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

Sponsor
Fatih Sultan Mehmet Training and Research Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06010485
Collaborator
(none)
30
1
3
7.5
4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Serial Casting
  • Other: Exercise
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized, single blinded, controlled studyRandomized, 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
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Apr 15, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Serial Casting

The serial casting group received intermittent serial casting once every three days for three weeks.

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.

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.

Outcome Measures

Primary Outcome Measures

  1. Range of Motion (ROM) [Day 0]

    Ankle dorsiflexion ROM with extended knee

  2. Range of Motion (ROM) [3rd week]

    Ankle dorsiflexion ROM with extended knee

  3. Range of Motion (ROM) [7th week]

    Ankle dorsiflexion ROM with extended knee

  4. Range of Motion (ROM) [15th week]

    Ankle dorsiflexion ROM with extended knee

  5. Range of Motion (ROM) [27th week]

    Ankle dorsiflexion ROM with extended knee

  6. Range of Motion (ROM) [Day 0]

    Ankle dorsiflexion ROM with flexed knee

  7. Range of Motion (ROM) [3rd week]

    Ankle dorsiflexion ROM with flexed knee

  8. Range of Motion (ROM) [7th week]

    Ankle dorsiflexion ROM with flexed knee

  9. Range of Motion (ROM) [15th week]

    Ankle dorsiflexion ROM with flexed knee

  10. Range of Motion (ROM) [27th week]

    Ankle dorsiflexion ROM with flexed knee

  11. Toe Walking Severity Scale [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

  12. Toe Walking Severity Scale [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

  13. Toe Walking Severity Scale [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

  14. Toe Walking Severity Scale [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

  15. Toe Walking Severity Scale [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

Secondary Outcome Measures

  1. Pediatric Outcomes Data Collection Instrument (PODCI) [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.

  2. Pediatric Outcomes Data Collection Instrument (PODCI) [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.

  3. Pediatric Outcomes Data Collection Instrument (PODCI) [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.

  4. Pediatric Outcomes Data Collection Instrument (PODCI) [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.

  5. Pediatric Outcomes Data Collection Instrument (PODCI) [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.

  6. Tandem Walk Test [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.

  7. Tandem Walk Test [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.

  8. Tandem Walk Test [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.

  9. Tandem Walk Test [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.

  10. Tandem Walk Test [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.

  11. Visual Analog Scale [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)

  12. Visual Analog Scale [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)

  13. Visual Analog Scale [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)

  14. Visual Analog Scale [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 10 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fatih Sultan Mehmet Trainig and Research Hospital Istanbul Turkey 34752

Sponsors and Collaborators

  • Fatih Sultan Mehmet Training and Research Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Fatih Sultan Mehmet Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT06010485
Other Study ID Numbers:
  • illeezozge
First Posted:
Aug 24, 2023
Last Update Posted:
Aug 24, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fatih Sultan Mehmet Training and Research Hospital

Study Results

No Results Posted as of Aug 24, 2023