The Effect of Serial Casting and Physical Therapy in Children With Idiopathic Toe Walking

NCT06010485 | Unknown

• 1 other identifier: illeezozge
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Children who continue to walk on their tiptoes after developing a heel-toe gait normally are diagnosed with idiopathic toe walking (ITW). The study's aim was to investigate the effects of serial casting and physical therapy on joint range of motion (ROM), toe walking severity, functional health and health-related quality of life, walking balance, and satisfaction from treatment in ITW, in comparison with the control group.

Conditions

Idiopathic Toe Walking

Keywords

Idiopathic Toe Walking; Serial Casting; Exercise

Outcome Measures

Primary Outcomes (15)

• Range of Motion (ROM)

  Ankle dorsiflexion ROM with extended knee

  Day 0

• Range of Motion (ROM)

  Ankle dorsiflexion ROM with extended knee

  3rd week

• Range of Motion (ROM)

  Ankle dorsiflexion ROM with extended knee

  7th week

• Range of Motion (ROM)

  Ankle dorsiflexion ROM with extended knee

  15th week

• Range of Motion (ROM)

  Ankle dorsiflexion ROM with extended knee

  27th week

• Range of Motion (ROM)

  Ankle dorsiflexion ROM with flexed knee

  Day 0

• Range of Motion (ROM)

  Ankle dorsiflexion ROM with flexed knee

  3rd week

• Range of Motion (ROM)

  Ankle dorsiflexion ROM with flexed knee

  7th week

• Range of Motion (ROM)

  Ankle dorsiflexion ROM with flexed knee

  15th week

• Range of Motion (ROM)

  Ankle dorsiflexion ROM with flexed knee

  27th week

• Toe Walking Severity Scale

  The family is asked how long the child tiptoe walks during the day. The evaluation is as follows. Stage 1: Toe walking 76-100% of the time Stage 2: Toe walking 51-75% of the time Stage 3: Toe walking 26-50% of the time Stage 4: Toe walking 10-25% of the time Stage 5: Sole pressing but early heel lift (occasional toe gait \<10%) Stage 6: Normal heel strike

  Day 0

• Toe Walking Severity Scale

  The family is asked how long the child tiptoe walks during the day. The evaluation is as follows. Stage 1: Toe walking 76-100% of the time Stage 2: Toe walking 51-75% of the time Stage 3: Toe walking 26-50% of the time Stage 4: Toe walking 10-25% of the time Stage 5: Sole pressing but early heel lift (occasional toe gait \<10%) Stage 6: Normal heel strike

  3rd week

• Toe Walking Severity Scale

  The family is asked how long the child tiptoe walks during the day. The evaluation is as follows. Stage 1: Toe walking 76-100% of the time Stage 2: Toe walking 51-75% of the time Stage 3: Toe walking 26-50% of the time Stage 4: Toe walking 10-25% of the time Stage 5: Sole pressing but early heel lift (occasional toe gait \<10%) Stage 6: Normal heel strike

  7th week

• Toe Walking Severity Scale

  The family is asked how long the child tiptoe walks during the day. The evaluation is as follows. Stage 1: Toe walking 76-100% of the time Stage 2: Toe walking 51-75% of the time Stage 3: Toe walking 26-50% of the time Stage 4: Toe walking 10-25% of the time Stage 5: Sole pressing but early heel lift (occasional toe gait \<10%) Stage 6: Normal heel strike

  15th week

• Toe Walking Severity Scale

  The family is asked how long the child tiptoe walks during the day. The evaluation is as follows. Stage 1: Toe walking 76-100% of the time Stage 2: Toe walking 51-75% of the time Stage 3: Toe walking 26-50% of the time Stage 4: Toe walking 10-25% of the time Stage 5: Sole pressing but early heel lift (occasional toe gait \<10%) Stage 6: Normal heel strike

  27th week

Secondary Outcomes (14)

• Pediatric Outcomes Data Collection Instrument (PODCI)

  Day 0

• Pediatric Outcomes Data Collection Instrument (PODCI)

  3rd week

• Pediatric Outcomes Data Collection Instrument (PODCI)

  7th week

• Pediatric Outcomes Data Collection Instrument (PODCI)

  15th week

• Pediatric Outcomes Data Collection Instrument (PODCI)

  27th week

Study Arms (3)

Serial Casting

ACTIVE COMPARATOR

The serial casting group received intermittent serial casting once every three days for three weeks.

Other: Serial Casting

Exercise

ACTIVE COMPARATOR

The physical therapy group underwent three sessions per week for three weeks, consisting of stretching exercises, strengthening exercises, balance training, proprioception exercises, and walking on heels.

Other: Exercise

Control Group

NO INTERVENTION

This group consists of the patients on the waitlist.

Interventions

Serial Casting OTHER

A short leg cast is applied to the serial casting group by an orthopedic specialist once every three days for three weeks.

Serial Casting

Exercise OTHER

Stretching exercises, strengthening exercises, balance exercises, proprioception exercises, and heel walking exercises are applied to the physical therapy group for 3 weeks with a physiotherapist for 3 sessions a week.

Exercise

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Aged 3-10 years
• Patients with idiopathic toe walking diagnosis
• To be evaluated by a pediatric neurologist, not to have abnormal findings in cranial and all spinal magnetic resonance imaging and electrophysiological examinations performed when deemed necessary, and creatinine kinase values are within normal limits ((Absence of any neurological, orthopedic or psychiatric pathology to explain the toe walking pattern (cerebral palsy, neuropathy, myopathy, autism, developmental disorders, etc.)

You may not qualify if:

• Have previously conservative or surgical treatment
• Presence of plantar flexion contracture

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

Study Sites (1)

Fatih Sultan Mehmet Trainig and Research Hospital

Istanbul, 34752, Turkey (Türkiye)

Location

Related Publications (8)

• Pomarino D, Ramirez Llamas J, Martin S, Pomarino A. Literature Review of Idiopathic Toe Walking: Etiology, Prevalence, Classification, and Treatment. Foot Ankle Spec. 2017 Aug;10(4):337-342. doi: 10.1177/1938640016687370. Epub 2017 Jan 16.

  PMID: 28092971 BACKGROUND

• Engelbert R, Gorter JW, Uiterwaal C, van de Putte E, Helders P. Idiopathic toe-walking in children, adolescents and young adults: a matter of local or generalised stiffness? BMC Musculoskelet Disord. 2011 Mar 21;12:61. doi: 10.1186/1471-2474-12-61.

  PMID: 21418634 BACKGROUND

• Herrin K, Geil M. A comparison of orthoses in the treatment of idiopathic toe walking: A randomized controlled trial. Prosthet Orthot Int. 2016 Apr;40(2):262-9. doi: 10.1177/0309364614564023. Epub 2015 Jan 27.

  PMID: 25628380 BACKGROUND

• Pomarino D, Ramirez Llamas J, Pomarino A. Idiopathic Toe Walking: Family Predisposition and Gender Distribution. Foot Ankle Spec. 2016 Oct;9(5):417-22. doi: 10.1177/1938640016656780. Epub 2016 Jul 1.

  PMID: 27370652 BACKGROUND

• Satila H, Beilmann A, Olsen P, Helander H, Eskelinen M, Huhtala H. Does Botulinum Toxin A Treatment Enhance the Walking Pattern in Idiopathic Toe-Walking? Neuropediatrics. 2016 Jun;47(3):162-8. doi: 10.1055/s-0036-1582138. Epub 2016 Apr 18.

  PMID: 27089542 BACKGROUND

• Engstrom P, Bartonek A, Tedroff K, Orefelt C, Haglund-Akerlind Y, Gutierrez-Farewik EM. Botulinum toxin A does not improve the results of cast treatment for idiopathic toe-walking: a randomized controlled trial. J Bone Joint Surg Am. 2013 Mar 6;95(5):400-7. doi: 10.2106/JBJS.L.00889.

  PMID: 23467862 BACKGROUND

• Williams CM, Tinley P, Curtin M. The Toe Walking Tool: a novel method for assessing idiopathic toe walking children. Gait Posture. 2010 Oct;32(4):508-11. doi: 10.1016/j.gaitpost.2010.07.011. Epub 2010 Aug 7.

  PMID: 20692159 BACKGROUND

• Giray E, Akpinar P, Illeez OG, Kahraman HC, Kocibar M, Kutsal A, Hacifazlioglu NE, Uyur E, Unlu Ozkan F, Aktas I, Yilmaz B, Karadag-Saygi E. A comparative randomized-controlled trial of serial casting and exercises on ankle range of motion, toe walking severity, walking balance, and functional health-related quality of life in children with idiopathic toe walking. J Pediatr Orthop B. 2025 Sep 1;34(5):465-476. doi: 10.1097/BPB.0000000000001250. Epub 2025 Jul 29.

  PMID: 40167594 DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Esra Giray

  Fatih Sultan Mehmet training and Research Hospital, Istanbul-Turkey

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Esra Giray

CONTACT

+905558134394; girayesra@hotmail.com

Özge İlleez

CONTACT

+905326255684; ozgeilleez@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, single blinded, controlled study

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: August 24, 2023
• Study Start: September 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: April 15, 2024
• Last Updated: August 24, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)