Implementation of Comprehensive Stroke Rehabilitation Therapy for Enhanced Quality of Life

NCT ID: NCT02225990

Last Updated: 2019-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2018-12-27

Brief 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.

Detailed 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.

Conditions

Stroke

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of Care, Sub-Acute

This group will receive standard of care stroke rehabilitation therapy.

Group Type: ACTIVE_COMPARATOR

Standard of Care, Sub-Acute

Intervention Type: OTHER

This group will receive standard of care stroke rehabilitation therapy.

Standard of Care, Chronic

This group will receive standard of care stroke rehabilitation therapy.

Group Type: ACTIVE_COMPARATOR

Standard of Care, Chronic

Intervention Type: OTHER

This group will receive standard of care stroke rehabilitation therapy.

Experimental Group, Sub-Acute

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.

Group Type: EXPERIMENTAL

Experimental Group, Sub-Acute

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Experimental Group, Chronic

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Standard of Care, Sub-Acute

This group will receive standard of care stroke rehabilitation therapy.

Intervention Type: OTHER

Standard of Care, Chronic

This group will receive standard of care stroke rehabilitation therapy.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janis J. Daly, PhD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

UF Health Rehab Center- Magnolia Parke

Gainesville, Florida, United States

UF Health Shands Rehab Hospital

Gainesville, Florida, United States

Brain Rehabilitation Research Center

Gainesville, Florida, United States

Countries

United States

Other Identifiers

IRB201400568

Identifier Type: -

Identifier Source: org_study_id