An experimental
exoskeleton device has given 12 paraplegics enrolled in a
clinical trial the opportunity to independently stand and walk. The ReWalk, a
user-controlled, wearable, motorized suit, allows patients with severe spinal
cord injuries to stand and walk with the assistance of crutches. Users must
have the ability to use their upper extremities in order to control the device.
“The device has the capacity to change or alter the way we provide
care to patients with spinal cord injuries and the expectations of what they
can do and accomplish,” Alberto Esquenazi, MD, chairman of the department
of physical medicine and rehabilitation at Moss Rehabilitation told
O&P Business News. “I believe the device will allow them
to be more mobile, maintain their bone density and it will certainly maintain
or improve their endurance.”
Although the patients remain paralyzed and their paralysis is in no way
changing, they are still benefitting from increased exercise. Several patients
in the clinical trial reported decreased spasms in their legs after walking
with the device.
“Working their cardiovascular and cardiopulmonary systems has been
beneficial to all the patients,” Esquenazi said.
The device has four motors — one on each hip and on each knee
— and weighs approximately 40 pounds.
“The weight of the device is of no critical importance,”
Esquenazi said. “The reason for that is because there is always one foot
on the ground and the system is connected from one side to the other. As such,
you are always transferring the weight to the limb that is on the floor.”
The ReWalk is worn around the legs. The user must also wear a backpack.
A microprocessor is placed inside the backpack along with a battery and a
backup.
The patient wears a sensor just above the pelvis. As the patient
generates forward body motion, the sensors trigger and the exoskeleton moves
forward one step at a time.
“It does not hurt in any way,” he said. “They are
basically wearing a brace on top of their regular clothing. They have no
sensation in their legs, but we have examined their skin and so far, there have
been no signs of breakdown or abnormal pressure on the skin.”
The patients attend training sessions to gain confidence in using the
device, and have not reported falling while using the ReWalk.
“You must train the patient to generate the movements so they are
coordinated, functional and efficient,” Esquenazi explained. “It is
difficult because they have no feeling in their legs.”
The patients, suffering from complete spinal cord injuries from the
mid-spine down, have been successfully using the device with little to no
complications. Esquenazi highlighted one patient who has been able to walk up
and down a flight of stairs.
“These are people who have been, on average, paralyzed and in a
wheelchair for 4 years,” Esquenazi said. “They are all excited about
walking again. In fact, all of the subjects have requested to be put on a
priority list to receive the device when it is commercially available.”
Currently, the ReWalk is in the experimental and clinical trial phase.
The Food and Drug Administration (FDA) must approve the ReWalk, which is made
by Argo Technologies in Israel. Esquenazi expects the FDA to approve the device
and if they do, researchers are hopeful it can be made available to the public
in the next 12 months.
“I think what you are going to see is that this device is going to
be commonplace and it will impact the way patients function,” Esquenazi
said. “It will give spinal cord patients a new sense of freedom. It is an
important addition to their quality of life.” — by Anthony Calabro
