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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Idiopathic Toe Walking

Intervention / Treatment
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* Other: Serial Casting
* Other: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 3-10 years Patients with idiopathic toe walking diagnosis 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: Have previously conservative or surgical treatment Presence of plantar flexion contracture

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, single blinded, controlled study
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Idiopathic Toe Walking, Serial Casting, Exercise