The Effect of Serial Casting and Physical Therapy in Children With Idiopathic Toe Walking
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ClinicalTrials.gov Identifier: NCT06010485 |
Recruitment Status :
Not yet recruiting
First Posted : August 24, 2023
Last Update Posted : August 24, 2023
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Condition or disease | Intervention/treatment | Phase |
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Idiopathic Toe Walking | Other: Serial Casting Other: Exercise | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Randomized, single blinded, controlled study |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Estimated Study Start Date : | September 1, 2023 |
Estimated Primary Completion Date : | March 1, 2024 |
Estimated Study Completion Date : | April 15, 2024 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Serial Casting
The serial casting group received intermittent serial casting once every three days for three weeks.
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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.
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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.
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- 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
- 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)
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Ages Eligible for Study: | 3 Years to 10 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06010485
Contact: Esra Giray | +905558134394 | girayesra@hotmail.com | |
Contact: Özge İlleez | +905326255684 | ozgeilleez@hotmail.com |
Turkey | |
Fatih Sultan Mehmet Trainig and Research Hospital | |
Istanbul, Turkey, 34752 |
Principal Investigator: | Esra Giray | Fatih Sultan Mehmet training and Research Hospital, Istanbul-Turkey |
Responsible Party: | Fatih Sultan Mehmet Training and Research Hospital |
ClinicalTrials.gov Identifier: | NCT06010485 |
Other Study ID Numbers: |
illeezozge |
First Posted: | August 24, 2023 Key Record Dates |
Last Update Posted: | August 24, 2023 |
Last Verified: | August 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Idiopathic Toe Walking Serial Casting Exercise |