Implementation of Gait Coordination, Mobility, and Fitness Training for Enhanced Quality of Life and Participation in Life Roles
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 6
- 主要终点
- Patient response to QualPro intervention in the clinical environment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
Standard of Care, Sub-Acute
This group will receive standard of care stroke rehabilitation therapy.
干预措施: Standard of Care, Sub-Acute (Other)
Standard of Care, Chronic
This group will receive standard of care stroke rehabilitation therapy.
干预措施: Standard of Care, Chronic (Other)
Experimental Group, Sub-Acute
This group consists of sub-acute stroke patients who are between three weeks and six months post-stroke and will receive the QualPro protocol. If the participant is an inpatient at Shands Rehabilitation Hospital at the beginning of the study, his/her first three weeks of research therapy sessions will take place at the Shands Rehabilitation Hospital. After being discharged, the remainder of the study sessions will take place at either UF Health Rehab Center- Magnolia Parke or in the North Tower (6th floor) physical therapy department of Shands Hospital.
干预措施: Experimental Group, Sub-Acute (Other)
Experimental Group, Chronic
This group consists of chronic stroke patients who are greater than six months post-stroke and will receive the QualPro protocol. The study sessions will take place at either UF Health Rehab Center-Magnolia Parke or in the North Tower (6th floor) physical therapy department of Shands Hospital.
干预措施: Experimental Group, Chronic (Other)
结局指标
主要结局
Patient response to QualPro intervention in the clinical environment
时间窗: 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.
次要结局
- Cost savings of implementation of the QualPro Protocol(24 Months)