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1 Member of the International Support Association for the Rehabilitation of Children and Youths e.v. Walkmühlenstr. 1 D Bremervörde Phone: +49 (0) 4761 / or -63 Fax: +49 (0) 4761 / info@thomashilfen.de

2 Thomashilfen Kinder- Reha

3 Schlummer-Tagebuch Dear parents, With the MiS Micro-Stimulation system Thevo-Adapt Sleeping Star we have developed a pressure care and positioning system for children, which provides for the improvement of the quality of sleep and positioning. The subject decubitus (getting bedsores) is a problem which is often underestimated with children. We have now evidenced the functionality and efficiency of MiS Thevo-Adapt Sleeping Star in a clinical study. 2Foreword / Contents Due to their disability and illness, a lot of children suffer from sleep disorders, which influence the general well-being. The reasons for this are diverse and often complex. With this brochure we would like to show you some experiences of parents and therapists in order to introduce this subject. We would like to offer you the possibility to learn more about the sleep behaviour of your child and to find new methods of resolution to improve the quality of sleep. Yours Contents MiS Thevo-Adapt Sleeping Star pressure care system Clinical trial Park Schönfeld MiS Thevo-Adapt Sleeping Star positioning system 05-11

4 Sleeping-Diary MiS Sleeping Star pressure care system The MiS Micro-Stimulation system Thevo-Adapt Sleeping Star for children has been clinically tested on behalf of Thomashilfen. Fa. Thomashilfen Walkmühlenstraße Bremervörde Children s Hospital Park Schönfeld Ward P3 Kassel, Germany Kassel, Sept. 16, 2001 Clinical trial of the pressure care system Thevo-Adapt Sleeping Star for children Tested object: The pressure care system for children Thevo-Adapt Sleeping Star Name of testing clinic: Children s Hospital Park Schönfeld, ward P3, Kassel, Germany This clinical trial was accompanied by IGAP on behalf of Thomashilfen. Short description of the institution: The children s hospital Park Schönfeld houses a total of more than 138 hospital beds. These include a total of 12 beds in an early rehabilitation ward for children after craniocerebral injuries. These ill babies, toddlers, schoolchildren, and juveniles up to the age of 18) are medically treated, nursed, and given therapy by a multifunctional team. The meaning of pressure ulcers to the childish patients: The subject decubitus has not been a focal point within general pediatrics, so far. However, when nursing seriously ill and disabled children the prevention and treatment of pressure ulcers is an important task for the team in charge. All children in a coma or with apallic syndrome/waking coma (ventilated, partly ventilated, and breathing independently) require special attention directed to the largest organ of the human body, the skin. Healthy nutrition, skin care, and professional skin stimulation, positioning, and positioning aids provide for an optimum care of an intact skin. A good lying surface can have an additional positive effect here. However, finding the right mattress for people in coma or waking coma is quite difficult. It has to fulfill certain prerequisites for the well-being and the support of the therapies of the patient (not too soft, not too stiff, creating no noise, ). Clinical trial 3

5 Schlummer-Tagebuch MiS Sleeping Star pressure care system Duration of clinical trial: In a test phase of approx. 6 months, the pressure care system was tested exclusively with 4 children aged 4 to 6 (in a coma / waking coma). The children clearly showed us when they felt bad and good by changing the critical signals, eye movement, bodily tension and/or skin coloration. Results and observations made during the clinical trial: The team of the early rehabilitation ward comes to the following conclusions resulting from targeted observations: Clinical trial The patient does not lose his own body feeling The patient does not lose his body perception The patient does not lose orientation by movement and/or positioning Pressure is relieved at the entire body Any kind of positioning can be carried out Positioning inside, as well as transfers into and out of the bed can optimally be carried out Own body movements are possible It is possible to maintain excellent skin conditions (no pressure sores observed after 8 hours of lying down) Longer and deeper sleep phases could be observed at 3 of 4 children No additional sweat was produced Easy handling, relatively low weight Easy to clean Suitable for any type of hospital beds (commonplace hospital beds, standing beds, floor positioning) Optically appealing and suitable for children Recommendation: Recapulating we can say that this pressure care system absolutely meets our demands. The childish patients obviously feel comfortable on the system. The system is well received by the parents. All in all the care for the children has become considerably easier. Therefore we can recommend the use of t he pressure care system Thevo-Adapt Sleeping Star from our point of view. The children s early rehabilitation team in the children s hospital Park Schönfeld 4

6 Sleeping-Diary MiS Sleeping Star pressure care system, experience reports The experiences and impressions of parents using the MiS Micro-Stimulation system Thevo-Adapt Sleeping Star have been documented on the following pages. The quality of sleep has been described before and after the use of the system. Below please find a brief introduction of the children and their clinical pictures. (Names and pictures have been changed for data protection reasons.) Philipp Julia Male, 4 years, 1.05 m, 11 kg Diagnosis: ICP, flexion contractures Lucas Laura Torben Shari Female, 6 years, 1.02 m, 14 kg Diagnosis: Muscular dystrophy Male, 5 years, 1.20 m, 19 kg Diagnosis: ICP, epilepsy Female, 7 years, 1.18 m, 35 kg Diagnosis: Multiple disability, adiposity, blind Male, 3 years, 0.87 m, 14 kg Diagnosis: Epidermolysis bullosa Female, 4 years Diagnosis: Idiopathic focal epilepsy 5

7 Schlummer-Tagebuch Philipp Philipp s father: What a relief. After a long time my wife and I can finally sleep 6 Sex: Male, 4 years, 1.05 m, 11 kg Diagnosis: ICP with distinct spasticity, flexion contractures Before Philipp suffers from spasticity with flexion contractures in hip and knees. Due to a lung problem a lateral positioning is possible only. Re-positioning every 1 to 2 hours. When in pain he needs to be re-positioned every hour. After After 4 weeks positioning on Sleeping Star the high spasticity considerable decreases during night. Due to the system the pressure can be reduced during lateral positioning and thus a clear relief is achieved. Consequently Philipp is free of pain and a re-positioning is necessary every 3 to 5 hours only. through with a good feeling again.

8 Sleeping-Diary Julia Julia s mother & therapist: We are so happy and relieved that her condition has improved so fast. Finally, Julia has a restorative sleep again. Before Julia suffers from a severe muscular dystrophy. She can make limited movements only. Due to her strong pain repositioning is necessary every 2 hours. Sex: Female, 6 years, 1.02 m, 14 kg Diagnosis: Muscular dystrophy After Already after 3 weeks using Sleeping Star, Julia is able to sleep through for 3 to 4 hours without re-positioning. The pain during the night has considerably decreased. 7

9 Schlummer-Tagebuch Lucas Lucas mother: After having tried so many things we have finally found something that helps. It is such a good feeling to see 8 Before Sex: Male, 5 years, 1.20 m, 19 kg Diagnosis: ICP, epilepsy Lucas suffers from ICP with high spasticity and relatively few own movement. He sleeps for 8 hours with a lot of interruptions; in bad phases Lucas wakes up 10 to 12 times. Unbalanced and cranky the next day. Difficult to stand therapy. After Already after a few nights the spastics have decreased by 30% during night and day. Lucas wakes up during night 1 to 2 times only. Amazingly, Lucas sleeps through all night after 2 to 3 weeks. During the day Lucas is well-tempered and the therapy is more pleasant for both mother and child. how even-tempered Lucas is in the morning.

10 Sleeping-Diary Laura Laura s mother: I was almost at the end of my rope, nothing has really helped. I am so glad that Laura is more relaxed. Thus, our family feels much better again, too. Before Delayed in her development and movement. Severe problems to fall asleep and sleep through. Waking up every hour. Unbalanced. Crying a lot. Sex: Female, 7 years, 1.18 m, 35 kg Diagnosis: Multiple disability, adiposity, blind After Due to her blindness, Laura got in contact with Sleeping Star by touching and immediately liked it. Already after one week she is able to sleep through for 4 hours. Laura is more relaxed. Therapy brings positive results (visible success). 9

11 Schlummer-Tagebuch Torben Torben s mother: I am so glad that Torben does not need to suffer that much pain during the night anymore, and that I am 10 Before Blistering due to pressure and shear, poor moisture removal. Strong pain. He sleeps for a total of 7 hours, but with a lot of interruptions. Male, 3 years, 0.87 m, 14 kg Diagnosis: Epidermolysis bullosa After Due to the optimum adjustable positioning on Sleeping Star a significant reduction of the blistering could be achieved. Due to the incontinence cover the important features like moisture removal and pressure reduction did not change. able to sleep better, too.

12 Sleeping-Diary Shari Shari s mother: I am so glad that after such a short time a fantastic improvement has taken place. Finally, Shari and we get a restorative sleep again Before With the aid of a cuddle cloth or baby blanket Shari tried to get into sleep with stereotype movements (frog movements). Severe disorders with getting into sleep and sleeping through. This strongly affected the family life from (7.00PM) on. Only minimal sounds were enough, and Shari was immediately wide awake again. Upon the advice of the neurologist Shari got sleeping pills (Melatonin) each evening. Sex: Female, 4 years Diagnosis: Idiopathic focal epilepsy After Now the parents can turn on the light without having to be afraid that Shari wakes up. No more sleeping pills have to be administered in the middle of the night. Shari s typical stereotype movements now only appear after seizures. The Falling asleep situation has considerably improved. Now Shari does need less than 2 hours to calm down and fall asleep. 11

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