1. Introduction of contractors

In this section the contractors of this project assignment will be introduced.

1.1 Client

Fisioterapia Alcobendas is a private practice specialized in physiotherapy treatments. Its owner is Marc van Zuilen, HvA graduate who has been operating his own clinic since 1999. The clinic’s main objective is to provide quality and personalized healthcare to the community and its clients. Among the areas of expertise , the following can be listed: tendinitis, hernias, low back pain, whiplash, cervicalgia, tennis elbow, rheumatoid arthritis, arthrosis, scoliosis, plantar fasciitis, fibromyalgia, cystic fibrosis, asthma, neuropathies, spina bifida, Bell’s palsy, etc. Besides being the owner of the clinic, Marc van Zuilen is also a lecturer for Universidad de Alcalá de Henares, Universidad de Castilla La Mancha, Asociación Fisioterapia Deporte de Élite. As part of his professional endeavours, by having this product in his hands, would benefit both the clinic and his actualization for use in lecturing.

The client would like to employ for use in his practice a systemized recommendation for exercise for patients with diabetic peripheral neuropathy (DPN). Providing the client with an evidence based approach toward treatment of DPN would improve the outcomes in their patients well being and would provide the clinic with a valuable tool to employ in prescribing the appropriate treatment parameters for this group.

1.2 Educational Institution

Hogeschool van Amsterdam, located at Amsterdam, Tafelbergweg 51, 1105 BD, pertaining to the Amsterdam School of Health Professions (ASHP) the European School of Physiotherapy (ESP), represented by our coach- Cia Kesselaar.

1.3 Students

Mihaela Cosarca and Finda Morsay, last year ESP students will be researching this topic as their professional assignment project.

1.4 Contact information contractors

2. Assignment

In this section the assignment proposed by the client will be introduced. Then, the background of the assignment will be described. Furthermore, the end products will be defined and the physiotherapeutic clinical relevance will be explained.

2.1 Introduction assignment

Fisioterapia Alcobenda is a well known, established institution in the surrounding community of Madrid, Spain. It is dedicated to the wellbeing of the community it’s serving. The clinic would like to apply an evidence based approach to treatment of some of the most common pathologies encountered in their patients: diabetic neuropathy. In order to do that, they would like to have available a research on the recommended exercise interventions supported by literature. By making use of this tool, the clinic will ensure the best results in their patients.

The purpose of this assignment is to investigate diabetic peripheral neuropathy (DPN) as a complication from diabetes and to present the evidence based in favor of exercising as a treatment modality that could prevent, delay or halt the course of this disease. Further on, we will focus on determining which exercise interventions should be incorporated into treatment plans for this group of patients and conclude which parameters of exercising are proven to be effective (type, intensity, frequency, duration).

This project plan is developed by Mihaela Cosarca and Finda Morsay, students at the European School of Physiotherapy (ESP) in order to provide a structural approach to tackle the project assignment proposed by our client.

2.2 Background problem and clinical relevance

In 2011, WHO estimated that 347 millions people worldwide were suffering from diabetes, with an estimated annual death toll of 3.4 millions. The International Diabetes Federation has an updated number for 2013: 382 mil people worldwide living with diabetes with a forecasted 55% increase to reach 592 million by year 2035.

Diabetes is an epidemic and people diagnosed with diabetes are at increased risk of developing a series of serious health problems: cardiovascular disease, nephropathy, neuropathy, retinopathy or dental disease (CDC 2011). According to American Diabetes Association (2011) of people diagnosed with diabetes, 60-70% will develop peripheral neuropathy and this complication has been deemed responsible for more than 60% of all non-traumatic amputations, in addition to contribution to other consequences: decreased sensation and strength, decreased proprioception, decreased reflexes, poor balance and increased risk of falling, decreased confidence, decreased level of activity and participation and overall decreased quality of life.

The 2010 joint statement of ACSM and American Diabetes Association (ADA) recommends different exercise interventions mostly for prevention and control of insulin resistance diabetes and to prevent complications. Similarly, a Cochrane review (Thomas et al. 2009) found that exercise was beneficial for people with diabetes as is correlated with glycemic control and significantly contributes to reduction in visceral and subcutaneous adipose tissue, decreases triglycerides and increases insulin response. However, this review did not research the effect of exercise on DPN. The purpose of our study is to determine if exercise is a valid treatment modality for DPN and it will go further into details and to probe which exercise interventions are benefic for those diabetes patients who developed neuropathy and in which combination.

The standard of care for diabetic peripheral neuropathy is based on a number of drugs and emphasis on feet care, but the main problem of the pharmacological approach is the fact that it produces side effects (Wamboldt et. al 2006), has been proven to have moderate to no improvement on this condition (Zochodne et. al 2008) and lacks the ability to lessen the progression of DPN (Zilliox et. al 2011, Callaghan et. al 2012).

It is our responsibility as healthcare professionals to improve the odds of this patients and to contribute to a better quality of life for this population. In physiotherapy practice, the physiotherapists make use of different treatment modalities for various conditions. Exercise is one of the most accessible and easily prescribed intervention with successful results in many pathologies. Given the existing literature will prove exercise as a worthy intervention, we believe it has the potential to change the course of the disease and the quality of life of the DPN patients and it will be a useful tool in any clinic that treats these patients.

Through this review, the students intend to research the main medical databases and to analyze the selected literature to determine the effectiveness of different exercise interventions in the treatment management of DPN. The findings will fill the lack of knowledge on the validity of this intervention as treatment of DPN and will outline the specifics of the treatment as evidenced by literature. This study has the potential to formalize the use of exercise as an evidence based modality for the treatment of peripheral neuropathy in diabetic patients.

3. Description of research question

3.1 Methods

All the delivered end products must meet the requirements of a Bachelor’s degree. In order to complete this task, the students will use the following resources:

3.1.1 Search strategy

To gather the studies for both background information and the systematic review part, we used the following methods:

1) For the evidence based part for the systematic review the students recruited RCT’s, systematic reviews, meta-analysis and existing guidelines. The search was conducted in the following databases: PubMed, PEDro, CINAHL, Cochrane, TripDatabase, ScienceDirect and Google Scholar. An individual Cochrane search was conducted to prevent any systematic reviews being omitted during the first step.

2) For all the background information considered relevant for this topic, we also gathered:

• articles from the reference list contained in the systematic reviews and guidelines and
• articles found through the aforesaid databases that fall under the inclusion/exclusion criteria.

3.1.2 Keywords

The keywords and the MESH terms (Medical Subject Headings) used were:

3.1.3 Inclusion criteria

For the background information on DPN, case series, population-based studies, clinical trials, clinical and pilot studies, randomised-controlled trials (RCTs), systematic reviews and guidelines published between January 2000 and September 2014 were taken into consideration. The background information focuses on definition, factors involved in pathogenesis of DPN, incidence and prevalence, clinical presentation: signs and symptoms, risk factors, diagnostic methods, evaluation (EBP scales) and prognosis, available treatment methods. The inclusion of these articles was considered only if they were included in the reference section of an existing guideline or systematic review.

For the systematic review- guidelines, systematic reviews, meta-analyses and randomized control studies published between 2000 and September 2014 were included. Available scientific studies in languages other than English or Spanish were excluded. In addition, some RCTs and case series were also included as long as they were published at a posterior date to the latest systematic reviews or guidelines.

3.1.4 Exclusion criteria

3.1.5 Criteria for grading articles

The articles are graded according to the Pedro criteria list (see appendix ?). In order to assess the

quality of the criteria list, we conducted a pilot study where articles were individually graded and

scores were compared by the reviewers. Where there was disagreement, discussion was done to reach a consensus. The list consists of 10 questions, scored between 0 and 1, max score 10. Each

article was scored as follows:

Good- if scored < 6 – 7

Very good – score between 7 and 9

Excellent – if scored 9 or 10

After the screening process with the criteria list ?? articles were considered relevant for the study.

4. End Products

The end products that will be delivered by the students are:

1. Project Plan- this document is meant as an organizational framework for the project. It outlines the content of the final end product of our PAP: a systematic review to help determine if using exercise as a treatment modality in the management of DPN is recommendable as good practice for PTs and other healthcare professionals. This plan describes the manner in which the students can guarantee quality end products. Efficient work is ensured by a clear task division and a thorough schedule. Buffer days/ weeks are set up to allow margins for the unexpected factors. Lastly, the quality of end products feedback and evaluation of the work is assured through collaboration with competent professionals and guidance from the ESP coach.

2. Systematic Review: the objectives of the proposed review are the following:

• To serve as an EBP tool for practitioners and students looking for an updated solution for using different exercise interventions in the management of DPN
• To provide practical guidance based on corroborating any existing EBP guidelines and including latest literature in terms of the exact interventio, the duration, frequency and the length of a standard treatment that could be beneficial for patients with this diagnosis.
• To provide a list of most common findings encountered through our research and conclude if exercise can be recommended and at what stage of the pathology can give a better prognosis- if evidence allows this conclusion
• Recommendations for future research

3.PowerPoint Presentation– on ………………………the students will present the project. The specifics of the investigated intervention will be thoroughly explained with the accent on the most relevant findings of the review.

5. Project phases

For optimal management, the project will be divided into three phases: preparation phase, decision making phase and completion phase.

5.1 Preparation phase

The preparatory phase (week 37 to.. ) was dedicated to an orientation and selection of relevant literature and an outlining of the project. At the moment, the project is more defined and a more concrete design process is under construction. In this phase the following activities take place:

• Online or phone meetings with the client and personal meetings with the PAP coordinator
• A contract between client, student and the university
• A project plan is being written by the students and approved by the assigned coach

5.2 Decision Making and Progression phase

In the decision making phase (week AA to AAA) the following activities take place:

• A progress report is made weekly and discussed with the coach
• A personal report is drawn up every two weeks
• Every day the student dedicates 6-8h/ day for synthesizing the selected literature and writing of the thesis
• Realization of project: deliver systematic review, leaflet and reports
• The presentation title plus brief description is submitted

5.3 Completion phase

In the completion phase (week AAA to BBB) the following activities will take place:

• A presentation of the results: given by the student
• The final interview with the coach to discuss: the process report and the personal report, the end product (protocol and thesis) and feedback of the client
• Submitting products to PAP coordinator

6. Goals

6.1 Individual SMART goals

MIHAELA

FINDA

6.2 Group SMART goals

6.3 End Product goal

7. Process

7.1. Pitfalls and safety net planning

7.2. Quality control

7.3 Rules and regulations for work

7.3.1 Task division

7.3.2 Coach contribution

8. Planning and timetable

The following are the external deadlines for the products

Deadlines and Official PAP coordinator & coach meetings (proposals)

Official client meetings

[1]to be determined which period we use