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临床试验/NCT05311384
NCT05311384已完成不适用

Application of a Reimbursable Form of Constraint-Induced Movement Therapy for Upper Extremity Recovery Following Stroke: A Pilot Study

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年4月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Motor Activity Log (MAL)

研究概览

简要总结

CI therapy is a family of techniques that has systematically applied intensive treatment daily over consecutive days, supervised motor training using a technique called shaping, behavioral strategies to improve the use of the more- affected limb in real life situations called a Transfer Package (TP), and strategies to remind participants to use the more-affected extremity; including restraint of the less-affected arm in the upper extremity (UE) protocol. Numerous studies examining use of CI therapy with UE rehabilitation have demonstrated robust evidence for increasing the amount and the quality of the paretic UE functional use in daily situations of individuals recovering from stroke.

Previous studies have explored the barriers for clinical implementation of the approach, including the amount of time needed by therapists, other resources required and lack of payment for the services. With regards to therapists' time/resources, in the signature CI therapy protocol, therapists supervised movement training for 3 hours daily (except for weekends) for a 12 consecutive-day period. This level of supervision in highly unusual for traditional rehabilitation clinical settings. The treatment schedule is also incompatible with most insurance reimbursement policies in the US. As such, most CI therapy clinics require patients to pay privately with little or no insurance reimbursement. Such practices severely limit the number of patients who can afford to receive CI therapy. Two lines of evidence have suggested that an alternative CI therapy protocol may allow for the essential (or "Key") CI therapy elements to be delivered in a schedule that better utilizes therapist time/resources and is compatible with payment policies of many US insurance companies. One line of evidence comes from findings that indicate that the original 6-hour supervised training schedule could be shortened to as little as 2-hours/daily without a reduction in outcomes. Additional evidence comes from a study exploring the systematic addition and deletion of the signature CI therapy protocol elements indicated that when the transfer package was omitted, outcomes related to functional use were reduced by 50%. These findings were also verified by brain imaging studies conducted concurrently that revealed a much-reduced level of brain remodeling in those not receiving the transfer package. These findings highlight the potential effectiveness of the transfer package and continued movement training by the patient while away from clinical supervision. The hypothesis of this study is that the amount of supervised training could be reduced further and delivered in a distributed schedule (1 to 4 times/ week over an 8-week period) instead of consecutively over a 12-day treatment period. This modification could be possible by adapting and strengthening the transfer package component of the protocol. In order to investigate if all of the Keys intervention protocol is necessary for producing optimal outcomes, the delivery of specific protocol elements will be also explored. Additionally, another round of testing at the 4-week point of the 8-week intervention will be administered to investigate the need for the final 4 weeks of the intervention.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • At least 6 months after stroke
  • Ability to demonstrate minimum movement criteria of more-affected UE including 10 degrees of wrist extension (starting from a fully flexed position), 10 degrees of thumb abduction, and 10 degrees of extension of two additional fingers at all joints
  • Score <2.5 on the MAL indicating significant functional deficits of the more-affected UE

排除标准

  • Inability to answer the MAL questions and/or provide informed consent
  • Score <24 on the Mini-Mental State Examination
  • No availability to come to the clinic for the sessions.

结局指标

主要结局

Motor Activity Log (MAL)

时间窗: 3 months after the end of the treatment.

The MAL assesses how much and how well the individuals uses the affected upper extremity in 30 different daily activities. It will be used to investigate the change in spontaneous use of the affected upper extremity comparing the scores collected before and in the middle of the treatment. The MAL includes two scales: Amount of use (AOU) and Quality of Movement (QOM) and each one of them is scored from 0-10, and higher scores denote more frequent spontaneous use and better quality of movement of the affected arm.

Canadian Occupational Performance Measure (COPM)

时间窗: 3 months after the end of the treatment.

The COPM is a self-reported measure regarding the individual's occupational performance in self-care, productivity, and leisure activities. The COPM will be administered to explore the changes in occupational performance comparing the scores collected before, in the middle of the treatment and after the treatment. Five of the activities considered more important to the individuals are scored through two different scales: the performance and the satisfaction scales. Each one is scored from 0-10, and higher scores denote higher satisfaction, and quality of performance.

Wolf Motor Function Test (WMFT) - Performance Time

时间窗: after the intervention (8 weeks after starting the protocol)

The WMFT measures upper extremity motor function in terms of quality of movement and performance time. The WMFT will be administered to investigate changes in motor function of the affected arm comparing the scores collected before and in the middle of the treatment. The WMFT is scored in two different ways: through performance times (in seconds) and quality of performance through the Functional Ability Scale (FAS). The FAS ranges from 0-5, in which 0 represents inability to perform the task, and 5 is given for performances close o before the stroke. The tasks are also timed with a stopwatch and lower performance time denotes better motor function.

Wolf Motor Function Test (WMFT) - Functional Ability Scale

时间窗: after the intervention (8 weeks after starting the protocol)

The WMFT measures upper extremity motor function in terms of quality of movement and performance time. The WMFT will be administered to investigate changes in motor function of the affected arm comparing the scores collected before and in the middle of the treatment. The WMFT is scored in two different ways: through performance times (in seconds) and quality of performance through the Functional Ability Scale (FAS). The FAS ranges from 0-5, in which 0 represents inability to perform the task, and 5 is given for performances close o before the stroke. The tasks are also timed with a stopwatch and lower performance time denotes better motor function.

次要结局

  • Stroke Impact Scale (SIS)(3 months after the end of the treatment.)
  • Zung Self-Rating Depression Scale(3 months after the end of the treatment.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sarah dos Anjos

Assistant Professor

University of Alabama at Birmingham

研究点 (2)

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