| CTRI Number |
CTRI/2025/10/096031 [Registered on: 14/10/2025] Trial Registered Prospectively |
| Last Modified On: |
10/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A research study to compare the effect of movement with mobilisation (A physiotherapy technique) to conventional methods in correcting the reduced mobility in rear foot joints in amateur runners. This is achieved by recording various foot angles, walking foot pressure and running performance. |
|
Scientific Title of Study
|
Effect of movement with mobilization for correction of tarsal joints hypomobility on foot biomechanical markers, foot pressure distribution, and performance enhancement in amateur runners- 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 |
Maitri Chaturvedi |
| Designation |
Senior Assistant Professor and PhD Scholar |
| Affiliation |
Sardar Bhagwan Singh University |
| Address |
C5, Faculty Residence,
Sardar Bhagwan Singh University New Campus,
Near Bangi Pulia,
Balawala, Dehradun.
Dehradun
UTTARANCHAL
248008
India |
| Phone |
7506378737 |
| Fax |
|
| Email |
dr.maitrichaturvedi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Maitri Chaturvedi |
| Designation |
Senior Assistant Professor and PhD Scholar |
| Affiliation |
Sardar Bhagwan Singh University |
| Address |
C5, Faculty Residence,
Sardar Bhagwan Singh University New Campus,
Near Bangi Pulia,
Balawala, Dehradun.
Dehradun
UTTARANCHAL
248008
India |
| Phone |
7506378737 |
| Fax |
|
| Email |
dr.maitrichaturvedi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Maitri Chaturvedi |
| Designation |
Senior Assistant Professor and PhD Scholar |
| Affiliation |
Sardar Bhagwan Singh University |
| Address |
C5, Faculty Residence,
Sardar Bhagwan Singh University New Campus,
Near Bangi Pulia,
Balawala, Dehradun.
Dehradun
UTTARANCHAL
248008
India |
| Phone |
7506378737 |
| Fax |
|
| Email |
dr.maitrichaturvedi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sardar Bhagwan Singh University |
| Address |
Dept. of Physiotherapy,
Sardar Bhagwan Singh Univeristy (New Campus),
Balawala, Dehradun- 248001. |
| Type of Sponsor |
Research institution |
|
|
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 |
| Prof R Arunmozhi |
Maharana Pratap Sports College |
Physiotherapy OPD,
Dhanwantri Block,
Maharapna Pratap Sports College,
Raipur,
Dehradun.
Dehradun
UTTARANCHAL |
7895617031
rmozhi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board (IRB) of Sardar Bhagwan Singh University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Tarsal joint hypomobility. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CONTROLLED GROUP |
The standard treatment was administered to the controlled group over six sessions, held on alternate days. The following are the details of the treatment:
1. Moist Heat over the foot and ankle through hydrocollator packs-10 minutes.
2. Short Foot Exercises- A set of 3 exercises was taught to the subjects. 10 repetitions of each exercise were performed under supervision. |
| Intervention |
Movement with Mobilization |
The standard treatment was administered to both groups over six sessions, held on alternate days (Total duration: 11 days). The following are the details of the treatment:
1. Moist Heat over the foot and ankle through hydrocollator packs-10 minutes.
2. Short Foot Exercises- A set of 3 exercises was taught to the subjects. 10 repetitions of each exercise were performed under supervision.
3. Movement with Mobilization for hypomobile Tarsal Joints- 5 repetitions 3 times in each session. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Amateur short and medium-distance runners.
2. Running for a minimum of 4 days a week.
|
|
| ExclusionCriteria |
| Details |
1. Recent injury to the lower limb.
2. Subjects with shoe sizes other than 7 and 8.
3. Receiving any other unscheduled training involving the foot.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Rear Foot Angle (RFA)
2. Medical Longitudinal Arch Angle
3. Navicular Drop test
4. 400-meter running performance.
5. Foot pressure distribution |
Start of the intervention and end of the intervention, i.e., at the end of the 11th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="53"
Sample Size from India="53"
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)
|
01/11/2025 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Proposals should be directed to dr.maitrichaturvedi@gmail.com. Currrently i do not have any access to a third party website for this purpose.
- For how long will this data be available start date provided 01-07-2026 and end date provided 31-07-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This will be a prospective,
double-blind, double-dummy, randomized, parallel-group, active-controlled
clinical trial aimed at evaluating the effect of Movement with Mobilization
(MWM) on correcting rear tarsal joint hypomobility and its subsequent influence
on foot pressure distribution, foot biomechanical markers, and running
performance in amateur runners.
Participants will be recruited from
the accessible population after pre-screening and assessment based on the
inclusion and exclusion criteria. Each participant will be informed about the
study procedure in a language they understand, and written informed consent
will be obtained before enrollment.
Eligible participants will be
randomly allocated into two groups using simple random sampling through an
online Study Randomizer tool. The allocation will be double-blinded,
with the randomization sequence maintained by an independent supervisor. Each
participant will be assigned a unique identification code for data
confidentiality.
The study will have two treatment methods
conducted in parallel:
- Group
A (Active Control): Will receive Moist Heat and Short Foot Exercises (SFE).
- Group
B (Experimental): Will receive Moist Heat, Short Foot Exercises (SFE), and
Movement with Mobilization (MWM) targeted to the hypomobile rear tarsal
joint(s) identified through joint mobility testing.
Both groups will undergo six
intervention sessions on alternate days. Pre- and post-intervention assessments
will be carried out using five outcome measures:
- Foot
Pressure Distribution (Curalgia Feet SX Smart Insoles with GaitAnalysis+
app)
- Medial
Longitudinal Arch Angle (MLAA)
- Rear
Foot Angle (RFA)
- Navicular
Drop (ND) Test
- 400-meter
Run Performance Test
Data will be statistically analyzed
using SPSS software version 20.0, and significance will be set at p <
0.05.
It is expected that correction of
rear tarsal hypomobility using MWM, when combined with conventional therapy,
will lead to significant improvements in foot pressure distribution,
biomechanical alignment, and running performance among amateur runners compared
to traditional treatment alone.
|