A randomized controlled trial to compare the effect of competitive and noncompetitive exercises (playful ball exercises) with nonlinear pedagogy method on functional balance and mobility, eye movements and activity level of trunk muscles in patients with Parkinson's disease

The aim of this study is to compare the effect of competitive and noncompetitive exercises (playful ball exercises) with nonlinear pedagogy method on functional balance and mobility, postural control, eye movements and activity level of trunk and ankle muscles in patients with Parkinson's disease.

This study is a controlled randomized trial with parallel groups and blinded outcome assessment. Forty-eight patients with idiopathic Parkinson's disease will participate in this study and they will be randomly assigned to three groups: a group receiving playful ball exercises in a competitive non-linear pedagogy method, a group receiving playful ball exercises in a noncompetitive non-linear pedagogy method and control group. Randomization will be performed by the person who is not involved in the study using sequentially numbered sealed envelopes.

This study will be performed in Djavad Mowafaghian Research Centre of Intelligent Neuro-Rehabilitation Technologies. Control group receives conventional rehabilitation. Competitive and noncompetitive non-linear pedagogy playful ball exercises groups receive 24 sessions of playful ball exercises in the form of volleyball (8 weeks, 3 sessions per week, 90 minutes per session) in addition to conventional rehabilitation. To induce competition in competitive group, exercises are associated with scoring while there is not any scoring in non-competitive group. Assessment of primary and secondary outcomes is performed by individuals who are blinded to the groups allocation before and after receiving playful ball exercises and 8 weeks after receiving these exercises in the intervention groups and before and after conventional rehabilitation and 8 weeks after conventional rehabilitation in the control group.

In this clinical trial study, 48 patients with idiopathic Parkinson's disease will participate. The main inclusion criteria include having Parkinson's disease according to the neurologist diagnosis, age between 35 to 70 years, having the disease's progression level of 1 to 3 according to Hoehn and Yahr Scale, an acceptable level of cognitive function, i.e. score of equal or greater than 24 on the Mini Mental State Examination. Subjects are excluded in the case of co-morbid other neurological diseases, orthopedic disorders, diabetes or addiction; having pathologic dementia or Juvenile Parkinsonism.

Control group; Group receiving playful ball exercises in a competitive non-linear pedagogy method; Group receiving playful ball exercises in a noncompetitive non-linear pedagogy method

Functional balance and mobility; Eye movements; Trunk muscle activity

Randomization will be performed by the person who is not involved in the study using sequentially numbered sealed envelopes.

Evaluation of the primary and secondary outcomes is performed by experienced individuals who are blind on the groups allocation.

After the completion of this study, a manuscript regarding the documentation and the results of the study will be prepared and published. If more details are needed, individuals can send their request by email to the person responsible for scientific accountability.

8 months after publishing the results

Researchers working in academic and scientific institutions

Use of the documentation is permitted upon written permission.

Ghorban Taghizadeh Adsress: Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran Tel: 00982122227124 E-mail: taghizadeh.gh@iums.ac.ir

Just sending a request by email and mentioning the explanation about the cause of the need for documentation is enough.