- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07438665
Toe Spread Out Exercise With and Without Walking Surface Training in Children With Autism
Effects of Toe Spread Out Exercise With and Without Walking Surface Training on Navicular Drop and Jumping Performance in Children With Autism
Flatfoot is a common postural deformity in children, characterized by the collapse of the medial longitudinal arch, leading to abnormal foot posture, gait disturbances, and postural instability. Arch collapse in flatfoot is also due to navicular drop a condition where the navicular bone, located in the midfoot, shifts downward excessively when bearing weight.
This excessive drop reflects poor structural support in the foot and is often linked to weakness in the intrinsic foot muscles. The intrinsic and extrinsic muscles of the foot, particularly the abductor hallucis (AbdH), play a vital role in maintaining arch stability.
Strengthening exercises like toe spread out movements are specifically designed to target these muscles by abducting and flexing the toes, helping to support and elevate the medial arch. This study aims to investigate the combined effect of toe spread out exercises and walking surface training on navicular drop and jumping performance in children with ASD, focusing on muscle strength and sensory-motor integration to support functional movement and postural control. This randomized controlled trial will be conducted over ten months at Step Up Autism Center and Rehab Care, Lahore, following ethical approval from the Research Ethical Committee of Riphah International University Islamabad (Lahore Campus). Children aged 7 to 12 years, clinically diagnosed with autism spectrum disorder, navicular drop, and poor locomotor skills will be recruited through non-probability convenient sampling. After obtaining informed consent from guardians, eligible participants will be randomly allocated into two groups. Group A will perform toe spread out exercises only, while Group B will perform toe spread out exercises combined with walking surface training. Both interventions will be carried out three times a week for eight weeks. This will be a single-blinded study, where the assessor will remain unaware of the group allocations. Data collection will involve pre- and post intervention assessment using the Navicular Drop Test, Wet Footprint Test (Clarke's Angle), Horizontal Jump Test, and the Test of Gross Motor Development-Second Edition (TGMD-2) to evaluate changes in foot posture, arch structure, lower limb power, and locomotor skills in participating children.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Imran Amjad, Phd
- Phone Number: 03324390125
- Email: imran.amjad@riphah.edu.pk
Study Contact Backup
- Name: Fareeha Kausar, PPDPT
- Phone Number: 03216758180
- Email: fareeha.kausar@riphah.edu.pk
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan
- Special needs and autism community center
-
Contact:
- Fareeha Kausar
- Phone Number: 03216758180
- Email: fareeha.kouser@gmail.com
-
Principal Investigator:
- Eman Amjad, MSPPT
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children aged 7 to 12 years of age
- Children of both genders male and female
- children having navicular drop >9mm
Exclusion Criteria:
- Neurological conditions affecting movement (e.g., CP)
- Inability to follow simple verbal commands
- Visual or auditory impairment impacting motor performance
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Toe spread out exercise group
|
Partcipant will sit on the edge of chair with hips and knees at 90 degree flexion, with foot flat on the floor.
This position makes sure that there is equal weight distibution across the calcaneus, metatarsals and phalanges.
It is also made sure that the feet are hip width apart.Then the participant is asked to lift the toes off the ground(dorsiflexion) , keeping the heel and ball(metarsals) of foot on the ground.
While maintaining dorsiflexion of toes, the participant will be asked to flex the first toe medially (bending downward and toward the midline), similarly the fifth toe will be flexed laterally (bending downward and away from the midline) .The position will be held for 3 to 5 seconds with 10 repetiotns.
|
|
Experimental: Toe spread out exercises with walking surface training group
|
Partcipant will sit on the edge of chair with hips and knees at 90 degree flexion, with foot flat on the floor.
This position makes sure that there is equal weight distibution across the calcaneus, metatarsals and phalanges.
It is also made sure that the feet are hip width apart.Then the participant is asked to lift the toes off the ground(dorsiflexion) , keeping the heel and ball(metarsals) of foot on the ground.
While maintaining dorsiflexion of toes, the participant will be asked to flex the first toe medially (bending downward and toward the midline), similarly the fifth toe will be flexed laterally (bending downward and away from the midline) .The position will be held for 3 to 5 seconds with 10 repetiotns.
Walking Surface • The participant will be barefoot and will be asked to walk in their usual manner and speed.
• There will be three different surfaces i.e pile carpet (18mm thickness) for soft sensation, vinyl tile for flat smooth and loose gravel (average height of 14mm) for uneven sensation respectively.
• The participant will be asked to walk on the 4 meter walking surface, taking 10 rounds on each
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Navicular Drop by Navicular Drop Test
Time Frame: Baseline and 8th Week
|
The Navicular Drop (ND) Test evaluates medial longitudinal arch stability by measuring the difference in navicular height between neutral/seated and weight-bearing positions.
A drop of 5-9 mm is typical, while > 10mm indicates excessive pronation (arch collapse) or instability, often linked to structural issues
|
Baseline and 8th Week
|
|
Jumping Performance by using Horizontal Jump Test
Time Frame: Baseline and 8th Week
|
Horizontal jump tests, particularly the Standing Long Jump (SLJ) or Broad Jump, measure lower-body explosive power by recording the furthest distance of three attempts from a takeoff line to the nearest heel landing.
Elite men typically exceed 2.50 m, while women excel over 2.0 m , often aiming for a distance greater than their height.
|
Baseline and 8th Week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Fareeha Kausar, PPDPT, Riphah International University
Publications and helpful links
General Publications
- A-C, BOCA I-C, RUSU M-E, CRISTEA D. The Benefits of Physical Therapy in the Rehabilitation of Flat Feet in Autism Students between the ages of 10 and 14. Romanian Journal of Physical Therapy/Revista Romana de Kinetoterapie. 2023;29(51)
- Kim J, Lee J, Kim D, Islomjon B, Lee K, Yoon T. Acute response of toe-spread-out exercise on medial longitudinal arch height and balance. The Asian Journal of Kinesiology. 2021;23(1):27-33
- Kang M-H, Cha S-M, Oh J-S. The effect of toe-tap exercise on abductor hallucis activity and medial longitudinal arch angle in individuals with pes planus. Isokinetics and Exercise Science. 2020;28(4):415-22
- Lee H-j, Kim S-h, Baik S-m, Cynn H-s. Comparison of Foot Muscle Activity During Short Foot and Toe Spread-out Exercises in Different Weight Bearing Conditions in Individuals With Pes Planus. Physical Therapy Korea. 2024;31(1):63-71.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Eman Amjad
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Autism
-
Fondazione I.R.C.C.S. Istituto Neurologico Carlo...Istituto Clinico HumanitasRecruitingAutism | Autism Spectrum Disorder (ASD) | Autism DisorderItaly
-
Istituto per la Ricerca e l'Innovazione BiomedicaRecruitingAutism | Autism DisorderItaly
-
University of NottinghamUniversity Hospitals of Derby and Burton NHS Foundation Trust; Lincolnshire...Not yet recruitingAutism Spectrum Disorder | Autism | Parent | Autism Disorder | Autism in Children | Parent Stress | Parent Mental Health | Autism Disorders and Maternal Stress | Parent SupportUnited Kingdom
-
Boston Children's HospitalRecruitingAutism Spectrum Disorder | Autism | Autism DisorderUnited States
-
The Children's Hospital of Zhejiang University...Not yet recruitingAutism | Autism Spectrum Disorder (ASD)China
-
Poznan University of Physical EducationCompletedAutism | Autism Spectrum Disorder (ASD)Poland
-
Adia Med of Winter Park LLCActive, not recruitingAutism Spectrum Disorder | Autism | ASD | Autism Spectrum Disorder (ASD)United States
-
Stanford UniversityJohn and Marcia Goldman FoundationNot yet recruitingAutism | Autism Spectrum Disorder (ASD)United States
-
Father Flanagan's Boys' HomeNational Institute on Deafness and Other Communication Disorders (NIDCD)Not yet recruitingAutism Spectrum Disorder | Autism | Autism, Susceptibility to, 6United States
-
Institut National de la Santé Et de la Recherche...Completed
Clinical Trials on Toe spread out exercise
-
Bahar AnaforogluNot yet recruitingHallux Valgus Deformity
-
Poznan University of Medical SciencesCompletedHallux ValgusPoland
-
Istanbul Training and Research HospitalCompleted
-
Eastern Mediterranean UniversityRecruiting
-
University of British ColumbiaUniversity of Melbourne; Arthritis Research Centre of CanadaCompleted
-
Riphah International UniversityCompletedSports Physical TherapyPakistan
-
Riphah International UniversityCompletedRunning | Athletic Performance | Resistance TrainingPakistan
-
Noha Khaled ShoukryActive, not recruiting
-
Mark RockleyCompletedPeripheral Vascular Diseases | Blood Pressure | Endovascular Procedures | Clinical Decision-Making | Monitoring, IntraoperativeCanada
-
Riphah International UniversityRecruiting