- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05304676
Additional Effects of Kinesiotape and Neuromuscular Electrical Stimulation on the Hand Activity.
December 9, 2022 updated by: Riphah International University
Additional Effects of Kinesio Tape and Neuromuscular Electrical Stimulation on the Hand Activity in Hemiplegic Cerebral Palsy
Children with cerebral palsy (CP) manifest several developmental disorders of movement and posture.
CP children have functional limitations so this study investigates the additional effects of kinesio taping and neuromuscular electrical stimulation on hands joint range of motion, muscle tone and functional ability in children with hemiplegic cerebral palsy
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Hemiplegia is a form of spastic Cerebral Palsy (CP) in which one arm and leg on either the right or left side of the body is affected.
It is the most common syndrome in children born at term and is second in frequency only to spastic diplegia among preterm infants.
Patients with spastic hemiplegia have unilateral prehensile dysfunction as a consequence of lesions in the sensorimotor cortex and corticospinal tract.
The upper limb is usually more severely involved than lower one.
This limit reaching, grasping and object manipulation, interfering also with exploration, play, self-care and other activities of daily living.
It is the most common cause of severe physical disabilities in childhood, in which hemiplegia is accounted for 36% of children with cerebral palsy.
Children with hemiplegic cerebral palsy usually have the independent walking ability and intellectual capacity to attend regular school.
However, impaired hand function restricts their activity and participation in lifestyle, educational, leisure and later vocational roles.
The most common postures of the upper extremity in children with cerebral palsy are shoulder internal rotation, elbow flexion, forearm pronation, wrist flexion, finger flexion and thumb in palm is a very common problem seen in children with cerebral palsy (CP) and its solution is difficult.
The deformity is complex and can include: contracture of the thumb metacarpophalangeal joint or global instability; contractures of the intrinsic muscles and spasticity; extrinsic motor imbalance with over lengthening and/or weakness of the extensor pollicus longus, extensor pollicus brevis, and abductor pollicus longus; and contracture and/or weakness of the flexor pollicus longus.
Thumb in palm deformity can cause restrictions in functional ability and prevent somatosensory input in these children.
Kinesio taping (KT) is a relatively new therapeutic tool used in rehabilitation program of children with cerebral palsy, although it has been used for a long time in sport or orthopedic fields, and has been approved as a supplemental intervention for other functional impairments.
Kinesio tape is a specialized elastic-like tape made of latex-free cotton fibers having no medication effect and designed to mimic the elasticity properties of the muscle, skin and fascia.
By proper taping, the elasticity of the tape not only does not restrict the soft tissue, but also supports the weak muscles and creates a full ROM.(8)
An adjunct therapy, which has gained increasing support for CP in the 1970s is neuromuscular electrical stimulation (NMES).
With NMES, electrical stimulation of sufficient intensity generally to produce visible muscle contraction is applied at the muscle motor point.
Several case studies have reported improvement in hand function
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Islamabad, Pakistan, 46000
- National Institute of Rehabilitation and Medicine
-
Rawalpindi, Pakistan, 46000
- Misbah Ghous
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 15 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
• Age: 3 year to 15 year
- Gender: Both Male and female.
- Diagnosis with hemiplegic cerebral palsy
- Refer for physiotherapy
- Classified as Gross Motor Function Classification System level II, III
- Ashworth grading: 1-3
- Able to follow and accept verbal instruction and communication
Exclusion Criteria:
- Medical procedures likely to affect motor function such as botulinum toxin injection.
- Any kind of surgery.
- Mental retardation or learning disability.
- Any other abnormality and pathology condition.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: KTT group
This group will receive neurodevelopmental treatment along with kinesotape and neuromuscular electrical stimulation.
Children will be treated for 3 days a week over 4 weeks.
|
This group will receive neurodevelopmental treatment along with kinesotape and neuromuscular electrical stimulation
|
|
Active Comparator: Conventional treatment
Group B will receive neurodevelopment treatment along with neuromuscular electrical stimulation.
|
Group B will receive neurodevelopment treatment along with neuromuscular electrical stimulation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Jebsen Hand Function Test
Time Frame: 4 weeks
|
The Jebsen Hand Function Test (JHFT/JTT) was developed to provide a standardized and objective evaluation of fine and gross motor hand function using simulated activities of daily living.
It consists of seven subsets which are writing, simulated page-turning, lifting small objects, simulated feeding, stacking, and lifting large, lightweight, and heavy objects.Total score is the sum of time taken for each sub-test, which are rounded to the nearest second.
Shorter times indicate better performance.Change from Baseline hand functions to 4th Week
|
4 weeks
|
|
Minnesota Hand Skill Test
Time Frame: 4 Week
|
The Minnesota Manual Dexterity test (MMDT) tool was developed to measure unilateral and bilateral gross and fine manual dexterity.his
involved a series of displacement and turning of plastic or wooden cylinders to be placed in a series of matched holes.
A log is maintained of the time taken for these steps.Change from Baseline manual ability and hand dexterity to 4 Week
|
4 Week
|
|
Goniometer
Time Frame: 4Week
|
Goniometer is used to measure range of motion of joints, following joints will be assessed shoulder, elbow, wrist.
Change from Baseline manual ability and hand dexterity to 4 Week
|
4Week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Manual Ability Classification System
Time Frame: 4Weeks
|
This proposed new classification, the Manual Ability Classification System (MACS), is designed to classify how children with CP use their hands when handling objects in daily activities.
MACS describes five levels.
The levels are based on the children's self-initiated ability to handle objects and their need for assistance or adaptation to perform manual activities in everyday life.Change from Baseline manual ability and hand dexterity to 4 Week
|
4Weeks
|
|
Gross Motor Function Classification System
Time Frame: 4Weeks
|
The gross motor function of children and young people with cerebral palsy can be categorized into 5 different levels using a tool called the Gross Motor Function Classification System.
Change from Baseline manual ability and hand dexterity to 4 Week
|
4Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Sankar C, Mundkur N. Cerebral palsy-definition, classification, etiology and early diagnosis. Indian J Pediatr. 2005 Oct;72(10):865-8. doi: 10.1007/BF02731117.
- Ozer K, Chesher SP, Scheker LR. Neuromuscular electrical stimulation and dynamic bracing for the management of upper-extremity spasticity in children with cerebral palsy. Dev Med Child Neurol. 2006 Jul;48(7):559-63. doi: 10.1017/S0012162206001186.
- Acıkbas E, Tarakcı D, Budak M. Comparison of the effects of Kinesio taping and neuromuscular electrical stimulation on hand extensors in children with cerebral palsy. Int J Ther Rehabil. 2020. https://doi.org/10.12968/ ijtr.2019.0053
- Kitai Y, Haginoya K, Hirai S, Ohmura K, Ogura K, Inui T, Endo W, Okubo Y, Anzai M, Takezawa Y, Arai H. Outcome of hemiplegic cerebral palsy born at term depends on its etiology. Brain Dev. 2016 Mar;38(3):267-73. doi: 10.1016/j.braindev.2015.09.007. Epub 2015 Oct 1.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 15, 2022
Primary Completion (Actual)
June 30, 2022
Study Completion (Actual)
June 30, 2022
Study Registration Dates
First Submitted
January 21, 2022
First Submitted That Met QC Criteria
March 30, 2022
First Posted (Actual)
March 31, 2022
Study Record Updates
Last Update Posted (Estimate)
December 12, 2022
Last Update Submitted That Met QC Criteria
December 9, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/01039 Umair
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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