| CTRI Number |
CTRI/2025/02/081382 [Registered on: 27/02/2025] Trial Registered Prospectively |
| Last Modified On: |
21/02/2025 |
| 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
|
to observe and compare the effect of Balance training on Sensamove mini board exercise training on Balance, instability and KinesioPhobia that is fear of movement In ACL recontruction Patients |
|
Scientific Title of Study
|
Et1ectiveness of the Balance training on Sensamove mini board on Balance, instability and KinesioPhobia In ACL recontruction 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 |
Dr Sanket Parekh |
| Designation |
Assistant professor |
| Affiliation |
k m Patel Institute of Physiotherapy |
| Address |
K M Patel Institute of Physiotherapy Shree Krishna Hospital Gokalnagar Karamsad
Anand
GUJARAT
388325
India |
| Phone |
09879352362 |
| Fax |
|
| Email |
sanketkp@charutarhealth.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Niyati Panchal (PT) |
| Designation |
Post Graduate Student |
| Affiliation |
k m Patel Institute of Physiotherapy |
| Address |
K M Patel Institute of Physiotherapy Shree Krishna Hospital Gokalnagar Karamsad
Anand
GUJARAT
388325
India |
| Phone |
07567945515 |
| Fax |
|
| Email |
niyatisasha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanket Parekh |
| Designation |
Assistant professor |
| Affiliation |
k m Patel Institute of Physiotherapy |
| Address |
K M Patel Institute of Physiotherapy Shree Krishna Hospital Gokalnagar Karamsad
GUJARAT
388325
India |
| Phone |
09879352362 |
| Fax |
|
| Email |
sanketkp@charutarhealth.org |
|
|
Source of Monetary or Material Support
|
| K M Patel Institute of Physiotherapy Shree Krishna Hospital Gokalnagar Karamsad 388325 |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
Nil |
| Type of Sponsor |
Other [NIL] |
|
|
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 sanket parekh PT |
K M Patel Institute of Physiotherapy Shree Krishna Hospital Karamsad |
Dept No 152 K M Patel Institute of Physiotherapy Shree Krishna Hospital Gokalnagar Karamsad
Anand
GUJARAT |
09879352362
sanketkp@charutarhealth.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee -2 Bhaikaka University Karamsad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Conventional |
Conventional strengthening exercise for the knee strengthening exercise for the knee joint on daily bases for 2 weeks |
| Comparator Agent |
Interventional therapy in terms of sensa move mini balance board |
in this exercise will be given by the sensa move mini balance board combines interactive training software and exercise games with the
well-known benefits of a conventional wobble board The personal computer is linked to the sensors.
After the board is in place, the apparatus will be adjust so that the marker or cursor, which
represents the participant’s center of pressure (COP), remained in the center. The
participants will be told to take off their shoes and set their feet four to five centimeters
apart on board. The monitor’s visual display will set to the participant’s eye level
this protocol will continue for the daily bases for the 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Aged between 20-40 years
Patients underwent surgical reconstruction of ACL with any graft
0-120 degrees ROM of affected knee
Minimal knee joint effusion
Walk without assistive device
Full weight bearing allowed by Orthopaedician |
|
| ExclusionCriteria |
| Details |
Radiographic of arthrities
meniscal Repair requiring the resection
any associated ligament injury |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
NPRS - Pain
Functional reach test - balance
TAMPA 11 for kinesiophobia
Tegner lysholm - instability |
pre assessment before starting intervention
post after completing intervention that is after 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Kinesiphobia, tagner lysolm score |
pre assessment before starting intervention
post after completing intervention that is after 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
14/03/2025 |
| 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="1"
Months="0"
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
|
There are several instrumentations available for Balance training. Existing Conventional protocols are available to be effective, Also the Sensamove mini balance board is effective for balance training, but no studies are available of ACL rehabilitation for the same. In conventional training it is not possible to quantify the improvement, whereas with Sensamove, improvement can be quantified. Hence this study is undertaken to compare Conventional training with Sensamove balance board training in patients with ACL reconstruction and to find out which intervention can be better for patients. |