- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06953284
Kinesiotaping Versus Functional Electrical Stimulation on Equinus Deformity (KINESOTAPING)
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
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:
- 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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Tanta, Egypt
- Kafrelsheikh University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion 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.
Children were level I or II on the Gross Motor Function Classifcation System (GMFCS) 5.No orthopedic surgeries
Exclusion Criteria:
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: group 1
children will receive kinesiotap technique in addition to the designed physiotherapy program for 3 months 3 session per week
|
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
|
|
Experimental: group 2
children will receive FUNCTIONAL ELECTRICAL STIMULATION in addition to the designed physiotherapy program for 3 months 3session per week
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
3 months
|
|
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 months
|
|
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
|
3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KFSIRB200-496
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on EQUINUS DEFORMITY
-
Fundación Universidad Católica de Valencia San...RecruitingEffectiveness of Rehabilitation Protocol in Patients With Shortened Posterior Leg Muscles (EREPSOLM)Contracture | Gastrocnemius Equinus | Equinus Deformity of FootSpain
-
Texas Scottish Rite Hospital for ChildrenRecruiting
-
Rennes University HospitalCompleted
-
Temple UniversityUnknownDiabetes | Equinus Contracture of the AnkleUnited States
-
Vestre Viken Hospital TrustRecruiting
-
Wake Forest University Health SciencesTerminatedEquinus ContractureUnited States
-
Dynasplint Systems, Inc.McMurry UniversityTerminatedDiabetes Mellitus | Ankle Contracture | Ankle EquinusUnited States
-
The Hospital for Sick ChildrenCompleted
-
University of British ColumbiaCompleted
Clinical Trials on KINESOTAPING
-
Superior UniversityRecruitingKnee OsteoarthritisPakistan
-
Beni-Suef UniversityRecruiting
-
Cairo UniversityCompletedOsgood-Schlatter DiseaseEgypt
-
Riphah International UniversityCompleted