Clinical trial NCT04839939: Efficacy of Combination Taping Technique vs Ankle Foot Orthosis on Improving Gait Parameters in Cerebral Palsy
Official title: Short Term Efficacy of Combination Taping Technique as an Alternative to Ankle Foot Orthosis on Improving Gait Parameters in Spastic Cerebral Palsy: A Controlled Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gait
Spastic Diplegia
Keywords: Combination Taping
Ankle foot orthosis
Spatio-temporal paremeters
Lead sponsor: Batterjee Medical College
Sponsor class: OTHER
Collaborators: name: Taif University
First posted: 2021-04-09
Enrollment: 36
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Gait in children with spastic CP is often characterized by abnormal gait kinematics as knee flexion and equines foot which associated with such gait deviations, an elevated walking energy cost is often observed which may contribute to activity limitations.

The ability to maintain proper joint alignment of the lower extremity, and control the position of the foot in standing and walking is a critical treatment objective for gait in children with cerebral palsy. Lower extremity orthoses, such as ankle-foot orthoses (AFOs) are widely recommended in children with spastic cerebral palsy to prevent the development or progression of this deformity and to improve the dynamic efficiency of the child's gait. The use of Kinesio taping in pediatric rehabilitation becomes increasingly popular in recent years. Recent systematic reviews reported moderate evidence that Kinesiology taping is a useful adjunct to physiotherapy intervention in higher functioning children with CP. Combination tapings is a technique first introduced by Kenzo Kase, in which Kinesio taping is coupled with the rigid athletic tape to maximize the treatment benefits. This approach remains briefly addressed in the literature with no prior studies has examined the effects of combination tapings in the CP pediatric population. Hypothesis: there is no difference between the effect of combining tapings and ankle-foot orthosis on spatiotemporal gait parameters in spastic cerebral palsied

Detailed description: This study was designed as a randomized controlled trial. The participants and their parents were given clear, detailed explanation of the proposed procedures before starting the experiment, and signed a written informed consent statement. Batterjee Medical College Research and Ethical committee reviewed and approved the study, which were conducted in compliance with the 1975 Helsinki Declaration. Thirty-six children (22 males and 14 females) with spastic diplegic cerebral palsy were enrolled in this study. The children were randomly assigned into two study groups (A \& B), and a control group (C). Randomization was done by asking each child to pick up an index card out of a box that contains 36 cards (12 cards for each group) to determine which group participants would be in. Measurements were taken in two occasions, baseline, and four weeks after application of the intervention. Spatiotemporal Gait parameters were measured as per the published guidelines using the GAITRite system. Parameters included were cadence, step length; stride length, single support time, double support time, and velocity were evaluated.

Eligibility criteria: Inclusion Criteria:

* Age range from 8 to 15 years old
* Able to stand and walk independently
* Spasticity ranged from 1 to 1+ grade according to Modified Ashworth Scale
* level I or II according to Gross Motor Function Classification System (GMFCS)
* Able to understand and follow instructions

Exclusion Criteria:

* Children with previous corrective orthopedic surgery or botulinum toxin injection in the lower extremities within the previous 6 months
* Skin disease
* Epilepsy
* Mental retardation
* Visual or auditory problems

Primary outcomes:
measure: Step Length (cm)
timeFrame: 4 Weeks
measure: Stride Length (cm)
timeFrame: 4 Weeks
measure: Velocity (cm/s)
timeFrame: 4 weeks
measure: Cadence (step/min)
timeFrame: 4 weeks
measure: Single leg support (% of gait cycle)
timeFrame: 4 weeks
measure: Double leg support (% of gait cycle)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: Fizik Center For Physiotherapy
Study officials:
affiliation: Batterjee Medical College
name: Mohamed M. Abdel Ghafar, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: