| CTRI Number |
CTRI/2025/02/080451 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
09/02/2025 |
| 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
|
Effect of Treatment based on Movement Modification and Correction in Daily Activities for Knee Joint Restriction |
|
Scientific Title of Study
|
Effectiveness of Movement System Impairment(MSI) based Classification Treatment on Clinical Outcomes among Subjects with Tibiofemoral Hypomobility Syndrome: A Randomized Controlled 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 |
Paarthasarathy K |
| Designation |
Student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Physical Rehabilitation Department, Ground Floor, New Block, Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research, Sri Ramachandra Nagar, Porur, Chennai.
Kancheepuram
TAMIL NADU
600116
India |
| Phone |
8428276858 |
| Fax |
|
| Email |
kmsarathy27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Soundararajan K |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Physical Rehabilitation Department, Ground Floor, New Block, Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research, Sri Ramachandra Nagar, Porur, Chennai.
Chennai
TAMIL NADU
600116
India |
| Phone |
9551163416 |
| Fax |
|
| Email |
k.soundararajan1995@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Soundararajan K |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Physical Rehabilitation Department, Ground Floor, New Block, Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research, Sri Ramachandra Nagar, Porur, Chennai.
Chennai
TAMIL NADU
600116
India |
| Phone |
9551163416 |
| Fax |
|
| Email |
k.soundararajan1995@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research, Physical Rehabilitation Department, Ground Floor, New Block, Faculty of Physiotherapy,Sri Ramachandra Nagar, Porur, Chennai. |
|
|
Primary Sponsor
|
| Name |
Paarthasarathy K |
| Address |
Physical Rehabilitation Department, Ground Floor, New Block, Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research, Sri Ramachandra Nagar, Porur, Chennai. |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Paarthasarathy K |
Sri Ramachandra Institute of Higher Education and Research |
Physical Rehabilitation Department, Ground Floor, New Block, Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research, Sri Ramachandra Nagar, Porur, Chennai.
Kancheepuram
TAMIL NADU |
8428276859
kmsarathy27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra Institute of Higher Education and Research Institutional Ethics Committee for Student Project |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
| Intervention |
Movement System Impairment Based Classification Treatment |
Treatment based on the MSI Classification System includes Patient Education, Modification and Correction of Performance of Daily Activities, and Prescription of Specific Flexibility and Strengthening Exercises. Duration-45 to 60 minutes |
| Comparator Agent |
Routine Physiotherapy |
A Routine Physiotherapy Based on Guidelines to improve the Quadriceps Function and Stretch the adjacent Structure. Exercises are Terminal Knee Extension, SLR, Isometric Quadriceps and Hamstrings, Hamstring and Gastrocnemius Stretches and VMO Strengthening. A Daily Home Exercise Program with Instruction will be provided to each Patient.Duration- 45 to 60 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
History of gradual pain at the knee complex
Specific movement system impairment(restricted ROM, Altered gait)
Patient with Flexed knee posture
|
|
| ExclusionCriteria |
| Details |
History of Knee surgery in last 3 months
Structural abnormalies of knee
Severe osteoporosis
Malignant tumors
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Physical Function (KOOS), Pain Intensity, Range of Motion |
Baseline, Week 1, Week 3, Week 4, Week 6, Week 8, Week 10, Week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Muscle Strength, Physical Performance Test |
Baseline, Week 1, Week 3, Week 4, Week 6, Week 8, Week 10, Week 12 |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
24/02/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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 participants will be screened for eligibility criteria. An initial assessment of evaluating the symptoms and signs of patients with tibiofemoral hypomobility syndrome made by a judgement based on MSI classification. Once participant fulfills inclusion criteria, informed consent will be obtained, and all baseline outcome measure will be recorded. Participants will be assigned to one of two groups (Group A: Experimental group, Group B: Standard Exercise care) using block randomization. The allocation sequence will be placed in opaque, sealed envelopes. The therapist treating the participants would open the sealed envelope and administer the treatment according to the group allocation during treatment time. A qualified therapist who unaware of the study protocol, participants group allocation will assess all outcome measures (Numeric pain rating scale, knee injury and osteoarthritis outcome score). Intervention group will receive MSI treatment based exercise. Control group will receive standarised exercise therapy. Between group comparison will be performed |