| CTRI Number |
CTRI/2025/09/094257 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| 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
|
Investigating the Impact of Primal Reflex Release Technique on Achilles Tendon Length and Balance Control in Young Adults |
|
Scientific Title of Study
|
Effect of Primal Reflex Release Technique On Achilles Tendon length and Centre of pressure excursion among college going students:-A randomized control 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 |
Bhumi Sanjaykumar Shah |
| Designation |
PG Student |
| Affiliation |
Parul Institute of physiotherapy |
| Address |
Department of physiotherapy,Room No : 309, physiotherapy lab. Parul University, P.O. Limda, tal. Waghodiya. Dist. Vadodara- 391760. Gujarat State, India
Vadodara
GUJARAT
391760
India |
| Phone |
9499629329 |
| Fax |
|
| Email |
bhumishah0801@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Dhwani Jani |
| Designation |
Assistant professor |
| Affiliation |
Parul Institute of physiotherapy |
| Address |
Department of Physiotherapy, Room No: 409 Electrotherapy lab Parul University, vadodara gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
8469578811 |
| Fax |
|
| Email |
dhwani.jani29352@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Bhumi Sanjaykumar Shah |
| Designation |
PG Student |
| Affiliation |
Parul Institute of physiotherapy |
| Address |
Department of physiotherapy,Room No : 309, physiotherapy lab. Parul University, P.O. Limda, tal. Waghodiya. Dist. Vadodara- 391760. Gujarat State, India
Vadodara
GUJARAT
391760
India |
| Phone |
9499629329 |
| Fax |
|
| Email |
bhumishah0801@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Institute of Physiotherapy , Vadodara , Gujarat
391760 |
|
|
Primary Sponsor
|
| Name |
Parul Institute pf physiotherapy |
| Address |
Parul Institute of physiotherapy,Parul university, limda, vadodara, Gujarat
391760 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Bhumi shah |
Parul Sevashram Hospital |
Department of physiotherapy Room No : 309 physiotherapy lab
Vadodara
GUJARAT |
9499629329
bhumishah0801@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PUIECHR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Young Adults |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Calf Stretching |
Patient Positioning:
Have the patient lie supine (face up) on a treatment table. The patient’s leg is extended,
and the foot is relaxed.
2. Therapist Positioning:
Stand at the patient’s side near the target leg.
Hold the patient’s foot with one hand under the heel and place the other hand over the
ball of the foot or metatarsals.
32
3. Stretch Application:
Gently dorsiflex the foot (move it towards the shin) while keeping the knee straight to
target the gastrocnemius muscle
For the soleus muscle, bend the knee slightly and then dorsiflex the foot.
4. Monitoring and Adjustment:
Maintain steady, controlled pressure without bouncing.
Ask the patient about their comfort level and stop if they experience pain.
Hold the stretch 20-30 second. |
| Intervention |
Primal Reflex Release Technique |
PRRT Application:
• The therapist delivers hacking (percussion) over the tibia is anterior and patellar
tendon using a rhythmic motion.
• Perform 12 strokes per set, repeating this 3 times (total of 36 strokes).
• During hacking, the therapist ensures:
• Ankle dorsiflexion and toe flexion are actively maintained by the patient
MONITORING AND ADJUSTMENTS
• Observe the patient’s response, ensuring relaxation and minimal discomfort.
• Adjust stroke intensity and frequency if excessive tension or discomfort is noted.
31
• Reassess after the procedure to determine any changes in movement or pain levels.
• Modify the technique based on the patient’s response in subsequent sessions. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Students between 18 to 25 years of age
Both male and females will be included
Individuals with calf tightness
More than 5 inches distance from the wall according to weight bearing lunge test
Dominant and non-dominant side calf tightness
• Willing To Participate in the Study |
|
| ExclusionCriteria |
| Details |
Any recent injury or surgery around knee or ankle |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Weight Bearing Lunge Test |
First Baseline and than After 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| OHM 3000 Plantar pressure analysis system |
First Baseline and than After 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
17/09/2025 |
| 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="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
|
The Primal Reflex Release Technique (PRRT) is a novel therapeutic approach aimed at restoring neuromuscular balance by targeting hyperactive reflexes that may contribute to tendon tightness and altered postural dynamics.The Achilles tendon plays a vital role in lower limb function, including activities such as walking, running, and maintaining balance. Restricted flexibility or dysfunction in this tendon can impaired mobility and increase the risk of musculoskeletal injuries.This study addresses this gap by exploring the effects of PRRT on Achilles tendon length and CoP standing in college students. Findings from this study may provide valuable insights for physical therapists and sports trainers, contributing to more effective injury prevention and rehabilitation strategies for young, active individuals.Despite its potential benefits, there is limited research on its efficacy, particularly concerning the elongation of the Achilles tendon and its influence on COP excursion. Moreover, inadequate COP control can lead to poor postural stability, impacting daily functional activities. Particularly, in young and active populations, such as college students. |