| CTRI Number |
CTRI/2024/04/065319 [Registered on: 05/04/2024] Trial Registered Prospectively |
| Last Modified On: |
14/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effects of Exercises In Adults With The Heel pain |
|
Scientific Title of Study
|
Evaluation Of Effects Of Three Dimensional Exercises With Subtalar Joint Mobilisation On Plantar Fascia, Intrinsic Muscles Of Foot And Medial Longitudinal Arch Of Foot Using Ultrasonography In Adults With Plantar Fasciitis |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Archakam Paramkusam Rakshitha |
| Designation |
Masters Of Physiotherapy Orthopaedics and Araumatology |
| Affiliation |
Sri Ramachandra Institute Of Higher Education and Research |
| Address |
Sri Ramachandra Institute Of Higher Education And Research (Deemed to be University)
Faculty Of Physiotherapy Sri Ramachandra Nagar Porur Chennai
Tamilnadu
Chennai
TAMIL NADU
600116
India |
| Phone |
8639366498 |
| Fax |
|
| Email |
aprakshitha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Geetha Hari Priya |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research (Deemed to be University) |
| Address |
Sri Ramachandra Institute Of Higher Education And Research (Deemed to be University)
Faculty Of Physiotherapy Sri Ramachandra Nagar Porur Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
7358580685 |
| Fax |
|
| Email |
geethaharipriya@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Archakam Paramkusam Rakshitha |
| Designation |
Masters Of Physiotherapy Orthopaedics And Traumatology |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research (Deemed to be University) |
| Address |
Sri Ramachandra Institute Of Higher Education And Research (Deemed to be University)
Faculty Of Physiotherapy Sri Ramachandra Nagar Porur Chennai
Tamilnadu
Chennai
TAMIL NADU
600116
India |
| Phone |
8639366498 |
| Fax |
|
| Email |
aprakshitha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research
(Deemed to be university) Faculty of Physiotherapy
Chennai, Tamil Nadu 600116 |
|
|
Primary Sponsor
|
| Name |
Archakam Parakmusam Rakshitha |
| Address |
Sri Ramachandra Institute of Higher Education and Research
Faculty Of Physiotherapy
Sri Ramachandra Nagar, Chennai, Tamil Nadu 600116 |
| Type of Sponsor |
Other [self funded research project] |
|
|
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 |
| DrGeetha Hari Priya |
Sri Ramachandra Institute of Higher Education and Research |
Faculty pf physiotherapy OPD Ground Floor Room no 1 ,sri Ramachandra Nagar Porur Chennai
Chennai
TAMIL NADU |
7358580685
geethaharipriya@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for students Project,Faculty of Physiotherapy Sri Ramachandra Institute Of Higher Education and Research Deemed to be University Porur Chennai 600116 Tamilnadu India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
-Exercises
-joint Mobilisation
|
-Three dimensional exercises which includes the following exercises
1.D2 Flexion Pattern - Dorsi flexion - Pronation- Eversion Toe Extension
2.D2 Extension Pattern - Plantar flexion-Supination Inversion -Toe Flexion
Sub Talar joint Mobilisation
Duration
-Two Weeks of intervention will be given
|
| Comparator Agent |
Exercises |
1.Intrinsic foot muscle strengthening exercises
2.Stretching Exercises |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria:
AGE : 30 -60 Years
GENDER : Male,Female
Acute heel pain
Positive windlass test
Unilateral plantar fasciitis
Acute flat foot
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
Deformity of the knee - valgus and varus knee, hammer toe
Undergone any recent surgery in the lower limb.
Having done any adjunctive procedure for achilles tendon
Ligament injuries of the ankle joint.
Achilles tendon rupture
Subcutaneous or retro calcaneal bursitis
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ultrasonography is taken for the Plantar Fascia thickness ,Cross sectional area for Quadratus plantae and Tibialis posterior |
Primary outcome is taken initially and the outcome is assessed again after two weeks after giving the intervention or comparator agent in experimental and control group |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Navicular drop test,
Pain thershold is measured using pain pressure algometer which is used for on gastrocnemius muscle. |
The values of navicular drop test & the pain threshold for gastrocnemius muscle is measured initially & after two weeks the values are measured after giving the intervention or comparator agent in both experimental & control group |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
15/04/2024 |
| 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) |
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
|
Methodology:
. The research will be performed at the outpatient
department of the physiotherapy at Sri Ramachandra Hospital. In Sri Ramachandra
Institute of Higher Education and Research.
Based on the inclusion and exclusion criteria patients will be allotted
into two groups Group A – experimental group, Group B control group.
For the group A (experimental group) will be given three dimensional exercises
which include D2 flexion pattern (dorsi flexion- pronation – eversion- toe
extension) and D2 extension pattern (plantar flexion – supination - inversion –
toe flexion) with the subtalar joint mobilization (10reps x 2 sets) will be
given to the affected side.
For the Group B control group stretching exercises and Intrinsic foot muscle
strengthening exercises (10reps x 2sets) are given. The exercises are given for
two weeks in both the experimental and control group respectively.
|