CLINICAL TEST CONCEPT

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CLINICAL TEST CONCEPT Alu Rehab AS Bedriftsvegen 23 4353 Klepp Stasjon Norway T: +47 51 78 62 20 F: +47 51 42 58 25

1 CLINICAL TEST CONCEPT Alu Rehab AS Bedriftsvegen Klepp Stasjon Norway T: F: Org.nr: NO MVA Bank: Edited by; Hans Sagen Edition; A

2 The Clinical Test Protocol for Comfort Wheelchairs Background and purpose of the clinical test protocol Alu Rehab committed to the clinical testing or its products and has conducted clinical studies together with users and clinicians on a wide range of their products: Netti Dynamic System, Netti III, Netti 4U products, Netti Vision and Netti Mini. So far, these clinical tests have been conducted in Norway, Germany, France, China, Japan and South Korea. The clinical test protocol is developed to measure outcomes when using different types of seating interventions or specific seating strategies for specific users or user groups. Measuring outcomes helps to determine if using Netti comfort wheelchairs or what adjustments can benefit the wheelchair user most. In addition the clinical testing provides information about: - How to improve seating interventions and seating strategies for the wheelchair user - Clinical applications and clinical limitations of product solutions - Feedback from users and the clinical community on when and how to use the each specific product. - New ideas for seating interventions, product development and product improvement. - Developing a comprehensive, best practice-based communication platform documenting possible features and benefits of the Netti comfort wheelchairs and their accessories. - Developing content for training and education programs. - How to explain Netti by Alu Rehab products and accessories, build clinical arguments, assessment techniques and fitting strategies. Alu Rehab organizes seminars on seating assessments techniques and the use of the clinical test protocol, seating interventions on specific clinical cases/diagnosis and on postural and mobility management of different diagnosis with specific seating challenges. Netti by Alu Rehab commits using and collecting the data from the clinical evaluations in an ethical way. About the clinical test protocol The specific clinical test protocol and the assessment form has been developed by Mr. Bart Van der Heyden, PT and an independent wound care, seating and mobility specialist. More info: The clinical test protocol can be used to collect data and measure outcomes when using seating and positioning systems and helps documenting seating interventions. The form will ask questions to get a better understanding of the client s situation, clinical challenges and goals and will try to document seating and/or clinical interventions and record their impact on the client. Sequences of the clinical test 1. Sign the release and user s authorization form. 2. Document the user s clinical data and initial posture 3. Document the user s functional ability and current seating solution (Pre Intervention) 4. Document the seating goals for a new seating intervention 5. Document the user s posture in the new seating intervention (Post Intervention). 6. Document the user s functional ability and new seating solution 7. Document the seating outcomes of the new seating intervention

3 The clinical test protocol template consists of 10 pages and is easy to use for care givers. Analyzing the impact of Dynamic Seating Components on the wheelchair user s seating position: A case review of 3 wheelchair users with Cerebral Palsy Background Cerebral palsy is a disorder of movement, muscle tone and / or posture that is caused by an insult to the immature, developing brain. In general, signs and symptoms are impaired movement, exaggerated reflexes, floppiness or rigidity of the limbs and trunk, abnormal posture, involuntary movements, unsteadiness of walking or a combination of these. Seating challenges linked with the lack of postural stability, reduced joint range of motion, involuntary movements and variations in tone are challenging to accommodate with seating. When involuntary movements or variations in tone occur with fixed distal segments, movements of proximal segments will occur which may impact core postural stability and functional seating. Normal seating systems would provide an environment for the user in which the distal segments meet considerable external resistance or resists movement caused by reflexes or involuntary movement. As a result of this, movement or instability of proximal segments can be expected. (1) Dynamic seating systems or dynamic components enable distal movement, creating an open kinetic chain (1), which may help to stabilize proximal segments and increase core seating stability and postural alignment. The purpose of this clinical evaluation was to analyze the outcomes of using dynamic seating components with users with cerebral palsy. Methodology Four cases have been review over a 3 to 6 months period. A seating assessment was performed with each wheelchair user prior to using a dynamic seating intervention. Tone, range of motion, posture, skin integrity and ADL status were assessed and S.M.A.R.T (Specific, Measurable, Achievable, Relevant and Time related) goals for the dynamic seating intervention were set. Posture, tone, range of motion and ADL status were checked immediately after the dynamic seating intervention and each month following the dynamic seating intervention. The seating outcomes were measured by evaluating the initial S.M.A.R.T goals for a period up to 6 months post dynamic seating intervention. Case report 1 will be shown on the next page.

Results case report 1 Seating intervention: Netti Dynamic Tilt and Recline Wheelchair, Netti by Alu Rehab M.O.

2014: 18 years 75 kg / male Assistive Independent Living center resident CP / Spastic Diplegia Very strong tone Cognitive impairments

Extremities Hip flexion limitation 90 degrees left and right Tight Hamstrings Windswept hips to L Postural Goals, Dynamic Seating

Decrease sliding: now every 10 min when seated - Address wear and tear on the equipment breaks as seating system breaks frequently due

s Netti Dynamic Wheelchair Seating outcomes on July 14 th, 2014: - Controlled movements & spasticity frequency: o Client has less tone

4 Results case report 1 Seating intervention: Netti Dynamic Tilt and Recline Wheelchair, Netti by Alu Rehab M.O. Initial Seating Solution Findings seating evaluation M.O. Feb. 2014: 18 years 75 kg / male Assistive Independent Living center resident CP / Spastic Diplegia Very strong tone Cognitive impairments Extension tendency Right Lower Extremity C- Scoliosis convex Right Symmetric Tonic Neck Reflexes, Athetosis Functional Upper Extremities Hip flexion limitation 90 degrees left and right Tight Hamstrings Windswept hips to L Postural Goals, Dynamic Seating Solution: - Address Tone: o Controlling movements & spasticity frequency o Decrease repositioning after sliding: now every 10 min o Decrease sliding: now every 10 min when seated - Address wear and tear on the equipment breaks as seating system breaks frequently due to high-tone episodes. - Improve symmetry to increase manual wheelchair propulsion ability M.O. s Netti Dynamic Wheelchair Seating outcomes on July 14 th, 2014: - Controlled movements & spasticity frequency: o Client has less tone and sits more aligned and stable even after spastic episodes. - Address wear and tear on the equipment: No visible signs of wear and tear after 5 months of use - User sits in the chair from 8-11am, pm, pm, repositioning need 5-10 times a day before up to every 10 min when seated.

Conclusion - outcomes Dynamic seating interventions which enable distal movements by creating an open kinetic chain, impacted: (1) the stability of

users with CP. M.O. during low-tone episodes (bottom, previous page) and high-tone episodes (this page) episodes (Netti Dynamic System) Reference 1.

5 Conclusion - outcomes Dynamic seating interventions which enable distal movements by creating an open kinetic chain, impacted: (1) the stability of proximal segments, (2) seating times, (3) sliding, (4) repositioning frequency, (5) tone, (6) pain and (7) equipment wear and tear on the wheelchair users with CP. M.O. during low-tone episodes (bottom, previous page) and high-tone episodes (this page) episodes (Netti Dynamic System) Reference 1. Ellenbecker, T.S., and Davies, G.J. (2001). Closed Kinetic Chain Exercise: A Comprehensive Guide to Multiple Joint Exercises, (1st ed.). Champaign, Ill.: Human Kinetics.

PURPOSE OF A COMFORT WHEELCHAIR

PURPOSE OF A COMFORT WHEELCHAIR PURPOSE OF A COMFORT WHEELCHAIR FEEDBACK AND ANSWERS FROM DISCUSSIONS WITH HEALTH PERSONNEL Get up from bed and be more healthy Long term passive seating is dangerous. A