On September 08, 2017, the Food and Drug Administration (FDA) approved Parker Hannifin’s request to expand Indego’s indications for use (IFU). This is great news for patients!
This expansion is a significant change from the previous FDA approved IFU, and now allows therapists to treat individuals with spinal cord injury at levels C7 and lower in rehabilitation institutions. Furthermore, it enables individuals with spinal cord injury at levels T3 and below to perform ambulatory functions at home and in the community.
Clinicians in U.S. rehabilitation centers are now able to use Indego with persons with C7 and lower SCI with ASIA Impairment Scale (AIS) A, B, C, or D.
The option for patients with tetraplegia or higher levels of paraplegia to walk, untethered, over inside and outside surfaces is not only highly motivating, but can also be a very effective therapy intervention. By adjusting Indego settings, clinicians are able to customize sessions, depending on each patient’s unique presentation and goals.
For clinicians who may not have as much experience using an exoskeleton with patients with tetraplegia or higher levels of paraplegia, the following recommendations may be helpful.
- A person with C7 SCI typically has full use of their shoulders, elbows, and wrists. However, the use of their hands, trunk, pelvis, and legs would either be impaired or absent. If the patient lacks strength in their hands and is unable to safely grip their stability aid, then a grasping glove may be required. These gloves come in many styles, but can effectively help the patient maintain his or her grip.
- Depending on their presentation, patients with tetraplegia or higher levels of paraplegia (T1-T4) may require the use of platform attachments on a rolling walker to improve their posture, upright control, and ability to use Indego with less effort. Platform attachments can be used unilaterally or bilaterally, and in combination with grasping gloves.
- Indego offers two different options for trunk support; regular height and tall height hip wings. Selection of the taller height wings will give patients additional trunk support when required.
- If the patient is having difficulty with orthostasis (decreased blood pressure when upright), using ace wraps on the legs and an abdominal binder may help control blood pressure. Blood pressure should be monitored before, during, and after Indego use.
Functional Transitions; Tetraplegia and Higher Levels of Paraplegia
When coming to stand, it is recommended to raise the mat height since patients with higher levels of injury may not have adequate upper body strength to come to stand from a lower surface.
During early Indego sessions, patients should have the assist of two trained staff for safety. Progressing the patient to the assist of only one staff member can always be done at the discretion of the Indego Specialist.
The two-person assist to stand works best with the Indego Specialist (IS) standing in front of the patient. The patient places his or her hands on the IS’s shoulders and leans forward while the IS provides lifting support. This technique is not unlike how a clinician would assist a patient to stand who is not in an exoskeleton. The second person helping would provide additional assist with the stand transition at the patient’s ischial tuberosities. Once standing, the stability aid can then be placed in front of the patient, and the patient’s hands can be secured to assist with grip if required.
Another option for coming to stand is to have the two persons assisting stand on either side of the patient, with the stability aid already in front of the patient. While the patient walks and returns to sit, continuing to have a two-person assist may or may not be required.
Two-person assist to stand with tetraplegic patient using grasping gloves
Assisting persons with high level of paraplegia, no grasping gloves
In the U.S., people with T3 and lower SCI are now able to purchase Indego for Personal Use.
Functional success and level of independence can depend on many factors aside from neurological level of injury including: body type (height/weight/short arms/long trunk); body awareness; sense of balance; trunk control; pre-injury athletic ability; age; spasticity level; pain; range of motion; and other co-morbidities. Clinicians are well aware that a person with a T10 SCI may or may not function better than a person with a T3 SCI in terms of upper body strength, transfers, and trunk control.
Regardless of thoracic injury level, Indego personal users and their support person must complete all competency skills to demonstrate mastery of the system. If for any reason the Indego user and support person team are not able to successfully complete competency skills with Minimal Assistance or less (FIM score of 4 or higher), they will not be cleared to take the device home. By continuing to hold Indego user and support person teams to the same high standards, the population in the expanded indications for use should continue to be safe to use Indego in their homes and community.
Indego’s expanded IFU in the U.S. could have a significant impact for patients in a rehabilitation setting now that persons with C7 and lower SCI can take advantage of this technology. Patients are highly motivated to train with Indego over inside and outside surfaces. The expanded indications for personal use will also provide Indego access to many of those who were unable to purchase previously due to their level of injury, not their functional ability.
This article was contributed by Clare Hartigan, PT, MPT. Clare is the Program Manager for Lower Extremity Robotics at The Virginia C Crawford Research Institute, Shepherd Center. Clare received her Bachelor of Science in Biology, Cum Laude, from Bucknell University in 1986 and a Master in Physical Therapy, Highest Honor, from Emory University in 1989. She has been working in the field of neurologic rehabilitation her entire career. Since 1991, she has been employed at Shepherd Center and served multiple roles as a clinician, supervisor/manager and researcher. Her work with exoskeletons began in 2010 trialing patients with Esko, ReWalk and Indego exoskeletons. Clare has conducted Indego research from 2010 to the present. Currently as a Certified Indego Instructor, Clare has travelled across the world educating and teaching others about exoskeleton technology. Clare is a member of the American Physical Therapy Association and the Neurologic Section.
Shepherd Center, located in Atlanta, Georgia, is a 152 bed, private, not-for-profit hospital specializing in medical treatment, research and rehabilitation for people with spinal cord injury, brain injury and multiple sclerosis.