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

NCT ID: NCT06373107

Last Updated: 2025-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2025-05-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 improvement 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.

The findings from this study will help the researchers and clinicians decide how to help people with stroke better. Further, the findings will determine how depressive symptoms, health literacy, and other factors such as language and education affect attendance to therapy.

About 24 subjects will take part in this research.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

High intensity gait training

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

Group Type EXPERIMENTAL

High intensity gait training

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

High intensity gait training

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18 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)

Exclusion Criteria

* 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
* Colostomy
* Poor skin integrity
* Unresolved deep vein thrombosis
* Lower limb prosthesis or amputation
* Leg length discrepancies \> 0.5 inches for upper legs, 0.75 inches for lower legs
* ROM restrictions preventing normal, reciprocal gait
* Inability to stand for \> 3 minutes due to pain or orthostatic hypotension
* Pusher syndrome
* Cortical blindness
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Lehigh Valley Health Network

OTHER

Sponsor Role collaborator

Alvernia University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Soo Yeon Sun, PT, PhD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Soo Yeon Sun, PhD

Role: PRINCIPAL_INVESTIGATOR

Alvernia University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Lehigh Valley Health Network Outpatient Neurologic Rehab

Allentown, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2117651-2

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

HIT-Stroke Trial 2
NCT06268041 RECRUITING NA