Recruiting

Rehabilitation Intervention

Sponsor:

VA Office of Research and Development

Code:

NCT06106984

Conditions

Phantom Limb Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Graded motor imagery mobile app

Study Details

Brief 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. 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.

Conditions

Phantom Limb Pain

Study ID

NCT06106984

Start date

Apr 1, 2024

Status verified date

Oct, 2025

Completion date

Mar 31, 2029

Anticipated

Primary completion date

Nov 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Must be a military Veteran
  • At least 18 years old;
  • >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; and
  • Able to participate in the telehealth study activities with a personal device.

Exclusion Criteria:

  • Unstable medical conditions (e.g., uncontrolled diabetes, heart failure exacerbation);
  • Unstable mental illness or substance use disorder (e.g., active suicidality or psychosis); and
  • Unable to give informed consent due to a cognitive impairment.
  • Fibromyalgia or complex regional pain syndrome-like symptoms

Study Design

Enrollment

36 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Intervention

Veterans will trial the Graded Motor Imagery mobile application.

Interventions

Graded motor imagery mobile app

The Graded Motor Imagery mobile app is a mobile app designed for intervention in phantom limb pain.

Primary outcome measure

  • Acceptability of Intervention Measure [ Time Frame: 6-week post-test ]
  • 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) ]

Central Contacts and Locations

Central contacts

Tonya L Rich, PhD MA BS

(612) 467-5463Tonya.Rich@va.gov

Andrew H Hansen, PhD

(612) 467-2910andrew.hansen2@va.gov

Locations

Minneapolis VA Health Care System, Minneapolis, MN

Recruiting

Minneapolis, Minnesota, United States, 55417-2309

Contacts

Tonya L Rich, PhD MA BS

612-467-5463Tonya.Rich@va.gov

Andrew H Hansen, PhD

(612) 467-2910andrew.hansen2@va.gov

Principal Investigator:

Tonya L Rich, PhD MA BS

More Information

Sponsor

VA Office of Research and Development

Last update posted

Oct 29, 2025

Last verified

Oct, 2025

Keywords

  • Amputation
  • Rehabilitation
  • Phantom limb pain
  • Pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2025-10-29.