Mobility Limitation Clinical Trial
Official title:
Efficacy and Cost Effectiveness of Utilizing a Hydraulically Adjustable Walker in the Treatment of Hip Fracture
Verified date | September 2021 |
Source | MaineHealth |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | March 1, 2021 |
Est. primary completion date | March 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years to 90 Years |
Eligibility | Inclusion Criteria: - 1. 40 consecutive mentally competent patients (as determined by a score of 22 or higher on the mini mental state exam.) 2. 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. Exclusion Criteria: - 1. Patients who are deemed cognitively impaired (scores less than 22 on mini mental state exam). 2. Patients who are unable to lift a walker up onto steps. 3. Patients who have upper extremity weakness or injury due to fall and unsafe to use a standard walker as intended. 4. 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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MaineHealth |
Berg KO, Wood-Dauphinee SL, Williams JI, Maki B. Measuring balance in the elderly: validation of an instrument. Can J Public Health. 1992 Jul-Aug;83 Suppl 2:S7-11. — View Citation
Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999 Apr;79(4):371-83. — View Citation
Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. — View Citation
University of California - Disability Statistics Center. (2018, September 28). Mobility Device Statistics: United States. Retrieved October 3, 2018, from https://www.disabled-world.com/disability/statistics/mobility-stats.php
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants with improved balance using the HAW assessed by Berg Balance Scale | 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. |
24 months | |
Primary | Number of Participants with improved mobility using the HAW assessed by Lower Extremity Functional Scale | 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 Quite a bit of difficulty Moderate difficulty A little bit of difficulty 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. |
24 months | |
Primary | Number of participants with accelerated recovery | 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. | 24 Months | |
Secondary | Number of participants with reduced costs associated with the HAW | The HAW will reduce the need for costly home repairs, while improving a patient's fear of falling on stairs, improve their community ambulation, decrease medical bills, and lower the need for assistance from outside people within the home. | 24 Months |
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