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Implementation of Comprehensive Stroke Rehabilitation Therapy for Enhanced Quality of Life (QualPro)

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Experimental Group, Sub-Acute
Experimental Group, Chronic
Standard of Care, Sub-Acute
Standard of Care, Chronic
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, stroke rehabilitation, stroke therapy

Eligibility Criteria

21 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UF Health Rehab Center- Magnolia Parke
  • UF Health Shands Rehab Hospital
  • Brain Rehabilitation Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Experimental

Experimental

Arm Label

Standard of Care, Sub-Acute

Standard of Care, Chronic

Experimental Group, Sub-Acute

Experimental Group, Chronic

Arm Description

This group will receive standard of care stroke rehabilitation therapy.

This group will receive standard of care stroke rehabilitation therapy.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 15, 2014
Last Updated
August 30, 2019
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT02225990
Brief Title
Implementation of Comprehensive Stroke Rehabilitation Therapy for Enhanced Quality of Life
Acronym
QualPro
Official Title
Implementation of Gait Coordination, Mobility, and Fitness Training for Enhanced Quality of Life and Participation in Life Roles
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
December 27, 2018 (Actual)
Study Completion Date
December 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, stroke rehabilitation, stroke therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care, Sub-Acute
Arm Type
Active Comparator
Arm Description
This group will receive standard of care stroke rehabilitation therapy.
Arm Title
Standard of Care, Chronic
Arm Type
Active Comparator
Arm Description
This group will receive standard of care stroke rehabilitation therapy.
Arm Title
Experimental Group, Sub-Acute
Arm Type
Experimental
Arm Description
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.
Arm Title
Experimental Group, Chronic
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Experimental Group, Sub-Acute
Intervention Description
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
Intervention Name(s)
Experimental Group, Chronic
Intervention Description
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
Intervention Name(s)
Standard of Care, Sub-Acute
Intervention Description
This group will receive standard of care stroke rehabilitation therapy.
Intervention Type
Other
Intervention Name(s)
Standard of Care, Chronic
Intervention Description
This group will receive standard of care stroke rehabilitation therapy.
Primary Outcome Measure Information:
Title
Patient response to QualPro intervention in the clinical environment
Description
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
Secondary Outcome Measure Information:
Title
Cost savings of implementation of the QualPro Protocol
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janis J. Daly, PhD, MS
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
UF Health Rehab Center- Magnolia Parke
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32606
Country
United States
Facility Name
UF Health Shands Rehab Hospital
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32606
Country
United States
Facility Name
Brain Rehabilitation Research Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Implementation of Comprehensive Stroke Rehabilitation Therapy for Enhanced Quality of Life

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