Pressure Relief Education and Training for Wheelchair Users

Education and Training for Wheelchair Users and Caregivers for Pressure Relief Performance and Barrier Management

There can be barriers for clients with progressive disorders who are power wheelchair users and their caregivers that prohibit them from performing pressure relief. Clients may struggle with consistent performance of pressure relief and may not recall the importance, have methods to perform, or be able to perform due to weakness or other disease changes.

Study Overview

• Status: Recruiting
• Conditions: Pressure Area
• Intervention / Treatment: Behavioral: education and training

Detailed Description

Study the population of power wheelchair users with progressive disorders at the Neurology Specialty Care - Edgehill, Carolina Neuromuscular Amyotrophic Lateral Sclerosis (ALS)/ Muscular Dystrophy Association (MDA) Center to identify barriers, provide potential solutions, and provide education and training to both increase knowledge and understanding of pressure relief options and processes as well as to overcome these perceived barriers amongst the clinic population. Current adults of the Neurology Specialty Care practice who are complex power wheelchair users will be eligible for this project as an extension of usual care.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clara L Schommer; Phone Number: 336 716-1195; Email: cschomme@wakehealth.edu

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Recruiting
      • Carolinas Neuromuscular ALS/MDA Center
      • Contact: Clara L Schommer; Phone Number: 336-716-1195; Email: cschomme@wakehealth.edu
      • Principal Investigator: Amber L Ward, MS, OTR/L

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult 18 years or older
• Diagnosis of a progressive disorder (amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), muscular dystrophy (MD), spinal muscular atrophy (SMA), Parkinson disease (PD)
• Current clinic client at the Neurology Specialty Care -Edgehill clinic
• Currently using a complex (group 3) power wheelchair with power positioning of at least tilt/recline
• Currently sitting in the chair at least 2 consecutive hours/day

Exclusion Criteria:

• Dementia as noted by Medical Doctor / speech-language pathologists (SLP) /SW in medical records
• Inability/unwillingness to control wheelchair power features (client)
• Unwillingness to be monitored, educated, trained by study staff
• Uses other mobility devices indoors (scooter, basic power wheelchair) more than complex power wheelchair
• Further exclusions may be added in future protocol versions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: education and training; After implementation of the pre-interview and determination/performance of necessity, education and training at a regularly scheduled occupational therapy clinic visit will be performed with handouts, verbal education, hands-on training, and video training.	Behavioral: education and training; education and training at a regularly scheduled occupational therapy clinic visit will be performed with handouts, verbal education, hands-on training, and video training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Likert Pain Scale Scores	0: Relaxed and comfortable. 1 to 3: Mild discomfort. 4 to 6: Moderate pain. 7 to 10: Severe discomfort/pain - higher scores equaling more discomfort/pain	Baseline
Likert Pain Scale Scores	0: Relaxed and comfortable. 1 to 3: Mild discomfort. 4 to 6: Moderate pain. 7 to 10: Severe discomfort/pain - higher scores equaling more discomfort/pain	Week 4
Standard Staging for any Pressure Injuries	Stage 1 pressure injuries are not open wounds Stage 2 pressure injuries are open wounds Stage 3 pressure injuries extend through the skin into deeper tissue and fat but do not reach muscle, tendon, or bone Stage 4 pressure injuries extend to muscle, tendon, or bone Higher scores equaling worse condition	Baseline
Standard Staging for any Pressure Injuries	Stage 1 pressure injuries are not open wounds Stage 2 pressure injuries are open wounds Stage 3 pressure injuries extend through the skin into deeper tissue and fat but do not reach muscle, tendon, or bone Stage 4 pressure injuries extend to muscle, tendon, or bone Higher scores equaling worse condition	Week 4

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Amber L Ward, MS, OTR/L, Carolinas Neuromuscular ALS/MDA Center

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: February 1, 2024
• First Submitted That Met QC Criteria: February 1, 2024
• First Posted (Actual): February 9, 2024

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: wheelchair users; complex power wheelchairs; progressive disorders
• Other Study ID Numbers: IRB00107536

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No