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

Alvernia University

Status: Terminated

Conditions: Stroke

Treatments: Behavioral: High intensity gait training

Study type: Interventional

Funder types: Other

Identifiers

NCT06373107

2117651-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

3 participants in 1 patient group

High intensity gait training

Experimental group

Description:

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

Treatment:

Behavioral: High intensity gait training