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CTRI Number  CTRI/2024/04/065445 [Registered on: 09/04/2024] Trial Registered Prospectively
Last Modified On: 05/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Effect Of Resistance Training With Task Oriented Training And Resistance Training Alone In Reducing Bradykinesia Of Upper Extremity In Parkinsons Individuals. 
Scientific Title of Study   Effectiveness Of Resistance Training With Task Oriented Training And Resistance Training Alone In Reducing Bradykinesia Of Upper Extremity In Parkinsons Individuals. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Preethi S 
Designation  MPT neurology student 
Affiliation  Sri Ramakrishna Institute of Paramedical Sciences  
Address  Sri Ramakrishna Institute of Paramedical Sciences Room No 4017 Division of Neurology Department of Physiotherapy #395 Sarojini Naidu Road Sidhapudhur Coimbatore Tamilnadu 641044

Coimbatore
TAMIL NADU
641044
India 
Phone  6380183694  
Fax    
Email  preethisaravanamuthu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Porkodi R 
Designation  Professor 
Affiliation  Sri Ramakrishna Institute of Paramedical Sciences 
Address  Sri Ramakrishna Institute of Paramedical Sciences Room No 4017 Division of Neurology Department of Physiotherapy #395 Sarojini Naidu Road Sidhapudhur Coimbatore Tamilnadu 641044

Coimbatore
TAMIL NADU
641044
India 
Phone  9443820164  
Fax    
Email  porkodi.mpt@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Porkodi R 
Designation  Professor 
Affiliation  Sri Ramakrishna Institute of Paramedical Sciences 
Address  Sri Ramakrishna Institute of Paramedical Sciences Room No 4017 Division of Neurology Department of Physiotherapy #395 Sarojini Naidu Road Sidhapudhur Coimbatore Tamilnadu 641044

Coimbatore
TAMIL NADU
641044
India 
Phone  9443820164  
Fax    
Email  porkodi.mpt@gmail.com  
 
Source of Monetary or Material Support  
Sri Ramakrishna Institute of Paramedical Sciences Room No 4017 Division of Neurology Department of Physiotherapy #395 Sarojini Naidu Road Sidhapudhur Coimbatore Tamilnadu 641044  
 
Primary Sponsor  
Name  Preethi S 
Address  Sri Ramakrishna Institute of Paramedical Sciences Room No 4017 Division of Neurology Department of Physiotherapy #395 Sarojini Naidu Road Sidhapudhur Coimbatore Tamilnadu 641044  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Porkodi R PT  Sri Ramakrishna Multi Specialty HospitaL  Sri Ramakrishna Institute Of Paramedical Sciences Room No 4017 Division Of Physiotherapy #395 Sarojininaidu Road Sidhapudur Coimbatore
Coimbatore
TAMIL NADU 		 9443820164

porkodi.mpt@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Ramakrishna Hospital Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G318||Other specified degenerative diseases of nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Resistance training Task oriented training   Resistance training and task orieted training for 55 minutes per day( 6 Weeks,treated for 1 hour per session,thrice a week.) resistance training alone for 30 minutes per day( 6 Weeks,treated for 1 hour per session,thrice a week).  
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Both gender Aged between 50 to 60 years
Subjects under medications
Hoehn and Yahr scale 2 to 3
Manual Muscle Testing grading 4 and 5
Cooperative and willing to participate
Able to follow the instructions
 
 
ExclusionCriteria 
Details  Unstable vital signs
Intentional tremor patients
Cognitive impairment Mini Mental Scale Examination greater than 24
Other neurological and orthopedic conditions
History of conventional surgery or deep brain stimulation for PD
Peripheral neuropathy with motor impairment
Hearing and visual impairment
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in Bradykinesia
 		 At baseline and after 6 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   16/04/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
                                               EFFECTIVENESS OF RESISTANCE TRAINING WITH TASK ORIENTED  TRAINING  AND RESISTANCE TRAINING ALONE IN REDUCING BRADYKINESIA  OF UPPER EXTREMITY  IN PARKINSON’S INDIVIDUALS
INTRODUCTION
              Parkinson’s disease is a neurodegenerative disease that is  caused by dopamine deficiency in the basal ganglia leading to movement disorder that is characterized by classical Parkinson’s motor  symptoms.
Parkinson’s disease is very common overall ,ranking second among age related degenerative brain diseases. incidence rate is 1.5 times higher at nearly 90,000 cases annually.
Most people diagnosed with Parkinson’s are age 50 years or older.  .The most characteristic motor symptoms  are Bradykinesia, Rigidity,tremor and postural instability.
Bradykinesia  is one of the cardinal symptom of Parkinson’s disease .Upto 98% of all people with Parkinson’s disease experience slowness of movement.
AIM 
             The study could focus on measuring changes in bradykinesia of upper limb .The goal is to determine which approach lead to more significant improvements in these Parkinson’s individuals-specific symptoms.
                                
 OBJECTIVE 
            To compare the effectiveness of two intervention approaches - Resistance training  with  task oriented training and resistance training alone in reducing bradykinesia in upper extremity of Parkinson’s individuals.
METHODOLOGY
             20 patients were divided into 2 groups  group 1 -task oriented training and resistance training   group 2 - resisted training alone training course will last for 6 Weeks,treated for 1 hour per session,thrice a week.
RESULTS
           Statistical analysis will be done after data collection and conclusion will be drawn
 
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