Clinical trial NCT06252597: Pressure Relief Education and Training for Wheelchair Users
Official title: Education and Training for Wheelchair Users and Caregivers for Pressure Relief Performance and Barrier Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Area
Keywords: wheelchair users
complex power wheelchairs
progressive disorders
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Clients with neuro-progressive disorders (ALS, multiple sclerosis, Parkinson's, muscular dystrophies, and spinal muscular atrophy) who also use complex power wheelchairs.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Likert Pain Scale Scores
timeFrame: Baseline
measure: Likert Pain Scale Scores
timeFrame: Week 4
measure: Standard Staging for any Pressure Injuries
timeFrame: Baseline
measure: Standard Staging for any Pressure Injuries
timeFrame: Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolinas Neuromuscular ALS/MDA Center
state: North Carolina
Study officials:
affiliation: Carolinas Neuromuscular ALS/MDA Center
name: Amber L Ward, MS, OTR/L
role: PRINCIPAL_INVESTIGATOR
References: