Another Robotic Suit

Well, actually, it is the latest version of a company’s exoskeleton.

I just read the article and saw the video on YahooNews. I went to the ReWalk website and learned more about it. It says that ReWalk is the first exoskeleton to receive FDA clearance for personal and rehabilitation use in the United States. Then I noticed that the Stair Function is currently not available in the United States.

It appears to be designed for spinal cord injuries. It also mentions rehab for stroke victims and people with Multiple sclerosis. Yet, in the FAQ Section, it mentions that people with ALS, Cerebral palsy, Traumatic brain injury, etc. can use it. So, it might be something for those of us living with Kennedy's Disease.

ReWalk has over eighty training centers in the United States and hundreds more throughout the world. I don’t know what it costs, but it appears some insurance companies and the V.A. are using it for rehab purposes.

It appears there are three different units. I grabbed this from the article. "The lightweight, small, wearable suit is much simpler than ReWalk’s device that enables paralyzed patients to stand, walk and navigate stairs. Unlike the ReWalk 6.0, which includes robotic leg attachments that can weigh nearly 50 pounds, the soft exoskeleton looks more like the harness construction workers wear for safety than a bionic system. It consists of a waist belt fitted with a motor and battery, flexible cables that transmit power from the motor to the ankles, leg braces and shoe sensors. And it’s all activated by the flick of a switch.

ReWalk has not yet determined how much the soft-exoskeleton suit will cost, but says it will be more affordable than the ReWalk 6.0, which has a list price of $77,000."

Who can use it?

Before using the device, confirm that the following prerequisites are met by the user:

• Hands and shoulders can support crutches or a walker
• Healthy bone density
• Skeleton does not suffer from any fractures
• Able to stand using a device such as EasyStand
• In general good health
• Height is between 160 cm and 190 cm (5′ 3″ – 6′ 2″)
• Weight does not exceed 100 kg (220 lbs)

People with the following conditions should not use the ReWalk™:

• History of severe neurological injuries other than SCI (MS, CP, ALS, TBI etc)
• Severe concurrent medical diseases: infections, circulatory, heart or lung, pressure sores
• Severe spasticity (Ashworth 4)
• Unstable spine or unhealed limbs or pelvic fractures
• Heterotopic ossification
• Significant contractures
• Psychiatric or cognitive situations that may interfere with proper operation of the device
• Pregnancy

FDA Benefit-Risk Assessment

The National Organization of Rare Disorders (NORD) has distributed the following message to its members.  The KDA participated in the initial solicitation of support, but the current proposed guidelines falls a little short by not asking for patient input.  For those of us with Kennedy's Disease, ALS or MS, for example, I believe we would like a say in this process ... especially as the disease progresses.

Below is NORD’s message plus the link to their letter:

Update on Benefit-Risk Assessments

Benefit-risk assessments are the basis of FDA's regulatory decisions in the pre-market and post-market review process of drugs and biologics. The patient voice in this process is critical. In our letter to the FDA September 27, 2011,we expressed our hope that patients and patient organizations would be able to contribute toward the agency's decision-making in assessing the benefit-risk equation of new products as well as the amount of risk patients at various stages of their condition are willing to take, the quality-of-life challenges they face, the ways they receive information about the proper use of their therapies, how often they see and receive information from their physicians, and other information that FDA medical reviewers and other relevant FDA staff may benefit from knowing directly from patients.

The FDA published a draft of their “Proposed Approach to Benefit-Risk Assessment in Drug Regulatory Decision-Making” in February 2013.  Unfortunately, this draft- as currently written- falls short of the expectations to include the patient voice in the process.

Please review our comments to the FDA, which are due May 7.  Your voice and support of these comments is critical.  To sign on to these comments, please contact Diane Dorman, ddorman@rarediseases.org, no later than Monday, April 29. If you have additional questions, please do not hesitate to contact her.

View the letter.
 
A paragraph from the linked letter needs reinforcing.
 
“We believe that the benefit-risk framework would be substantially improved if it were revised to include the meaningful and timely involvement of patients. FDA should also establish mechanisms to communicate with patients, and receive information from patients, to enhance the factual basis of individual benefit-risk assessments in real time. Such a mechanism would serve FDA’s goal of avoiding incorrect assumptions about patient risk tolerance, as well as providing the contextual information that is key to the benefit-risk framework. We also believe that FDA can, and should, exercise leadership to include patients and to include the regulated industry which has the resources to develop the kinds of contextual data that FDA seeks. As new drugs, particularly those to address unmet medical needs, are continuously being offered for review, FDA needs an enhanced timetable for assuring patient input.”

If interested, I recommend that you contact your Senators and Representatives expressing your support of ‘patient involvement’ in the benefit-risk assessment process.

Rules to Live By

This weekend my wife showed me an article in the Chattanooga Sunday paper titled, “Four Rules for Living” by Dr. Nell Mohney. She interviewed a fifty year old woman with multiple sclerosis (MS) in 1999 who had been introduced to her by a friend. Zoe Koplowitz had lived a normal life until she was diagnosed with MS at the age of 25. Multiple Sclerosis is a chronic, progressive and disabling disease of the central nervous system that eventually leads to paralysis and blindness.

When Dr. Mohney interviewed her, Zoe had just finished her eleventh New York City Marathon, finishing the 26 miles in 30 hours.  Can you imagine … 30 straight hours?  That is amazing.

Ms. Koplowitz went through some of the same shock, why me and denial that most of us do when something like this happens. Over time, however, she accepted her situation and developed four rules to live by. As a result of her marathons, she wrote “Winning Spirit – Life’s Lessons Learned in Last Place.”
 
Zoe Koplowitz’s Four Rules to Live By:

1. If you don’t like what you see, change the channel. She believes God gives each of us a TV set with 100 channels. Only one channel has static ... reflecting on our disease, problems and difficulties. You can sit in front of the one channel with static, or you can change the channel. (It is your choice and she obviously changed the channel)

2. Have a mission or purpose in life. Zoe’s mission is to help children trapped in inner-city ghettos to develop confidence and self-esteem. She accomplishes this by visiting inner-city schools with other disabled athletes and telling them what it means to win. She also leads Marathon Strides for MS to raise funds for research.

3. Decide to be a winner. You can either pursue your dreams or fall by the wayside. The choice is yours.

4. Live your life with courage, faith and laughter.

Dr. Mohney said that there is no doubt Zoe Koplowitz lives by these rules. After a ten minute conversation with her, you will be motivated to change the channel if you are still on the station with static.

Learning to live with any disease is difficult.  However, we are all born with free-will … the ability to choose how we will respond to adversity and what our purpose in life will be. 

After reading the article I came up with four questions that I need to ask myself regularly.

• Will I recognize that the only disability in life is a bad attitude?
• Will I be a beneficial presence in this world? 
• Will I inspire others by my words and actions? 
• Will I look for opportunities to help another person or creature today?

The choice is mine to make.