Phantom Limb PainNCT06106984
Home-based Rehabilitation Intervention for Phantom Limb Pain in Veterans With Lower Limb Amputations
A study testing Graded motor imagery mobile app in people with Phantom Limb Pain, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Nearly 60-85% of Veterans with amputations experience pain at the location of the amputated limb called phantom limb pain (PLP). PLP is a major problem and can have a profound impact on Veteran's daily function and ability to fully participate in life. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Phantom Limb Pain
- What is being tested?
- Graded motor imagery mobile app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 31 Mar 2029
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be a military Veteran
- >1 year since unilateral below knee amputation
- Moderate or severe (NRS score 4 on a 0-10 scale) PLP
- Stable medications over the past 2 weeks
- Willing and able to give informed consent
- Able to participate in the telehealth study activities with a personal device
Who cannot join
- Unstable medical conditions (e.g., uncontrolled diabetes, heart failure exacerbation)
- Unstable mental illness or substance use disorder (e.g., active suicidality or psychosis)
- Unable to give informed consent due to a cognitive impairment
- Fibromyalgia or complex regional pain syndrome-like symptoms
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417-2309
Tonya L Rich, PhD MA BS, (612) 467-5463, Tonya.Rich@va.gov
Andrew H Hansen, PhD, (612) 467-2910, andrew.hansen2@va.gov
About this study
Nearly 60-85% of Veterans with amputations experience pain at the location of the amputated limb called phantom limb pain (PLP). PLP is a major problem and can have a profound impact on Veteran's daily function and ability to fully participate in life. Although several rehabilitation interventions are promising, advances in novel rehabilitation interventions are limited. The objective of this project is to refine a mobile app for graded motor imagery in 12 Veterans with amputations and test the mobile app with 36 Veterans with amputations. For this pilot project, the investigators will measure the preliminary feasibility and acceptability of the intervention. Knowledge from this project will provide evidence to guide future larger studies of this graded motor imagery intervention. Developing novel strategies for chronic pain in this population will positively impact quality of life for Veterans with amputations.
Read the detailed description
Background: Phantom Limb Pain (PLP) is a form of unpredictable neuropathic pain in Veterans with amputation. Current non-medication treatments for PLP are limited and more interventions are needed that take into consideration the unique needs of the Veteran population. PLP significantly impairs rehabilitation outcomes and community participation. One non-medication intervention is graded motor imagery (GMI). GMI consists of sequentially progressing from limb laterality training, to motor imagery, and then mirror therapy (i.e., observing movement using the visual illusion of an intact limb in a mirror). Although clinicians report benefit from use of the technique, barriers exist to supporting at-home use of the intervention.
Research Questions (Objectives) - This VA Career Development Award-2 proposal focuses on refining a mobile app for GMI (VA-GMI) (Aim 1) and then pilot testing serial sessions of mobile app use in a sample of Veterans with lower limb amputation and moderate to severe PLP in their home setting (Aim 2).
Relevance to VA - There is a growing population of Veterans with amputation in the VA system. Many of whom will experience amputation pain, like phantom limb pain, and other amputation-related experiences. There are currently limited non-drug treatment options for phantom limb pain. Graded Motor Imagery could be one tool as a part of a comprehensive treatment plan for phantom limb pain. With the support of the expert mentor team in place, this work will incorporate Veteran input into the design of a novel intervention with high translational value. This work will lead to future investigations of optimized GMI intervention for the reduction of PLP in Veterans with amputations.
Number of Research Participants (Sample Size) - For Aim 1 that involves refining the mobile app, the investigators will recruit 12 Veterans. For Aim 2 that involves the clinical trial, the investigators will recruit 36 Veterans with unilateral below knee amputation to participate in the pilot testing of serial sessions.
Participating Sites - Minneapolis VA Health Care System
Duration of Participant Intake (Study Duration) - This project is projected to occur over 5 years. This project will begin with a 1 year refinement of the investigators' Graded Motor Imagery mobile app with 12 Veterans with amputation and moderate to severe PLP. In years 2-5, the investigators will conduct a pilot study to evaluate the feasibility and acceptability of the intervention with 36 Veterans with amputation and moderate to severe PLP. The investigators will conduct this study virtually with all Veterans in their home environment. All Veterans will receive twelve intervention sessions. Recruitment will conclude with 6-months remaining in the study timeline, which will be used for the dissemination of results and closure of the project.
Treatment (follow-up) - The Veterans in the pilot study will have 12 sessions of Graded Motor Imagery using the mobile app. The investigators will then follow Veterans for 3 and 6 month follow ups to learn more about their perspective of the Graded Motor Imagery mobile app.
Endpoints - The primary outcomes for this study are acceptability (Acceptability of Intervention Measure) and secondary measures of health outcomes, specifically pain interference (Amputation Related Pain and Experiences).
Qualitative Data - In addition to measuring acceptability and pain interference, the investigators will conduct semi-structured interviews with participants to develop further understanding of the benefits and drawbacks of Graded Motor Imagery in the home setting, using the mobile app.
- Conditions
- Phantom Limb Pain
- Being tested
- Graded motor imagery mobile app
- Keywords
- Amputation, Rehabilitation, Phantom limb pain, Pain
- Medical subject headings
- Phantom Limb, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graded motor imagery mobile appDevice
The Graded Motor Imagery mobile app is a mobile app designed for intervention in phantom limb pain.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Veterans will trial the Graded Motor Imagery mobile application. Receives: Device: Graded motor imagery mobile app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of Intervention Measure
The Acceptability of Intervention Measure is a measure of the acceptability of the intervention sessions and if acceptability changes over time. This measure will evaluate the acceptability of using a mobile app with a telehealth platform. Minimum score: 12, maximum score: 60. A higher score indicates greater acceptability of the intervention, a lower score indicates lower acceptability of the intervention.
Measured: 6-week post-test
Change from 6-week post-test on the Acceptability of Intervention Measure to 6 months
The Acceptability of Intervention Measure is a measure of the acceptability of the intervention sessions and if acceptability changes over time. This measure will evaluate the acceptability of using a mobile app with a telehealth platform. Minimum score: 12, maximum score: 60. A higher score indicates greater acceptability of the intervention, a lower score indicates lower acceptability of the intervention.
Measured: 6 month follow up (an average of 24 weeks from 6-week post test)
Secondary outcomes (4)
Change from baseline Amputation Related Pain and Experiences to 6-weeks (post-test)
The Amputation Related Pain and Experiences is a measure to differentiate types of amputation-related pain and measure intensity, frequency, and pain interference with residual limb, phantom sensation, and phantom limb pain. For each section of residual limb pain, phantom sensation, and phantom limb pain, the minimum score is 0 and the maximum score is 60. A higher score indicates greater pain or sensation in each of the categories and a lower score indicates lower pain or sensation in each of the categories.
Measured: Baseline, 6-week Post-Test
Change from 6-week post-test on the Acceptability of Intervention Measure at 3 months
The Acceptability of Intervention Measure is a measure of the acceptability of the intervention sessions and if acceptability changes over time. This measure will evaluate the acceptability of using a mobile app with a telehealth platform. Minimum score: 12, maximum score: 60. A higher score indicates greater acceptability of the intervention, a lower score indicates lower acceptability of the intervention.
Measured: 3 month follow up (an average of 12 weeks after baseline)
Change from 6-week post-test Amputation Related Pain and Experiences to 3 months
The Amputation Related Pain and Experiences is a measure to differentiate types of amputation-related pain and measure intensity, frequency, and pain interference with residual limb, phantom sensation, and phantom limb pain. For each section of residual limb pain, phantom sensation, and phantom limb pain, the minimum score is 0 and the maximum score is 60. A higher score indicates greater pain or sensation in each of the categories and a lower score indicates lower pain or sensation in each of the categories.
Measured: Baseline, 3 month follow up (an average of 12 weeks from baseline)
Change from baseline Amputation Related Pain and Experiences to 6 months
The Amputation Related Pain and Experiences is a measure to differentiate types of amputation-related pain and measure intensity, frequency, and pain interference with residual limb, phantom sensation, and phantom limb pain. For each section of residual limb pain, phantom sensation, and phantom limb pain, the minimum score is 0 and the maximum score is 60. A higher score indicates greater pain or sensation in each of the categories and a lower score indicates lower pain or sensation in each of the categories.
Measured: Baseline, 6 month follow up (an average of 24 weeks from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start1 Apr 2024
- Primary completion30 Nov 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Phantom Limb PainStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- The investigators will conduct pilot testing of serial sessions of Graded Motor Imagery with Veterans using telehealth to their home environment.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Tonya L Rich, PhD MA BS, Principal investigator, Minneapolis VA Health Care System, Minneapolis, MN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06106984
- Sponsor's protocol ID
- B4805-W
- Other IDs
- 1IK2RX004805-01A1
- Status last verified
- Sep 2026
- First submitted
- 24 Oct 2023
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rich TL, Cristan KG, Truty TP, Hansen AH, Ackland PE. HUMAN CENTERED DESIGN: VETERAN TESTING OF A MOBILE APP WITH AUGMENTED REALITY FOR PHANTOM LIMB PAIN. Proc Des Med Devices Conf. 2025 May 24;2025:10.1115/dmd2025-1021. doi: 10.1115/dmd2025-1021.
PubMed 41836102Rich TL, Cristan KG, Marth L, Ackland PE. Pain Neuroscience Education for Postamputation Pain and Functioning: Testing Embedded Education in a Mobile App for Occupational Therapy Pain Treatment. Am J Occup Ther. 2026 May 1;80(3):8003185070. doi: 10.5014/ajot.2026.051449.
PubMed 41871396
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Rehabilitation Intervention for Phantom Limb Pain in Veterans With Lower Limb Amputations
- ClinicalTrials.gov ID
- NCT06106984
- Acronym / sponsor ID
- B4805-W
- Conditions
- Phantom Limb Pain
- Keywords
- Amputation, Rehabilitation, Phantom limb pain, Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 30 Oct 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.
Nearly 60-85% of Veterans with amputations experience pain at the location of the amputated limb called phantom limb pain (PLP). PLP is a major problem and can have a profound impact on Veteran's daily function and ability to fully participate in life. Although several rehabilitation interventions are promising, advances in novel rehabilitation interventions are limited. The objective of this project is to refine a mobile app for graded motor imagery in 12 Veterans with amputations and test the mobile app with 36 Veterans with amputations. For this pilot project, the investigators will measure the preliminary feasibility and acceptability of the intervention. Knowledge from this project will provide evidence to guide future larger studies of this graded motor imagery intervention. Developing novel strategies for chronic pain in this population will positively impact quality of life for Veterans with amputations.
Detailed description
Background: Phantom Limb Pain (PLP) is a form of unpredictable neuropathic pain in Veterans with amputation. Current non-medication treatments for PLP are limited and more interventions are needed that take into consideration the unique needs of the Veteran population. PLP significantly impairs rehabilitation outcomes and community participation. One non-medication intervention is graded motor imagery (GMI). GMI consists of sequentially progressing from limb laterality training, to motor imagery, and then mirror therapy (i.e., observing movement using the visual illusion of an intact limb in a mirror). Although clinicians report benefit from use of the technique, barriers exist to supporting at-home use of the intervention.
Research Questions (Objectives) - This VA Career Development Award-2 proposal focuses on refining a mobile app for GMI (VA-GMI) (Aim 1) and then pilot testing serial sessions of mobile app use in a sample of Veterans with lower limb amputation and moderate to severe PLP in their home setting (Aim 2).
Relevance to VA - There is a growing population of Veterans with amputation in the VA system. Many of whom will experience amputation pain, like phantom limb pain, and other amputation-related experiences. There are currently limited non-drug treatment options for phantom limb pain. Graded Motor Imagery could be one tool as a part of a comprehensive treatment plan for phantom limb pain. With the support of the expert mentor team in place, this work will incorporate Veteran input into the design of a novel intervention with high translational value. This work will lead to future investigations of optimized GMI intervention for the reduction of PLP in Veterans with amputations.
Number of Research Participants (Sample Size) - For Aim 1 that involves refining the mobile app, the investigators will recruit 12 Veterans. For Aim 2 that involves the clinical trial, the investigators will recruit 36 Veterans with unilateral below knee amputation to participate in the pilot testing of serial sessions.
Participating Sites - Minneapolis VA Health Care System
Duration of Participant Intake (Study Duration) - This project is projected to occur over 5 years. This project will begin with a 1 year refinement of the investigators' Graded Motor Imagery mobile app with 12 Veterans with amputation and moderate to severe PLP. In years 2-5, the investigators will conduct a pilot study to evaluate the feasibility and acceptability of the intervention with 36 Veterans with amputation and moderate to severe PLP. The investigators will conduct this study virtually with all Veterans in their home environment. All Veterans will receive twelve intervention sessions. Recruitment will conclude with 6-months remaining in the study timeline, which will be used for the dissemination of results and closure of the project.
Treatment (follow-up) - The Veterans in the pilot study will have 12 sessions of Graded Motor Imagery using the mobile app. The investigators will then follow Veterans for 3 and 6 month follow ups to learn more about their perspective of the Graded Motor Imagery mobile app.
Endpoints - The primary outcomes for this study are acceptability (Acceptability of Intervention Measure) and secondary measures of health outcomes, specifically pain interference (Amputation Related Pain and Experiences).
Qualitative Data - In addition to measuring acceptability and pain interference, the investigators will conduct semi-structured interviews with participants to develop further understanding of the benefits and drawbacks of Graded Motor Imagery in the home setting, using the mobile app.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The investigators will conduct pilot testing of serial sessions of Graded Motor Imagery with Veterans using telehealth to their home environment.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Graded motor imagery mobile appVeterans will trial the Graded Motor Imagery mobile application. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must be a military Veteran
- >1 year since unilateral below knee amputation
- Moderate or severe (NRS score 4 on a 0-10 scale) PLP
- Stable medications over the past 2 weeks
- Willing and able to give informed consent
Key exclusion criteria (4 listed)
- Unstable medical conditions (e.g., uncontrolled diabetes, heart failure exacerbation)
- Unstable mental illness or substance use disorder (e.g., active suicidality or psychosis)
- Unable to give informed consent due to a cognitive impairment
- Fibromyalgia or complex regional pain syndrome-like symptoms
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 |
|---|---|---|
| Graded motor imagery mobile appThe Graded Motor Imagery mobile app is a mobile app designed for intervention in phantom limb pain. | Device | Intervention |
Primary outcome
Acceptability of Intervention Measure
Time frame: 6-week post-test
The Acceptability of Intervention Measure is a measure of the acceptability of the intervention sessions and if acceptability changes over time. This measure will evaluate the acceptability of using a mobile app with a telehealth platform. Minimum score: 12, maximum score: 60. A higher score indicates greater acceptability of the intervention, a lower score indicates lower acceptability of the intervention.
Change from 6-week post-test on the Acceptability of Intervention Measure to 6 months
Time frame: 6 month follow up (an average of 24 weeks from 6-week post test)
The Acceptability of Intervention Measure is a measure of the acceptability of the intervention sessions and if acceptability changes over time. This measure will evaluate the acceptability of using a mobile app with a telehealth platform. Minimum score: 12, maximum score: 60. A higher score indicates greater acceptability of the intervention, a lower score indicates lower acceptability of the intervention.
4 secondary outcomes
Change from baseline Amputation Related Pain and Experiences to 6-weeks (post-test)
Time frame: Baseline, 6-week Post-Test
Change from 6-week post-test on the Acceptability of Intervention Measure at 3 months
Time frame: 3 month follow up (an average of 12 weeks after baseline)
Change from 6-week post-test Amputation Related Pain and Experiences to 3 months
Time frame: Baseline, 3 month follow up (an average of 12 weeks from baseline)
Change from baseline Amputation Related Pain and Experiences to 6 months
Time frame: Baseline, 6 month follow up (an average of 24 weeks from baseline)
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 2 Oct 2026.
- Results publication: PubMed 41836102Rich TL, Cristan KG, Truty TP, Hansen AH, Ackland PE. HUMAN CENTERED DESIGN: VETERAN TESTING OF A MOBILE APP WITH AUGMENTED REALITY FOR PHANTOM LIMB PAIN. Proc Des Med Devices Conf. 2025 May 24;2025:10.1115/dmd2025-1021. doi: 10.1115/dmd2025-1021.
- Results publication: PubMed 41871396Rich TL, Cristan KG, Marth L, Ackland PE. Pain Neuroscience Education for Postamputation Pain and Functioning: Testing Embedded Education in a Mobile App for Occupational Therapy Pain Treatment. Am J Occup Ther. 2026 May 1;80(3):8003185070. doi: 10.5014/ajot.2026.051449.
- 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.
Tonya L Rich, PhD MA BS principal investigator
Minneapolis VA Health Care System, Minneapolis, MN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Graded motor imagery mobile app in people with Phantom Limb Pain, run by VA Office of Research and Development 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 6 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: looking for participants now, as of the sponsor's last update on 2 Oct 2026. 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?
Contact Tonya L Rich, PhD MA BS ((612) 467-5463, Tonya.Rich@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Intervention Measure (time frame: 6-week post-test). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06106984, which also lists 2 linked publications.
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 2 Oct 2026.