Clinical Trials Directory

Trials / Terminated

TerminatedNCT05650606

Inpatient Rehabilitation and Post-Discharge Outcomes With High Intensity Gait Training (HIGT) of Patients With Stroke

Inpatient Rehabilitation and Post-Discharge Outcomes of Patients With Stroke Participating in High Intensity Gait Training

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
2 (actual)
Sponsor
Sunnyview Rehabilitation Hospital · Academic / Other
Sex
All
Age
18 Years – 85 Years
Healthy volunteers
Not accepted

Summary

Stroke is a major cause of disability, with 2-3% of Americans reporting stroke related impairments (Tsao 2022). Following stroke, over half of Medicare patients are discharged to post-acute care facilities or receive home-based health care (Tsao 2022). Inpatient rehabilitation guidelines are lacking, with many interventions based on research of patients with chronic stroke. There is great need for randomized clinical trials during the early subacute period (Bernhardt 2017, Jordan 2021). Clinical practice guidelines recommend high intensity gait training (HIGT) for ambulatory patients with chronic stroke (Hornby 2020). Outpatient HIGT protocols incorporating variable stepping demonstrate equivalent effectiveness to forward stepping protocols (Hornby 2019) and have yielded superior results to lower intensity therapies (Hornby 2019, Hornby 2016). Research suggests that HIGT with variable stepping is feasible during inpatient rehabilitation (Hornby 2015, Moore 2020). Pre-post studies suggest that participation in HIGT during inpatient rehabilitation yields greater improvements in walking without an increase in adverse events. (Moore 2020). Despite this, there are no randomized controlled trials evaluating HIGT in the inpatient setting. The subacute phase of stroke recovery may be a critical time for neuroplasticity (Dromerick 2021). Not only might rehabilitation interventions be more effective when initiated earlier (Biernaskie 2004, Dromerick 2021) but because inpatient rehabilitation represents the transition from hospital to home, interventions during this timeframe have the potential to improve discharge disposition, enhance quality of life, and reduce utilization of post-discharge services. In this randomized controlled study, investigators will determine how participation in HIGT during inpatient rehabilitation affects balance, ambulation, and quality of life after 14 and/or 21 days of inpatient rehabilitation, and 8 weeks post-discharge. Investigators will also determine if HIGT reduces health care burden with a cost-effectiveness analysis.

Conditions

Interventions

TypeNameDescription
OTHERHigh Intensity Gait TrainingPhysical therapy intervention for improving gait in patients post Cerebral Vascular Accident.
OTHERConventional TherapyStandard inpatient rehabilitation physical therapy treatments for Cerebral Vascular Accident.

Timeline

Start date
2023-03-18
Primary completion
2023-10-11
Completion
2023-10-11
First posted
2022-12-14
Last updated
2023-10-13

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05650606. Inclusion in this directory is not an endorsement.