An interventional study of Experimental Group, Sub-Acute and Experimental Group, Chronic in Stroke, sponsored by University of Florida. Completed at 3 sites in United States. Open to participants aged 21 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-09-04.
Sponsored by University of Florida · Not applicable, Interventional, and Treatment
The purpose of this research study is to implement into clinical practice, the comprehensive QualPro protocol for stroke survivors, which includes gait coordination, balance, mobility, and fitness training. Feasibility will be tested in the clinical environment by providing the intervention, measuring patient outcomes, and identifying the obstacles to insurance payment for the QualPro intervention. By productively addressing issues of implementation, the hypotheses of this study include proven feasibility in the clinical environment and clinically significant gains for stroke patients in the areas of strength, balance, gait coordination, endurance, physical function, and increased life role participation.
This comprehensive intervention targets the impairments preventing recovery to normal and safe gait, mobility, function, and life role participation (quality of life). It has been tested in chronic stroke survivors and found efficacious.
The QualPro protocol will include three phases, all of which contain components previously mentioned. The QualPro protocol includes implementation of gait coordination training to address weakness, impaired endurance, and dyscoordination. The protocol will include implementation of balance training for falls prevention composed of Yang style, 24-posture, short-form Tai Chi. Additionally, the QualPro protocol will include implementation of aerobic training for fitness, health, and endurance of stroke survivors, which will be composed of low-volume, high intensity interval training (HIIT) on a cycle ergometer. Strength exercises will also be included. All exercises will address weakness, impaired endurance, and dyscoordination.
The long-range financial goal of this research study is to realize the cost savings of implementing the proposed combination of interventions that will preclude much of the very costly and downwardly spiraling sequellae currently observed after stroke, and that currently costs managed care and insurance companies an exorbitant and unnecessary amount of precious resources.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 9 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.
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Exclusion Criteria:
This group will receive standard of care stroke rehabilitation therapy.
Other: Standard of Care, Sub-Acute
This group will receive standard of care stroke rehabilitation therapy.
Other: Standard of Care, Chronic
This group consists of sub-acute stroke patients who are between three weeks and six months post-stroke and will receive the QualPro protocol. If the participant is an inpatient at Shands Rehabilitation Hospital at the beginning of the study, his/her first three weeks of research therapy sessions will take place at the Shands Rehabilitation Hospital. After being discharged, the remainder of the study sessions will take place at either UF Health Rehab Center- Magnolia Parke or in the North Tower (6th floor) physical therapy department of Shands Hospital.
Other: Experimental Group, Sub-Acute
This group consists of chronic stroke patients who are greater than six months post-stroke and will receive the QualPro protocol. The study sessions will take place at either UF Health Rehab Center-Magnolia Parke or in the North Tower (6th floor) physical therapy department of Shands Hospital.
Other: Experimental Group, Chronic
For the sub-acute experimental group, the intervention schedule will be as follows: six months of individual therapy five times weekly (1 - 2.5 hours/session); 6 months of 'refresher' individual therapy twice monthly (1 - 2.5 hours/session) + group therapy up to three times weekly (1 hour/session); and 1 year of group therapy, up to three times weekly (1 hour/session) + 1 'refresher' individual therapy session every 3 months for a total study duration of 2 years.
For the chronic experimental group, the intervention schedule will be as follows: six months of individual therapy five times weekly (1 - 2.5 hours/session); 6 months of 'refresher' individual therapy twice monthly (1 - 2.5 hours/session) + group therapy up to three times weekly (1 hour/session); and 1 year of group therapy, up to three times weekly (1 hour/session) + 1 'refresher' individual therapy session every 3 months for a total study duration of 2 years.
This group will receive standard of care stroke rehabilitation therapy.
This group will receive standard of care stroke rehabilitation therapy.
Patient response to QualPro intervention in the clinical environment
Implementation of the comprehensive QualPro protocol into clinical practice will be done in order to determine patient outcomes during interventions of gait coordination, balance, mobility, and fitness training.
Time frame: 24 months
Cost savings of implementation of the QualPro Protocol
Information with respect to the cost of standard care and cost of the proposed care model will be collected and compiled in order to determine feasibility in the clinical environment.
Time frame: 24 Months
Plan to share: Undecided
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This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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