Spinal Cord InjuriesNCT04266808
Interactive Telehealth for Wheelchair Users
A study testing An interactive telehealth monitoring and biofeedback system in people with Spinal Cord Injuries and Paraplegia, run by Rancho Research Institute, Inc. at 1 site in United States.
Trial summary
During typical daily activity, people with established spinal cord injury perform significantly fewer pressure-relief maneuvers than the recommended frequency while overestimating their adherence on recall surveys of pressure relief activity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Paraplegia, Pressure Ulcer, Buttock
- What is being tested?
- An interactive telehealth monitoring and biofeedback system
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2020to Jan 2022
- 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
- paraplegia from Spinal Cord Injury
- a history of pressure ulcer that has healed or 6 months post surgical repair
- use a manual wheelchair for mobility
- able to perform pressure relief maneuvers independently
Who cannot join
- unable/unwilling to return to clinic for follow-up visits
Trial locations and contacts
1 site in 1 country.
United States1 site
Rancho Los Amigos National Rehabilitaiton Center
Downey, California, 90242
Sara Mulroy, PT, DPT, 562-385-7177, smulroy@dhs.lacounty.gov
Sara J Mulroy, PhD, PT
About this study
Official title: Interactive Telehealth and Auto-Biofeedback Sensor System for Individuals Who Use a Wheelchair: Phase II
During typical daily activity, people with established spinal cord injury perform significantly fewer pressure-relief maneuvers than the recommended frequency while overestimating their adherence on recall surveys of pressure relief activity. The rate of pressure ulcer recurrence in individuals with a prior ulcer is 44% in those with surgical repair and as high as 75% in those with non-surgical healing indicating that increased attention to pressure relief is critical for these individuals.This study will evaluate the efficacy of a wheelchair sensor and app-based biofeedback for establishing healthy self-management behaviors (pressure relief maneuvers and daily physical activity). Investigators will enroll 50 participants with paraplegia from spinal cord injury who use a manual wheelchair for mobility and have a history of pressure ulcer that has healed or is six months post-surgical repair. Participants will be randomized into one of two groups: an intervention group that will receive an education intervention and the proposed technology to be used for one year, and a control group that will receive only the education intervention. The primary outcome will be pressure ulcer occurrence over one year. Investigators hypothesize that participants receiving the intervention of biofeedback on their pressure relief activity will have a lower recurrence of pressure ulcer than the education only control group. Secondary outcomes include depressive symptoms, self-efficacy, participation and satisfaction with life. Investigators hypothesize that increasing physical activity will reduce depressive symptoms and improve participation and satisfaction with life.
Read the detailed description
Purpose: The purpose of this study is to evaluate the efficacy of an interactive tele-health monitoring and biofeedback system to establish healthy behaviors and promote self-management of pressure relief maneuvers and physical activity.
Procedures and Course of Study:
Baseline 50 participants will be enrolled. At study entry participants will complete four baseline questionnaires and have a Nurse Practitioner or Physician's Assistant inspect their ischial skin to ensure that their prior ulcer is fully healed. A pressure-sensing mat (PRESS) will be placed under their wheelchair cushion, and a wheelchair propulsion motion sensor (WAMS) will be placed on the rear wheel of their wheelchair. The PRESS and WAMS sensors will record participants' pressure relief and wheelchair propulsion activity for the next two weeks.
Intervention:
Participants will then return to the clinic and the study physical therapist will provide all participants with education on importance of pressure relief maneuvers and physical activity for health as well as training in the 3 styles of pressure relief (forward and side leans, depression raise) and shoulder strengthening exercises to protect against shoulder impingement and pain with increased pressure relief and wheelchair propulsion activity. The study physical therapist will then assist all participants in setting goals to increase pressure relief frequency and/or duration and wheelchair propulsion pushes for the future based on their baseline activity. Participants will be randomized into one of two groups: feedback and no feedback. In both groups pressure relief and wheelchair propulsion activity will be recorded by the PRESS and WAMS sensors for the 12 months. Those participants in the no-feedback group will have the feedback features of the system disabled. Those participants in the feedback group will receive instant visual feedback on pressure relief duration and daily summary charts for both pressure relief and wheelchair propulsion activities.
Follow-up:
Every month following the intervention for 12 months, a physical therapist will contact participants by phone to inquire whether their ischial skin integrity has changed and whether they have developed a pressure ulcer. Additionally, all participants will return to the clinic at 3, 6, 9, and 12 months after the intervention and a nurse practitioner will examine their ischial skin and review their medical records to determine if a pressure ulcer has developed. Participants will repeat the 4 questionnaires from the baseline evaluation at each follow-up visit. At the 12 month follow-up visit, participants will return the sensor equipment.
- Conditions
- Spinal Cord Injuries, Paraplegia, Pressure Ulcer, Buttock
- Being tested
- An interactive telehealth monitoring and biofeedback system, Education Control
- Keywords
- Spinal cord injury, Pressure Ulcer
- Medical subject headings
- Spinal Cord Injuries, Paraplegia, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An interactive telehealth monitoring and biofeedback systemDevice
A pressure sensitive mat located under the user's wheelchair seat cushion and a wheelchair propulsion monitoring device attached to the chair which are interfaced with a phone App based user interface to provide feed back to promote physical activity and pressure relief maneuver performance among wheelchair users.
Education ControlBehavioural
Participants will receive education on importance of pressure relief maneuvers and physical activity and the recommended amounts of each for prevention of pressure ulcer/injury and for physical health.
| Study group | Role | What they receive |
|---|---|---|
| An interactive telehealth monitoring and biofeedback system | Experimental | Participants in this group will receive feedback of pressure relief maneuvers and wheelchair propulsion activity. Feedback for pressure relief will include information during the activity to identify adequate duration and magnitude of pressure relief activity, reminders of when the next pressure relief is due, and daily aggregate information regarding the number of successful pressure relief maneuvers performed. Receives: Device: An interactive telehealth monitoring and biofeedback system |
| Education Control | Sham comparator | Participants will receive education on the importance and recommended frequency of pressure relief maneuver for prevention of pressure ulcer/injury and on the importance and recommended amounts of physical activity for health. Receives: Behavioral: Education Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of Pressure Ulcer
Any stage of Pressure Ulcer/Injury identified in the ischial region
Measured: Any time during the one year active phase of the study intervention
Change in mean number of cycles of self-propulsion per day from Baseline
The increase or decrease in number of cycles of self-propulsion per day over the 4 weeks preceding the 12 month assessment
Measured: The four weeks preceding the 12 month assessments
Change in mean number of pressure relief maneuvers per day from Baseline
The increase or decrease in mean number of pressure relief maneuvers per day over the 4 weeks preceding the 12 month assessment from Baseline
Measured: The four weeks preceding the 12 month assessments
Time to Recurrence of Pressure Ulcer
The number of days from study entry to identification of recurrence of Pressure Ulcer/Injury
Measured: Any time during the one year active phase of the study intervention
Secondary outcomes (4)
Change in Patient Health Questionnaire-9 score
Change in Questionnaire scores measuring depressive symptoms at 12 month assessment from baseline score
Measured: 12 months
Change in University of Washington Self Efficacy Short Form
Change in scores on Questionnaire measuring self-efficacy at 12 month assessment from baseline score
Measured: 12 months
Change in Reintegration to Normal Living Index
Change score on Questionnaire measuring participation at 12 month assessment from baseline score
Measured: 12 months
Change in Satisfaction with Life Scale
Change in score on Questionnaire measuring satisfaction with life at 12 month assessment from baseline score
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study startMar 2020 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized trial with one intervention arm and one control arm.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rancho Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- BioSensics, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Sara Mulroy, Rancho Research Institute, Inc.
- Investigators
- Sara Mulroy, PhD, PT, Principal investigator, Rancho Los Amigos National Rehab Ce
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266808
- Sponsor's protocol ID
- 5R44AG059275-04
- Other IDs
- 5R44AG059275-04
- Status last verified
- Feb 2020
- First submitted
- 7 Feb 2020
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactive Telehealth and Auto-Biofeedback Sensor System for Individuals Who Use a Wheelchair: Phase II
- ClinicalTrials.gov ID
- NCT04266808
- Acronym / sponsor ID
- 5R44AG059275-04
- Conditions
- Spinal Cord Injuries, Paraplegia, Pressure Ulcer, Buttock
- Keywords
- Spinal cord injury, Pressure Ulcer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rancho Research Institute, Inc.University, hospital or other
- Collaborators
- BioSensics, National Institute on Aging (NIA)
- Study start
- Mar 2020 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 12 Feb 2020 (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.
During typical daily activity, people with established spinal cord injury perform significantly fewer pressure-relief maneuvers than the recommended frequency while overestimating their adherence on recall surveys of pressure relief activity. The rate of pressure ulcer recurrence in individuals with a prior ulcer is 44% in those with surgical repair and as high as 75% in those with non-surgical healing indicating that increased attention to pressure relief is critical for these individuals.This study will evaluate the efficacy of a wheelchair sensor and app-based biofeedback for establishing healthy self-management behaviors (pressure relief maneuvers and daily physical activity). Investigators will enroll 50 participants with paraplegia from spinal cord injury who use a manual wheelchair for mobility and have a history of pressure ulcer that has healed or is six months post-surgical repair. Participants will be randomized into one of two groups: an intervention group that will receive an education intervention and the proposed technology to be used for one year, and a control group that will receive only the education intervention. The primary outcome will be pressure ulcer occurrence over one year. Investigators hypothesize that participants receiving the intervention of biofeedback on their pressure relief activity will have a lower recurrence of pressure ulcer than the education only control group. Secondary outcomes include depressive symptoms, self-efficacy, participation and satisfaction with life. Investigators hypothesize that increasing physical activity will reduce depressive symptoms and improve participation and satisfaction with life.
Detailed description
Purpose: The purpose of this study is to evaluate the efficacy of an interactive tele-health monitoring and biofeedback system to establish healthy behaviors and promote self-management of pressure relief maneuvers and physical activity.
Procedures and Course of Study:
Baseline 50 participants will be enrolled. At study entry participants will complete four baseline questionnaires and have a Nurse Practitioner or Physician's Assistant inspect their ischial skin to ensure that their prior ulcer is fully healed. A pressure-sensing mat (PRESS) will be placed under their wheelchair cushion, and a wheelchair propulsion motion sensor (WAMS) will be placed on the rear wheel of their wheelchair. The PRESS and WAMS sensors will record participants' pressure relief and wheelchair propulsion activity for the next two weeks.
Intervention:
Participants will then return to the clinic and the study physical therapist will provide all participants with education on importance of pressure relief maneuvers and physical activity for health as well as training in the 3 styles of pressure relief (forward and side leans, depression raise) and shoulder strengthening exercises to protect against shoulder impingement and pain with increased pressure relief and wheelchair propulsion activity. The study physical therapist will then assist all participants in setting goals to increase pressure relief frequency and/or duration and wheelchair propulsion pushes for the future based on their baseline activity. Participants will be randomized into one of two groups: feedback and no feedback. In both groups pressure relief and wheelchair propulsion activity will be recorded by the PRESS and WAMS sensors for the 12 months. Those participants in the no-feedback group will have the feedback features of the system disabled. Those participants in the feedback group will receive instant visual feedback on pressure relief duration and daily summary charts for both pressure relief and wheelchair propulsion activities.
Follow-up:
Every month following the intervention for 12 months, a physical therapist will contact participants by phone to inquire whether their ischial skin integrity has changed and whether they have developed a pressure ulcer. Additionally, all participants will return to the clinic at 3, 6, 9, and 12 months after the intervention and a nurse practitioner will examine their ischial skin and review their medical records to determine if a pressure ulcer has developed. Participants will repeat the 4 questionnaires from the baseline evaluation at each follow-up visit. At the 12 month follow-up visit, participants will return the sensor equipment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized trial with one intervention arm and one control arm.
| Arm | Type | Receives |
|---|---|---|
| An interactive telehealth monitoring and biofeedback system | Experimental | Device: An interactive telehealth monitoring and biofeedback systemParticipants in this group will receive feedback of pressure relief maneuvers and wheelchair propulsion activity. Feedback for pressure relief will include information during the activity to identify adequate duration and magnitude of pressure relief activity, reminders of when the next pressure relief is due, and daily aggregate information regarding the number of successful pressure relief maneuvers performed. |
| Education Control | Sham comparator | Behavioral: Education ControlParticipants will receive education on the importance and recommended frequency of pressure relief maneuver for prevention of pressure ulcer/injury and on the importance and recommended amounts of physical activity for health. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- paraplegia from Spinal Cord Injury
- a history of pressure ulcer that has healed or 6 months post surgical repair
- use a manual wheelchair for mobility
- able to perform pressure relief maneuvers independently
Key exclusion criteria (1 listed)
- unable/unwilling to return to clinic for follow-up visits
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 |
|---|---|---|
| An interactive telehealth monitoring and biofeedback systemA pressure sensitive mat located under the user's wheelchair seat cushion and a wheelchair propulsion monitoring device attached to the chair which are interfaced with a phone App based user interface to provide feed back to promote physical activity and pressure relief maneuver performance among wheelchair users. | Device | An interactive telehealth monitoring and biofeedback system |
| Education ControlParticipants will receive education on importance of pressure relief maneuvers and physical activity and the recommended amounts of each for prevention of pressure ulcer/injury and for physical health. | Behavioural | Education Control |
Primary outcome
Recurrence of Pressure Ulcer
Time frame: Any time during the one year active phase of the study intervention
Any stage of Pressure Ulcer/Injury identified in the ischial region
Change in mean number of cycles of self-propulsion per day from Baseline
Time frame: The four weeks preceding the 12 month assessments
The increase or decrease in number of cycles of self-propulsion per day over the 4 weeks preceding the 12 month assessment
Change in mean number of pressure relief maneuvers per day from Baseline
Time frame: The four weeks preceding the 12 month assessments
The increase or decrease in mean number of pressure relief maneuvers per day over the 4 weeks preceding the 12 month assessment from Baseline
Time to Recurrence of Pressure Ulcer
Time frame: Any time during the one year active phase of the study intervention
The number of days from study entry to identification of recurrence of Pressure Ulcer/Injury
4 secondary outcomes
Change in Patient Health Questionnaire-9 score
Time frame: 12 months
Change in University of Washington Self Efficacy Short Form
Time frame: 12 months
Change in Reintegration to Normal Living Index
Time frame: 12 months
Change in Satisfaction with Life Scale
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Spinal Cord Injuries
Recruiting
Implant for Walking After Incomplete SCI
Spinal Cord Injury (SCI), Gait
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
Recruiting
tSCS Combined With Rehabilitation Training in Treating Paraplegic Patients After SCI
Spinal Cord Injury, Paraplegia, Spinal
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Recruiting
Neuromodulation for Metabolic Dysfunction
Spinal Cord Injuries (SCI), Prediabetes / Type 2 Diabetes
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.
Sara Mulroy, PhD, PT principal investigator
Rancho Los Amigos National Rehab Ce
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing An interactive telehealth monitoring and biofeedback system in people with Spinal Cord Injuries and Paraplegia, run by Rancho Research Institute, Inc. 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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 12 Feb 2020. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Mulroy, PhD, PT (562-385-7177, smulroy@dhs.lacounty.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of Pressure Ulcer (time frame: Any time during the one year active phase of the study intervention). 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 12 Feb 2020.