Patient Handling Techniques and New Technology for Health Care Workers

NCT06285786 | Unknown

• 1 other identifier: REB 2023-109
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Patient handling is a major risk-factor for the development of musculoskeletal injuries in healthcare providers. To have a significant impact on injury reduction related to patient handling will require the incorporation of technology. This project is to investigate a piece of technology that has been designed to facilitate in-bed patient handling: The Vendlet. The purpose of this research project is to assess the ability of the Vendlet system outfitted on a Span-America Medical Systems (SAMS) bed to reduce the physical load on healthcare providers performing patient handling tasks. This evidence-based outcomes will be used to support the mitigation of the Vendlet from the European market into the Canadian market. The SAMS bed is currently available in North America and has several adjustable features to support patient transfer activities. The project will provide a biomechanical comparison of commonly used patient handling techniques performed using a SAMS bed outfitted with and without a Vendlet patient transfer device. This Vendlet technology has the potential to significantly reduce the musculoskeletal and joint strain of healthcare providers while handling patients.

Conditions

Work-related Injury

Keywords

Patient Handling; Injury Prevention; Technology; Intervention; Training

Outcome Measures

Primary Outcomes (9)

• Neuromuscular Activity - Average muscle activation

  Eight bilateral muscles will be examined: anterior deltoid \[AD\], trapezius descendens \[TD\], biceps brachii \[BB\], thoracic erector spinae \[TES\] located at the level of the T9 spinous process, lumbar erector spinae \[LES\] located at the level of the L3 spinous process, external oblique \[EO\], rectus femoris \[RF\], and biceps femoris \[BF\]. The raw EMG signal will be rectified, and Butterworth low passed filtered (RMS converted) using MATLAB. Peak activity will be found for each muscle during the maximum voluntary contraction (MVC) trials and used to normalize all subsequent EMG data. Therefore, the EMG data will represent a percent change from the participants' MVCs for each muscle, during each patient handling trial. An analysis of the neuromuscular activation changes (%MVC) will be compared during each patient handling technique between 1- SAMS bed (with the Vendlet) vs the SAMS bed (without the Vendlet), and 2- Pre vs Post Intervention.

  Pre-Intervention and Post-intervention (within 2 weeks after intervention)

• Neuromuscular Activity - Peak muscle activation

  Eight bilateral muscles will be examined: anterior deltoid \[AD\], trapezius descendens \[TD\], biceps brachii \[BB\], thoracic erector spinae \[TES\] located at the level of the T9 spinous process, lumbar erector spinae \[LES\] located at the level of the L3 spinous process, external oblique \[EO\], rectus femoris \[RF\], and biceps femoris \[BF\]. The raw EMG signal will be rectified, and Butterworth low passed filtered (RMS converted) using MATLAB. Peak activity will be found for each muscle during the maximum voluntary contraction (MVC) trials and used to normalize all subsequent EMG data. Therefore, the EMG data will represent a percent change from the participants' MVCs for each muscle, during each patient handling trial. An analysis of the neuromuscular activation changes (%MVC) will be compared during each patient handling technique between 1- SAMS bed (with the Vendlet) vs the SAMS bed (without the Vendlet), and 2- Pre vs Post Intervention.

  Pre-Intervention and Post-intervention (within 2 weeks after intervention)

• Motion Capture: To assess postural changes in patient handling technique.

  Kinematic coordinates of markers will be gap filled (spline smoothing algorithm) and then filtered using a 2nd order Butterworth low pass filter (cut off frequency of 10Hz). Visual 3D, C-motion software will be used to filter raw kinematic data as well as calculate specific joint angles. 3D movement (flexion/extension, lateral bend, and twist) of the neck, both arms, pelvis, trunk-pelvis, hips, knees, and trunk-thigh will be used in Visual 3D to calculate three-axis joint angles. Visual 3D software will be used to calculate kinematic and kinetic values. The kinematics (joint angles) and kinetics (inverse dynamics) will be compared for each patient handling technique between 1- SAMS bed (with the Vendlet) vs the SAMS bed (without the Vendlet), and 2- Pre vs Post Intervention.

  Pre-Intervention and Post-intervention (within 2 weeks after intervention)

• Motion Capture: To assess cumulative load forces

  Kinematic coordinates of markers will be gap filled (spline smoothing algorithm) and then filtered using a 2nd order Butterworth low pass filter (cut off frequency of 10Hz). Visual 3D, C-motion software will be used to filter raw kinematic data as well as calculate specific joint angles. 3D movement (flexion/extension, lateral bend, and twist) of the neck, both arms, pelvis, trunk-pelvis, hips, knees, and trunk-thigh will be used in Visual 3D to calculate three-axis joint angles. Visual 3D software will be used to calculate kinematic and kinetic values. Visual 3D will also be used to calculate the inverse dynamics of the participants; calculating kinetics will help us determine the force and cumulative load demands of the participant while they handle a patient. The kinematics (joint angles) and kinetics (inverse dynamics) will be compared for each patient handling technique between 1- SAMS bed (with the Vendlet) vs the SAMS bed (without the Vendlet), and 2- Pre vs Post Intervention.

  Pre-Intervention and Post-intervention (within 2 weeks after intervention)

• Motion Capture: To assess joint angles

  Kinematic coordinates of markers will be gap filled (spline smoothing algorithm) and then filtered using a 2nd order Butterworth low pass filter (cut off frequency of 10Hz). Visual 3D, C-motion software will be used to filter raw kinematic data as well as calculate specific joint angles. 3D movement (flexion/extension, lateral bend, and twist) of the neck, both arms, pelvis, trunk-pelvis, hips, knees, and trunk-thigh will be used in Visual 3D to calculate three-axis joint angles. Visual 3D software will be used to calculate kinematic and kinetic values. The kinematics (joint angles) and kinetics (inverse dynamics) will be compared for each patient handling technique between 1- SAMS bed (with the Vendlet) vs the SAMS bed (without the Vendlet), and 2- Pre vs Post Intervention.

  Pre-Intervention and Post-intervention (within 2 weeks after intervention)

• Foot Pressure Distribution: Peak pressure will be the outcome measure of interest to assess postural balance and stability of the participant performing the patient handling technique.

  The Xsensor FOOT and GAIT software (Xsensor, Calgary, AB, Canada) will be used to measure the peak pressure in each section of the patient's sole and plantar contact area during each patient handling techniques. To study the pressure variations in greater detail, the foot data will be subdivided into the following : 1- the toe (T); 2- the metatarsals (M) separated into three parts (metatarsal 1: M1, metatarsal 2\&3: M2, metatarsal 4\&5: M3); 3- the midfoot (MF); and 4- the heel (H) separated into two parts (medial heel: MH, and lateral heel: LH) . Peak pressure values will also be assessed for each section of the foot during each patient handling techniques. The foot pressure distribution outcomes will be compared between each patient handling technique between 1- SAMS bed (with the Vendlet) vs the SAMS bed (without the Vendlet), and 2- Pre vs Post Intervention.

  Post-intervention (within 2 weeks after intervention)

• Foot Pressure Distribution: Contact area will be the outcome measure of interest to assess postural balance and stability of the participant performing the patient handling technique.

  The Xsensor FOOT and GAIT software (Xsensor, Calgary, AB, Canada) will be used to measure the peak pressure in each section of the patient's sole and plantar contact area during each patient handling techniques. To study the pressure variations in greater detail, the foot data will be subdivided into the following : 1- the toe (T); 2- the metatarsals (M) separated into three parts (metatarsal 1: M1, metatarsal 2\&3: M2, metatarsal 4\&5: M3); 3- the midfoot (MF); and 4- the heel (H) separated into two parts (medial heel: MH, and lateral heel: LH). Peak pressure values will also be assessed for each section of the foot during each patient handling techniques. The foot pressure distribution outcomes will be compared between each patient handling technique between 1- SAMS bed (with the Vendlet) vs the SAMS bed (without the Vendlet), and 2- Pre vs Post Intervention.

  Post-intervention (within 2 weeks after intervention)

• Bed Pressure Distribution: Average pressure distribution will be outcome measures to assess the safe placement of the patient.

  Bed Pressure Distribution will be considered in four body regions at two-time points on both beds. The body regions include the right and left regions of the back (including the shoulders and upper back) and the right and left areas of the pelvis (hips). These regions will be compared at two separate time points: the initial participant position (lying supine prior to any patient handling technique) and the final participant position (once the patient handling technique is completed). At each timepoint, pressure-related outcome measures will be computed for each task. Contact area (in2), average pressure on contact area (mmHg), and peak pressure will be among the outcome measures (mmHg). The bed pressure distribution outcomes will be compared between each patient handling technique between 1- SAMS bed (with the Vendlet) vs the SAMS bed (without the Vendlet), and 2- Pre vs Post Intervention.

  Pre-Intervention and Post-intervention (within 2 weeks after intervention)

• Bed Pressure Distribution: Peak pressure distribution will be outcome measures to assess the safe placement of the patient.

  Bed Pressure Distribution will be considered in four body regions at two-time points on both beds. The body regions include the right and left regions of the back (including the shoulders and upper back) and the right and left areas of the pelvis (hips). These regions will be compared at two separate time points: the initial participant position (lying supine prior to any patient handling technique) and the final participant position (once the patient handling technique is completed). At each timepoint, pressure-related outcome measures will be computed for each task. Contact area (in2), average pressure on contact area (mmHg), and peak pressure will be among the outcome measures (mmHg). The bed pressure distribution outcomes will be compared between each patient handling technique between 1- SAMS bed (with the Vendlet) vs the SAMS bed (without the Vendlet), and 2- Pre vs Post Intervention.

  Pre-Intervention and Post-intervention (within 2 weeks after intervention)

Secondary Outcomes (3)

• Self Reported Questionnaires

  Pre-Intervention and Post-intervention (within 2 weeks after intervention)

• Exit Survey

  Pre-Intervention and Post-intervention (within 2 weeks after intervention)

• Rating of Perceived Exertion (RPE)

  Pre-Intervention and Post-intervention (within 2 weeks after intervention)

Study Arms (1)

Nursing Student

EXPERIMENTAL

The study involves 1 single arm. A single group of participants will experience all experimental conditions. From an ergonomic standpoint, it has been recognized that providing patient-handling ergonomics training is crucial to their safety. This project will compare the same group performing patient handling tasks without training versus training while utilizing both long term care beds.

Other: Ergonomic Training on Patient Handling Techniques

Interventions

Ergonomic Training on Patient Handling Techniques OTHER

Each participant will receive an ergonomic training on proper patient handling technique, adhering to the appropriate program to use with the SAMS bed and the Vendlet between session 1 \& 2. In small groups of 6-10 participants, a healthcare ergonomist (M. Leger) will be responsible to demonstrate, instruct and evaluate each participant on all 4 techniques on the SAMS bed. Each participant will have multiple opportunities to demonstrate their skills. In the same session, each participant will also receive proper training from a specialized occupational therapist on how to use the Vendlet. Each participant will have multiple opportunities to demonstrate their skills. After completing the intervention, each participant will be prepared to participate in the post-intervention data collection session in the laboratory.

Nursing Student

Eligibility Criteria

• Age: 17 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- One-month history of no pain or injury in the low back or shoulder region.

You may not qualify if:

• \- Participant received a training on proper patient handling techniques.

Sponsors & Collaborators

• University of New Brunswick: lead

Study Sites (1)

Universite de Moncton

Moncton, New Brunswick, E1A 3E9, Canada

RECRUITING

Related Publications (2)

• Jiang Y, Wang D, Ying J, Chu P, Qian Y, Chen W. Design and Preliminary Validation of Individual Customized Insole for Adults with Flexible Flatfeet Based on the Plantar Pressure Redistribution. Sensors (Basel). 2021 Mar 4;21(5):1780. doi: 10.3390/s21051780.

  PMID: 33806449 BACKGROUND

• Budarick AR, Moore C, Fischer SL. Evaluating patient turn effectiveness using turn-assist technologies. J Med Eng Technol. 2020 Jan;44(1):1-11. doi: 10.1080/03091902.2019.1707889. Epub 2020 Jan 15.

  PMID: 31939691 BACKGROUND

Study Officials

• Dr. Wayne J Albert, PhD., Doctorate

  University of New Brunswick

  PRINCIPAL INVESTIGATOR

• Dre. Michelle Cardoso, PhD, Doctorate

  Universite de Moncton

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle C Leger, PhD Candidate ABD, Master's

CONTACT

506-543-0804; michelle.leger@unb.ca

Dre. Michelle Cardoso, PhD, Doctorate

CONTACT

506-470-3979; michelle.cardoso@umoncton.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants will be masked of the proper technique/training during the pre-intervention session (with and without the use of technology). Specifically, on how to manually move the patient in both beds.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One single group of participants will be performing the same patient handling tasks: 1. During session 1 (Pre-Intervention) participants will not receive any instruction on how to perform the patient handling techniques on both beds. 2. During session 2 (Post-Intervention) participants will be asked to perform the patient handling techniques as seen during the intervention on both beds.

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: February 29, 2024
• Study Start: September 20, 2023
• Primary Completion: March 15, 2024
• Study Completion: April 20, 2024
• Last Updated: February 29, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)