Pressure Relief Education and Training for Wheelchair Users

NCT06252597 | Completed

• 1 other identifier: IRB00107536
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Pressure Area

Keywords

wheelchair users; complex power wheelchairs; progressive disorders

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

education and training

EXPERIMENTAL

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

Interventions

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

education and training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Carolinas Neuromuscular ALS/MDA Center

Charlotte, North Carolina, 28207, United States

Location

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Amber L Ward, MS, OTR/L

  Carolinas Neuromuscular ALS/MDA Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Clients with neuro-progressive disorders (ALS, multiple sclerosis, Parkinson's, muscular dystrophies, and spinal muscular atrophy) who also use complex power wheelchairs.

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 9, 2024
• Study Start: February 1, 2024
• Primary Completion: April 12, 2024
• Study Completion: November 15, 2024
• Last Updated: January 1, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)