| CTRI Number |
CTRI/2025/04/084392 [Registered on: 08/04/2025] Trial Registered Prospectively |
| Last Modified On: |
29/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Does SENSORIMOTOR Exercises are effective in improving balance proprioception and h reflex in patients with first ray instability. |
|
Scientific Title of Study
|
Effect of Sensorimotor Training on H-Reflex, Balance and Proprioception in patients with First Ray Instability |
| 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. Siddhartha Sen |
| Designation |
Associate Dean of FPHY |
| Affiliation |
SGT University |
| Address |
SGT University, DEPARTMENT OF PHYSIOTHERAPY.
Chandu budhera, Gurgaon-badli road.
DEPARTMENT OF PHYSIOTHERAPY
SGT HOSPITAL , PHYSIOTHERAPY OPD
Gurgaon
HARYANA
122505
India |
| Phone |
9412385124 |
| Fax |
|
| Email |
Siddhartha_fphy@sgtuniversity.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Jyoti Ramani |
| Designation |
PG Student |
| Affiliation |
SGT University |
| Address |
SGT University, Chandu budhera, Gurgaon-badli road.
Gurgaon
HARYANA
122505
India |
| Phone |
8770178003 |
| Fax |
|
| Email |
jyotiramani1108@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jyoti Ramani |
| Designation |
PG Student |
| Affiliation |
SGT University |
| Address |
SGT University, Chandu budhera, Gurgaon-badli road.
Gurgaon
HARYANA
122505
India |
| Phone |
8770178003 |
| Fax |
|
| Email |
jyotiramani1108@gmail.com |
|
|
Source of Monetary or Material Support
|
| SGT University And Research Institute Gurgaon-Badli Road, Chandu Budhera
122505 |
|
|
Primary Sponsor
|
| Name |
SGT University |
| Address |
chandu, budhera
gurgaon-badli road,Haryana, India
122505 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Siddhartha Sen |
SGT Hospital |
Department of Physiotherapy, Physiotherapy OPD, basement SGT University, Chandu budhera, Gurgaon-badli road.
Gurgaon
HARYANA |
9412985124
Siddhartha_fphy@sgtuniversity.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Faculty Of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
First Ray Instability
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Sensorimotor Training |
sensory training
balance motor training
balance sensory training
4 weeks intervention |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
(1) Age between 18-65 years of both males and females.
(2) Individuals with first ray instability –Planter Fasciitis, Hammer Toe, Hallux Valgus, Flat Foot and Metatarsalgia.
(3) Positive Double Dorsiflexion test for First Ray Instability.
(4) Participants must be willing to participate.
|
|
| ExclusionCriteria |
| Details |
1. Patient who have undergone prior foot or ankle surgery
2. History of fracture in either lower extremity.
3. Patient with arthrodesis of foot.
4. Subjects who had neuromuscular disorders,
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| H-Reflex, Balance and Proprioception |
Baseline, and at the end of 4th week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| navicular drop height |
Baseline, & at the end 4th week. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
20/04/2025 |
| 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)
|
Open to Recruitment |
| 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
|
Aim of the study is To find out
the effect of sensorimotor training on H reflex, proprioception and balance in
patients with First Ray Instability. Background- The first
ray includes the first metatarsal, the first metatarsocuneiform joint, the
medial cuneiform and the medial naviculo-cuneiform joint. Weightbearing forces
are transmitted from the first metatarsal head to the ankle through the medial
column. The first ray and medial column act as a rigid lever during the heel
rise phase of the gait cycle. When the gastroc-soleus contracts, the foot
plantarflexes, rotating around the centre of the talar body. The combined
forces of weightbearing and Achilles’ tendon tension must be transmitted to the
ground through the medial column/first ray, in order to propel a person
forward. [Corinne Van Beek, et al 2011]
|