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A Novel Walking Cane With Haptic Biofeedback Reduces Degenerative Loading in the Arthritic Knee

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Haptic cane
typical cane
Sponsored by
VA Puget Sound Health Care System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Knee Osteoarthritis focused on measuring Knee Osteoarthritis, Knee adduction moment, Knee loading, Walking cane

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • • Radiographic evidence of tibiofemoral knee OA

    • Between 35-80 years
    • Stand and/or walk for at least 30 minutes without difficulty
    • Have a VA medical record

Exclusion Criteria:

  • • Knee joint replacement (<1 year)

    • Lateral OA greater than medial OA
    • Inadequate cognitive or language function to consent or participate
    • BMI > 40
    • pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    No Intervention

    Active Comparator

    Active Comparator

    Experimental

    Experimental

    Arm Label

    Naïve

    Scale training

    Scale recall

    Haptics training

    Haptics recall

    Arm Description

    Conventional cane with no instruction given

    Conventional cane, scale training, and instruction on proper cane use

    Conventional cane with no further instruction or practice given

    Haptic biofeedback cane with explanation and training.

    Haptic biofeedback cane with no further instruction or practice given.

    Outcomes

    Primary Outcome Measures

    Knee adduction moment (KAM) (percent body weight x height)
    Calculated during stance phase of each step using inverse kinematics then normalized to body weight and height.
    Peak knee adduction moment (PKAM) (percent body weight x height)
    calculated as highest KAM
    Knee adduction angular impulse (KAAI) (percent body weight x height x seconds)
    calculated as the area under the KAM curve.
    Cane loading (percent body weight)
    normalized by weight and peak cane load per step

    Secondary Outcome Measures

    Full Information

    First Posted
    March 18, 2019
    Last Updated
    April 2, 2019
    Sponsor
    VA Puget Sound Health Care System
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03900052
    Brief Title
    A Novel Walking Cane With Haptic Biofeedback Reduces Degenerative Loading in the Arthritic Knee
    Official Title
    The Effects of a Novel Walking Cane With Haptic Biofeedback on Degenerative Loading in the Arthritic Knee
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    June 25, 2015 (Actual)
    Primary Completion Date
    July 10, 2017 (Actual)
    Study Completion Date
    July 10, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    VA Puget Sound Health Care System

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The most commonly prescribed mobility aid, the walking cane, is often underloaded and therefore fails to reduce knee joint loading and provide symptomatic relief for those with knee osteoarthritis. For this study, a novel walking cane with haptic biofeedback was designed to improve cane loading. The purpose of this study was twofold; 1) to determine the effectiveness of a novel walking haptic biofeedback cane to encourage proper cane loading compared with a conventional cane, and 2) to determine whether scale training or haptic feedback influences short term retention of cane loading. It is hypothesized that haptic biofeedback would increase cane loading (H1) and decrease knee loading (peak knee adduction moment (H2) and knee adduction angular impulse (H3)) when compared to naïve cane use.
    Detailed Description
    Up to 40 individuals who have experience using a walking cane and who self-report a clinical diagnosis of knee OA can participate in this study. Participants will be excluded if they had a knee replacement in the knee diagnosed with OA, had undergone knee surgery within the past year, could not perform cane walking continuously for 30 minutes, or exhibited other neurological and/or rheumatologic conditions that would impact gait. Participant biometrics, such as height, weight, and age will be collected in addition to information about OA and cane use history. Participants will complete the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire, from which scores between 0 and 96 can be used to evaluate the impact of knee OA on the individual's quality of life. A haptic biofeedback cane was designed and manufactured to measure the user applied axial cane load, compare the load to the targeted 20% BW threshold, and then deliver a vibrotactile feedback in the cane handle when the loading was greater than threshold. The cane data acquisition was temporally synchronized to the motion analysis system and recorded axial cane loads at 100 Hz for later analysis. The haptic biofeedback cane consisted of a conventional bariatric walking cane (Patterson Medical Ltd) with a loadcell (Digi-Key100 LBS. Load Cell) placed inside a 3D printed modular cane foot. A microcontroller (Sparkfun™ Pro Micro), SD disk storage (Sparkfun™ OpenLog), eccentric rotating mass vibration motor (model 306-109, Precision Microdrives Limited), USB communications port, and battery completed the system. Each participant will attend a single laboratory data collection session for the acquisition of kinematic, kinetic, and biometric data. First, the participant will be asked to walk 20 m down a hallway with a conventional cane to establish a self-selected walking speed (SSWS). Participants will then change into motion capture conducive clothing and retro-reflective markers were placed using a modified Plug-In-Gait model with additional markers on the foot, thigh, and shank, via the Kadaba Model, for observation of the Kenn Adduction Moment (KAM) during level ground walking. Markers will also placed on the cane to track its motion. Participants will then be instructed to walk at their SSWS along an approximately 9-meter walkway containing five force-plates but will remain naïve as to the purpose of the plates throughout data collection, to avoid influencing gait. Data were collected under each of the following five conditions: 1) naïve, 2) scale training, 3) scale recall, 4) haptics training, and 5) haptics-only (Table 2). The order of the scale and haptics conditions was randomized at the beginning of data collection to avoid a learning bias. During all conditions the instrumented cane will be used, and axial loading recoded. However, haptic biofeedback from the cane will only be provided in the haptic conditions. For scale and haptic conditions, the participants will be instructed to hold the cane in the hand opposite their most affected knee. Before the recall and haptics-only conditions, a five-minute break will be given to test short-term instruction retention. For each condition, between five and eight successful steps will be collected. A successful walk trial is defined as at least one gait cycle with the affected limb's foot cleanly striking the force plate and the cane contacting the floor, not the force plate, during stance phase. Successful trials will also have to be within ± 10% of the subjects SSWS. Naïve condition Participants will be instructed to "walk across the lab and use the cane as is typical." During these trials the cane will record axial load but provided no biofeedback (i.e. the cane will act as a conventional cane). Scale conditions During scale training, participants will practice applying 20% BW to their canes while standing, using a beam scale set to the correct weight, until they feel comfortable recreating the technique. Participants then practice applying the 20% BW to their canes while walking, no external feedback regarding the load applied to the cane will be provided, however feedback on cane technique will be. Data will be collected during these walking trials. In the scale recall trials participants are to load the cane to 20% during walking without any feedback from a scale or the cane. Haptic conditions During haptic training, participants will be instructed to walk around the lab and load the cane during each step until they feel a vibration in the handle. The participants will then familiarize themselves with the biofeedback mechanism and practice loading the haptic cane while walking around the lab space. In the haptic-only trails participants will be instructed to load the cane during walking until they feel a vibration in the handle Three-dimensional kinematics will be collected using a camera 12 Vicon Nexus system (Vicon Motion Systems, Oxford, United Kingdom) with a sampling frequency of 120 Hz. Five force plates (AMTI) sampling at 1200 Hz were used for collection of ground reaction forces (GRFs) and identification of gait events during walking trials. Two time gates placed 2 meters apart will measure walking speed. The KAM will be calculated for the arthritic knee during stance phase of each processed step using the inverse kinematics packages in Visual 3D then normalized to body weight and height. KAMs will then be exported to MATLAB for further processing and analysis. Cane load will be normalized by weight and peak cane load per step will be determined in MATLAB. PKAM is calculated as highest KAM and KAAI is calculated as the area under the KAM curve.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Osteoarthritis
    Keywords
    Knee Osteoarthritis, Knee adduction moment, Knee loading, Walking cane

    7. Study Design

    Primary Purpose
    Device Feasibility
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    1: Naïve - Conventional cane with no instruction given. 2A: Scale training - Conventional cane, scale training, and instruction on proper cane use. 2B: Scale recall - Conventional cane with no further instruction or practice given 3A: Haptics training - Haptic biofeedback cane with explanation and training. 3B: Haptics recall - Haptic biofeedback cane with no further instruction or practice given.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    21 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Naïve
    Arm Type
    No Intervention
    Arm Description
    Conventional cane with no instruction given
    Arm Title
    Scale training
    Arm Type
    Active Comparator
    Arm Description
    Conventional cane, scale training, and instruction on proper cane use
    Arm Title
    Scale recall
    Arm Type
    Active Comparator
    Arm Description
    Conventional cane with no further instruction or practice given
    Arm Title
    Haptics training
    Arm Type
    Experimental
    Arm Description
    Haptic biofeedback cane with explanation and training.
    Arm Title
    Haptics recall
    Arm Type
    Experimental
    Arm Description
    Haptic biofeedback cane with no further instruction or practice given.
    Intervention Type
    Device
    Intervention Name(s)
    Haptic cane
    Intervention Description
    • A haptic biofeedback cane was designed and manufactured to measure the user applied axial cane load, compare the load to the targeted 20% BW threshold, and then deliver a vibrotactile feedback in the cane handle when the loading was greater than threshold. The cane data acquisition was temporally synchronized to the motion analysis system and recorded axial cane loads at 100 Hz for later analysis. The haptic biofeedback cane consisted of a conventional bariatric walking cane (Patterson Medical Ltd) with a loadcell (Digi-Key100 LBS. Load Cell) placed inside a 3D printed modular cane foot. A microcontroller (Sparkfun™ Pro Micro), SD disk storage (Sparkfun™ OpenLog), eccentric rotating mass vibration motor (model 306-109, Precision Microdrives Limited), USB communications port, and battery completed the system.
    Intervention Type
    Device
    Intervention Name(s)
    typical cane
    Intervention Description
    Typical training cane loading training
    Primary Outcome Measure Information:
    Title
    Knee adduction moment (KAM) (percent body weight x height)
    Description
    Calculated during stance phase of each step using inverse kinematics then normalized to body weight and height.
    Time Frame
    5 minutes
    Title
    Peak knee adduction moment (PKAM) (percent body weight x height)
    Description
    calculated as highest KAM
    Time Frame
    5 minutes
    Title
    Knee adduction angular impulse (KAAI) (percent body weight x height x seconds)
    Description
    calculated as the area under the KAM curve.
    Time Frame
    5 minutes
    Title
    Cane loading (percent body weight)
    Description
    normalized by weight and peak cane load per step
    Time Frame
    5 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: • Radiographic evidence of tibiofemoral knee OA Between 35-80 years Stand and/or walk for at least 30 minutes without difficulty Have a VA medical record Exclusion Criteria: • Knee joint replacement (<1 year) Lateral OA greater than medial OA Inadequate cognitive or language function to consent or participate BMI > 40 pregnancy

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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