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CTRI Number  CTRI/2019/12/022415 [Registered on: 18/12/2019] Trial Registered Prospectively
Last Modified On: 15/08/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Efficacy of Proprioceptive Neuromuscular Facilitation (Physiotherapy Technique) on Forward Head Posture in Patient of Parkinsons Disease. 
Scientific Title of Study   Efficacy of Proprioceptive Neuromuscular Facilitation on Posture in Parkinson Disease: A Randomised Controlled Trial.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manoj Malik 
Designation  Assistant Professor 
Affiliation  Guru Jambeshwar University Science and technology 
Address  Department of physiotherapy Guru Jambeshwer University Science And Technology Hisar Haryana
Guru Jambeshwer University Science And Technology Hisar Haryana
Hisar
HARYANA
125001
India 
Phone  9896221262  
Fax    
Email  malik_manoj@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sonu Punia 
Designation  Assistant Professor 
Affiliation  Guru Jumbeshwer University Science And Technology Hisar Haryana 
Address  Department of physiotherapy Guru Jambeshwer University Science And Technology Hisar Haryana
Guru Jambeshwer University Science And Technology Hisar Haryana
Hisar
HARYANA
125001
India 
Phone  9466373990  
Fax    
Email  sonu.punianeuropt@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sonu Punia 
Designation  Assistant Professor 
Affiliation  Guru Jumbeshwer University Science And Technology Hisar Haryana 
Address  Department of physiotherapy Guru Jambeshwer University Science And Technology Hisar Haryana
Guru Jambeshwer University Science And Technology Hisar Haryana
Hisar
HARYANA
125001
India 
Phone  9466373990  
Fax    
Email  sonu.punianeuropt@gmail.com  
 
Source of Monetary or Material Support  
Ms Kritika PG Student Department of Physiotherpay Guru Jumbeshwer University Science And Technology Hisar Haryana 
 
Primary Sponsor  
Name  Department of Physiotherapy 
Address  Guru Jambeshwer University Science And Technology Hisar Haryana 
Type of Sponsor  Other [] 
 
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 
Ms Kritika  Department of Physiotherapy  OPD Room no.4 and division of Physiotherapy Guru Jambeshwer University Science And Technology
Hisar
HARYANA 
8053166205

kritikabodwal95@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G219||Secondary parkinsonism, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  PNF Technique in Upper Limb will be given   The intervention will be given thrice in a week for 2 weeks.  
Comparator Agent  Resisted Exercises of Upper Limb to correct forward head posture  The intervention will be given thrice in a week for 2 weeks 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patient suffering from Parkinson disease with forward head posture 
 
ExclusionCriteria 
Details  Patients with
Metabolic disorders
Heart disease
Congenital anomaly of cervical spine
Uncooperative patient
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Craniovertebral angle  1 Month 
 
Secondary Outcome  
Outcome  TimePoints 
not available  not available 
 
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   N/A 
Date of First Enrollment (India)   20/12/2019 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Parkinson’s disease is second most common neurodegenerative disease. Parkinson’s disease or Paralysis was first described as “the shaking palsy” by James Parkinson in 1817. It is chronic, progressive degenerative disorder of nervous system characterised by cardinal features of rigidity, akinesia, bradykinesia, tremors and postural instability.About 5 million people are affected worldwide. Prevalence rises from 1% with those with 60years age to 4% in population over 80 years.

The disease is slightly more frequent in men than women. The prevalence of the disease is generally accepted to range from 100 to 200 per 100,000 people and the annual incidence is thought to be 15 per 100,000.

Parkinson disease is a disorder of the dopamine producing neuron of the substantianigra in the basal ganglia. The substantianigra is subcortical grey matter that contain pigmented neurons. The severity of loss of dopamine correlated well with the amount of movement slowness or bredykinesia exhibited by the patients. Loss of dopamine neurons and the production of lewy bodies within the pigmented substantianigra neurons are hallmarks of idiopathic Parkinson disease.

Four motor symptoms are considered cardinal in PD: tremor, rigidity, slowness of movement, and postural instability. The range of other motor symptoms include posture and gait disturbances such as a forward-flexed posture with a typical festinating gait.1 Forward head posture (FHP) is the anterior positioning of the cervical spine. It is the most common deviation from the normal curvature of the cervical spine. It involves an excessive anterior position of the head in relation to the theoretical plumb line perpendicular to the body centre of gravity. In forward head posture there is extension of upper cervical spine, flattening and flexion of lower cervical spine with an increase in lordsis and rounding of the upper back and elevation and protraction of the shoulders.4Physiotherapy treatment i.e. PNF and resisted exercise is better to improve range of motion and forward head posture in Parkinson’s patients.

 

Need of the study:

Parkinson’s disease affects 1–2 per 1000 of the population at any time. PD prevalence is increasing with age and PD affects 1% of the population above 60 years. The posture in Parkinson’s disease deteriorate. Forward head and stooped posture is very common in these patients. Pharmacological treatment doesn’t curepostural instability. Hence physiotherapy correction i.e. strengthening exercises and PNF techniques are very effective in treatment of forward head posture.

 
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