Efficacy and Cost Effectiveness of Utilizing a Hydraulically Adjustable Walker in the Treatment of Hip Fracture

NCT03829163 | Withdrawn

• 1 other identifier: klausmeyerHAW
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Mobility Limitation

Outcome Measures

Primary Outcomes (3)

• 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

• 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 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.

  24 months

• 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 Outcomes (1)

• Number of participants with reduced costs associated with the HAW

  24 Months

Study Arms (2)

Conventional Walker Group

ACTIVE COMPARATOR

Device: Conventional Walker

HAW Group

EXPERIMENTAL

Device: Hydraulic Adjustable Walker

Interventions

Hydraulic Adjustable Walker DEVICE

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.

HAW Group

Conventional Walker DEVICE

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.

Conventional Walker Group

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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. 3. 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.

Sponsors & Collaborators

• MaineHealth: lead

Related Publications (4)

• 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

  BACKGROUND

• 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. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

  PMID: 1202204 BACKGROUND

• 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.

  PMID: 10201543 BACKGROUND

• 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.

  PMID: 1468055 BACKGROUND

Related Links

• Official Website for the "HAW" -- invited and built by one of the investigators of 3 Wills, LLC.

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter Klausmeyer, PT, DPT

  Waldo County General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study is a randomized prospective, parallel, voluntary study to test the effectiveness of a newly designed stair-climbing walker on post-acute care patients with hip fractures. Consecutive patients participating in the study will be given participant numbers 1- 40 (odd numbered participant numbers = conventional walker, even numbered participant numbers = HAW) to protect their privacy and to eliminate selection bias. They each will receive training on each assistive device via their assigned inpatient physical therapist. The HAW should not be kept in a vehicle overnight or in temperatures below 45 degrees due to possible hydraulic system failures. A standard walker will be offered along with the HAW to the even numbered patients to ensure that the patient will have an assistive device after the study is completed or if there was an issue with the HAW during the study and needed to be discontinued.

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: February 4, 2019
• Study Start: March 1, 2019
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: September 23, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share