Clinical trial NCT06010485: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Idiopathic Toe Walking
Keywords: Idiopathic Toe Walking
Serial Casting
Exercise
Lead sponsor: Fatih Sultan Mehmet Training and Research Hospital
Sponsor class: OTHER
First posted: 2023-08-24
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, single blinded, controlled study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Range of Motion (ROM)
timeFrame: Day 0
measure: Range of Motion (ROM)
timeFrame: 3rd week
measure: Range of Motion (ROM)
timeFrame: 7th week
measure: Range of Motion (ROM)
timeFrame: 15th week
measure: Range of Motion (ROM)
timeFrame: 27th week
measure: Range of Motion (ROM)
timeFrame: Day 0
measure: Range of Motion (ROM)
timeFrame: 3rd week
measure: Range of Motion (ROM)
timeFrame: 7th week
measure: Range of Motion (ROM)
timeFrame: 15th week
measure: Range of Motion (ROM)
timeFrame: 27th week
measure: Toe Walking Severity Scale
timeFrame: Day 0
measure: Toe Walking Severity Scale
timeFrame: 3rd week
measure: Toe Walking Severity Scale
timeFrame: 7th week
measure: Toe Walking Severity Scale
timeFrame: 15th week
measure: Toe Walking Severity Scale
timeFrame: 27th week
Secondary outcomes:
measure: Pediatric Outcomes Data Collection Instrument (PODCI)
timeFrame: Day 0
measure: Pediatric Outcomes Data Collection Instrument (PODCI)
timeFrame: 3rd week
measure: Pediatric Outcomes Data Collection Instrument (PODCI)
timeFrame: 7th week
measure: Pediatric Outcomes Data Collection Instrument (PODCI)
timeFrame: 15th week
measure: Pediatric Outcomes Data Collection Instrument (PODCI)
timeFrame: 27th week
measure: Tandem Walk Test
timeFrame: Day 0
measure: Tandem Walk Test
timeFrame: 3rd week
measure: Tandem Walk Test
timeFrame: 7th week
measure: Tandem Walk Test
timeFrame: 15th week
measure: Tandem Walk Test
timeFrame: 27th week
measure: Visual Analog Scale
timeFrame: 3rd week
measure: Visual Analog Scale
timeFrame: 7th week
measure: Visual Analog Scale
timeFrame: 15th week
measure: Visual Analog Scale
timeFrame: 27th week
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Fatih Sultan Mehmet Trainig and Research Hospital
Study officials:
affiliation: Fatih Sultan Mehmet training and Research Hospital, Istanbul-Turkey
name: Esra Giray
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.