High-intensity walking training for stroke recovery
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
NA · Alvernia University · NCT06373107
This study tests if high-intensity walking training can help stroke patients improve their walking and mental health during therapy sessions.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Alvernia University (other) |
| Locations | 1 site (Allentown, Pennsylvania) |
| Trial ID | NCT06373107 on ClinicalTrials.gov |
What this trial studies
This research investigates the effects of high-intensity gait training on improving walking function and mental health in stroke patients. Participants will engage in vigorous walking practice during physical therapy sessions, aiming to maintain a target heart rate. The study will also assess how factors like mental health, social support, and health literacy influence attendance at therapy sessions. A total of 24 subjects will be involved in this intervention over 20 sessions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have experienced a stroke and are referred to outpatient neurologic rehabilitation.
Not a fit: Patients who are unable to follow simple commands or have severe physical limitations may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance recovery outcomes for stroke patients by improving their mobility and mental well-being.
How similar studies have performed: Other studies have shown promising results with high-intensity training approaches for stroke rehabilitation, indicating potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Allentown, Pennsylvania
- Lehigh Valley Health Network Outpatient Neurologic Rehab — Allentown, Pennsylvania, United States (RECRUITING)
Study contacts
- Principal investigator: Soo Yeon Sun, PhD — Alvernia University
- Study coordinator: Soo Yeon Sun, PhD
- Email: soo.sun@alvernia.edu
- Phone: 6107968398
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stroke, High intensity gait training