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

Primary Purpose

Gait, Spastic Diplegia

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Conventional physical therapy
Ankle Foot Orthosis
Combination Taping
Sponsored by
Batterjee Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gait focused on measuring Combination Taping, Ankle foot orthosis, Spatio-temporal paremeters

Eligibility Criteria

8 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fizik Center For Physiotherapy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Control Group

AFO Group

Combination Taping Group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 31, 2021
Last Updated
April 11, 2021
Sponsor
Batterjee Medical College
Collaborators
Taif University
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1. Study Identification

Unique Protocol Identification Number
NCT04839939
Brief Title
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
March 15, 2021 (Actual)
Study Completion Date
March 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Batterjee Medical College
Collaborators
Taif University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gait, Spastic Diplegia
Keywords
Combination Taping, Ankle foot orthosis, Spatio-temporal paremeters

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
AFO Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Combination Taping Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional physical therapy
Intervention Description
Stretching for tight muscles, weak muscles Strengthening, Postural reactions training, Proprioceptive training, and Walking training
Intervention Type
Other
Intervention Name(s)
Ankle Foot Orthosis
Intervention Description
Solid prescribed AFO with a wearing schedule of 6-12 hours per day
Intervention Type
Other
Intervention Name(s)
Combination Taping
Intervention Description
Combination between elastic and inelastic taping
Primary Outcome Measure Information:
Title
Step Length (cm)
Description
Change of the step length was measured using GAITRite System
Time Frame
4 Weeks
Title
Stride Length (cm)
Description
Change of the stride length was measured using GAITRite System
Time Frame
4 Weeks
Title
Velocity (cm/s)
Description
Change of the velocity was measured using GAITRite System
Time Frame
4 weeks
Title
Cadence (step/min)
Description
Change of the cadence was measured using GAITRite System
Time Frame
4 weeks
Title
Single leg support (% of gait cycle)
Description
Change of the single leg support was measured using GAITRite System
Time Frame
4 weeks
Title
Double leg support (% of gait cycle)
Description
Change of the double leg support was measured using GAITRite System
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed M. Abdel Ghafar, Ph.D
Organizational Affiliation
Batterjee Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fizik Center For Physiotherapy
City
Jeddah
ZIP/Postal Code
23521
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No

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

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