Kinesiotaping Versus Functional Electrical Stimulation on Equinus Deformity

NCT ID: NCT06953284

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-05
• Study Completion Date: 2025-08-01

Brief 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

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.

Conditions

EQUINUS DEFORMITY

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

group 1

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

Group Type: EXPERIMENTAL

KINESOTAPING

Intervention Type: OTHER

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

group 2

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

Group Type: EXPERIMENTAL

Functional Electrical Stimulation

Intervention Type: OTHER

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

Interventions

KINESOTAPING

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

Intervention Type: OTHER

Functional 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

Intervention Type: OTHER

Eligibility Criteria

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.

1. Children were level I or II on the Gross Motor Function Classifcation System (GMFCS) 5.No orthopedic surgeries

Exclusion Criteria

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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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kafrelsheikh University

OTHER

Sponsor Role: lead

Responsible Party

Sara Yousef Abdel Elglil Yousef Elsebahy

lecturer of physical therapy for pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kafrelsheikh University

Tanta, , Egypt

Countries

Egypt

Other Identifiers

KFSIRB200-496

Identifier Type: -

Identifier Source: org_study_id