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CTRI Number  CTRI/2023/06/054393 [Registered on: 26/06/2023] Trial Registered Prospectively
Last Modified On: 23/06/2023
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   Effectiveness of abductor motor imagery practice in improving short term outcome in individuals with surgically managed proximalhip fracture  
Scientific Title of Study   Effectiveness of abductor motor imagery practice improving short term outcome in individuals with surgically managed proximal hip fracture 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pswetha 
Designation  postgraduate 
Affiliation  sri Ramachandra Institute of Higher Education and Research 
Address  sri Ramachandra Institute of Higher Education and Research porur,chennai.
sri Ramachandra Institute of Higher Education and Research, porur,chennai.
Chennai
TAMIL NADU
600116
India 
Phone  8667526674  
Fax    
Email  swethapugal997@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  K Subbiah 
Designation  Associate professor 
Affiliation  sri Ramachandra Institute of Higher Education and Research 
Address  sri Ramachandra Institute of Higher Education and Research porur,chennai.

Kancheepuram
TAMIL NADU
600116
India 
Phone  9443033118  
Fax    
Email  subbiah@sriramachandra.edu.in  
 
Details of Contact Person
Public Query
 
Name  K Subbiah 
Designation  Associate professor 
Affiliation  sri Ramachandra Institute of Higher Education and Research 
Address  sri Ramachandra Institute of Higher Education and Research porur,chennai.

Chennai
TAMIL NADU
600116
India 
Phone  9443033118  
Fax    
Email  subbiah@sriramachandra.edu.in  
 
Source of Monetary or Material Support  
sri ramachandra institute of higher education and research 
 
Primary Sponsor  
Name  nil 
Address  nil 
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 
swetha P  Sri Ramachandra hospital. (IN PATIENT ORTHO WARD)  Sri Ramachandra Institute of Higher Education and Research physiotherapy department
Chennai
TAMIL NADU 
8667526674

swethapugal997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional ethics commitee  Approved 
Institutional ethics commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M99||Biomechanical lesions, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  hip rehabilitation conditioning exercises  proximal femur fracture patients in this programme will be diagnosed in sri ramachandra hospital from (Inpatient department-male and female ortho wards)will be taken for this study.Based on the inclusion criteria and exclusion criteria subjects will be randomly divided into 2 groups.Group B will be receiving the hip rehabilitation conditioning exercises based on the 30 mins duration 2 sets and 10s repeitions daily twice a day. in between 5 min of the cool-down. following that Group B will be assessed through lower extremity functional scale,falls efficiacy scale,inclinometer,dynamometer.  
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Individuals diagnosed proximal femur fracture
Patients underwent proximal femoral nailing, screw fixation
 
 
ExclusionCriteria 
Details  previous fracture/THA
severe acute metabolic,neuromuscular and cardiovacular disease
excessive obesity
cognitive problems
infectious diseses,cancer,bleeding 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
lower extremity functional scale
falls efficacy scale-I
dynamometer
inclinometer 
6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
lower extremity functional scale
falls efficacy scale-I
inclinometer
dynanometer 
pre and post 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
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)   02/07/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  02/07/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="30" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

                          Proximal femoral Fracture account for a large proportion of hospitalization among trauma cases. An overwhelming majority of these patients (>90%) are aged above 50 years. The incidence of hip fracture is estimated to rise from 1.66 million in 1990 to 6.26 million in 2050 in India. Studies of elderly adults have demonstrated that strength deficit affecting abductor muscles is extremely large after Proximal Femoral Fractures. Although literature reports this strength and power deficit to be as high as 50%, postoperative abductor weakness is often overlooked, patients very often describe a lurch (or limp) in their gait. Abductor muscle power assessment and management is recommended for complete rehabilitation. Hence abductor conditioning and strengthening was studied in most of the researches.

                              Motor imagery(MI) is a cognitive process in which a subject imagines that he/she performs a movemernt without actually performing the movement without even tensing the muscles.MI was found able to work equqlly well in musculoskeletal disorders rehabilitation.

                              AIM- To compare the effect of abductor motor imagery practice with conventional therapy on the short term outcome in individuals with surgically managed proximal femur fracture.

                              objectives-To compare the immediate and short term hip abductor strength between groups;To compare the immediate and short term pain and hip range of motion between groups;To compare the immediate and short term lower lim functional between the groups;To compare the immediate and short term in fear of fall between the groups.

                              Procedure- the subjects who have meet the inclusion criteria will be recruited for the study after obtaining written consent and the subjects will be undergoing hip abductor weakness patient he/she receiving the motor imagery paractice a short bout of breathing exercise for relaxation will watch a video showing an active individual performing activities and exercises to condition hip abductor muscle.the length of the video will range of 60-120 seconds depending the levels.Evaluation of hip range of motion using inclinometer,for checking hip abductor muscle using dynamoter then baseline scales will be using lower extremity functional scale(LEFS),and falls efficacy scale(FES-I).



 
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