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Clinical Trials/NCT02225990
NCT02225990
Completed
Not Applicable

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

University of Florida3 sites in 1 country9 target enrollmentJuly 2015
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
University of Florida
Enrollment
9
Locations
3
Primary Endpoint
Patient response to QualPro intervention in the clinical environment
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2015
End Date
December 27, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

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
  • 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

Outcomes

Primary Outcomes

Patient response to QualPro intervention in the clinical environment

Time Frame: 24 months

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 Outcomes

  • Cost savings of implementation of the QualPro Protocol(24 Months)

Study Sites (3)

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