| CTRI Number |
CTRI/2025/05/087064 [Registered on: 16/05/2025] Trial Registered Prospectively |
| Last Modified On: |
16/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Effectiveness of Motorized Proprioceptive Training Program among ACL reconstruction patients |
|
Scientific Title of Study
|
“Effectiveness of Motorized Proprioceptive Training Program Using Huber 360 Machine on Postural Stability, Coordination, and Gait Recovery in Post-Operative Anterior Cruciate Ligament Reconstruction Patients” |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ankit Dobhal |
| Designation |
Physiotherapist |
| Affiliation |
Manav Rachna International Institute Of Research And Studies |
| Address |
Exercise therapy Lab, Room no. QFT-11, Q blcok, 3rd floor, Manav Rachna International Institute of Research and Studies, Faridabad
Plot A, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad 121004
Faridabad
HARYANA
121004
India |
| Phone |
7247843966 |
| Fax |
|
| Email |
ankit98687@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nitesh malhotra |
| Designation |
Profressor |
| Affiliation |
Manav Rachna International Institute Of Research And Studies |
| Address |
Q Block, QS 11 Department of physiotherapy Manav Rachana University Sector 43 Aravalli Hills Delhi-Surajkund Road
Plot A, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad 121004
Faridabad
HARYANA
121004
India |
| Phone |
7503229661 |
| Fax |
|
| Email |
nitesh.sahs@mriu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nitesh malhotra |
| Designation |
Profressor |
| Affiliation |
Manav Rachna International Institute Of Research And Studies |
| Address |
Q Block, QS 11 Department of physiotherapy Manav Rachana University Sector 43 Aravalli Hills Delhi-Surajkund Road
Plot A, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad 121004
Faridabad
HARYANA
121004
India |
| Phone |
7503229661 |
| Fax |
|
| Email |
nitesh.sahs@mriu.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Manav Rachna International Institute of Research and Studies |
| Address |
Manav Rachna Institute of Research and Studies Sector 43 Faridabad Haryana 121004 |
| Type of Sponsor |
Other [University] |
|
|
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 Nitesh malhotra |
Manav Rachna Sport Science Centre |
F72M+5F5 Manav Rachna International Institute Of Research And Studies, Suraj Kund Badkhal Rd, Gadakhor Basti Village, Sector 43, Faridabad, Haryana 121003
Faridabad
HARYANA |
7503229661
nitesh.sahs@mriu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICAL COMMITEE, MANAV RACHANA INTERNATIONAL INSTITUTE OF RESEARCH AND STUDIES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
After 6weeks of ACL Reconstruction
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comparision between traditional training and motorized balance training vs only traditional training. |
Group 1 (Intervention Group):
Participants in this group will receive traditional balance training combined with motorized balance training using the Huber 360 platform. The intervention will be conducted over a 4-week period, with sessions held e.g., 3 times per week, and each session lasting approximately [session duration, 30–45 minutes]. The motorized training component involves dynamic balance tasks using the Huber 360 machine, targeting postural stability and neuromuscular coordination.
Group 2 (Comparator Group):
Participants in this group will receive only traditional balance training, consisting of standard balance and coordination exercises commonly used in rehabilitation settings.
|
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Male |
| Details |
Individuals who have undergone ACL reconstruction surgery within the last 6 months.
Must have received medical clearance from an orthopaedic surgeon to engage in rehabilitation exercises. |
|
| ExclusionCriteria |
| Details |
History of additional lower limb injuries (e.g., meniscus tear, fractures) post-surgery.
Any neurological disorders or musculoskeletal conditions that would affect rehabilitation.
Psychiatric disorders that may interfere with participation or understanding of instructions
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Length
Area
Speed
Acquisition time
Stability quotient
Level achieved
No. of ground support
|
At baseline and after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Postural stability
Coordination
Gait |
At baseline and after 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
28/05/2025 |
| 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="2"
Days="0" |
|
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
|
Subjects will be recruited based on specific inclusion and exclusion criteria. Over a 4-week intervention period, participants will be divided into two groups: one group will receive both traditional balance training and motorized balance training using the Huber 360, while the other group will perform only traditional balance exercises. Pre- and post-intervention data will be collected, and data analysis will be conducted accordingly. |