GaitNCT04839939
Efficacy of Combination Taping Technique vs Ankle Foot Orthosis on Improving Gait Parameters in Cerebral Palsy
A study testing Conventional physical therapy, Ankle Foot Orthosis and Combination Taping in people with Gait and Spastic Diplegia, run by Batterjee Medical College at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 8 to 15 years
- Conditions the study is for
- Gait, Spastic Diplegia
- What is being tested?
- Conventional physical therapy, Ankle Foot Orthosis and Combination Taping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jan 2021to 30 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Gait, Spastic Diplegia
- Being tested
- Conventional physical therapy, Ankle Foot Orthosis, Combination Taping
- Keywords
- Combination Taping, Ankle foot orthosis, Spatio-temporal paremeters
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional physical therapyOther
Stretching for tight muscles, weak muscles Strengthening, Postural reactions training, Proprioceptive training, and Walking training
Ankle Foot OrthosisOther
Solid prescribed AFO with a wearing schedule of 6-12 hours per day
Combination TapingOther
Combination between elastic and inelastic taping
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Combination Taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Step Length (cm)
Change of the step length was measured using GAITRite System
Measured: 4 Weeks
Stride Length (cm)
Change of the stride length was measured using GAITRite System
Measured: 4 Weeks
Velocity (cm/s)
Change of the velocity was measured using GAITRite System
Measured: 4 weeks
Cadence (step/min)
Change of the cadence was measured using GAITRite System
Measured: 4 weeks
Single leg support (% of gait cycle)
Change of the single leg support was measured using GAITRite System
Measured: 4 weeks
Double leg support (% of gait cycle)
Change of the double leg support was measured using GAITRite System
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start1 Jan 2021
- Primary completion15 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GaitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Batterjee Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Taif University
- Responsible party
- Principal investigator, Mohamed A. Abdel Ghafar, Batterjee Medical College
- Investigators
- Mohamed M. Abdel Ghafar, Ph.D, Principal investigator, Batterjee Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839939
- Sponsor's protocol ID
- Batterjee
- Status last verified
- Apr 2021
- First submitted
- 31 Mar 2021
- Last updated
- 14 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04839939
- Acronym / sponsor ID
- Batterjee
- Conditions
- Gait, Spastic Diplegia
- Keywords
- Combination Taping, Ankle foot orthosis, Spatio-temporal paremeters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Batterjee Medical CollegeUniversity, hospital or other
- Collaborators
- Taif University
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 9 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Conventional physical therapyChildren 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. |
| AFO Group | Experimental | Other: Ankle Foot OrthosisChildren 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. |
| Combination Taping Group | Experimental | Other: Combination TapingChildren 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. |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional physical therapyStretching for tight muscles, weak muscles Strengthening, Postural reactions training, Proprioceptive training, and Walking training | Other | Control Group |
| Ankle Foot OrthosisSolid prescribed AFO with a wearing schedule of 6-12 hours per day | Other | AFO Group |
| Combination TapingCombination between elastic and inelastic taping | Other | Combination Taping Group |
Primary outcome
Step Length (cm)
Time frame: 4 Weeks
Change of the step length was measured using GAITRite System
Stride Length (cm)
Time frame: 4 Weeks
Change of the stride length was measured using GAITRite System
Velocity (cm/s)
Time frame: 4 weeks
Change of the velocity was measured using GAITRite System
Cadence (step/min)
Time frame: 4 weeks
Change of the cadence was measured using GAITRite System
Single leg support (% of gait cycle)
Time frame: 4 weeks
Change of the single leg support was measured using GAITRite System
Double leg support (% of gait cycle)
Time frame: 4 weeks
Change of the double leg support was measured using GAITRite System
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed M. Abdel Ghafar, Ph.D principal investigator
Batterjee Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional physical therapy, Ankle Foot Orthosis and Combination Taping in people with Gait and Spastic Diplegia, run by Batterjee Medical College at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Step Length (cm) (time frame: 4 Weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2021.