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

Gait Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04839939
• Other study ID #: Batterjee
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: March 30, 2021

Study information

• Verified date: April 2021
• Source: Batterjee Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 30, 2021
• Est. primary completion date: March 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Gait
• Muscle Spasticity
• Spastic Diplegia

Intervention

Other:
• Conventional physical therapy
Stretching for tight muscles, weak muscles Strengthening, Postural reactions training, Proprioceptive training, and Walking training
• Ankle Foot Orthosis
Solid prescribed AFO with a wearing schedule of 6-12 hours per day
• Combination Taping
Combination between elastic and inelastic taping

Locations

Country	Name	City	State
Saudi Arabia	Fizik Center For Physiotherapy	Jeddah

Sponsors (2)

Lead Sponsor	Collaborator
Batterjee Medical College	Taif University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

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