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Enrolling by invitationNCT06953284KINESOTAPINGUpdated May 15, 2025

Kinesiotaping Versus Functional Electrical Stimulation on Equinus Deformity

An interventional study of KINESOTAPING and Functional Electrical Stimulation in EQUINUS DEFORMITY, sponsored by Kafrelsheikh University. Enrolling by invitation at 1 site in Egypt. Open to participants aged 4 Years to 10 Years. Per ClinicalTrials.gov, last updated 2025-05-15.

Sponsored by Kafrelsheikh University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 3 months ago, but the record still lists the study as enrolling by invitation.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
4 Years to 10 Years
Sex
All
01

Study summary

Effect of FES Versus No FES intervention. A statistically significant between-group difference in activity in favor of FES was reported for all 3 studies, immediately after the intervention period. This difference represented a 30% to 32% greater increase in activity compared with no FES intervention. A follow-up measurement was reported for 1 study, but no data were reported.

Effect of FES Versus Activity Training. Both studies reported a statistically nonsignificant between-group difference in activity compared with activity training, immediately after the intervention period. One study included a follow-up measurement, but no data were reported

Read the detailed description

This study will be conducted at the Outpatient clinics, Faculty of Physical

Therapy Kafrelsheikh University to prove the effect of core stability exercises on standing , balance and gait in diplegic CP children.

the children will be randomly allocated by simple random method via choosing one of two wrapped cards representing the two treatment groups, which are: Group (A): will receive core stability exercises in addition to the designed physiotherapy program.

Group (B): will receive the designed physiotherapy program only . Inclusion criteria

Children will be included in the study if they fulfil the following criteria:

  1. A medical diagnosis of diplegic CP made by paediatricians or pediatric neurologists.
  2. Children with spasticity grades ranged from 1 to 1+ according to MAS.
  3. Their age range from 4 to 10 years.
  1. Children were level I or II on the Gross Motor Function Classifcation System (GMFCS) 5.No orthopedic surgeries.

Exclusion criteria

Children will be excluded from the study if:

  1. They had a permanent deformity (bony or soft tissue contractures).
  2. Children having visual or auditory defects.
  3. Children who had Botox application to the lower extremity in the past 6 months or had undergone a previous surgical intervention to ankle and knee.
  4. A history of epileptic seizure and any diagnosed cardiac or orthopaedic disability that may prevent the use of assessment methods.
  5. Children who are absent in two successive sessions.
02

Conditions studied

  • EQUINUS DEFORMITY

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Keywords

  • KINESOTAPING
  • FUNCTIONAL ELECTRICAL STIMULATION
  • EQUINUS DEFORMITY
  • DIAPLEGIC CEREBRAL PALSY
03

In context

Equinus Deformity

10 studies on the registry are indexed under Equinus Deformity; 3 are open to participants now.

Browse Equinus Deformity studies →

Lead sponsor

Kafrelsheikh University is the lead sponsor of 294 studies on the registry; 114 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

    1. A medical diagnosis of diplegic CP made by paediatricians or pediatric neurologists.

      1. Children with spasticity grades ranged from 1 to 1+ according to MAS. 3. Their age range from 4 to 10 years.
      2. Children were level I or II on the Gross Motor Function Classifcation System (GMFCS) 5.No orthopedic surgeries

Exclusion criteria

Exclusion Criteria:

<!-- -->

  1. They had a permanent deformity (bony or soft tissue contractures).
  2. Children having visual or auditory defects.
  3. Children who had Botox application to the lower extremity in the past 6 months or had undergone a previous surgical intervention to ankle and knee.
  4. A history of epileptic seizure and any diagnosed cardiac or orthopaedic disability that may prevent the use of assessment methods.
  5. Children who are absent in two successive sessions.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    group 1

    children will receive kinesiotap technique in addition to the designed physiotherapy program for 3 months 3 session per week

    Other: KINESOTAPING

  • Experimental
    group 2

    children will receive FUNCTIONAL ELECTRICAL STIMULATION in addition to the designed physiotherapy program for 3 months 3session per week

    Other: Functional Electrical Stimulation

Interventions

  • OtherKINESOTAPING

    Kinesio Taping (KT) is commonly used in sport injuries, in neurology and oncology patients following the surgical protocols, and for paediatric rehabilitation to reduce pain, facilitate or inhibit muscle activity, prevent injuries, reposition joints, aid the lymphatic system, support postural alignment, and improve proprioception.7-9 Although its mechanism of action has not been fully understood, it is believed that activation of the cutaneous receptors could influence neuromuscular functions.10 The cutaneous sensory system provides preliminary information about limb positions and muscle forces to the central nervous system for monitoring and controlling limb movements, planning actions, and providing fluent movement.11 Common causes of unilateral spastic CP are middle cerebral artery infarct, hemi-brain atrophy, periventricular lesions, and brain malformations that disturb the integrity of the motor areas. Middle cerebral artery infarctions can particularly impair the somatosensory sy

  • OtherFunctional Electrical Stimulation

    This systematic review is the first to examine the effect of FES on activity in children with CP using only randomized trials.However, evidence was limited with only 5 trials being included. This limited evidence suggests that FES is effective, that is, it is better than no FES intervention, but that it is no more effective than activity training, that is, practicing the activity without FES will be just as effective. Furthermore, no evidence was found on whether any benefits are maintained beyond the intervention period because even though a follow-up measurement was reported for 2 studies, the authors failed to provide data. Even though the review was restricted to the highest standard of evidence, randomized trials, firm conclusions cannot be made. This is primarily because of the absence of group data (means and SD) in the papers, preventing a meta-analysis. This poor reporting is disappointing given that 3 of the 5 trials were published within the last 5 years. Therefore, we may b

06

What researchers measure

Primary outcomes

  1. 1. balance

    pediatric balance scale is clinical assessment tool designed to evaluate functional balance in children, particularly those with motor impairments such as cerebral palsy or developmental delays. It is a modified version of the Berg Balance Scale, adapted to suit the functional capabilities and developmental stages of children aged approximately 2 to 15 years.

    Time frame: 3 months

  2. 2. Evaluation of gait

    Kinovea is a free, open-source video analysis software widely used in clinical and research settings for the assessment of human movement, including gait analysis. It allows for detailed observation and measurement of kinematic parameters, such as joint angles, stride length, step time, and gait symmetry, through frame-by-frame video playback and annotation tools. To assess gait, videos of a subject walking are captured using a standard camera and then imported into Kinovea. The software enables users to place markers on key anatomical landmarks, which can then be tracked throughout the gait cycle

    Time frame: 3 months

  3. 3. Evaluation of standing

    The Gross Motor Function Classification System (GMFCS) is a standardized tool used to evaluate and classify the gross motor function of children with cerebral palsy, focusing on self-initiated movements, particularly in sitting and walking. It consists of five levels (I to V), with Level I indicating the most independent motor function and Level V the most severe limitations. In the context of evaluating standing progress, the GMFCS provides a reliable framework to monitor changes in a child's ability to maintain or achieve standing posture over time. For example, a transition from requiring support to stand (Level IV or III) to standing independently or with minimal assistance (Level II or I) reflects significant motor improvement. The classification system is age-specific and considers developmental milestones, making it especially useful for tracking functional gains during rehabilitation or intervention programs. Its ease of use, validity, and consistency make GMFCS an essential t

    Time frame: 3 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06953284
Responsible party
Sara Yousef Abdel Elglil Yousef Elsebahy (lecturer of physical therapy for pediatrics, Kafrelsheikh University) — Principal investigator
First posted
May 1, 2025
Start date
May 5, 2025
Primary completion
Jul 20, 2025 (estimated)
Completion
Aug 1, 2025 (estimated)
Last update
May 15, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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