Efficacy of Combination Taping Technique vs Ankle Foot Orthosis on Improving Gait Parameters in Cerebral Palsy

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

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

Study Overview

• Status: Completed
• Conditions: Gait; Spastic Diplegia
• Intervention / Treatment: Other: Conventional physical therapy; Other: Ankle Foot Orthosis; Other: Combination Taping

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Jeddah, Saudi Arabia, 23521
    • Fizik Center For Physiotherapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group; Children in this group received conventional physical therapy program in form of Stretching for tight muscles, weak muscles Strengthening, Postural reactions training, Proprioceptive training, and Walking training were all part of the treatment plan, which was based on the neurodevelopmental approach.	Other: Conventional physical therapy; Stretching for tight muscles, weak muscles Strengthening, Postural reactions training, Proprioceptive training, and Walking training
Experimental: AFO Group; Children in this group received the same conventional treatment plus they were provided with solid community-prescribed AFO with a wearing schedule of 6-12 hours per day. Parents were given a detailed demonstration about how to use the AFO probably and watching for areas of skin overpressure. AFO needs to be worn with a smooth, long sock underneath with the child's heel is right down in the AFO with the ankle strap and/or shoe fastened firmly.	Other: Ankle Foot Orthosis; Solid prescribed AFO with a wearing schedule of 6-12 hours per day
Experimental: Combination Taping Group; Children in this group received the same conventional treatment plus the combination taping technique, which was performed by one qualified physical therapist with over five years of experience. The technique started with the application of two 5-cm wide Kinesio tape "I" straps. The first strap was applied from the lateral condyle of the tibia to the base of the first metatarsal bone with the ankle joint in plantar flexion. The tape was not stretched for 5 cm from the initial site and was then stretched up to 30% for the remaining parts15. The second "I" strap While the therapist holds the ankle in dorsiflexion, he applied the distal end of the tape 10 cm below the ankle joint. With almost 70% tension, the proximal end is applied 10 cm above the ankle joint. While one hand was holding each end of the tape, the child was asked to move the joint into plantar flexion. Finally, both hands moved towards the middle of the joint to apply the remaining tape.	Other: Combination Taping; Combination between elastic and inelastic taping

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Step Length (cm)	Change of the step length was measured using GAITRite System	4 Weeks
Stride Length (cm)	Change of the stride length was measured using GAITRite System	4 Weeks
Velocity (cm/s)	Change of the velocity was measured using GAITRite System	4 weeks
Cadence (step/min)	Change of the cadence was measured using GAITRite System	4 weeks
Single leg support (% of gait cycle)	Change of the single leg support was measured using GAITRite System	4 weeks
Double leg support (% of gait cycle)	Change of the double leg support was measured using GAITRite System	4 weeks

Collaborators and Investigators

• Sponsor: Batterjee Medical College
• Collaborators: Taif University
• Investigators: Principal Investigator: Mohamed M. Abdel Ghafar, Ph.D, Batterjee Medical College

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): March 15, 2021
• Study Completion (Actual): March 30, 2021

Study Registration Dates

• First Submitted: March 31, 2021
• First Submitted That Met QC Criteria: April 8, 2021
• First Posted (Actual): April 9, 2021

Study Record Updates

• Last Update Posted (Actual): April 14, 2021
• Last Update Submitted That Met QC Criteria: April 11, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Combination Taping; Ankle foot orthosis; Spatio-temporal paremeters
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Cerebral Palsy; Muscle Spasticity
• Other Study ID Numbers: Batterjee

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No