post-stroke hemiplegic patients and is one of the most widely used quantitative measures of motor impairment. The quality of reflexes, coordination, and voluntary movements of the lower extremity will be assessed by a physical therapist using the FMA-LE.

  Baseline, 6 Weeks Post-Training

• Change in Modified Ashworth Scale Score

  The Modified Ashworth Scale measures spasticity in patients with lesions of the central nervous system by testing resistance to passive movement. Scores range from 0 to 4 with 6 choices and are scored as follows: * 0 = No increase in muscle tone * 1 =Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension * 1+ = Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of motion * 2 = More marked increase in muscle tone through most of the range of motion, but affected part(s) easily moved * 3 = Considerable increase in muscle tone, passive movement difficult * 4 = Affected part(s) rigid in flexion or extension

  Baseline, 6 Weeks Post-Training

• Change in Stroke Impact Scale (SIS) Score

  The Stroke Impact Scale is a self-report questionnaire that evaluates disability and health-related quality of life after stroke, including: activities of daily living, cognition, communication, depression, functional mobility, gait, general health, life participation, quality of life, social relationships, social support, and upper extremity function. For each of the 59 questionnaire items, the individual is asked to rate the level of difficulty of the item in the past 2 weeks using a 5-point Likert scale.

  Baseline, Week 4 (after 12 training sessions), 6 Weeks Post-Training

• Change in gait propulsion

  Gait biomechanics testing will be conducted in the motion analysis assessing gait asymmetry. A 7-camera system will be used to collect motion analysis data. Ground reaction forces during treadmill walking will be collected using force platforms.

  Baseline, Week 1 (after 3 training sessions), Week 2 (after 6 training sessions), Week 4 (after 12 training sessions), 3 Weeks Post-training, 6 Weeks Post-Training

• Change in TMS motor evoked potential (MEP) amplitude

  Change in MEP amplitude is used as a measure of corticospinal excitability that is assessed using a non-invasive technique called transcranial magnetic stimulation (TMS). Electrical activity from muscles in response to the TMS will be collected using surface electromyography (EMG) sensors attached to muscles that play critical roles during FastFES.

  Baseline, Week 1 (after 3 training sessions), Week 2 (after 6 training sessions), Week 4 (after 12 training sessions), 3 Weeks Post-training, 6 Weeks Post-Training

Secondary Outcomes (5)

• Change in intracortical facilitation (ICF)

  Baseline, Week 1 (after 3 training sessions), Week 2 (after 6 training sessions), Week 4 (after 12 training sessions), 3 Weeks Post-training, 6 Weeks Post-Training

• Change in H-max/M-max ratio for the soleus

  Baseline, Week 1 (after 3 training sessions), Week 2 (after 6 training sessions), Week 4 (after 12 training sessions), 3 Weeks Post-training, 6 Weeks Post-Training

• Change in energy cost (EC) of walking

  Baseline, Week 1 (after 3 training sessions), Week 2 (after 6 training sessions), Week 4 (after 12 training sessions), 3 Weeks Post-training, 6 Weeks Post-Training

• Change in ankle peak plantarflexor moment during gait

  Baseline, Week 1 (after 3 training sessions), Week 2 (after 6 training sessions), Week 4 (after 12 training sessions), 3 Weeks Post-training, 6 Weeks Post-Training

• Change in ankle power during gait

  Baseline, Week 1 (after 3 training sessions), Week 2 (after 6 training sessions), Week 4 (after 12 training sessions), 3 Weeks Post-training, 6 Weeks Post-Training

Study Arms (2)

Fast treadmill walking with functional electrical stimulation (FastFES)

EXPERIMENTAL

Participants with post-stroke hemiparesis who are randomized to receive 12 sessions of FastFES. FastFES is a targeted intervention that provides motor level stimulation-induced cues to improve ankle propulsion. FES is delivered only to the paretic ankle muscles, enhancing afferent ascending as well as descending corticomotor drive. Increased corticomotor drive in lesioned corticomotor circuits in turn promotes improved timing and intensity of muscle activation in the paretic plantar- and dorsi-flexor muscles, increasing plantarflexor moment and propulsion from the paretic ankle.

Device: Functional electrical stimulation (FES); Other: Fast treadmill walking

Fast treadmill walking (Fast)

ACTIVE COMPARATOR

Participants with post-stroke hemiparesis who are randomized to receive 12 sessions of Fast. Fast is a non-targeted intervention that provides similar structure, dose, and intensity of stepping practice as FastFES, but does not include FES, and no specific instructions are provided to target practice to the paretic leg or specific ankle deficits

Other: Fast treadmill walking

Interventions

Functional electrical stimulation (FES) DEVICE

Functional electrical stimulation (FES) is a targeted intervention that provides motor level stimulation-induced cues to improve ankle propulsion. An electrical stimulator will be used to deliver stimulation during walking (Grass S8800 stimulator with SIU8TB stimulus isolation unit; UDel stimulator). A customized, real-time system will be used to control the stimulator and deliver stimulation during appropriate phases of the gait cycle. Stimulation will be delivered to the ankle dorsiflexors when the subject's foot is in the air (swing phase). Stimulation will be delivered to the ankle plantarflexors during the terminal stance phase of gait. 30-Hz variable frequency stimulation trains 170 will be delivered during gait. The intervention comprises 3 training sessions per week for a total of 12 training sessions. FES intensity is determined at the start of every training session as motor-level stimulation that elicits appropriate functional movements.

Fast treadmill walking with functional electrical stimulation (FastFES)

Fast treadmill walking OTHER

Fast treadmill walking (Fast) is a non-targeted intervention where no specific instructions are provided to target practice to the paretic leg or specific ankle deficits. The intervention comprises 3 training sessions per week for a total of 12 training sessions. Each training session includes six 6-minute walking bouts with 5-minute breaks between bouts.

Fast treadmill walking (Fast); Fast treadmill walking with functional electrical stimulation (FastFES)

Eligibility Criteria

• Age: 35 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• at least 6 months since stroke
• single cortical or subcortical ischemic stroke
• able to walk 10-meters with or without assistive device
• sufficient cardiovascular health and ankle stability to walk on treadmill for 2-minutes at self-selected speed without orthosis
• resting heart rate 40-100 bpm

You may not qualify if:

• hemorrhagic stroke
• cerebellar signs (ataxic ("drunken") gait or decreased coordination during rapid alternating hand or foot movements
• score of \>1 on question 1b and \>0 on question 1c on NIH Stroke Scale
• inability to communicate with investigators
• musculoskeletal conditions or pain that limit walking
• neglect/hemianopia, or unexplained dizziness in last 6 months
• neurologic conditions or diagnoses other than stroke
• lack of sensation in lower limb affected by stroke
• any medical diagnosis that would hinder the participant from completing the experimental trial

Sponsors & Collaborators

• Emory University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Trisha Kesar, PT, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 8, 2020
• Study Start: March 16, 2021
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and for 2 years after publication of the manuscript presenting the study primary results
• Access Criteria: Researchers who provide a methodologically sound proposal to achieve the aims proposed by the requestor; for replication studies, meta-analyses or systematic reviews, other special requests, etc should direct their requests to tkesar@emory.edu. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website.

Locations

US (1)