Some U.S. Alzheimer's and dementia patients in the coming months will be receiving therapy from a rather unlikely source – Paro, a robotic replica of a baby harp seal.

Developed by Takanori Shibata, PhD, a senior research scientist at Japan's National Institute of Advanced Industrial Science and Technology (AIST; Ibaraki), along with Japanese Intelligent Systems, the robotic animal is about the size of an infant baby and resembles a child's play toy, replete with furry covering and sparkly eyes.

About 1,000 or so of the robots exist in other countries, and the cuddly device is being marketed here by Paro Robotics U.S. (Fort Myers, Florida).

Walt Weisel, CEO and chairman of Paro Robotics, argues that Paro is innovative med-tech, providing important therapeutic benefits, and anything but a child's plaything.

"It's not a toy," he told Medical Device Daily in a stern voice, indicating his dislike of that idea. "One of the things I'm worried about is that when this catches on [in the U.S.] people will try to market [Paro] that way. It's a true therapeutic medical device."

He said that Paro is what is known as a "mental commitment" robot, specifically developed to interact with human beings and to provide three types of benefits to patients: psychological, by encouraging relaxation and motivation; physiological, by promoting improvement in vital signs; and social, such as by instigating communication among inpatients and caregivers.

Beneath its furry white exterior, Paro features a hard inner skeleton under which dual processors are placed that control proprietary software behavior generation and voice recognition systems, and an array of sensors that, working together, enable Paro to respond in a lifelike manner. The Paro robot can "see," "hear," and move proactively as well as reactively, according to the company — in other words, programmed to behave like a real animal.

The seal has sensors, reacts to the slightest touch and has a front processor that interprets voice inflections. Highly flexible, it turns its head and moves its limbs. Paro even has a long-term memory and responds to what is called "preferred simulation, such as being stroked, and negative value on undesired simulation, such as biting. It operates with a simple on/off switch and can boot up in just 10 seconds.

The seal assigns "value" in relationships between stimulation and behavior. Users can't change Paro's behavior program manually, but the seal can be gradually "trained" in response to certain individual behaviors of its user. It can "memorize" and respond to a frequently articulated word, such as the name it's given.

To study the impact of Paro's interaction with elderly people, the company conducted a number of long-term experiments at several nursing homes in Japan. In the experiments, three questionnaires and a urinary test were used to assess results.

The questionnaires administered to patients analyzed their feelings and gauged levels of depression, while the "burn-out" questionnaire was administered to the nursing staff.

The urinary test was used to detect the presence of various hormones that might be activated in patients by interaction with Paro.

The results of these tests showed that the interaction with Paro can provide the same effects as real animals, such as the use of dogs in interacting with the sick and certain disabled groups.

For example, the company said that after playing with Paro for a time, a child who could not communicate and smile for more than six months, started to talk and smile again.

And elderly people showed a better ability to adjust to stresses after playing with Paro.

Analysis of answers to the "burn-out" questionnaire showed that the mental burden on caregivers working with difficult patients decreased with the use of Paro in the ward. One way this worked was by using Paro to play the role of intermediary between caregivers and their elderly patients.

The robot costs $5,000 a unit and runs off of a rechargeable battery.

The design process for Paro started in 2003, and the unit became commercially available in Japan in 2005.

Paro's developers said that initially they had used a dog as the robotic representation, but that this was rejected by many of the patients. Some of the dog models brought up old memories of past pets or were effectively a turn-off to some dementia patients. In one case cited by the company, a patient suffering from dementia was terrified of them because of still having the memory of being bitten by one when young.

A kitten also was used, but was found to be too polarizing. "Cat's really aren't good lap animals," Weisel said.

"A lot of research went into selecting a seal as the model," he said. "Because no one's ever held one before, that made the seal a perfect fit. We had to pick something that people aren't use to, so they wouldn't reject it."

Weisel, who has more than 30 years of experience in the robotic industry, was tapped by Japanese Intelligence Systems and Shibara in February to launch the robotics company to market Paro in the U.S. About $14.3 million was developed for capitalizing the company, primarily from Japanese Intelligence Systems and Weisel.

"Production for the U.S. is under way now," he said. "My goal would be to have some available by October or November. We're looking to have 300 produced by year's end."

Weisel said there will also be centers for repairing the cuddly constructs in cases of the inevitable damage by accidents or mishaps.

Other robotic products are in the planning stages, those products depending on the company's success here in the U.S. But Weisel is confident that the necessary success is just around the corner.

"I've been in robotics for more than 30 years," Weisel said. "And Paro is the greatest example of artificial intelligence that I have ever seen."