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Completed

NCT Number: NCT06252597

Pressure Relief Education and Training for Wheelchair Users

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.

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Key information

Conditions

Pressure Area

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carolinas Neuromuscular ALS/MDA Center

Charlotte, North Carolina, 28207, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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) 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

Treatment and study plan

Education and Training

Behavioral

education and training at a regularly scheduled occupational therapy clinic visit will be performed with handouts, verbal education, hands-on training, and video training

Primary outcomes

  1. Likert Pain Scale Scores

    Time frame: Baseline

    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

  2. Likert Pain Scale Scores

    Time frame: Week 4

    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

  3. Standard Staging for any Pressure Injuries

    Time frame: Baseline

    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

  4. Standard Staging for any Pressure Injuries

    Time frame: Week 4

    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

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 9, 2024
Registry last updated
Jan 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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