Phantom Limb PainNCT05915065
VR to Evaluate Phantom Limb Pain
A study testing Coapt Phantom Limb Pain Management System in people with Phantom Limb Pain and Phantom Pain, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
The objective of this study is to develop a virtual rehabilitation system that can be used to effectively treat Phantom Limb Pain (PLP) within the research setting and for at-home use by individuals with upper and lower extremity amputation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Phantom Limb Pain, Phantom Pain, Phantom Sensation
- What is being tested?
- Coapt Phantom Limb Pain Management System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adults over the age of 18 years old
- Amputation of the upper or lower limb, including amputation of multiple limbs
- English Speaking
- Chronic phantom limb pain (at least 6-months duration)
- Average phantom limb pain intensity of 4 or greater on a 0-10 numerical rating scale
- Average frequency of phantom limb pain episode of at least twice per month.
- Residual limb pain of less than 5 on the Numerical Pain Rating Scale
- Pain medication use stable for > 1 month
Who cannot join
- Unable to tolerate use of liner or cuff on their residual limb
- Skin irritation/wounds on residual limb that would prevent use of the electrode cuff
- Significant cognitive deficits or visual impairment that would preclude them from giving informed consent or following instructions during the experiments, or the ability to obtain relevant user feedback.
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intuitively Controlled Virtual Reality to Treat Phantom Limb Pain
The objective of this study is to develop a virtual rehabilitation system that can be used to effectively treat Phantom Limb Pain (PLP) within the research setting and for at-home use by individuals with upper and lower extremity amputation.
We hypothesize that the system will improve PLP for individuals with upper or lower extremity amputation, as measured through with various outcome measures and questionnaires.
Read the detailed description
The objective of this study is to develop a virtual rehabilitation system that can be used to effectively treat Phantom Limb Pain (PLP) within the research setting and for at-home use by individuals with upper and lower extremity limb absence.
Phase 1: Complete in-lab or virtual iterative usability and functionality testing of hardware and software components of The Coapt Phantom Limb Pain Management System to ensure readiness for at-home use - COMPLETED
Phase 2: A clinical trial of The Coapt Phantom Limb Pain Management System during at-home use. We hypothesize that the system will improve PLP for individuals with upper or lower extremity absence, as measured through various questionnaires.
VR systems have been proposed as alternative technologies to treat PLP since they are relatively inexpensive and more readily available. Virtual reality environments allow for real-time control practice utilizing different tasks and games, and have been widely accepted as clinically viable options for administering therapy.
Effective PLP treatment methods are needed for individuals with limb absence that can be utilized on an as-needed basis in the home. VR therapy could potentially be an effective treatment for individuals with chronic upper or lower limb PLP.
- Conditions
- Phantom Limb Pain, Phantom Pain, Phantom Sensation, Phantom Limb Syndrome With Pain, Phantom Pain Following Amputation of Lower Limb, Phantom Pain Following Amputation of Upper Limb
- Being tested
- Coapt Phantom Limb Pain Management System
- Keywords
- Virtual Reality, Limb Loss, Amputation, Phantom Pain
- Medical subject headings
- Phantom Limb, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coapt Phantom Limb Pain Management SystemDevice
The PLP-MS consists of (1) an expandable arm/leg cuff with electrode sensors to collect EMG signals from residual limb muscles, (2) an integrated hardware module (the Coapt Complete Control Gen2.5 system) that translates users' EMG signals into game commands, (3) game software for mobile applications, and (4) a secure, HIPAA-compliant cloud-based data storage system for storing and retrieving user data remotely.
| Study group | Role | What they receive |
|---|---|---|
| Phantom Limb Pain Management System during at-home use. | Other | Participants attend either in person at Shirley Ryan AbilityLab or virtually via Zoom
* Educational documents provided on pain and phantom limb pain.
* Participants are measured for an electrode cuff either in person or virtually
* Complete several questionnaires.
* Provided training on the Phantom Limb Pain Program with use of the electrode cuff and muscular contractions of their limb
* Participate in a 8 week home trial (1.5 hours per week of use, 20-40 minutes, 4-5x each week)
* Once home trial is complete - participants will be asked to participate in a phone or Zoom call at weeks 16,24 and 32 to repeat questionnaires. Receives: Device: Coapt Phantom Limb Pain Management System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-form McGill Pain Questionnaire
The primary outcome measure in this study is change in the pain rating index (PRI) between the baseline score and at the post-treatment assessment at the end of the 8-week intervention. The PRI is computed as the sum of the scores for all descriptors of the Short Form of the McGill Pain Questionnaire (SF-MPQ).
Measured: Baseline score and at the post-treatment assessment at the end of the 8-week intervention
Secondary outcomes (3)
Visual Analogue Scale (VAS)
The pain VAS is a unidimensional measure of pain intensity, used to record a persons pain progression, or compare pain severity between paints with similar conditions.
Measured: Baseline score and at the post-treatment assessment at the end of the 8-week intervention
Numerical Pain Rating Scale (NPRS)
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.
Measured: Baseline score and at the post-treatment assessment at the end of the 8-week intervention
Patient-Reported Outcomes Measurement Information Systems (PROMIS)
ROMIS® (Patient-Reported Outcomes Measurement Information System®) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults. PROMIS measures can be used with the general population and with individuals living with chronic conditions.
Measured: Baseline score and at the post-treatment assessment at the end of the 8-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start1 Oct 2020
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phantom Limb PainStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study will enroll one, non-random group of amputees to participate in 2-4 in person or virtual research visits, participate in a home trial and complete questionnaires pre home trial, at various points during the home trial and upon conclusion of the home trial.
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- Coapt, LLC
- Responsible party
- Principal investigator, Levi Hargrove, Shirley Ryan AbilityLab
- Investigators
- Levi Hargrove, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05915065
- Sponsor's protocol ID
- STU00213205
- Status last verified
- Mar 2025
- First submitted
- 13 Jun 2023
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intuitively Controlled Virtual Reality to Treat Phantom Limb Pain
- ClinicalTrials.gov ID
- NCT05915065
- Acronym / sponsor ID
- STU00213205
- Conditions
- Phantom Limb Pain, Phantom Pain, Phantom Sensation, Phantom Limb Syndrome With Pain, Phantom Pain Following Amputation of Lower Limb, Phantom Pain Following Amputation of Upper Limb
- Keywords
- Virtual Reality, Limb Loss, Amputation, Phantom Pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- Coapt, LLC
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 22 Jun 2023 (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.
The objective of this study is to develop a virtual rehabilitation system that can be used to effectively treat Phantom Limb Pain (PLP) within the research setting and for at-home use by individuals with upper and lower extremity amputation.
We hypothesize that the system will improve PLP for individuals with upper or lower extremity amputation, as measured through with various outcome measures and questionnaires.
Detailed description
The objective of this study is to develop a virtual rehabilitation system that can be used to effectively treat Phantom Limb Pain (PLP) within the research setting and for at-home use by individuals with upper and lower extremity limb absence.
Phase 1: Complete in-lab or virtual iterative usability and functionality testing of hardware and software components of The Coapt Phantom Limb Pain Management System to ensure readiness for at-home use - COMPLETED
Phase 2: A clinical trial of The Coapt Phantom Limb Pain Management System during at-home use. We hypothesize that the system will improve PLP for individuals with upper or lower extremity absence, as measured through various questionnaires.
VR systems have been proposed as alternative technologies to treat PLP since they are relatively inexpensive and more readily available. Virtual reality environments allow for real-time control practice utilizing different tasks and games, and have been widely accepted as clinically viable options for administering therapy.
Effective PLP treatment methods are needed for individuals with limb absence that can be utilized on an as-needed basis in the home. VR therapy could potentially be an effective treatment for individuals with chronic upper or lower limb PLP.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study will enroll one, non-random group of amputees to participate in 2-4 in person or virtual research visits, participate in a home trial and complete questionnaires pre home trial, at various points during the home trial and upon conclusion of the home trial.
| Arm | Type | Receives |
|---|---|---|
| Phantom Limb Pain Management System during at-home use. | Other | Device: Coapt Phantom Limb Pain Management SystemParticipants attend either in person at Shirley Ryan AbilityLab or virtually via Zoom * Educational documents provided on pain and phantom limb pain. * Participants are measured for an electrode cuff either in person or virtually * Complete several questionnaires. * Provided training on the Phantom Limb Pain Program with use of the electrode cuff and muscular contractions of their limb * Participate in a 8 week home trial (1.5 hours per week of use, 20-40 minutes, 4-5x each week) * Once home trial is complete - participants will be asked to participate in a phone or Zoom call at weeks 16,24 and 32 to repeat questionnaires. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults over the age of 18 years old
- Amputation of the upper or lower limb, including amputation of multiple limbs
- English Speaking
- Chronic phantom limb pain (at least 6-months duration)
- Average phantom limb pain intensity of 4 or greater on a 0-10 numerical rating scale
Key exclusion criteria (4 listed)
- Unable to tolerate use of liner or cuff on their residual limb
- Skin irritation/wounds on residual limb that would prevent use of the electrode cuff
- Significant cognitive deficits or visual impairment that would preclude them from giving informed consent or following instructions during the experiments, or the ability to obtain relevant user feedback.
- Non-English speaking
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 |
|---|---|---|
| Coapt Phantom Limb Pain Management SystemThe PLP-MS consists of (1) an expandable arm/leg cuff with electrode sensors to collect EMG signals from residual limb muscles, (2) an integrated hardware module (the Coapt Complete Control Gen2.5 system) that translates users' EMG signals into game commands, (3) game software for mobile applications, and (4) a secure, HIPAA-compliant cloud-based data storage system for storing and retrieving user data remotely. | Device | Phantom Limb Pain Management System during at-home use. |
Primary outcome
Short-form McGill Pain Questionnaire
Time frame: Baseline score and at the post-treatment assessment at the end of the 8-week intervention
The primary outcome measure in this study is change in the pain rating index (PRI) between the baseline score and at the post-treatment assessment at the end of the 8-week intervention. The PRI is computed as the sum of the scores for all descriptors of the Short Form of the McGill Pain Questionnaire (SF-MPQ).
3 secondary outcomes
Visual Analogue Scale (VAS)
Time frame: Baseline score and at the post-treatment assessment at the end of the 8-week intervention
Numerical Pain Rating Scale (NPRS)
Time frame: Baseline score and at the post-treatment assessment at the end of the 8-week intervention
Patient-Reported Outcomes Measurement Information Systems (PROMIS)
Time frame: Baseline score and at the post-treatment assessment at the end of the 8-week intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
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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.
Levi Hargrove, PhD principal investigator
Shirley Ryan AbilityLab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coapt Phantom Limb Pain Management System in people with Phantom Limb Pain and Phantom Pain, run by Shirley Ryan AbilityLab 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 8 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 14 Mar 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?
This study is still under way. Results are not available in the source record yet.
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?
Short-form McGill Pain Questionnaire (time frame: Baseline score and at the post-treatment assessment at the end of the 8-week intervention). 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 14 Mar 2025.