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临床试验/NCT03103464
NCT03103464撤回不适用

Sit-to-Stand Progression Using Movi Chair vs Traditional Practices

University of Alabama at Birmingham2 个研究点 分布在 1 个国家开始时间: 2018年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Rate of progression from moderate to minimal assist

研究概览

简要总结

Prior to discharging admitted patients, current UAB Hospital policy recommends physical therapy intervention for patients with impaired functional mobility. However, UAB Hospital currently does not have a standardized physical therapy protocol to rehabilitate admitted patients with impaired functional mobility who require moderate assist (defined as physical therapist expending 25-50% effort to assist the patient in standing). In order to reduce the effect of impaired mobility, numerous interventions have been employed at UAB. As a result, there is great variability of treatment procedures performed by various physical therapists to help moderate assist patients return to their level of functioning prior to hospital admission. The purpose of the study is three-fold: 1) to evaluate whether a proposed physical therapy protocol using a commercially available medical device, the Movi chair, contributes to improved mobility for moderate assist patients, 2) to investigate how patient rate of rehabilitation to prior level of functioning is similar/different with the proposed physical therapy protocol using Movi vs the current non-standardized practice for moderate assist patients, and 3) to compare patient confidence in physical therapy with Movi vs the current non-standardized practice using survey for moderate assist patients. In addition, we will track participant's disposition i.e. continued motor and functional change following discharge from the hospital through review of physical therapy records.

详细描述

Most activities of daily living require unassisted ability to stand from a sitting position. Therefore, physical therapy exercises aimed at improving this essential action are critically important for patients with impaired functional mobility. Although sit-to-stand tests are a well-known tool used to assess physical function, they have only recently has been proposed for systematic strength training.

Those patients who would most benefit from sit-to-stand training require moderate assist or greater. However, these patients have significant difficulty initiating sit-to-stand exercises from a horizontal chair surface and have been largely excluded from prior studies examining sit-to-stand for strength training. These patients have been excluded not only because they cannot safely stand on their own, but also because manually lifting these patients poses a significant lifting-injury risk to physical therapists.

Movi is a commercially available hybrid mechanical lift and chair who's key feature is a built in battery powered motor (rated for 600 lbs) that pivots on its axis to raise and lower a patient up to 20 degrees. We believe that this feature represents an opportunity for introducing sit-to-stand strength training to previously excluded moderate assist patients. Progressively lowering the chair's angle of inclination over consecutive physical therapy sessions will allow the patient to practice sit-to-stand at a reduced effort until the to horizontal angle is reached.

As sit-to-stand strength training is a concept only proposed in 2011, no previous studies exist concerning a sit-to-stand physical therapy protocol using a chair progressively lowering the seat's angle of inclination. Currently, therapists use their clinical judgment when approaching patients with difficulty standing by utilizing exercise, skill repetition, in addition to other strengthening strategies and equipment to reach goals. Timed sit-to-stand has already been used at UAB in order to test a patient's progress in physical therapy but not as a therapy protocol in itself, partly because equipment allowing progressive lowering of the seat's angle of inclination has not been available until now. This study was conceived due to the great variability of physical therapy in the Hospital setting and the critical need for standardization and evaluating a protocol that has potential to positively impact patient speed and ease of recovery to prior level of functioning.

The therapy protocol utilizing the Movi chair will include the following:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Care Provider)

盲法说明

Patient's primary physical therapist will not be aware whether the patient is in the intervention or control group.

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

  • Patients receiving physical therapy at UAB hospital that require moderate assistance or greater with sit-to-stand transfers during initial evaluation
  • Patients with baseline function of supervision as obtained in the initial physical therapy (PT) evaluation
  • Patients who have an inpatient hospital stay of at least 4 days

排除标准

  • Patients with diagnoses that are progressive in nature
  • Patients in intensive care units due to critical medical condition and confounding factors
  • Patients with cognitive impairment as noted in the medical record
  • Patients with weight bearing precautions other than free weight bearing (FWB) or weight bearing as tolerated (WBAT)
  • Children (under the age of 18), prisoners and pregnant women
  • Patients who are not able to speak English

研究组 & 干预措施

Intervention Group

Experimental

Patients to receive standard-of-care physical therapy + sit-to-stand therapy using the Movi chair 3x/wk.

干预措施: Standard-of-Care Therapy + Sit-to-Stand Therapy (Other)

Control Group

Active Comparator

Patients to receive standard-of-care physical therapy 3x/wk.

干预措施: Standard-of-Care Therapy (Other)

结局指标

主要结局

Rate of progression from moderate to minimal assist

时间窗: Through study completion, an average of 2 weeks

Patient rate of progression from moderate (\<50% assistance from physical therapist) to minimal (\<25% assistance from physical therapist) assist during hospital admission

次要结局

  • Five-time sit-to-stand time(Through study completion, an average of 2 weeks)
  • Hierarchical Assessment of Balance and Mobility Score(Through study completion, an average of 2 weeks)

研究者

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

Lavon Beard

Principle Investigator

University of Alabama at Birmingham

研究点 (2)

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