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

Idiopathic Toe Walking Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06010485
• Other study ID #: illeezozge
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: April 15, 2024

Study information

• Verified date: August 2023
• Source: Fatih Sultan Mehmet Training and Research Hospital
• Contact: Esra Giray
• Phone: +905558134394
• Email: girayesra[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: April 15, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Fatih Sultan Mehmet Trainig and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Fatih Sultan Mehmet Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Erratum In: Gait Posture. 2011 Jul;34(3):442. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Range of Motion (ROM)	Ankle dorsiflexion ROM with extended knee	Day 0
Primary	Range of Motion (ROM)	Ankle dorsiflexion ROM with extended knee	3rd week
Primary	Range of Motion (ROM)	Ankle dorsiflexion ROM with extended knee	7th week
Primary	Range of Motion (ROM)	Ankle dorsiflexion ROM with extended knee	15th week
Primary	Range of Motion (ROM)	Ankle dorsiflexion ROM with extended knee	27th week
Primary	Range of Motion (ROM)	Ankle dorsiflexion ROM with flexed knee	Day 0
Primary	Range of Motion (ROM)	Ankle dorsiflexion ROM with flexed knee	3rd week
Primary	Range of Motion (ROM)	Ankle dorsiflexion ROM with flexed knee	7th week
Primary	Range of Motion (ROM)	Ankle dorsiflexion ROM with flexed knee	15th week
Primary	Range of Motion (ROM)	Ankle dorsiflexion ROM with flexed knee	27th week
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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