A randomized controlled trial to compare the effect of competitive and non-competitive non linear pedagogy exercises (playful exercises in the form of volleyball) on sensory and motor function of upper extremity and eye movements in people with Parkinson’s disease

The aim of this study is to compare the effect of competitive and noncompetitive exercises with nonlinear pedagogy method on sensory and motor function of upper extremity and eye movements 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: competitive playful ball exercises group, noncompetitive playful ball exercises group and control group. Randomization will be conducted by an individual who is not involved in the study using sealed envelopes method.

This study will be performed in Djavad Mowafaghian Neuro-Rehabilitation Research Center. 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. Assessors are blind on the groups allocation.

The main inclusion criteria are: having Parkinson's disease according to the neurologist diagnosis, 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 24 on the Mini Mental State Examination). Subjects are excluded in the case of co-morbid other neurological diseases or Juvenile Parkinsonism.

Control group; Competitive playful ball exercises; Noncompetitive playful ball exercises

Upper extremity motor function including motor-control related parameters (e.g. peak velocity, movement time, etc) and gross manual dexterity; Eye movements parameters (saccade latency, peak velocity and amplitude)

The patients who were included in the study will randomly allocated to one of the following three groups: control group or competitive playful ball exercises group or noncompetitive playful ball exercises group. Randomization will be conducted by an individual who is not involved in the study using sealed envelopes method. A letter indicating the intervention group is placed in a sealed opaque envelope and the envelopes will kept in the randomized order in a container. For each patient, one envelope will be randomly drawn from the container and the intervention group of that patients will be determined based on a letter in the envelope.

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, Tehranو Tel: 00982122227124و 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.