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

Last updated: July 8, 2025
Sponsor: Alvernia University
Overall Status: Terminated

Phase

N/A

Condition

Stroke

Depression

Cerebral Ischemia

Treatment

High intensity gait training

Clinical Study ID

NCT06373107
2117651-2
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 outpatientPT)

Exclusion

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

Study Design

Total Participants: 3
Treatment Group(s): 1
Primary Treatment: High intensity gait training
Phase:
Study Start date:
December 01, 2024
Estimated Completion Date:
May 30, 2025

Study Description

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.

Connect with a study center

  • Lehigh Valley Health Network Outpatient Neurologic Rehab

    Allentown, Pennsylvania 18104-2310
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.