Clinical trial NCT06373107: Investigating Effects of High-intensity Gait Training on Gait, Balance and Depression Post-stroke
Official title: Investigating Effects of High-intensity Gait Training on Gait Function, Balance and Depression Following Stroke and the Impact of Social Determinants of Health and Depression on Patients' Adherence to Physical Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: High intensity gait training
Stroke
Lead sponsor: Alvernia University
Sponsor class: OTHER
Collaborators: name: Lehigh Valley Health Network
First posted: 2024-04-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 3-meter backwards walk test
timeFrame: Pre-, mid- (week 5) and post-intervention (within 2 weeks after the conclusion of intervention)
measure: 6-minute walk test
timeFrame: Pre-, mid- (week 5) and post-intervention (within 2 weeks after the conclusion of intervention)
measure: 10-meter walk test
timeFrame: Pre-, mid- (week 5) and post-intervention (within 2 weeks after the conclusion of intervention)
measure: Surface electromyography (EMG)
timeFrame: Pre-, mid- (week 5) and post-intervention (within 2 weeks after the conclusion of intervention)
measure: Berg Balance Scale
timeFrame: Pre-, mid- (week 5) and post-intervention (within 2 weeks after the conclusion of intervention)
measure: Functional Gait Assessment
timeFrame: Pre-, mid- (week 5) and post-intervention (within 2 weeks after the conclusion of intervention)
measure: Borg Rating Scale of Perceived Exertion (RPE)
timeFrame: Pre-, mid- (week 5) and post-intervention (within 2 weeks after the conclusion of intervention)
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Pre-, mid- (week 5) and post-intervention (within 2 weeks after the conclusion of intervention)
measure: Rate of patient attendance (Compliance) to physical therapy
timeFrame: Participant's attendance to physical therapy is tracked throughout the intervention sessions.
measure: Newest Vital Sign
timeFrame: Pre-intervention (baseline)
measure: Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: Pre-intervention (baseline)
Secondary outcomes:
Other outcomes:
Locations:
city: Allentown
country: United States
facility: Lehigh Valley Health Network Outpatient Neurologic Rehab
state: Pennsylvania
Study officials:
affiliation: Alvernia University
name: Soo Yeon Sun, PhD
role: PRINCIPAL_INVESTIGATOR
References: