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CTRI Number  CTRI/2019/11/021939 [Registered on: 08/11/2019] Trial Registered Prospectively
Last Modified On: 08/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   The Effect of Proprioceptive Neuromuscular Facilitation for balance and muscle strength among diabetic neuropathy patients  
Scientific Title of Study   Effect of proprioceptive Neuromuscular Facilitation on Balance and Muscle strength in patients with Diabetic Neuropathy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sharad Kumar 
Designation  MPT Student, Maharishi Marakndeshwar Institute of Physiotherapy and Rehabilitation 
Affiliation  MPT Student,Maharishi Marakndeshwar Institute of Physiotherapy and Rehabilitation. 
Address  Maharishi Marakndeshwar Institute of Physiotherapy and Rehabilitation,Maharishi Marakndeshwar Deemed to be University, Mullana, Ambala

Ambala
HARYANA
133207
India 
Phone  9729552360  
Fax    
Email  sharadkumar281995@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nidhi Sharma 
Designation  Associate Professor 
Affiliation  Maharishi Marakndeshwar Institute of Physiotherapy and Rehabilitation 
Address  Department of Nerological Physiotherapy, Maharishi Marakndeshwar Institute of Physiotherapy and Rehabilitation, MMDU, Mullana, Ambala

Ambala
HARYANA
133207
India 
Phone  9760835605  
Fax    
Email  sharma.nidhi.physio@mmumullana.org  
 
Details of Contact Person
Public Query  
Name  Sharad Kumar 
Designation  (MPT - Neurological disorders) 
Affiliation  Maharishi Marakndeshwar Institute of Physiotherapy and Rehabilitation 
Address  Department of Nerological Physiotherapy, Maharishi Marakndeshwar Institute of Physiotherapy and Rehabilitation, MMDU, Mullana, Ambala

Ambala
HARYANA
133207
India 
Phone  9729552360  
Fax    
Email  sharadkumar281995@gmail.com  
 
Source of Monetary or Material Support  
NA 
 
Primary Sponsor  
Name  Maharishi Marakndeshwar Institute of Physiotherapy and Rehabilitation MMDU 
Address  Mullana, Ambala, Haryana 
Type of Sponsor  Private medical college 
 
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 
sharad kumar  Neurological Physiotherapy OPD MMIPR  MM Hospital Department of Neurological Physiotherapy MMIPR MM(DU) Mullana Ambala
Ambala
HARYANA 		 9729552360

sharadkumar281995@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: E114||Type 2 diabetes mellitus with neurological complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control group  Generalized strengthening exercise for lower limb and balance training will be given for four days in a week upto one month 
Intervention  Experimental group  Proprioceptive Neuromuscular Facilitation (PNF)for lower limb as a treatment measure using four techniques - Hold relax, Contract relax, Slow reversal and Rhythmic stabilization. Ten repetitions of each technique in both diagonal patterns will be done before proceeding to the next technique. The treatment session will continue for four days in a week upto one month. 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Diabetic neuropathy examination score (8-12)
Berg Balance Scale (BBS) score (24-30)
patients with type II diabetes mellitus

 
 
ExclusionCriteria 
Details  Individuals having any other systemic manifestation other than diabetes.
Diabetic foot patients
Individual having any neurological disorder (like stroke, Parkinson)
Individual having any diagnosed psychological disorder
history of trauma leading to nerve injuries
Individual affected with any musculoskeletal disorder of the lower limb
Any lower limb infection
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1.berg balance scale(BBS)
2.isokinetic dynamometer(ID)
3.Diabetic neuropathy examination score(DNE) 		 1.BBS-20-30 minute
2.ID-20 minute
3.DNE-10 minute 
 
Secondary Outcome  
Outcome  TimePoints 
1.Berg balance scale
2.isokinetic dynamometer 		 1.BBS-20-30 minute
2.ID-20 minute 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   10/11/2019 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Background:  Diabetic Neuropathy (DN) is a complex metabolic disorder which can affect the patient’s life to a great extent in terms of balance and muscle strength especially of lower limbs because of which quality of life is also hampered in patients with diabetic neuropathy. There are lots of researches which provide evidences for various treatment methods to improve balance and muscle strength separately in these patients. Proprioceptive Neuromuscular Facilitation (PNF) is a technique which works on balance as well as muscle strength.

Purpose:  To assess the effect of Proprioceptive Neuromuscular Facilitation on balance and muscle strength in patients with diabetic neuropathy.

 

Method: Subjects will be selected in the study on the basis of inclusion criteria. Then pre assesment will be done with Diabetic Neuropathy Examination (DNE) for scoring the extent of diabetic neuropathy, Berg Balance Scale (BBS) for balance testing and Isokinetic Dynamometer (IDM) for measurement of muscle strength. Then experimental group will  receive PNF techniques - 1.Hold relax. 2. Contract relax. 3. Dynamic reversal 4. Rhythmic stabilization technique.and control group generalized lower limb strengthening exercise for muscle strength and balance training for balance Then we will reassess the patients through DNE, BBS and Isokinetic Dynamometer. 
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