Implementation of Comprehensive Stroke Rehabilitation Therapy for Enhanced Quality of Life



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:21 - 90
Updated:12/30/2018
Start Date:July 2015
End Date:December 27, 2018

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

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.

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
We found this trial at
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Gainesville, Florida 32606
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Gainesville, Florida 32606
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1310 Southwest 13th Street
Gainesville, Florida 32608
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