Pronation Distotion SyndromeNCT06761040
Intrinsic Foot Muscle With and Without Hip Abductor Muscle Strengthening Training in Overweight Females
A study testing Intrinsic foot muscle training and hip abductor muscle training with intrinsic foot muscle training in people with Pronation Distotion Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
pronation distortion syndrome is a common postural distortion of the lower extremity, involving the anterior part of the leg. It may cause pain in the leg and disturbances in the tarsal part, in addition to distal and proximal parts. Read more about this study
- Who is it for?
- Ages 30 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pronation Distotion Syndrome
- What is being tested?
- Intrinsic foot muscle training and hip abductor muscle training with intrinsic foot muscle training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Sep 2024to 15 Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages 30-35 years
- Female gender
- BMI of overweight women (25-29.9)
- Foot pronation on observation
- Navicular Drop Test more than 10mm (measured in weight bearing and non-weight bearing positions distance between ground and navicular tuberosity and difference calculated).(16)
- Increased Q angle :females 15-18
Who cannot join
- • Other deformities such as tarsal coalition and vertical talus.
- BMI underweight,normal ,obese.
- Any history of surgery involving both lower extremities.
- Neuromuscular disorder(GBS,MG,Muscular dystrophies extremities.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Ganga Ram Hospital
Lahore, Punjab Province, 54000
Sidra Afzal, PP-DPT, 03124378540, sidra.afzal@riphah.edu.pk
About this study
Official title: Effects of Intrinsic Foot Muscle With and Without Hip Abductor Muscle Strengthening Training in Overweight Females With Pronation Distortion Syndrome
pronation distortion syndrome is a common postural distortion of the lower extremity, involving the anterior part of the leg. It may cause pain in the leg and disturbances in the tarsal part, in addition to distal and proximal parts. In this deformity, the head of the talus and navicular bones are rotated inward and downward, and the body's center of gravity shifts inward, resulting in flat feet. It is also associated with a union and increased pressure on the medial parts of the first and second metatarso phalangeal joints. The characteristics of pronation distortion syndrome due to excessive foot pronation include inward rotation of the tibia, internal rotation of the thighs associated with flat feet, genu valgum (knock-knee), and increased lordosis in case of hyperpronation. The randomized clinical trial study design will be used with the sample of 48 womens. The data will be collected from ganga ram hospital and mukhtara rafique welfare hospital by using convenient sampling technique.The inclusion criteria Ages 30-35 years, Female gender, BMI of overweight women (25-29.9). Foot pronation on observation, Navicular Drop Test more than 10mm (measured in weight bearing and non-weight bearing positions distance between ground and navicular tuberosity and difference calculated), Increased Q angle :females 15-18. The exclusion criteria is Other deformities such as tarsal coalition and vertical talus, BMI under weight,normal,obese.Any history of surgery involving both lower extremities.and Neuromuscular disorder(GBS,MG,Muscular dystrophies extremities)|.The tools used is Numeric Pain Rating Scale (NPRS), Navicular drop test, Goniometer for Q angle measurement, and Lower extremity functional scale (LEFS). Data will be analyzed by using SPSS version 26,0.
- Conditions
- Pronation Distotion Syndrome
- Being tested
- Intrinsic foot muscle training, hip abductor muscle training with intrinsic foot muscle training
- Keywords
- Intrinsic Foot Muscle, Hip Abductor, Pronation Distortion Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrinsic foot muscle trainingOther
Technique In intrinsic foot muscle training, there are following exercises:
- Toe spread out
- First toe extension
- Second to fifth toe extension The exercise would be performed in following positions 1. Sitting position for the first 2 weeks (3sec hold; 4 sets ×15 reps) 2. Standing position on the 3rd and 4th weeks (8sec hold; 4 sets × 8 reps) 3. One-leg standing position during the 5th and 6th week (20 sec hold;4 sets ×3 reps)
hip abductor muscle training with intrinsic foot muscle trainingOther
Hip abductor muscle training consists of the following two exercise
- Resisted hip abduction 90° (2 sec hold; 3 sets × 10 reps)
- Resisted hip abduction 45° (2 sec hold; 3 sets × 10 reps)
Standard treatment
- Shoe insoles (eight hours a day, medial longitudinal arch support,raised for by about 1.8 cm)
- Stretching of Hamstrings and Calf muscles (3 times for 30 seconds hold) Number of Sessions Per Week : 3 times Per week for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intrinsic foot muscle training | Experimental | Technique In intrinsic foot muscle training, there are following exercises:
1. Toe spread out
2. First toe extension
3. Second to fifth toe extension Receives: Other: Intrinsic foot muscle training |
| hip abductor muscle training with intrinsic foot muscle training. | Active comparator | Hip abductor muscle training consists of the following two exercise using
1. Resisted hip abduction 90° (2 sec hold; 3 sets × 10 reps)
2. Resisted hip abduction 45° (2 sec hold; 3 sets × 10 reps) Receives: Other: Intrinsic foot muscle training; Other: hip abductor muscle training with intrinsic foot muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Goniometer
universal goniometer has been shown to have good to excellent reliability, and is more reliable than visual estimation especially with inexperienced examiners.The Q angle is formed between a line representing the resultant line of force of the quadriceps (connecting a point near the anterior superior iliac spine (ASIS) to the mid-point of the patella) and a line from the center of the patella to the center of the tibial tubercle. In women, the Q angle should be less than 22 degrees with the knee in extension and less than 9 degrees with the knee in 90 degrees of flexion.normal 14 to 16. In female 15 degree.
Measured: baseline and fourth week
Numeric Pain Rating Scale
The Numeric Pain Rating Scale (NPRS) that is a unidimensional measure of pain intensity in adults,including those with chronic pain due to rheumatic diseases. The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.
Measured: baseline and fourth week
Navicular Drop Test:
The ND test was performed to confirm whether subjects had flexibility flatfoot.The examiner measured the height of the navicular tuberosity from the ground with the subject being non-weight bearing.Subject then stood,with weight bearing equally on both feet,as the examinar remeasured the height of the navicular tuberosity.The difference in the height of the navicular tuberosity between weight bearing and non weight bearing situation was determined.A difference of 10>mm was considered as flexibal flat foot.ND test have proven valid and reliable for the assessment of the medial arch.
Measured: baseline and fourth week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start15 Sep 2024
- Primary completion30 Dec 2024 (estimated)
- Study completion15 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pronation Distotion SyndromeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rabiya Noor, PHD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761040
- Sponsor's protocol ID
- REC/RCR&AHS/24/0517
- Status last verified
- Jan 2025
- First submitted
- 1 Jan 2025
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mulligan EP, Cook PG. Effect of plantar intrinsic muscle training on medial longitudinal arch morphology and dynamic function. Man Ther. 2013 Oct;18(5):425-30. doi: 10.1016/j.math.2013.02.007. Epub 2013 Apr 28.
PubMed 23632367Pabon-Carrasco M, Castro-Mendez A, Vilar-Palomo S, Jimenez-Cebrian AM, Garcia-Paya I, Palomo-Toucedo IC. Randomized Clinical Trial: The Effect of Exercise of the Intrinsic Muscle on Foot Pronation. Int J Environ Res Public Health. 2020 Jul 7;17(13):4882. doi: 10.3390/ijerph17134882.
PubMed 32645830Lee DR, Choi YE. Effects of a 6-week intrinsic foot muscle exercise program on the functions of intrinsic foot muscle and dynamic balance in patients with chronic ankle instability. J Exerc Rehabil. 2019 Oct 28;15(5):709-714. doi: 10.12965/jer.1938488.244. eCollection 2019 Oct.
PubMed 31723561
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intrinsic Foot Muscle With and Without Hip Abductor Muscle Strengthening Training in Overweight Females With Pronation Distortion Syndrome
- ClinicalTrials.gov ID
- NCT06761040
- Acronym / sponsor ID
- REC/RCR&AHS/24/0517
- Conditions
- Pronation Distotion Syndrome
- Keywords
- Intrinsic Foot Muscle, Hip Abductor, Pronation Distortion Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 15 Jan 2025 (estimated)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
pronation distortion syndrome is a common postural distortion of the lower extremity, involving the anterior part of the leg. It may cause pain in the leg and disturbances in the tarsal part, in addition to distal and proximal parts. In this deformity, the head of the talus and navicular bones are rotated inward and downward, and the body's center of gravity shifts inward, resulting in flat feet. It is also associated with a union and increased pressure on the medial parts of the first and second metatarso phalangeal joints. The characteristics of pronation distortion syndrome due to excessive foot pronation include inward rotation of the tibia, internal rotation of the thighs associated with flat feet, genu valgum (knock-knee), and increased lordosis in case of hyperpronation. The randomized clinical trial study design will be used with the sample of 48 womens. The data will be collected from ganga ram hospital and mukhtara rafique welfare hospital by using convenient sampling technique.The inclusion criteria Ages 30-35 years, Female gender, BMI of overweight women (25-29.9). Foot pronation on observation, Navicular Drop Test more than 10mm (measured in weight bearing and non-weight bearing positions distance between ground and navicular tuberosity and difference calculated), Increased Q angle :females 15-18. The exclusion criteria is Other deformities such as tarsal coalition and vertical talus, BMI under weight,normal,obese.Any history of surgery involving both lower extremities.and Neuromuscular disorder(GBS,MG,Muscular dystrophies extremities)|.The tools used is Numeric Pain Rating Scale (NPRS), Navicular drop test, Goniometer for Q angle measurement, and Lower extremity functional scale (LEFS). Data will be analyzed by using SPSS version 26,0.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrinsic foot muscle training | Experimental | Other: Intrinsic foot muscle trainingTechnique In intrinsic foot muscle training, there are following exercises: 1. Toe spread out 2. First toe extension 3. Second to fifth toe extension |
| hip abductor muscle training with intrinsic foot muscle training. | Active comparator | Other: Intrinsic foot muscle training, Other: hip abductor muscle training with intrinsic foot muscle trainingHip abductor muscle training consists of the following two exercise using 1. Resisted hip abduction 90° (2 sec hold; 3 sets × 10 reps) 2. Resisted hip abduction 45° (2 sec hold; 3 sets × 10 reps) |
Who may qualify
- Ages
- 30 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Ages 30-35 years
- Female gender
- BMI of overweight women (25-29.9)
- Foot pronation on observation
- Navicular Drop Test more than 10mm (measured in weight bearing and non-weight bearing positions distance between ground and navicular tuberosity and difference calculated).(16)
Key exclusion criteria (4 listed)
- • Other deformities such as tarsal coalition and vertical talus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrinsic foot muscle trainingTechnique In intrinsic foot muscle training, there are following exercises: 1. Toe spread out 2. First toe extension 3. Second to fifth toe extension The exercise would be performed in following positions 1. Sitting position for the first 2 weeks (3sec hold; 4 sets ×15 reps) 2. Standing position on the 3rd and 4th weeks (8sec hold; 4 sets × 8 reps) 3. One-leg standing position during the 5th and 6th week (20 sec hold;4 sets ×3 reps) | Other | Intrinsic foot muscle training, hip abductor muscle training with intrinsic foot muscle training. |
| hip abductor muscle training with intrinsic foot muscle trainingHip abductor muscle training consists of the following two exercise 1. Resisted hip abduction 90° (2 sec hold; 3 sets × 10 reps) 2. Resisted hip abduction 45° (2 sec hold; 3 sets × 10 reps) Standard treatment * Shoe insoles (eight hours a day, medial longitudinal arch support,raised for by about 1.8 cm) * Stretching of Hamstrings and Calf muscles (3 times for 30 seconds hold) Number of Sessions Per Week : 3 times Per week for 6 weeks | Other | hip abductor muscle training with intrinsic foot muscle training. |
Primary outcome
Goniometer
Time frame: baseline and fourth week
universal goniometer has been shown to have good to excellent reliability, and is more reliable than visual estimation especially with inexperienced examiners.The Q angle is formed between a line representing the resultant line of force of the quadriceps (connecting a point near the anterior superior iliac spine (ASIS) to the mid-point of the patella) and a line from the center of the patella to the center of the tibial tubercle. In women, the Q angle should be less than 22 degrees with the knee in extension and less than 9 degrees with the knee in 90 degrees of flexion.normal 14 to 16. In female 15 degree.
Numeric Pain Rating Scale
Time frame: baseline and fourth week
The Numeric Pain Rating Scale (NPRS) that is a unidimensional measure of pain intensity in adults,including those with chronic pain due to rheumatic diseases. The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.
Navicular Drop Test:
Time frame: baseline and fourth week
The ND test was performed to confirm whether subjects had flexibility flatfoot.The examiner measured the height of the navicular tuberosity from the ground with the subject being non-weight bearing.Subject then stood,with weight bearing equally on both feet,as the examinar remeasured the height of the navicular tuberosity.The difference in the height of the navicular tuberosity between weight bearing and non weight bearing situation was determined.A difference of 10>mm was considered as flexibal flat foot.ND test have proven valid and reliable for the assessment of the medial arch.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Background: PubMed 23632367Mulligan EP, Cook PG. Effect of plantar intrinsic muscle training on medial longitudinal arch morphology and dynamic function. Man Ther. 2013 Oct;18(5):425-30. doi: 10.1016/j.math.2013.02.007. Epub 2013 Apr 28.
- Background: PubMed 32645830Pabon-Carrasco M, Castro-Mendez A, Vilar-Palomo S, Jimenez-Cebrian AM, Garcia-Paya I, Palomo-Toucedo IC. Randomized Clinical Trial: The Effect of Exercise of the Intrinsic Muscle on Foot Pronation. Int J Environ Res Public Health. 2020 Jul 7;17(13):4882. doi: 10.3390/ijerph17134882.
- Background: PubMed 31723561Lee DR, Choi YE. Effects of a 6-week intrinsic foot muscle exercise program on the functions of intrinsic foot muscle and dynamic balance in patients with chronic ankle instability. J Exerc Rehabil. 2019 Oct 28;15(5):709-714. doi: 10.12965/jer.1938488.244. eCollection 2019 Oct.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rabiya Noor, PHD principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrinsic foot muscle training and hip abductor muscle training with intrinsic foot muscle training in people with Pronation Distotion Syndrome, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact IQBAL TARIQ, PHD (03338236752, iqbal.tariq@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Goniometer (time frame: baseline and fourth week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06761040, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.