<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03829163</url>
  </required_header>
  <id_info>
    <org_study_id>klausmeyerHAW</org_study_id>
    <nct_id>NCT03829163</nct_id>
  </id_info>
  <brief_title>Efficacy and Cost Effectiveness of Utilizing a Hydraulically Adjustable Walker in the Treatment of Hip Fracture</brief_title>
  <official_title>Efficacy and Cost Effectiveness of Utilizing a Hydraulically Adjustable Walker in the Treatment of Hip Fracture</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MaineHealth</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MaineHealth</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to establish the efficacy of a new walker with hydraulically&#xD;
      adjustable legs (HAW) in increasing patients' mobility, especially over uneven terrains such&#xD;
      as stairs. An attempt will be made to determine patients' satisfaction with this new&#xD;
      instrument as well as comparing it to current walkers' effects on mobility, patient&#xD;
      confidence, safety and security. In addition, an estimate of financial advantages/savings&#xD;
      will be reviewed. Patient using the HAW should benefit from increased mobility, increased&#xD;
      freedom home and in the community, as well as decreased medical costs and need for home&#xD;
      modifications along with burden on family members caring for them after the injury.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Assistive walking devices are well known and come in various forms, such as canes, crutches,&#xD;
      and walkers. Their primary purpose has been to allow someone to be more functional, safe, and&#xD;
      independent after a sudden or gradual decline in some aspect of their health. Even with vast&#xD;
      changes in all areas of human development the standard walking devices still have their&#xD;
      limitations especially when it comes to stairs. The HAW takes one of the most common and&#xD;
      dependable devices, a conventional walker, and upgrades its functionality to handle stairs&#xD;
      and uneven ground.&#xD;
&#xD;
      A walker consists primarily of a metal frame with four legs which are stabilized by&#xD;
      crossbars. These walker frames come in a variety of shapes and sizes; many consist primarily&#xD;
      of two inverted U-shaped leg modules connected by crossbars. Regardless of the shape or form&#xD;
      of the leg modules, each walker frame forms a 3-sided box with an opening in which the user&#xD;
      may stand (See Figure 1).&#xD;
&#xD;
      The frame often includes two handles located on each side of the user at the upper region of&#xD;
      each inverted U-shaped member. The height is matched to each individual's height by keeping&#xD;
      the handles at the height of their inner wrist (See Figure 1).&#xD;
&#xD;
      Most basic walkers include mechanical means to allow the length of the legs to be increased&#xD;
      or decreased. Push button locking pins that fit into pre-drilled holes in the legs are used&#xD;
      to secure the walkers height to match the person [HO10] using it. The adjustment is also a&#xD;
      time-consuming process requiring significant dexterity, and if a patient is trying to do it&#xD;
      themselves, this can lead to falls or injury.&#xD;
&#xD;
      The US spends over $30 billion on health care-related to falls each year. 1 There are over&#xD;
      1,000,000 hip and knee surgeries performed each year. 1 In the US, the National Institute of&#xD;
      Health (NIH) estimates that there are 6.9 million assistive device users (crutches, canes, or&#xD;
      walker) in the US patient that are over the age of 65. 1 Currently there is an estimated 2&#xD;
      million walker users. It is estimated that of those 2 million, 62% of them have to use a&#xD;
      walker to navigate stairs on a daily basis.1 This means that conservatively 1.24 million&#xD;
      elderly people would benefit from a walker that negotiates stairs optimally. This number of&#xD;
      elderly people will undoubtedly be increasing as the elderly population is estimated to more&#xD;
      than double by the year 2050, reaching an astounding 89,000,000. 1 The HAW is the only known&#xD;
      device that would allow its user the safety of a standard walker as well as protection on&#xD;
      stairs while maintaining or improving their muscle strength, balance and endurance. 1 The HAW&#xD;
      is a based on a conventional walker but has innovative telescoping legs with a leg adjustment&#xD;
      assembly that includes at least one valve and at least one tube that delivers hydraulic fluid&#xD;
      into the legs and allows a user to control the length of each leg. The legs of the walker are&#xD;
      hydraulically adjustable, so that the front legs may be shortened and the back legs extended,&#xD;
      or two side legs shortened and the two opposing side legs extended, so as to allow the walker&#xD;
      to be securely placed on two different steps. This allows the user to be able to stand on a&#xD;
      stair without worrying about sharing the same stair with the device. It also ensures that the&#xD;
      height of the walker continues to be the right height for the user to minimize loss of&#xD;
      balance.&#xD;
&#xD;
      The design has been tested to be able to withstand 300 pounds of force per leg without&#xD;
      failure, so a conservative maximum load would be 600 lbs. Hydraulics were used instead of a&#xD;
      mechanical designed to allow for infinite number of adjustments for varying stair heights. A&#xD;
      standard stair is 8.25 inches tall, but can range from 6 inches up to 9 inches in some homes.&#xD;
      The HAW allows for a wide variety of stairs to be able to be fit with a single adjustment&#xD;
      instead of the multiple adjustments required with a conventional walker or crutch.&#xD;
&#xD;
      Dwaine Philbrook, PT, and Director of Rehab for Coastal Health Care Alliance of Maine,&#xD;
      commented on the HAW: &quot;In 32 years of clinical practice this is one of the most innovative&#xD;
      medical products that I have ever seen. The biggest obstacle for patients returning home from&#xD;
      a hospital stay, that require a walker, is how to negotiate stairs. Many are unable to use&#xD;
      crutches due to balance issues or general weakness. The hydraulic walker will enable those&#xD;
      patients to safely use stairs and enjoy a higher level of functional mobility&quot; (May, 2016&#xD;
      personal communication to author).&#xD;
&#xD;
      It is anticipated that the study should confirm that patients using the HAW on stairs and for&#xD;
      general mobility should improve the patient's satisfaction after the initial injury, improve&#xD;
      their fear of falling again, and give them the confidence and ability to become an active&#xD;
      member in their community earlier than those with a convention walker. Daily logs completed&#xD;
      by the patients should show improved ambulation distances as compared to the control group&#xD;
      which will improve the patients recovery and decrease need for further healthcare costs.&#xD;
&#xD;
      The use of the HAW for patients with an acute hip fracture should improve the patient's&#xD;
      recovery and possibly decrease time spent in the hospital following the injury. The HAW will&#xD;
      reduce the need for costly home repairs while improving a patient's fear of falling on&#xD;
      stairs, improve their community ambulation, decrease medical bills, and lower the need for&#xD;
      assistance from outside people within the home.&#xD;
&#xD;
      Using data that is collected by the study coordinator from the patient themselves, and their&#xD;
      scores on the functional outcome measures in the tables below, the studies aim is to show an&#xD;
      accelerated recovery and return to a prior level of function faster than the control group.&#xD;
      This data along with the patient's testimonials will hopefully show that the HAW can be used&#xD;
      for a wide variety of patients to improve their level of mobility and safety during&#xD;
      ambulation on stairs along with uneven ground.&#xD;
&#xD;
      Conventional walkers are not well suited or functionally intended for use on stairways or&#xD;
      uneven surfaces. The inability of conventional walkers to allow patients to properly balance&#xD;
      on such surfaces limits their usefulness and may introduce significant risk to the user.&#xD;
      There exists a need for a walker that allows its user to have safety, stability, control, and&#xD;
      ease of use for navigating inclined, declined or uneven surfaces. Thus, the Hydraulically&#xD;
      Adjustable Stair Climbing Walker (HAW) was developed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    IRB -- need to reframe study as a feasibility study before it being a RCT.&#xD;
  </why_stopped>
  <start_date type="Anticipated">March 1, 2019</start_date>
  <completion_date type="Anticipated">March 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>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.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants with improved balance using the HAW assessed by Berg Balance Scale</measure>
    <time_frame>24 months</time_frame>
    <description>Berg Balance Scale About: This scale measures balance in older adults. Items: 14&#xD;
Equipment:&#xD;
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.&#xD;
Scoring:&#xD;
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 &lt; 45 indicates a greater risk of falling 41-56 = low fall risk 21-40 = medium fall risk 0 -20 = high fall risk&#xD;
Reference:&#xD;
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&#xD;
Norms:&#xD;
Lusardi, M.M. (2004). Functional Performance in Community Living Older Adults. Journal of Geriatric Physical Therapy, 26(3), 14-22.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants with improved mobility using the HAW assessed by Lower Extremity Functional Scale</measure>
    <time_frame>24 months</time_frame>
    <description>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:&#xD;
0. Extreme difficulty, including inability to perform an activity&#xD;
Quite a bit of difficulty&#xD;
Moderate difficulty&#xD;
A little bit of difficulty&#xD;
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.&#xD;
The LEFS has a margin of error of +/- 5 points, which means that a patient's tabulated score is within 5 points of his &quot;true&quot; score.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with accelerated recovery</measure>
    <time_frame>24 Months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with reduced costs associated with the HAW</measure>
    <time_frame>24 Months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Mobility Limitation</condition>
  <arm_group>
    <arm_group_label>Conventional Walker Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>HAW Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hydraulic Adjustable Walker</intervention_name>
    <description>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.</description>
    <arm_group_label>HAW Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Conventional Walker</intervention_name>
    <description>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.</description>
    <arm_group_label>Conventional Walker Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. 40 consecutive mentally competent patients (as determined by a score of 22 or&#xD;
             higher on the mini mental state exam.) 2. Patients age 65-90 who suffer an acute hip&#xD;
             fracture from a fall and will be assigned to the use of a walker. The patient will be&#xD;
             given and instructed on the use of the Waldo County General Hospital standard walker&#xD;
             or the HAW.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Patients who are deemed cognitively impaired (scores less than 22 on mini mental&#xD;
             state exam).&#xD;
&#xD;
             2. Patients who are unable to lift a walker up onto steps. 3. Patients who have upper&#xD;
             extremity weakness or injury due to fall and unsafe to use a standard walker as&#xD;
             intended.&#xD;
&#xD;
             4. Patient who are shorter than five foot two inches tall or patients six foot three&#xD;
             inches or taller as height limitations are based on prototypes available at this time.&#xD;
&#xD;
        Early withdrawal can be done at any time by a patient for any reason especially if the&#xD;
        patient feels unsafe with the assigned walker or if surgery is indicated for a non-union of&#xD;
        the fracture or failure of the implanted TFN.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Klausmeyer, PT, DPT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Waldo County General Hospital</affiliation>
  </overall_official>
  <link>
    <url>https://3willswalkers.wixsite.com/walker</url>
    <description>Official Website for the &quot;HAW&quot; -- invited and built by one of the investigators of 3 Wills, LLC.</description>
  </link>
  <reference>
    <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</citation>
  </reference>
  <reference>
    <citation>Folstein MF, Folstein SE, McHugh PR. &quot;Mini-mental state&quot;. 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.</citation>
    <PMID>1202204</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>10201543</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>1468055</PMID>
  </reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>September 22, 2021</last_update_submitted>
  <last_update_submitted_qc>September 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>MaineHealth</investigator_affiliation>
    <investigator_full_name>Peter Klausmeyer</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mobility Limitation</mesh_term>
    <mesh_term>Hip Fractures</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03829163
org study id: klausmeyerHAW
nct id: NCT03829163
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.

      The design has been tested to be able to withstand 300 pounds of force per leg without
      failure, so a conservative maximum load would be 600 lbs. Hydraulics were used instead of a
      mechanical designed to allow for infinite number of adjustments for varying stair heights. A
      standard stair is 8.25 inches tall, but can range from 6 inches up to 9 inches in some homes.
      The HAW allows for a wide variety of stairs to be able to be fit with a single adjustment
      instead of the multiple adjustments required with a conventional walker or crutch.

      Dwaine Philbrook, PT, and Director of Rehab for Coastal Health Care Alliance of Maine,
      commented on the HAW: "In 32 years of clinical practice this is one of the most innovative
      medical products that I have ever seen. The biggest obstacle for patients returning home from
      a hospital stay, that require a walker, is how to negotiate stairs. Many are unable to use
      crutches due to balance issues or general weakness. The hydraulic walker will enable those
      patients to safely use stairs and enjoy a higher level of functional mobility" (May, 2016
      personal communication to author).

      It is anticipated that the study should confirm that patients using the HAW on stairs and for
      general mobility should improve the patient's satisfaction after the initial injury, improve
      their fear of falling again, and give them the confidence and ability to become an active
      member in their community earlier than those with a convention walker. Daily logs completed
      by the patients should show improved ambulation distances as compared to the control group
      which will improve the patients recovery and decrease need for further healthcare costs.

      The use of the HAW for patients with an acute hip fracture should improve the patient's
      recovery and possibly decrease time spent in the hospital following the injury. 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.

      Using data that is collected by the study coordinator from the patient themselves, and their
      scores on the functional outcome measures in the tables below, the studies aim is to show an
      accelerated recovery and return to a prior level of function faster than the control group.
      This data along with the patient's 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 along with uneven ground.

      Conventional walkers are not well suited or functionally intended for use on stairways or
      uneven surfaces. The inability of conventional walkers to allow patients to properly balance
      on such surfaces limits their usefulness and may introduce significant risk to the user.
      There exists a need for a walker that allows its user to have safety, stability, control, and
      ease of use for navigating inclined, declined or uneven surfaces. Thus, the Hydraulically
      Adjustable Stair Climbing Walker (HAW) was developed.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 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.
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants with improved balance using the HAW assessed by Berg Balance Scale
time frame: 24 months
description: 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.
measure: Number of Participants with improved mobility using the HAW assessed by Lower Extremity Functional Scale
time frame: 24 months
description: 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.
measure: Number of participants with accelerated recovery
time frame: 24 Months
description: 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.
measure: Number of participants with reduced costs associated with the HAW
time frame: 24 Months
description: 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.
arm group label: Conventional Walker Group
arm group type: Active Comparator
arm group label: HAW Group
arm group type: Experimental
intervention type: Device
intervention name: Hydraulic Adjustable Walker
description: 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.
arm group label: HAW Group
intervention type: Device
intervention name: Conventional Walker
description: 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.
arm group label: Conventional Walker Group
criteria: 
gender: All
minimum age: 65 Years
maximum age: 90 Years
healthy volunteers: No
last name: Peter Klausmeyer, PT, DPT
role: Principal Investigator
affiliation: Waldo County General Hospital
url: https://3willswalkers.wixsite.com/walker
description: Official Website for the "HAW" -- invited and built by one of the investigators of 3 Wills, LLC.
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
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. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
PMID: 1202204
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.
PMID: 10201543
citation: 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
responsible party type: Principal Investigator
investigator affiliation: MaineHealth
investigator full name: Peter Klausmeyer
investigator title: Principal Investigator
mesh term: Mobility Limitation
mesh term: Hip Fractures
sharing ipd: No