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

NCT ID: NCT06010485

Last Updated: 2023-08-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2024-04-15

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.

Detailed Description

Children with ITW aged 3-10 years are randomized into three groups: the serial casting group (n=10), the physical therapy group (n=10), and the wait-list control group (n=10). Patients with ankle contracture and previous interventions are excluded. The serial casting group is planned to receive intermittent serial casting once every three days for three weeks. The physical therapy group is planned to undergo three sessions per week for three weeks, consisting of stretching exercises, strengthening exercises, balance training, proprioception exercises, and walking on heels. The patients were assessed by blinded investigators at before treatment (BT), post-treatment (PT: 3th week), 1st month (1MPT), 3rd months (3MPT), and 6th months post-treatment (6MPT). To ensure ethical considerations, only control group was followed-up until the 1MPT.

Conditions

Idiopathic Toe Walking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Serial Casting

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

Group Type: ACTIVE_COMPARATOR

Serial Casting

Intervention Type: OTHER

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

Exercise

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.

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: 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.

Control Group

This group consists of the patients on the waitlist.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Serial Casting

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

Intervention Type: OTHER

Exercise

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Aged 3-10 years

2. Patients with idiopathic toe walking diagnosis

3. 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.)

Exclusion Criteria

1. Have previously conservative or surgical treatment

2. Presence of plantar flexion contracture

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fatih Sultan Mehmet Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Esra Giray

Role: PRINCIPAL_INVESTIGATOR

Fatih Sultan Mehmet training and Research Hospital, Istanbul-Turkey

Locations

Fatih Sultan Mehmet Trainig and Research Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Esra Giray

Role: CONTACT

girayesra@hotmail.com

+905558134394

Özge İlleez

Role: CONTACT

ozgeilleez@hotmail.com

+905326255684

References

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.

Reference Type: BACKGROUND

PMID: 28092971 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21418634 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25628380 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27370652 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27089542 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23467862 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20692159 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 40167594 (View on PubMed)

Other Identifiers

illeezozge

Identifier Type: -

Identifier Source: org_study_id