EQUINUS DEFORMITYKINESOTAPINGNCT06953284
Kinesiotaping Versus Functional Electrical Stimulation on Equinus Deformity
A study testing KINESOTAPING and Functional Electrical Stimulation in people with EQUINUS DEFORMITY, run by Kafrelsheikh University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- EQUINUS DEFORMITY
- What is being tested?
- KINESOTAPING and Functional Electrical Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 5 May 2025to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
- Children were level I or II on the Gross Motor Function Classifcation System (GMFCS) 5.No orthopedic surgeries
Who cannot join
- <!-- -->
- They had a permanent deformity (bony or soft tissue contractures).
- Children having visual or auditory defects.
- 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.
- A history of epileptic seizure and any diagnosed cardiac or orthopaedic disability that may prevent the use of assessment methods.
- Children who are absent in two successive sessions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy of Kinesiotaping Versus Functional Electrical Stimulation on Equinus Deformity in Children With Diplegic Cerebral Palsy
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:
- A medical diagnosis of diplegic CP made by paediatricians or pediatric neurologists.
- Children with spasticity grades ranged from 1 to 1+ according to MAS.
- Their age range from 4 to 10 years.
- 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:
- They had a permanent deformity (bony or soft tissue contractures).
- Children having visual or auditory defects.
- 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.
- A history of epileptic seizure and any diagnosed cardiac or orthopaedic disability that may prevent the use of assessment methods.
- Children who are absent in two successive sessions.
- Conditions
- EQUINUS DEFORMITY
- Being tested
- KINESOTAPING, Functional Electrical Stimulation
- Keywords
- KINESOTAPING, FUNCTIONAL ELECTRICAL STIMULATION, EQUINUS DEFORMITY, DIAPLEGIC CEREBRAL PALSY
- Medical subject headings
- Equinus Deformity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KINESOTAPINGOther
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
Functional Electrical StimulationOther
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
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | children will receive kinesiotap technique in addition to the designed physiotherapy program for 3 months 3 session per week Receives: Other: KINESOTAPING |
| group 2 | Experimental | children will receive FUNCTIONAL ELECTRICAL STIMULATION in addition to the designed physiotherapy program for 3 months 3session per week Receives: Other: Functional Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
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
Measured: 3 months
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start5 May 2025
- Primary completion20 Jul 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EQUINUS DEFORMITYStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Yousef Abdel Elglil Yousef Elsebahy, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953284
- Sponsor's protocol ID
- KFSIRB200-496
- Acronym
- KINESOTAPING
- Status last verified
- May 2025
- First submitted
- 12 Apr 2025
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Kinesiotaping Versus Functional Electrical Stimulation on Equinus Deformity in Children With Diplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06953284
- Acronym / sponsor ID
- KINESOTAPING / KFSIRB200-496
- Conditions
- EQUINUS DEFORMITY
- Keywords
- KINESOTAPING, FUNCTIONAL ELECTRICAL STIMULATION, EQUINUS DEFORMITY, DIAPLEGIC CEREBRAL PALSY
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 5 May 2025 (actual)
- Primary completion
- 20 Jul 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- A medical diagnosis of diplegic CP made by paediatricians or pediatric neurologists.
- Children with spasticity grades ranged from 1 to 1+ according to MAS.
- Their age range from 4 to 10 years.
- 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:
- They had a permanent deformity (bony or soft tissue contractures).
- Children having visual or auditory defects.
- 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.
- A history of epileptic seizure and any diagnosed cardiac or orthopaedic disability that may prevent the use of assessment methods.
- Children who are absent in two successive sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Other: KINESOTAPINGchildren will receive kinesiotap technique in addition to the designed physiotherapy program for 3 months 3 session per week |
| group 2 | Experimental | Other: Functional Electrical Stimulationchildren will receive FUNCTIONAL ELECTRICAL STIMULATION in addition to the designed physiotherapy program for 3 months 3session per week |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- <!-- -->
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KINESOTAPINGKinesio 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 | Other | group 1 |
| Functional Electrical StimulationThis 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 | Other | group 2 |
Primary outcome
1. balance
Time frame: 3 months
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.
2. Evaluation of gait
Time frame: 3 months
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
3. Evaluation of standing
Time frame: 3 months
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KINESOTAPING and Functional Electrical Stimulation in people with EQUINUS DEFORMITY, run by Kafrelsheikh University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. balance (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.