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

The Effect of Serial Casting and Physical Therapy on Ankle Range of Motion, Toe Walking Severity, Walking Balance, Functional Health Related Quality of Life in Children With Idiopathic Toe Walking

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Idiopathic Toe Walking
• Intervention / Treatment: Other: Serial Casting; Other: Exercise

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Esra Giray; Phone Number: +905558134394; Email: girayesra@hotmail.com
• Study Contact Backup: Name: Özge İlleez; Phone Number: +905326255684; Email: ozgeilleez@hotmail.com

Study Locations

• Turkey
  • Istanbul, Turkey, 34752
    • Fatih Sultan Mehmet Trainig and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Serial Casting; The serial casting group received intermittent serial casting once every three days for three weeks.	Other: Serial Casting; A short leg cast is applied to the serial casting group by an orthopedic specialist once every three days for three weeks.
Active Comparator: 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.	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.
No Intervention: Control Group; This group consists of the patients on the waitlist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pediatric Outcomes Data Collection Instrument (PODCI)	PODCI evaluates functional health status through an 86 item questionnaire. Scoring varies greatly due to the multiple weighted scores of some items, scores range from 0-3 for some items and 0-6 for others. The overall score comes from 4 functional assessment scores, a global function score, and a happiness score. These scores range from 0-100 with lower scores representing higher levels of disability.	Day 0
Pediatric Outcomes Data Collection Instrument (PODCI)	PODCI evaluates functional health status through an 86 item questionnaire. Scoring varies greatly due to the multiple weighted scores of some items, scores range from 0-3 for some items and 0-6 for others. The overall score comes from 4 functional assessment scores, a global function score, and a happiness score. These scores range from 0-100 with lower scores representing higher levels of disability.	3rd week
Pediatric Outcomes Data Collection Instrument (PODCI)	PODCI evaluates functional health status through an 86 item questionnaire. Scoring varies greatly due to the multiple weighted scores of some items, scores range from 0-3 for some items and 0-6 for others. The overall score comes from 4 functional assessment scores, a global function score, and a happiness score. These scores range from 0-100 with lower scores representing higher levels of disability.	7th week
Pediatric Outcomes Data Collection Instrument (PODCI)	PODCI evaluates functional health status through an 86 item questionnaire. Scoring varies greatly due to the multiple weighted scores of some items, scores range from 0-3 for some items and 0-6 for others. The overall score comes from 4 functional assessment scores, a global function score, and a happiness score. These scores range from 0-100 with lower scores representing higher levels of disability.	15th week
Pediatric Outcomes Data Collection Instrument (PODCI)	PODCI evaluates functional health status through an 86 item questionnaire. Scoring varies greatly due to the multiple weighted scores of some items, scores range from 0-3 for some items and 0-6 for others. The overall score comes from 4 functional assessment scores, a global function score, and a happiness score. These scores range from 0-100 with lower scores representing higher levels of disability.	27th week
Tandem Walk Test	The participants are asked to walk in a straight line with one foot just in front of the other (heel to toe), arms at their sides.	Day 0
Tandem Walk Test	The participants are asked to walk in a straight line with one foot just in front of the other (heel to toe), arms at their sides.	3rd week
Tandem Walk Test	The participants are asked to walk in a straight line with one foot just in front of the other (heel to toe), arms at their sides.	7th week
Tandem Walk Test	The participants are asked to walk in a straight line with one foot just in front of the other (heel to toe), arms at their sides.	15th week
Tandem Walk Test	The participants are asked to walk in a straight line with one foot just in front of the other (heel to toe), arms at their sides.	27th week
Visual Analog Scale	All participants are asked about satisfaction with treatment through a smiley face visual analog scale 'smiley face' visual analogue scale (0-10, 0 for full satisfaction)	3rd week
Visual Analog Scale	All participants are asked about satisfaction with treatment through a smiley face visual analog scale 'smiley face' visual analogue scale (0-10, 0 for full satisfaction)	7th week
Visual Analog Scale	All participants are asked about satisfaction with treatment through a smiley face visual analog scale 'smiley face' visual analogue scale (0-10, 0 for full satisfaction)	15th week
Visual Analog Scale	All participants are asked about satisfaction with treatment through a smiley face visual analog scale 'smiley face' visual analogue scale (0-10, 0 for full satisfaction)	27th week

Collaborators and Investigators

• Sponsor: Fatih Sultan Mehmet Training and Research Hospital
• Investigators: Principal Investigator: Esra Giray, Fatih Sultan Mehmet training and Research Hospital, Istanbul-Turkey

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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. Erratum In: Gait Posture. 2011 Jul;34(3):442.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): April 15, 2024

Study Registration Dates

• First Submitted: August 21, 2023
• First Submitted That Met QC Criteria: August 23, 2023
• First Posted (Actual): August 24, 2023

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Exercise; Idiopathic Toe Walking; Serial Casting
• Other Study ID Numbers: illeezozge

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No