Status:
COMPLETED
Implementation of Comprehensive Stroke Rehabilitation Therapy for Enhanced Quality of Life
Lead Sponsor:
University of Florida
Conditions:
Stroke
Eligibility:
All Genders
21-90 years
Phase:
NA
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 tra...
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 st...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 27 2018
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT02225990
Start Date
July 1 2015
End Date
December 27 2018
Last Update
September 4 2019
Active Locations (3)
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1
UF Health Rehab Center- Magnolia Parke
Gainesville, Florida, United States, 32606
2
UF Health Shands Rehab Hospital
Gainesville, Florida, United States, 32606
3
Brain Rehabilitation Research Center
Gainesville, Florida, United States, 32608