Investigating Emotional, Cognitive, and Motor Planning Status Following Group Rehabilitation Therapy in Individuals with Parkinson's Disease: A Clinical Trial

assessment of the effects of group therapy on emotional well-being, cognitive function, and motor planning in Parkinson’s disease patients

This clinical trial is a randomized, double-blind, controlled study with parallel groups involving 30 patients. Randomization will be performed using a computer-generated sequence with allocation concealment.

The study will be conducted at faculty of rehabilitation of Tabriz University of Medical Sciences. Parkinson’s patients, after assessment and eligibility confirmation, will be assigned to intervention groups. Baseline and follow-up evaluations of emotional, cognitive, and motor status will be performed. The study is double-blind; outcome assessors and data analysts will be blinded to group allocation, and therapists will not be involved in outcome assessments.

Inclusion Criteria: Diagnosis of Parkinson’s disease by a specialist physician, Adequate cognitive level, Absence of serious comorbid conditions that would prevent participation in the study, Willingness to participate in the therapeutic interventions of the study, Provision of informed consent to participate in the study Exclusion Criteria: Concurrent participation in other therapeutic interventions that could affect the study outcomes, Presence of severe or chronic comorbid diseases, Inability to complete the required study assessments

Intervention group will be provided with cognitive, motivational, and motor activities based on the Moho model and with a cognitive-motivational approach, to improve emotion, cognitive function, and motor planning in 12 60-minute group sessions over 4 weeks. Control group will receive a conventional rehabilitation program including stretching, muscle strengthening, and endurance exercises with the same standard equipment, in the same number of sessions and duration.

Emotional status, Cognitive function, Motor function

Randomization Method: Participants who meet the inclusion criteria and provide informed consent will be randomly assigned in a 1:1 ratio to one of two groups: the intervention group (Group A) or the control group (Group B). Type and Unit of Randomization: In this study, block randomization with variable block sizes will be used to maintain balance in the number of participants in each group throughout the study. The unit of randomization is the individual participant. Block Size: Block sizes will be variable, consisting of blocks of 4 and 6 participants. This method helps to prevent prediction of the allocation sequence. Stratified Randomization: To ensure balance between groups regarding key variables, stratified randomization will be performed. The strata will be defined based on the following two main variables: Disease severity (according to the Hoehn and Yahr scale), Age group (less than 60 years, and 60 years or older) Generation of Random Sequence: The random sequence will be generated using Microsoft Excel and the RAND function. Separate sequences will be created for each stratum and then arranged into variable-sized blocks. Allocation Concealment: The allocation of participants to groups will be performed by an independent researcher who is not involved in recruitment, assessment, or intervention of participants. The randomization sequences will be kept in sealed and numbered envelopes. After each participant is enrolled, the researcher responsible for allocation will open the envelope corresponding to the next sequence to determine the assigned group. This method ensures that group allocation remains concealed from both the researcher and the participant until the appropriate time, thereby preventing selection bias.

In this study, a double-blind design will be implemented to reduce bias and increase the validity of the results; this means that both the outcome assessors and the data analysts will be blinded to the allocation of participants to the intervention and control groups. Participants will be fully informed of the group to which they are assigned; however, to prevent expectation bias, detailed and specific information about the differences between the interventions will not be provided, and only general explanations regarding the study’s purpose and the type of interventions will be given. This approach is conducted in accordance with ethical principles and respect for participants' right to be informed. Assessors who measure emotional status, cognitive function, and motor planning will operate independently and will have no access to group allocation information. Additionally, therapists delivering the interventions will not be involved in outcome assessment or data analysis. Data analysts will also conduct statistical analyses blinded to group allocation to prevent bias.