Investigating Effects of High-intensity Gait Training on Gait, Balance and Depression Post-stroke

NCT06373107 | Terminated

• 1 other identifier: 2117651-2
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to study the improvements from walking practice that is vigorous enough to keep participants' heart rate over a certain target level during their physical therapy sessions. The investigators want to know about improvements in participants' walking function and mental health after 20 interventions. The study also aims to evaluate if participants' mental health, social support, and health literacy affect their attendance at physical therapy sessions.

Conditions

Stroke

Keywords

High intensity gait training; Stroke

Outcome Measures

Primary Outcomes (11)

• 3-meter backwards walk test

  Measures backward gait velocity

  Pre-, mid- (week 5) and post-intervention (within 2 weeks after the conclusion of intervention)

• 6-minute walk test

  Measures aerobic capacity and endurance

  Pre-, mid- (week 5) and post-intervention (within 2 weeks after the conclusion of intervention)

• 10-meter walk test

  Measures forward gait velocity

  Pre-, mid- (week 5) and post-intervention (within 2 weeks after the conclusion of intervention)

• Surface electromyography (EMG)

  Electromyographical recording of 8 leg muscles () is done during forward and backward walking tests.The EMG will be recorded during 3-meter Backward Walk Test, 6-minute Walk Test, and 10-meter Walk Test in all participants

  Pre-, mid- (week 5) and post-intervention (within 2 weeks after the conclusion of intervention)

• Berg Balance Scale

  a 14-item objective measure that assesses static balance and fall risk in adults. Berg balance scale scoring ranges from 0 to 56, with higher scores mean a better outcome.

  Pre-, mid- (week 5) and post-intervention (within 2 weeks after the conclusion of intervention)

• Functional Gait Assessment

  This scale assess postural stability during walking and assesses an individual's ability to perform multiple motor tasks while walking. Scoring for each FGA item ranges from 0 for severe impairment to 3 for normal performance. The highest score possible is 30, with higher scores correlating better gait function.

  Pre-, mid- (week 5) and post-intervention (within 2 weeks after the conclusion of intervention)

• Borg Rating Scale of Perceived Exertion (RPE)

  RPE is used to prescribe and monitor exercise intensity and correlates well with physiological measures of exercise intensity, including heart rate. The Borg Rating Scale of Perceived Exertion will be measured in all participants at the completion of 6 Minute Walk test. It ranges from 6 to 20, where 6 means "no exertion at all" and 20 means "maximal exertion." A lower score indicates a better exercise endurance.

  Pre-, mid- (week 5) and post-intervention (within 2 weeks after the conclusion of intervention)

• Patient Health Questionnaire (PHQ-9)

  Depressive symptom questionnaire. As a severity measure, the PHQ-9 score can range from 0 to 27, since each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day). A lower score indicates less depressive symptoms.

  Pre-, mid- (week 5) and post-intervention (within 2 weeks after the conclusion of intervention)

• Rate of patient attendance (Compliance) to physical therapy

  Greater than or equal to 80% attendance to physical therapy is considered compliance to physical therapy.

  Participant's attendance to physical therapy is tracked throughout the intervention sessions.

• Newest Vital Sign

  The NVS is a 6-question screening tool that identifies participants' risk of low or limited health literacy based on interpreting an ice cream nutrition label. It is available from Pfizer Pharmaceutical Company. The level of health literacy for each individual will be categorized based on the scores: a score of 0-1 suggests a high likelihood of limited literacy, a score of 2-3 indicates the possibility of limited literacy, and a score of 4-6 almost always indicates adequate literacy. This categorical variable will be used to determine the association with adherence to physical therapy.

  Pre-intervention (baseline)

• Multidimensional Scale of Perceived Social Support (MSPSS)

  The MSPSS is a 12-item self-administered scale that measures social support. It contains 12-items, rated on a 7-point Likert-type scale, ranging from 1 "very strongly disagree" to 7 "very strongly agree." The scale was divided into 3 subscales: family, friends, and significant other, with each section consisting of 4 items. The response scale ranges from 12 to 84. Higher scores indicate a greater family social support.

  Pre-intervention (baseline)

Study Arms (1)

High intensity gait training

EXPERIMENTAL

Participants will receive 20 sessions of vigorous walking practice. These sessions are 2-3 times a week.

Behavioral: High intensity gait training

Interventions

High intensity gait training BEHAVIORAL

Participants will practice walking that is vigorous enough to keep their heart rate over a certain level during their physical therapy sessions. During the sessions, participants will walk and step vigorously enough to keep the heart rate between 60-80% of their maximum heart rate. Maintaining this heart rate during exercise helps to improve heart health and walking, which can affect people after a stroke.

High intensity gait training

Eligibility Criteria

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

You may qualify if:

• years of age or older
• English or Spanish speaking
• A diagnosis of stroke (intracerebral hemorrhage or acute ischemic stroke)
• Referred to LVHN Outpatient Neurologic Rehab (hereafter referred to as outpatient PT)

You may not qualify if:

• Unable to follow 1-step commands
• \> 220 pounds (100 kg)
• Height \< 5'0" or \> 6'4"
• Unable to take a few steps with assistance
• A score of ≥ 50/56 on Berg Balance Scale (BBS)
• A score of ≥ 26/30 on Functional Gait Assessment (FGA)
• Resting blood pressure \>180/110 mmHg
• Resting heart rate \> 120 bpm
• Severe cardiac disease (New York Heart Association Classification IV)
• Severe spasticity (Modified Ashworth score \> 3)
• Unstable spine or unhealed pelvic/limb fractures
• Active heterotrophic ossification impacting lower extremity range of motion
• Significant lower or upper extremity contractures
• Inability to achieve neutral ankle dorsiflexion with 12° of knee flexion
• Pregnancy

Sponsors & Collaborators

• Alvernia University: lead
• Lehigh Valley Health Network: collaborator

Study Sites (1)

Lehigh Valley Health Network Outpatient Neurologic Rehab

Allentown, Pennsylvania, 18104-2310, 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

• Soo Yeon Sun, PhD

  Alvernia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 18, 2024
• Study Start: December 1, 2024
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Locations

US (1)