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

• ClinicalTrials.gov Identifier: NCT06010485
• Recruitment Status: Not yet recruiting
• First Posted: August 24, 2023
• Last Update Posted: August 24, 2023
• Sponsor: Fatih Sultan Mehmet Training and Research Hospital
• Information provided by (Responsible Party): Fatih Sultan Mehmet Training and Research Hospital

Tracking Information

• First Submitted Date: August 21, 2023
• First Posted Date: August 24, 2023
• Last Update Posted Date: August 24, 2023
• Estimated Study Start Date: September 1, 2023
• Estimated Primary Completion Date: March 1, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 23, 2023)

• Range of Motion (ROM) [ Time Frame: Day 0 ]
  Ankle dorsiflexion ROM with extended knee
• Range of Motion (ROM) [ Time Frame: 3rd week ]
  Ankle dorsiflexion ROM with extended knee
• Range of Motion (ROM) [ Time Frame: 7th week ]
  Ankle dorsiflexion ROM with extended knee
• Range of Motion (ROM) [ Time Frame: 15th week ]
  Ankle dorsiflexion ROM with extended knee
• Range of Motion (ROM) [ Time Frame: 27th week ]
  Ankle dorsiflexion ROM with extended knee
• Range of Motion (ROM) [ Time Frame: Day 0 ]
  Ankle dorsiflexion ROM with flexed knee
• Range of Motion (ROM) [ Time Frame: 3rd week ]
  Ankle dorsiflexion ROM with flexed knee
• Range of Motion (ROM) [ Time Frame: 7th week ]
  Ankle dorsiflexion ROM with flexed knee
• Range of Motion (ROM) [ Time Frame: 15th week ]
  Ankle dorsiflexion ROM with flexed knee
• Range of Motion (ROM) [ Time Frame: 27th week ]
  Ankle dorsiflexion ROM with flexed knee
• Toe Walking Severity Scale [ Time Frame: Day 0 ]
  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
• Toe Walking Severity Scale [ Time Frame: 3rd week ]
  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
• Toe Walking Severity Scale [ Time Frame: 7th week ]
  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
• Toe Walking Severity Scale [ Time Frame: 15th week ]
  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
• Toe Walking Severity Scale [ Time Frame: 27th week ]
  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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: August 23, 2023)

• Pediatric Outcomes Data Collection Instrument (PODCI) [ Time Frame: Day 0 ]
  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.
• Pediatric Outcomes Data Collection Instrument (PODCI) [ Time Frame: 3rd week ]
  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.
• Pediatric Outcomes Data Collection Instrument (PODCI) [ Time Frame: 7th week ]
  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.
• Pediatric Outcomes Data Collection Instrument (PODCI) [ Time Frame: 15th week ]
  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.
• Pediatric Outcomes Data Collection Instrument (PODCI) [ Time Frame: 27th week ]
  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.
• Tandem Walk Test [ Time Frame: Day 0 ]
  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.
• Tandem Walk Test [ Time Frame: 3rd week ]
  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.
• Tandem Walk Test [ Time Frame: 7th week ]
  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.
• Tandem Walk Test [ Time Frame: 15th week ]
  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.
• Tandem Walk Test [ Time Frame: 27th week ]
  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.
• Visual Analog Scale [ Time Frame: 3rd week ]
  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)
• Visual Analog Scale [ Time Frame: 7th week ]
  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)
• Visual Analog Scale [ Time Frame: 15th week ]
  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)
• Visual Analog Scale [ Time Frame: 27th week ]
  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)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effect of Serial Casting and Physical Therapy in Children With Idiopathic Toe Walking
• Official Title: 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
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomized, single blinded, controlled study

Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment

• Condition: Idiopathic Toe Walking

Intervention

• 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.
• 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.

Study Arms

• Active Comparator: Serial Casting
  The serial casting group received intermittent serial casting once every three days for three weeks.
  Intervention: Other: Serial Casting
• 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.
  Intervention: Other: Exercise
• No Intervention: Control Group
  This group consists of the patients on the waitlist.

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.

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: August 23, 2023): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 15, 2024
• Estimated Primary Completion Date: March 1, 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 3 Years to 10 Years (Child)
• Accepts Healthy Volunteers: No

Contacts

Contact: Esra Giray; +905558134394; girayesra@hotmail.com

Contact: Özge İlleez; +905326255684; ozgeilleez@hotmail.com

• Listed Location Countries: Turkey

Administrative Information

• NCT Number: NCT06010485
• Other Study ID Numbers: illeezozge
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Fatih Sultan Mehmet Training and Research Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Fatih Sultan Mehmet Training and Research Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Fatih Sultan Mehmet Training and Research Hospital
• Verification Date: August 2023