Skip to main content
OpenTrials
Completed

NCT Number: NCT04839939

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gait Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases Spastic Diplegia

Age range

8 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fizik Center For Physiotherapy

Jeddah, 23521, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional physical therapy

Other

Stretching for tight muscles, weak muscles Strengthening, Postural reactions training, Proprioceptive training, and Walking training

Ankle foot orthosis

Other

Solid prescribed AFO with a wearing schedule of 6-12 hours per day

Combination taping

Other

Combination between elastic and inelastic taping

Primary outcomes

  1. Step Length (cm)

    Time frame: 4 Weeks

    Change of the step length was measured using GAITRite System

  2. Stride Length (cm)

    Time frame: 4 Weeks

    Change of the stride length was measured using GAITRite System

  3. Velocity (cm/s)

    Time frame: 4 weeks

    Change of the velocity was measured using GAITRite System

  4. Cadence (step/min)

    Time frame: 4 weeks

    Change of the cadence was measured using GAITRite System

  5. Single leg support (% of gait cycle)

    Time frame: 4 weeks

    Change of the single leg support was measured using GAITRite System

  6. Double leg support (% of gait cycle)

    Time frame: 4 weeks

    Change of the double leg support was measured using GAITRite System

Sponsors and collaborators

Lead sponsor

Batterjee Medical College

Other

Collaborators

  • Taif University

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 9, 2021
Registry last updated
Apr 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.