Pressure AreaNCT06252597
Pressure Relief Education and Training for Wheelchair Users
A study testing education and training in people with Pressure Area, run by Wake Forest University Health Sciences at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Area
- What is being tested?
- education and training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2024to 15 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolinas Neuromuscular ALS/MDA Center
Charlotte, North Carolina, 28207
About this study
Official title: 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.
Read the 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.
- Conditions
- Pressure Area
- Being tested
- education and training
- Keywords
- wheelchair users, complex power wheelchairs, progressive disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
education and trainingBehavioural
education and training at a regularly scheduled occupational therapy clinic visit will be performed with handouts, verbal education, hands-on training, and video training
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: education and training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start1 Feb 2024
- Primary completion12 Apr 2024
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure AreaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Clients with neuro-progressive disorders (ALS, multiple sclerosis, Parkinson's, muscular dystrophies, and spinal muscular atrophy) who also use complex power wheelchairs.
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amber L Ward, MS, OTR/L, Principal investigator, Carolinas Neuromuscular ALS/MDA Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06252597
- Sponsor's protocol ID
- IRB00107536
- Status last verified
- Nov 2024
- First submitted
- 1 Feb 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Education and Training for Wheelchair Users and Caregivers for Pressure Relief Performance and Barrier Management
- ClinicalTrials.gov ID
- NCT06252597
- Acronym / sponsor ID
- IRB00107536
- Conditions
- Pressure Area
- Keywords
- wheelchair users, complex power wheelchairs, progressive disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 12 Apr 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Clients with neuro-progressive disorders (ALS, multiple sclerosis, Parkinson's, muscular dystrophies, and spinal muscular atrophy) who also use complex power wheelchairs.
| Arm | Type | Receives |
|---|---|---|
| education and training | Experimental | Behavioral: education and trainingAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| education and trainingeducation and training at a regularly scheduled occupational therapy clinic visit will be performed with handouts, verbal education, hands-on training, and video training | Behavioural | education and training |
Primary outcome
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amber L Ward, MS, OTR/L principal investigator
Carolinas Neuromuscular ALS/MDA Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing education and training in people with Pressure Area, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Likert Pain Scale Scores (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2025.