R4 Telerehabilitation for self-management of chronic edema/lymphedema in individuals with mobility limitations
Charles Vukotich, MBE
Nancy Sims, BSN, CLT-LANA
Suzanne Cavanaugh, DPT, CLT-LANA
Ana Allegretti, PhD
Chronic lower extremity edema or lymphedema is a common, but often underestimated secondary complication of immobility that has increased in conjunction with life expectancy for wheelchair-dependent persons. If chronic edema is not treated, it eventually results in lymphedema. Lymphedema is a chronic, incurable edematous state due to dysfunction of lymphatic transport. This leads to build-up of protein and fluid in the interstitial space causing inflammation, fibrosis and fatty changes in the tissue. Individuals with lymphedema are at increased risk for chronic wounds and infections. The presence of multiple secondary complications such as edema, wounds and depression are strong predictors of premature death in the spinal cord injured population. Other wheelchair-dependent subgroups are likely similar in this regard. Epidemiological data on the prevalence of lymphedema is scarce. US estimates range from 1 to 10 million persons. This number does not include the subgroup of individuals who use wheelchairs occasionally or as their primary means of mobility. This subgroup accounts for approximately 10 million including 1 million individuals who are institutionalized.
There are many reasons for the observed increase in chronic lower extremity edema in the immobile population. The primary causes include a loss of all skeletal muscle pumps, a diminished respiratory pump and leg dependency. Secondary issues include improper wheelchair seating and positioning, obesity, constricting clothing and restraints, improper or complete lack of preventive lower limb elevation, and injuries to the lower limbs acquired during transfers. Limited numbers of caregivers, qualified wheeled mobility and seating specialists and certified lymphedema specialists makes it very difficult to obtain treatment. Individuals with disabilities are likely to have difficulty committing to traditional complex decongestive therapy due to the travel time and labor intensive nature of treatment and maintenance regimens. For many reasons, simple manual lymph drainage in combination with sequential gradient pneumatic compression delivered in the home has the potential to provide an alternative means of effective treatment. However, no clinical trials using intermittent sequential pneumatic compression have been conducted in the immobile population. Unsupervised intermittent compression in this population may lead to adverse clinical effects. Abnormal pressures and skin lesions may not be detected due to limited sensation and limb dependency contributes to the formation of thromboses in which case compression is contraindicated. In addition, the compression profiles of most pneumatic devices are unknown and many have no mechanism to prevent patients from manipulating the prescribed protocol. Intermittent compression without adequate preparation of the lymphatic system may result in moving the fluid to the genitals or trunk rather than the vascular space making treatment more difficult. However, we propose to train and monitor immobile individuals in self-management of their chronic edema through the use of telerehabilitation thereby minimizing these risks.
- To determine the effectiveness of a telerehab method (real-time videoconferencing and follow-up monitoring in lymphedema self-care tasks and maintenance behavior) for self-management of lymphedema in individuals with mobility limitations.
- To describe the effects of a telerehab method for self-management of lymphedema as demonstrated by lymphedema outcomes, quality of life measures, medical outcomes, and health care utilization.
A quasi-experimental, one-way repeated measures design over time will be used to evaluate the effects of a telerehab self-management intervention including simple manual lymph drainage and sequential intermittent pneumatic compression.
Expected Findings and Deliverables:
- Develop novel technologies and clinical methods to determine the effects of treatment on lymphatic tissue including 1) 3-D laser scanning for volumetric measurements, 2) various instruments to measure the viscoelastic properties of lymphatic tissue, 3) measures of local tissue fluid changes and 4) measures of inflammatory biomarkers linked to tissue fibrosis
- Characterize lymphatic tissue in order to develop a more definitive international staging system for lymphedema that will facilitate meta-analysis of clinical trials
- Contribute to the international minimum data set for lymphedema
- Define the pressure profile and characterize the clinical features of the specific pneumatic device used in the study. This will establish a template for evaluation of all pneumatic devices and lay the ground work for international standards for pneumatic compression and other forms of compression (bandaging, stockings, wraps, etc.)
- Demonstrate strategies to overcome limited health literacy in telerehab applications
- Determine the effectiveness of a telerehabilitation self-management protocol including simple massage and the use of a sequential pneumatic compression device in reducing lymphedema and maintaining function in immobile individuals
Project Updates (most recent listed first):
- Presented on the topic of chronic edema/lymphedema in the immobile population at two international lymphedema symposia
- Received permission from Hanger Orthopedics to utilize the Insignia 3-D laser scanner for measurement of lower extremity and trunk volume.
- Selected the Wright Linear sequential compression pump Model 52 as the intervention device
- Submitted IRB protocol for comparative studies on lower limb volume
- Determined optimal instrumentation for measurement of limb and trunk volume, viscoelastic tissue properties, local tissue fluid changes
- Worked with Wright Therapy Products to develop patient educational videos for instruction in the use of the pump
- Conducted a workshop on manual edema mobilization to train co-investigators and collaborators in standard simple lymphatic massage techniques
- Recorded a portion of the workshop for use in ongoing continuing education through the RST department (webinars)
- Developed a protocol for immunological assay of lymphedema subjects with subsequent principal component analysis in cooperation with the McGowan Center for Regenerative Medicine to determine the effects of the intervention
International Lymphoedema Framework Conference, Brighton, UK, March 23-25th, 2010, "Chronic Edema in Wheelchair-Dependent Persons"
International Compression Club Conference, Brighton, UK, March 26th, 2010, "Telerehabilitation for Self-Management of Chronic Edema/Lymphedema in Immobile Persons"
A great deal of time has been spent in obtaining the instrumentation for the objective measures of improvement in lymphedema and perfecting the testing protocols. This process was very complicated and required switching from one pump manufacturer to another, obtaining the best state of the art instrumentation for measurement of interface pressure, tissue mechanical properties, and body scanning to determine limb and trunk volume. Dr. Geyer has been successful in obtaining almost $500,000 in in-kind equipment and supply contributions from Tactile Systems, Inc, Bauerfeind USA, Dynamic Compression, and TUPS over the past year to begin the trial.
We have exceeded all expectations for the quality of the instrumentation we will use to evaluate the effects of the trial.
In addition, we have developed training materials that have application for use in multiple markets. The digital training videos were evaluated by lymphedema experts and were perceived to be very valuable for use in patient education. These training modules "10 Steps to Healthier Feet & Legs" will be used to supplement the telerehab intervention which is focused on improving self-efficacy. We anticipate using these training modules for additional interventions in other disabled populations and will experiment with delivery via slate or mobile phone.
We have produced two publications thus far:
- Telerehabilitation (TR) tools for self-management of chronic limb swelling
- Use of a laser scanning system to measure limb volume in chronic edema
The later publication was recognized as a winner of student competition at RESNA.
In addition, Dr. Geyer has been using the basic educational concepts developed in this project in her international work. This work is focused on the prevention of disability from diseases/conditions affecting the lower limb across diseases www.legstostandon.org. This initiative is linked to the Rotary International/Gates Foundation Clean Water Project in Ghana & has recently been funded to initiate a demonstration project in 2011. We are hoping to utilize mobile phone technology to provide for data collection, communication and health worker clinical decision support in implementing this project.
A great deal of time has been spent in evaluating and obtaining the instrumentation required to conduct this study. For example, obtaining permission from the Hanger Orthopedics research committee took 9 months since we were the first study to request the use of the Insignia 3-D body scanner and we will be the first external group to use this proprietary device. We also had a custom pressure mapping strip designed by Vista Medical to be able to accurately measure the pressure profile for each subject using the pneumatic compression device. We changed the intervention from the Wright linear pump to the Flexitouch because it provides lower interface pressure and it will enable standardization of the manual lymphatic drainage component of the intervention. Flexitouch is also under contract to UPMC and we will be able to recruit subjects more easily. We have also decided to obtain blood samples to determine molecular responses to the interventions that will provide greater understanding of the mechanisms responsible for lymphedema outcomes. We will match the molecular changes to changes in the volume of extracellular fluid in the dermis directly over the lymphatic vessels (Delfin Moisture Meter-D). These measures will aid in early detection, improved classification and better treatment in the future.
We have obtained permissions to use the SF-36 and the S-TOFHLA and have received training in the administration of these tools. The patient training modules that are specific to each level of health literacy have been designed and scripted. The filming of these modules is scheduled for late June. The IRB protocol for performing validation of the 3D scanner was approved on June 14th and the full IRB protocol will be submitted by next week with anticipated approval no later than July 7th. Recruitment of subjects and the initiation of the study is scheduled to begin in July. Thus, despite the extensive start-up work related to instrumentation, we are on schedule.