Pressure Relief Education and Training for Wheelchair Users

Pressure Area Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06252597
• Other study ID #: IRB00107536
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: December 2027

Study information

• Verified date: December 2023
• Source: Wake Forest University Health Sciences
• Contact: Clara L Schommer
• Phone: 336 716-1195
• Email: cschomme[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pressure Area

Intervention

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

Locations

Country	Name	City	State
United States	Carolinas Neuromuscular ALS/MDA Center	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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