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CTRI Number  CTRI/2022/01/039581 [Registered on: 20/01/2022] Trial Registered Prospectively
Last Modified On: 19/01/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   COMPARATIVE STUDY OF CONVENTIONAL PHYSICAL THERAPY AND WITH NINTENDO IN HEEL PAIN(PLANTAR FASCIITIS) - A RANDOMIZED CONTROL TRIAL 
Scientific Title of Study   COMPARATIVE STUDY OF CONVENTIONAL PHYSICAL THERAPY WITH NINTENDO AND CONVENTIONAL PHYSICAL THERAPY ALONE IN PLANTAR FASCITIS - A RANDOMIZED CONTROL TRIAL 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ashwini Shirahatti 
Designation  POST GRADUATE STUDENT 
Affiliation  SDM COLLEGE OF PHYSIOTHERAPY 
Address  SDM COLLEGE OF PHYSIOTHERAPY MANJUSHRI NAGAR SATTUR DHARWAD

Dharwad
KARNATAKA
580009
India 
Phone  9148142901  
Fax    
Email  ashwinishirahatti16@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ashwini Shirahatti 
Designation  POST GRADUATE STUDENT 
Affiliation  SDM COLLEGE OF PHYSIOTHERAPY 
Address  SDM COLLEGE OF PHYSIOTHERAPY MANJUSHRI NAGAR SATTUR DHARWAD

Dharwad
KARNATAKA
580009
India 
Phone  9148142901  
Fax    
Email  ashwinishirahatti16@gmail.com  
 
Details of Contact Person
Public Query  
Name  RAJEEV LAL 
Designation  PROFESSOR 
Affiliation  SDM COLLEGE OF PHYSIOTHERAPY 
Address  SDM COLLEGE OF PHYSIOTHERAPY MANJUSHRI NAGAR SATTUR DHARWAD

Dharwad
KARNATAKA
580009
India 
Phone  9986202056  
Fax    
Email  lalrk@yahoo.com  
 
Source of Monetary or Material Support  
SDM COLLEGE OF PHYSIOTHERAPY 
 
Primary Sponsor  
Name  Ashwini Shirahatti 
Address  Sdm college of Physiotherapy,Manjushree nagar Sattur Dharwad 580009 GANESH EMPIRE,2ND FLOOR RPD CROSS BELAGAVI 
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 
ASHWINI SHIRAHATTI  SDM college of medical sciences and hospital  Physiotherapy opd No.5
Dharwad
KARNATAKA 		 9148142901

ashwinishirahatti16@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE PERMISSION  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  CONTROLLED GROUP  conventional physical therapy as calf muscle stretching,hamstring stretching,intrinsic foot strengthening and therapeutic ultrasound  
Intervention  Nintendo  Nintendo wii-balance board is used where patient stand on the board and play exergames by weight bearing on affected foot duration is 3 sessions in one week for consecutive 4 weeks 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Subjects diagnosed with plantar fasciitis by medical practitioner,
subjects with age group of 40-60years,
subjects with either of gender 
 
ExclusionCriteria 
Details  Subjects with neuromuscular disorders,
Subjects with cardiac problems,
Subjects with any surgeries related to lumbar and lower limb region,
Subjects with any lower limb fractures,
Subjects with arterial and venous disorders,
subjects with any pain in the foot other than plantar fasciitis,
Subjects not willing to participate in the study,
Subjects with vision disorders,
Subjects with bilateral plantar fasciitis,
Subjects with diabetic neuropathy,
Subjects(females who are pregnant) 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Jamar hand dynamometer,
goniometer,
foot function index,Nintendo
Nintendo 		 prior to the treatment and after 4 weeks post treatment 
 
Secondary Outcome  
Outcome  TimePoints 
NONE  NONE 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 1 
Date of First Enrollment (India)   23/01/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  23/01/2022 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
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)?  

Response - NO
Brief Summary   One of the major complaints of foot is plantar fasciitis which is commonly seen in the age group between 40-60 years ,plantar fasciitis is a condition where there is thickening of plantar aponeurosis caused due to many factors such as obesity, flat foot, prolonged standing and tight tendo -achilles and hamstring group of muscles. The usual clinical presentation by patients is pain and morning stiffness while standing and walking. There has been approach of pharmacological interventions in the terms of steriod injections, non-steroidal anti-inflammatory drugs to surgical intervention where there is removal of fascia. On the other hand ,non-pharmacological intervention as conventional physical therapy which includes both manual therapy and electrotherapy, is proven to be effective.
In the current study prior to the treatment ankle range of motion is assessed through goniometer and ankle musculature strength assessed through jamar hand dynamometer and foot function index scale is used. In the control group conventional physical therapy such as stretching exercise  calf muscle stretching  and passive hamstring stretch is given along with  intrinsic foot strengthening and therapeutic ultrasound for pain relief.
In the experimental group Nintendo is used. The use of nintendo as a virtual reality has resulted in significant reduction of pain, targetting the attention of patient in the task, various distracting activities can be given involving different sensory systems that functions relatively independent. Hence engaging the patient in interactive video games and distracting them with the use of sensory systems can lead to effective management of pain. Virtual reality rehabilitation in the form of technology driven video games has shown improvement in increasing muscle strength, body balance and leg range of motion.The subjects stand on wii-board and interact with video based exergames which aims to weight bearing on affected foot.
As there are no studies done to find the effectiveness of virtual reality in the form of nintendo in plantar fasciitis ,so there is a need to assess the same.
 
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