Backed by Scientific Research

Prelivia IES1 Device

Rehabtronics has developed a proprietary neurostimulation protocol called ‘IES’. IES has been integrated into the Prelivia IES1 device. It has been established that a pressure injury may form via extrinsic and intrinsic factors. Externally, sustained pressure over bony prominences (extrinsic) and a lack of blood circulation, tissue oxygenation and tissue perfusion (intrinsic). Prelivia is the first technology to addresses both factors. 

In a series of animal, human, and clinical studies it has been shown that ‘IES’ aids in: 

  • redistributing pressure, 
  • reforming compressed muscle tissue, 
  • increasing tissue oxygenation by 28%, and 
  • reduced deep tissue damage by 80%.

Clinical studies have demonstrated that Prelivia is safe and easy to deploy in hospital settings. Use by patients and health care workers demonstrates that there are no barriers to implementation and acceptance by all stakeholders. 

The U.S. Food and Drug Administration has provided 510 (k) Clearance for the Prelivia neurostimulation device to be used to promote healthy blood circulation and maintains healthy tissue in people who are bedridden or chair bound.

Scroll below for details on Prelivia studies currently underway and conducted since 2010.

Prelivia IES1 Device neurostimulation pressure injury
Nurse applying Prelivia electrodes

Prelivia studies: Currently Underway

Active recruiting:

The PROTECT 2 ICU Study: Pressure Injury Treatment by Intermittent Electrical Stimulation: A Randomized, Controlled Trial

Brief Summary:

Multicentered randomized controlled study with adaptive design to evaluate if Intermittent Electrical Stimulation (IES) decreases progression and facilitates healing of pressure injuries for patients with, sacral / ischial pressure injuries.

Condition: Stage 1 and Stage 2 Sacral or Ischial Pressure ulcer 

Recruiting sites: 

USA: 

Cleveland Clinic Foundation 

Wake Forest University 

Austria: 

University of Graz 

Clinicaltrials.gov Identifier NCT05085288

Active recruiting:

The Protect study 3:  Pressure Injury Prevention by Intermittent Electrical Stimulation

Brief Summary: Prospective observational study 90 days 

Subjects at risk to develop pressure injury PURSE > 5, Stage I and Stage II will have Prelivia for 90 days. The progression of skin condition will be observed. The group will be compared with matched historical cohort. 

Recruiting sites: 

Lancaster Long Term Care Center 

O’Neill Long term Care Center 

Need Support for Your Clinical Study of Pressure Injuries?

If you are a pressure injury researcher, we would be delighted to support your study with access to Prelivia our new product, which is designed to protect patients from pressure injuries by restoring blood circulation and tissue oxygenation.  Contact us to learn more!

Prelivia Trials – Study Results

A series of trials have been conducted using the Prelivia IES1 device between 2011 and 2017. Download our Scientific Data page for more information.

Ahmetovic, A., V. K. Mushahwar, R. Sommer, D. Schnepf, L. Kawasaki, R. Rogers, G. Isaacson, M. Ferguson-­­Pell, S. Dukelow and K.M. Chan, “Clinical implementation of an intermittent electrical stimulation system, the Smart-e- Pants, for prevention of deep tissue injury in long term care, rehabilitation hospital, and acute neuro-rehabilitation settings” Advances Wound Care, 4, 192-201, 2015

Curtis, C.A., S. L. Chong, I. Kornelson, R. R. E. Uwiera, P. Seres and V. K. Mushahwar, “The Effects of Intermittent Electrical Stimulation on the Prevention of Deep Tissue Injury: Varying Loads and Stimulation Paradigms” Artificial Organs, 35: 226-236, 2011.

Gyawali, S., L. Solis, S. L. Chong, P. Seres, C. A. Cutis, I. Kornelson, R. B. Thompson and V. K. Mushahwar, “Intermittent Electrical Stimulation Redistributes Pressure and Promotes Tissue Oxygenation in Loaded Muscles of Individuals with Spinal Cord Injury” J Appl Physiol, 110: 246­55, 2011.

Kane, A., Warwaruk-Rogers, R., Ho, C., Chan, M., Stein, R., Mushahwar, V.K., Dukelow, S.P., “A Feasibility Study on Intermittent Electrical Stimulation to Prevent Deep Tissue Injury in the Intensive Care Unit” Advances in Wound Care, 6, 115-124, 2017.

Solis, L., S. Gyawali, S. L. Chong, C. A. Curtis, P. Seres, R. B. Thompson and V. K. Mushahwar, “Effects of Intermittent Electrical Stimulation on Superficial Pressure, Tissue Oxygenation, and Discomfort Levels for the Prevention of Deep Tissue Injury” Ann Biomed Eng, 39: 649-663, 2011.

Solis,L.R., A. Liggins, R. Uwiera, N. Poppe, E. Pehowich, P. Seres, R. B. Thompson and V. K. Mushahwar, “Distribution of Internal Pressure around Bony Prominences: Implications to Deep Tissue Injury and Effectiveness of Intermittent Electrical Stimulation” Ann Biomed Eng, 40(8):1740-59, 2012.

Solis, L., P. Seres, R. B. Thompson and V. K. Mushahwar, “Long-term effectiveness of Intermittent Electrical Stimulation in the Prevention of Deep Tissue Injury in Pigs” J Appl Physiol, 114(2): 286-96, 2013.

Hand using Rehabtronics Prelivia pressure injuries

ReJoyce and ReGrasp: Summary of Clinical Studies

Since the company was founded as a spinoff from the Neuroscience and Mental Health Institute of the University of Alberta, ReJoyce has been the subject of clinical studies around the world. Studies have tested the system with acute and chronic stroke and spinal cord injured populations. In many of these studies, ReJoyce has been combined with FES (functional electrical stimulation) devices for the hand such as the ReGrasp, another Rehabtronics rehabilitation device. Read on for summaries of some of the studies conducted. 

1

Computer Game Assisted Task Specific Exercises in the Treatment of Motor and Cognitive Function and Quality of Life in Stroke: A Randomized Control Study; Ozen S, Senlikci H.B, Guzel S,and  Yemisci O.Y; Journal of Stroke and Cerebrovascular Diseases, Vol. 30, No. 9 (September), 2021: 105991

30 participants with hemiplegia secondary to stroke were enrolled in the study. Patients were randomly assigned one of two groups: one hour “one-to-one” sessions of conventional physical therapy five days a week for a total of 20 hours four weeks, and one hour/day conventional occupational therapy seven days a week for a total of 28 hours four weeks. The interventional group received one hour of ‘one-on-one’ conventional physical therapy five days a week for a total of twenty hours within a four-week period. Furthermore, these patients received half an hour of conventional occupational therapy and half an hour of ReJoyce computerized exercise seven days a week for a total of twenty-eight hours. In the intervention group, Brunnstrom stages of stroke recovery (BSSR) of the hand improved significantly. The authors concluded that gaming systems such as ReJoyce may be considered a feasible option for stroke rehabilitation both in the hospital and home setting, especially in times such as the Covid-19 epidemic when home-based rehabilitation options are becoming increasingly important.

2

Passive Devices for Upper Limb Training: A. Prochazka  : Springer International Publishing 2016, 533 D.J. Reinkensmeyer, V. Dietz (eds.), Neurorehabilitation Technology, DOI 10.1007/978-3-319-28603-7_26

In the article, results of a RCT involving 13 tetraplegics who sustained a spinal cord injury more than a year prior are presented. In this study, participants were randomly divided into two groups, each performing Exercise Therapy (ET) at home while receiving tele coaching for one hour per day, five days per week for six weeks. The control group engaged in conventional ET, computer games played with a trackball, and 20 minutes of TES per day. Treatment participants used ReJoyce workstations to play computer games. Functional Electrostimulation (FES) was used to enhance voluntary hand grasps and releases using a wireless earpiece that detected small voluntary tooth clickings. Clinically significant improvements in upper limb function were observed in the treatment group.

3

Tele-supervised FES-assisted exercise for hemiplegic upper limb. Buick A, Kowalczewski J, Carson R, Prochazka A IEEE Trans Neural Syst Rehabil Eng. 2015;24:79–87.

As part of the prospective case study, ReJoyce was deployed in the homes of 11 chronic stroke survivors, 1 hour per day for a period of six weeks, as well as weekly telecoaching five days a week. The use of functional electrical stimulation assisted the opening and grasping of the hands. A significant improvement was observed in all functional tests, with the greatest improvement in the groups with a baseline intermediate score.

4

Use of accelerometers and MEPs to assess corticospinal excitability following novel combined therapy in chronic stroke Buick A., Unterschultz L., Kowalczewski J. , Prochazka A. Society for Neuroscience 42nd annual general meeting; New Orleans; 2012

This is a pilot study involving 3 chronic stroke victims with a mini-mental score greater than 24 and right-handed hemiparesis at least one year following the stroke. Functional Electrostimulation (FES) enabled participants to enhance their grasp and hand aperture. ReJoyce exercise therapy was performed telesupervised five days a week for six weeks. ReJoyce exercize therapy consisted of playing custom games with the aid of a surface FES hand stimulator that stimulated the muscles extensor digitorum (ED) and extensor pollicis longus (EPL) for hand opening. A tooth-click trigger was used to trigger the stimulator wirelessly. The hand function of all three subjects improved after six weeks.

5

Technology improves upper extremity rehabilitation. Kowalczewski J, Prochazka A. Prog Brain Res. 2011;192:147–59.

The study involved the deployment of Internet-connected ReJoyce workstations in the homes of 13 tetraplegic participants, located across a wide geographical region in Western Canada. A small team of therapists and students provided tele-coaching to participants on a daily basis. It was found that tele-coaching can be convenient and effective for both therapists and patients.

6

In-home tele-rehabilitation improves tetraplegic hand function.Kowalczewski J, Chong SL, Galea M, Prochazka A Neurorehabil Neural Repair. 2011;25(5):412–22.

Thirteen patients with C5-C7 tetraplegia were enrolled in a randomized controlled trial (RCT) comparing two treatment options. ReJoyce workstation with functional electrostimulation (FES) garment assisting regrasp and release in comparison to conventional exercise therapy with therapeutic electrostimulation. The treatments were tele supervised for six weeks at a rate of one hour per day, five days a week. It was concluded that the results were clinically relevant and were maintained for a period of three months.

Need Support for Your Clinical Study of Pressure Injuries?

If you are a pressure injury researcher, we would be delighted to support your study with access to Prelivia our new product, which is designed to protect patients from pressure injuries by restoring blood circulation and tissue oxygenation. Contact us to learn more!

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