| 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 |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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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 |
|
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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
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M99||Biomechanical lesions, not elsewhere classified, |
|
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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. |
|
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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 |
|
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Method of Generating Random Sequence
|
Other |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
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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 |
|
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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" |
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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
|
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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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