Implementation of Comprehensive Stroke Rehabilitation Therapy for Enhanced Quality of Life

Stroke Clinical Trial

— QualPro  

Official title:

Implementation of Gait Coordination, Mobility, and Fitness Training for Enhanced Quality of Life and Participation in Life Roles

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02225990
• Other study ID #: IRB201400568
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: December 27, 2018

Study information

• Verified date: August 2019
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 27, 2018
• Est. primary completion date: December 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

Inclusion Criteria:

• Cognition sufficiently intact to give valid informed consent to participate.

• Sufficient endurance to participate in rehabilitation sessions.

• Ability to follow 2 stage commands.

• Medically stable

• Age > 21 years

• Impaired ambulation as follows: inability to flex the knee and ankle in the sagittal plane, in a normal manner so the foot clears the floor; inability to control normal knee angle during single limb weight bearing during stance phase.

• Trace contraction of hip, knee, and ankle flexors and extensors.

• Passive range of motion (ROM) at hip, knee, ankle greater than or equal to normal gait kinematics.

• Reported comfort of surface FES at a stimulus level producing a visible or palpable muscle contraction of ankle dorsiflexors.

• Greater than 3 weeks post-stroke.

• Living in the community and able to travel to training and assessment sites.

• Approval of participation by primary care physician

Exclusion Criteria:

• Acute or progressive cardiac, renal, respiratory, neurological disorders or malignancy.

• Active psychiatric diagnosis or psychological condition, or active drug/alcohol abuse.

• Lower motor neuron damage or radiculopathy.

• More than one stroke.

• Cerebellar dysfunction.

• Fugl-Meyer lower limb motor sub-score greater than 32.

• Severe obesity (body mass index > 35)

• For the chronic group: current participation in physical therapy or cardiopulmonary rehabilitation.

• Significant visual impairment affecting capability to gauge movement accuracy.

• Current enrollment in any clinical trial

• Planning to relocate out of the greater Gainesville, FL area during the study period

• Unable to communicate sufficiently with study personnel

• Clinical judgement regarding safety or non-compliance

• Refusal to be recorded by video for gait assessment

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Experimental Group, Sub-Acute
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.
• Experimental Group, Chronic
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.
• Standard of Care, Sub-Acute
This group will receive standard of care stroke rehabilitation therapy.
• Standard of Care, Chronic
This group will receive standard of care stroke rehabilitation therapy.

Locations

Country	Name	City	State
United States	Brain Rehabilitation Research Center	Gainesville	Florida
United States	UF Health Rehab Center- Magnolia Parke	Gainesville	Florida
United States	UF Health Shands Rehab Hospital	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 months
Secondary	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.	24 Months