Protocol summary

Study aim
To evaluate the effects of 6-week ankle stretching on Achilles tendon stiffness, anterior knee pain, genu recurvatum, and gait parameters in children with ankle pronation
Design
Semi-experimental, single-blind, randomized controlled trial, parallel groups (1:1), phase N/A (exercise therapy) on 40 children (6–10 years). Individual simple randomization via Excel (RAND and MOD ROW functions). Allocation concealment used sequentially numbered, opaque, sealed envelopes opened by an independent supervisor
Settings and conduct
Conducted at Shahid Beheshti University sports hall. 40 children randomly assigned to stretching (n=20) or control (n=20) groups. Intervention: 6 weeks of ankle stretching (3 sessions/week, 40 min/session). Control: routine activities. Tested at baseline and post-intervention. Blinding: Open-label (no blinding
Participants/Inclusion and exclusion criteria
Children aged 6–10 years, Chronic anterior knee pain (WBFS score 4–6), dorsiflexion range of motion <10 degrees. New orthopedic injury during the intervention, Unwillingness to continue the study, Irregular attendance in training sessions.
Intervention groups
5 static stretching exercises targeting gastrocnemius and soleus muscles (5 sets, 15–60s hold, 1-min rest) for 6 weeks, totaling 40 min/session Received no specific stretching or therapeutic intervention during the 6-week study period and maintained their routine daily activities
Main outcome variables
Anterior knee pain; Achilles tendon stiffness (ankle dorsiflexion range of motion); Genu recurvatum angle

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240306061185N7
Registration date: 2026-06-09, 1405/03/19
Registration timing: prospective

Last update: 2026-06-09, 1405/03/19
Update count: 0
Registration date
2026-06-09, 1405/03/19
Registrant information
Name
Hossein Rezaei
Name of organization / entity
The University of Shahid Beheshti
Country
Iran (Islamic Republic of)
Phone
+98 24 3562 3177
Email address
hosse.rezaei@mail.sbu.ac.ir
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2026-06-22, 1405/04/01
Expected recruitment end date
2026-07-06, 1405/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Six Weeks of Ankle-Stretching Exercises on Achilles Tendon Stiffness, Anterior Knee Pain, Genu Recurvatum, Stride Length and Walking Speed in Children with Ankle pronation
Public title
Stretching Effects on Child Pronated Ankles
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Boys and girls aged 6 to 10 years Chronic and persistent anterior knee pain with a WBFS score of 4 to 6 Limited ankle dorsiflexion range of motion less than 10 degrees Ankle pronation confirmed by a Navicular Drop Test greater than 10 mm Genu recurvatum angle greater than 5 degrees
Exclusion criteria:
History of lower limb surgery, fractures, or severe orthopedic injuries within the past year Severe structural deformities or neuromuscular disorders in the lower extremities Previous physical therapy, exercise therapy, or medical injections for the ankle/knee within the past 6 months Use of orthopedic insoles or specialized corrective footwear at the study onset
Age
From 6 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple randomization method is used and the randomization unit is "individual". Random sequence is generated in Excel software using RAND function and MOD ROW function is used for grouping. In order to observe allocation concealment, each individual's allocation code is placed in illegible and sealed envelopes after being determined in Excel.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahid Beheshti University Ethics Committee
Street address
Shahid Beheshti University, Shahriari square, Volanjek Town, Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2025-12-06, 1404/09/15
Ethics committee reference number
IR.SBU.REC.1404.249

Health conditions studied

1

Description of health condition studied
Anterior knee pain
ICD-10 code
M22.2X
ICD-10 code description
Patellofemoral disorders

2

Description of health condition studied
Ankle pronation
ICD-10 code
ICD-10 code description

3

Description of health condition studied
Genu recurvatum
ICD-10 code
ICD-10 code description

4

Description of health condition studied
Achilles tendon stiffness
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Anterior knee pain severity
Timepoint
Baseline and Six weeks post-intervention
Method of measurement
Wong-Baker Faces Pain Rating Scale

2

Description
Ankle dorsiflexion range of motion
Timepoint
Baseline and six weeks post-intervention
Method of measurement
goniometer

3

Description
Genu recurvatum angle
Timepoint
Baseline and six weeks post-intervention
Method of measurement
گونیامتر

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Consisted of twenty children who performed a static stretching exercise protocol targeting the gastrocnemius and soleus muscles of the ankle. The program included five static stretching exercises, performed in five sets, with a holding duration of fifteen to sixty seconds and one minute of rest between sets. The exercises were conducted for six weeks, with a frequency of three sessions per week and a duration of forty minutes per session, under the direct supervision of the researcher in the sports hall
Category
Rehabilitation

2

Description
Control group: During the research period, there will be no intervention in the control group and they will continue with their usual exercises.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Sports Science Laboratory of Shahid Beheshti University
Full name of responsible person
Sirus Sheikhi
Street address
Shahid Beheshti University, Shahriari square, Volanjek Town, Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 1953
Email
Moh_hosseini@sbu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Shahid Beheshti
Full name of responsible person
Seyed Mohammad Hosseini
Street address
Shahid Beheshti University, Shahriari square, Volanjek Town, Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 1953
Email
Moh_hosseini@sbu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The University of Shahid Beheshti
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
The University of Shahid Beheshti
Full name of responsible person
Hossein Rezaei
Position
PhD student
Latest degree
Master
Other areas of specialty/work
sport injury and corrective exercises
Street address
Sain Qala
City
Sain Qala
Province
Zanjan
Postal code
4574148543
Phone
+98 24 3562 3177
Email
hosse.rezaei@mail.sbu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Shahid Beheshti
Full name of responsible person
Hossein Rezaei
Position
PhD student
Latest degree
Master
Other areas of specialty/work
sport injury and corrective exercises
Street address
No 403., Nawab Safavi Ave., Imam Hossein Square., Sain Qala
City
Sain Qala
Province
Zanjan
Postal code
4574148543
Phone
+98 24 3562 3177
Email
hosse.rezaei@mail.sbu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
The University of Shahid Beheshti
Full name of responsible person
Hossein Rezaei
Position
PhD student
Latest degree
Master
Other areas of specialty/work
sport injury and corrective exercises
Street address
No 403., Nawab Safavi Ave., Imam Hossein Square., Sain Qala
City
Sain Qala
Province
Zanjan
Postal code
4574148543
Phone
+98 24 3562 3177
Email
hosse.rezaei@mail.sbu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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