| CTRI Number |
CTRI/2024/10/075354 [Registered on: 16/10/2024] Trial Registered Prospectively |
| Last Modified On: |
15/10/2024 |
| 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
|
what will be the immediate effect of mobilization of hip joint and sacroiliac joint on strength of gluteus maximus muscle |
|
Scientific Title of Study
|
Immediate effect of hip joint mobilization versus sacroiliac joint mobilization on gluteus maximus muscle strength- A randomized clinical trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Goutami Katage |
| Designation |
Associate Professor |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Department of Physiotherapy, MGM Institute of Physiotherapy, N-6 Cidco, Chh. Sambhajinagar
Aurangabad MAHARASHTRA 431001 India |
| Phone |
8007937686 |
| Fax |
|
| Email |
goutamikatage@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr V Sarath Babu |
| Designation |
Principal & Professor |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Department of Physiotherapy, MGM Institute of Physiotherapy, N-6 Cidco, Chh. Sambhajinagar
Aurangabad MAHARASHTRA 431001 India |
| Phone |
9309148769 |
| Fax |
|
| Email |
sharathcrisp@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr V Sarath Babu |
| Designation |
Principal & Professor |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Department of Physiotherapy, MGM Institute of Physiotherapy, N-6 Cidco, Chh. Sambhajinagar
Aurangabad MAHARASHTRA 431001 India |
| Phone |
9309148769 |
| Fax |
|
| Email |
sharathcrisp@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM Institute of Physiotherapy, N-6, Cidco, Chh. Sambhajinagar,431001,Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
MGM Institute of Physiotherapy Chh Sambhajinagar |
| Address |
MGM Institute of Physiotherapy, N-6, Cidco, Chh. Sambhajinagar,431001,Maharashtra,India |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Goutami Katage |
MGM Physiotherapy and Rehabilitation Centre |
C Building, MGM Physiotherapy and Rehabilitation Centre, N-6, Cidco, Chh. Sambhajinagar Aurangabad MAHARASHTRA |
8007937686
goutamikatage@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGM Institute of Physiotherapy Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hip Joint Mobilization |
Grade IV postero-anterior central hip joint mobilization- 1 set of 10 oscillations given once |
| Comparator Agent |
Mobilization of the Sacroiliac Joint |
Grade IV sacroiliac joint mobilization- 1 set of 10 oscillation given once |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Asymptomatic male and female were included
2. Individuals between age group 18 to 30 |
|
| ExclusionCriteria |
| Details |
1. Individuals with a history of trauma or surgery, 2. Any underlying pathological conditions,
3. Muscle strains, ligament injuries, bony abnormalities like scoliosis, systemic arthritis
4. Disorders of the central nervous system |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gluteus Maximus muscle strength |
During baseline and after post treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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)
|
31/10/2024 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The gluteus maximus, the largest and most superficial muscle, plays a crucial role in adapting to the postural changes from quadrupedal to bipedal locomotion. Its proximal insertion includes the sacrum, dorsal sacral ligaments, posterior crest section, and sacrotuberous ligament, with fibers extending to insert into the iliotibial tract and gluteal tuberosity of the femur. This muscle is vital for generating the force necessary to maintain an upright bipedal posture. Weakness or delayed activation of the gluteus maximus can lead to injuries and chronic pain, impacting performance and strength, and potentially causing ankle injuries, hamstring strains, lower back pain, and increased stress on the anterior hip joint. Muscle strength assessment is essential in clinical examinations and can be done using various methods such as manual muscle testing, hand-held dynamometers, and digital dynamometers. Strengthening exercises involve applying external loads through different techniques like isometric contraction, weight cuffs, Therabands, plyometrics, mobilization, and manipulation techniques. Joint immobilization can lead to restrictions and adhesions, reducing tissue load-bearing capacity, which can be reversed by joint mobilization to improve muscle function. The arthrokinetic reflex (AKR) refers to reflexes regulating neuromuscular activity through articular receptors. These receptors can inhibit or facilitate muscle tone, with stretching of the joint capsule triggering mechanoreceptors to influence muscle tone and reflexes. AKR protects the body from overstressing structures related to fixated joints, and mobilization can improve muscle strength by enhancing the extensibility of capsuloligamentous structures, affecting mechanoreceptor activation. Mobilization stretches these tissues to their ideal length, removing the AKR’s inhibitory effect and potentially improving motor activity and muscle strength. This study aimed to assess the immediate impact of hip joint versus sacroiliac joint mobilization on gluteus maximus muscle strength, given its crucial role in hip extension and importance in rehabilitation. The application of Maitland mobilization techniques on these joints and their effects on gluteus maximus strength were explored. |