Implementation of Comprehensive Stroke Rehabilitation Therapy for Enhanced Quality of Life

Completed · Not applicable

Conditions studied: Stroke

In brief

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.

Key facts

Study ID

NCT02225990

Run by

University of Florida

People needed

9

Starts

2015-07-01

Expected to finish

2018-12-27

Last updated by the study team

2019-09-04

Who can join

Age: 21 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.