Efficacy and Cost Effectiveness of Utilizing a Hydraulically Adjustable Walker in the Treatment of Hip Fracture
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- MaineHealth
- 主要终点
- Number of Participants with improved balance using the HAW assessed by Berg Balance Scale
研究概览
简要总结
The purpose of this study is to establish the efficacy of a new walker with hydraulically adjustable legs (HAW) in increasing patients' mobility, especially over uneven terrains such as stairs. An attempt will be made to determine patients' satisfaction with this new instrument as well as comparing it to current walkers' effects on mobility, patient confidence, safety and security. In addition, an estimate of financial advantages/savings will be reviewed. Patient using the HAW should benefit from increased mobility, increased freedom home and in the community, as well as decreased medical costs and need for home modifications along with burden on family members caring for them after the injury.
详细描述
Assistive walking devices are well known and come in various forms, such as canes, crutches, and walkers. Their primary purpose has been to allow someone to be more functional, safe, and independent after a sudden or gradual decline in some aspect of their health. Even with vast changes in all areas of human development the standard walking devices still have their limitations especially when it comes to stairs. The HAW takes one of the most common and dependable devices, a conventional walker, and upgrades its functionality to handle stairs and uneven ground.
A walker consists primarily of a metal frame with four legs which are stabilized by crossbars. These walker frames come in a variety of shapes and sizes; many consist primarily of two inverted U-shaped leg modules connected by crossbars. Regardless of the shape or form of the leg modules, each walker frame forms a 3-sided box with an opening in which the user may stand (See Figure 1).
The frame often includes two handles located on each side of the user at the upper region of each inverted U-shaped member. The height is matched to each individual's height by keeping the handles at the height of their inner wrist (See Figure 1).
Most basic walkers include mechanical means to allow the length of the legs to be increased or decreased. Push button locking pins that fit into pre-drilled holes in the legs are used to secure the walkers height to match the person [HO10] using it. The adjustment is also a time-consuming process requiring significant dexterity, and if a patient is trying to do it themselves, this can lead to falls or injury.
The US spends over $30 billion on health care-related to falls each year. 1 There are over 1,000,000 hip and knee surgeries performed each year. 1 In the US, the National Institute of Health (NIH) estimates that there are 6.9 million assistive device users (crutches, canes, or walker) in the US patient that are over the age of 65. 1 Currently there is an estimated 2 million walker users. It is estimated that of those 2 million, 62% of them have to use a walker to navigate stairs on a daily basis.1 This means that conservatively 1.24 million elderly people would benefit from a walker that negotiates stairs optimally. This number of elderly people will undoubtedly be increasing as the elderly population is estimated to more than double by the year 2050, reaching an astounding 89,000,000. 1 The HAW is the only known device that would allow its user the safety of a standard walker as well as protection on stairs while maintaining or improving their muscle strength, balance and endurance. 1 The HAW is a based on a conventional walker but has innovative telescoping legs with a leg adjustment assembly that includes at least one valve and at least one tube that delivers hydraulic fluid into the legs and allows a user to control the length of each leg. The legs of the walker are hydraulically adjustable, so that the front legs may be shortened and the back legs extended, or two side legs shortened and the two opposing side legs extended, so as to allow the walker to be securely placed on two different steps. This allows the user to be able to stand on a stair without worrying about sharing the same stair with the device. It also ensures that the height of the walker continues to be the right height for the user to minimize loss of balance.
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
- None
入排标准
- 年龄范围
- 65 Years 至 90 Years(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40 consecutive mentally competent patients (as determined by a score of 22 or higher on the mini mental state exam.)
- •Patients age 65-90 who suffer an acute hip fracture from a fall and will be assigned to the use of a walker. The patient will be given and instructed on the use of the Waldo County General Hospital standard walker or the HAW.
排除标准
- •Patients who are deemed cognitively impaired (scores less than 22 on mini mental state exam).
- •Patients who are unable to lift a walker up onto steps.
- •Patients who have upper extremity weakness or injury due to fall and unsafe to use a standard walker as intended.
- •Patient who are shorter than five foot two inches tall or patients six foot three inches or taller as height limitations are based on prototypes available at this time.
- •Early withdrawal can be done at any time by a patient for any reason especially if the patient feels unsafe with the assigned walker or if surgery is indicated for a non-union of the fracture or failure of the implanted TFN.
结局指标
主要结局
Number of Participants with improved balance using the HAW assessed by Berg Balance Scale
时间窗: 24 months
Berg Balance Scale About: This scale measures balance in older adults. Items: 14 Equipment: Yardstick One standard chair with arm rests One standard chair without arm rests Footstool/step Stopwatch or wristwatch 15 foot walkway Reliability: Cronbach's alphas were greater than 0.83 for stroke patients and 0.97 for elderly residents. Scoring: A five-point scale, a range of 0-4. 0 = lowest level of function 4 = highest level of function. Highest possible score = 56 Score of \< 45 indicates a greater risk of falling 41-56 = low fall risk 21-40 = medium fall risk 0 -20 = high fall risk Reference: Berg K, Wood-Dauphinee S, Williams JI, Maki, B (1992). Measuring balance in the elderly: validation of an instrument. Can. J. Pub. Health July/August supplement 2:S7-11 Norms: Lusardi, M.M. (2004). Functional Performance in Community Living Older Adults. Journal of Geriatric Physical Therapy, 26(3), 14-22.
Number of Participants with improved mobility using the HAW assessed by Lower Extremity Functional Scale
时间窗: 24 months
The Lower Extremity Functional scale (LFES) is a self-administered set of 20 questions with answers ranging from 0-4 to assess the function of one or both lower extremities. The rating scale is as follows: 0. Extreme difficulty, including inability to perform an activity 1. Quite a bit of difficulty 2. Moderate difficulty 3. A little bit of difficulty 4. No difficulty The totals are summed at the bottom of the table. The minimum important change on the scale is 9 points, which means that a clinical change exists with a change of 9 points on the scale. The LEFS has a margin of error of +/- 5 points, which means that a patient's tabulated score is within 5 points of his "true" score.
Number of participants with accelerated recovery
时间窗: 24 Months
Using data that is collected by the study coordinator from patients involved in the study, and their scores on the functional outcome measures in the tables below, the study aim is to show an accelerated recovery and return to a prior level of function among use of the HAW faster than the control group using a conventional walker. This data, along with patient testimonials, will hopefully show that the HAW can be used for a wide variety of patients to improve their level of mobility and safety during ambulation on stairs and uneven ground.
次要结局
- Number of participants with reduced costs associated with the HAW(24 Months)
研究者
Peter Klausmeyer
Principal Investigator
MaineHealth
