NCT04839939

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2021

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 31, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 9, 2021

Completed
Last Updated

April 14, 2021

Status Verified

April 1, 2021

Enrollment Period

2 months

First QC Date

March 31, 2021

Last Update Submit

April 11, 2021

Conditions

Keywords

Combination TapingAnkle foot orthosisSpatio-temporal paremeters

Outcome Measures

Primary Outcomes (6)

  • 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

Study Arms (3)

Control Group

ACTIVE COMPARATOR

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

AFO Group

EXPERIMENTAL

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

Combination Taping Group

EXPERIMENTAL

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

Interventions

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

Control Group

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

AFO Group

Combination between elastic and inelastic taping

Combination Taping Group

Eligibility Criteria

Age8 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fizik Center For Physiotherapy

Jeddah, 23521, Saudi Arabia

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Mohamed M. Abdel Ghafar, Ph.D

    Batterjee Medical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 31, 2021

First Posted

April 9, 2021

Study Start

January 1, 2021

Primary Completion

March 15, 2021

Study Completion

March 30, 2021

Last Updated

April 14, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations