Clinical trial NCT02225990: Implementation of Comprehensive Stroke Rehabilitation Therapy for Enhanced Quality of Life
Official title: Implementation of Gait Coordination, Mobility, and Fitness Training for Enhanced Quality of Life and Participation in Life Roles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
stroke rehabilitation
stroke therapy
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2014-08-26
Enrollment: 9
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Patient response to QualPro intervention in the clinical environment
timeFrame: 24 months
Secondary outcomes:
measure: Cost savings of implementation of the QualPro Protocol
timeFrame: 24 Months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health Rehab Center- Magnolia Parke
state: Florida
city: Gainesville
country: United States
facility: UF Health Shands Rehab Hospital
state: Florida
city: Gainesville
country: United States
facility: Brain Rehabilitation Research Center
state: Florida
Study officials:
affiliation: University of Florida
name: Janis J. Daly, PhD, MS
role: PRINCIPAL_INVESTIGATOR
References: