Additional Effects of Kinesiotape and Neuromuscular Electrical Stimulation on the Hand Activity.
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Experimental: KTT group
Active Comparator: conventional treatment
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy
Eligibility Criteria
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.
Sites / Locations
- National Institute of Rehabilitation and Medicine
- Misbah Ghous
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
KTT group
Conventional treatment
Arm Description
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.
Group B will receive neurodevelopment treatment along with neuromuscular electrical stimulation.
Outcomes
Primary Outcome Measures
Jebsen Hand Function Test
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
Minnesota Hand Skill Test
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
Goniometer
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
Secondary Outcome Measures
Manual Ability Classification System
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
Gross Motor Function Classification System
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
Full Information
NCT ID
NCT05304676
First Posted
January 21, 2022
Last Updated
December 9, 2022
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05304676
Brief Title
Additional Effects of Kinesiotape and Neuromuscular Electrical Stimulation on the Hand Activity.
Official Title
Additional Effects of Kinesio Tape and Neuromuscular Electrical Stimulation on the Hand Activity in Hemiplegic Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
March 15, 2022 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KTT group
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional treatment
Arm Type
Active Comparator
Arm Description
Group B will receive neurodevelopment treatment along with neuromuscular electrical stimulation.
Intervention Type
Other
Intervention Name(s)
Experimental: KTT group
Intervention Description
This group will receive neurodevelopmental treatment along with kinesotape and neuromuscular electrical stimulation
Intervention Type
Other
Intervention Name(s)
Active Comparator: conventional treatment
Intervention Description
Group B will receive neurodevelopment treatment along with neuromuscular electrical stimulation.
Primary Outcome Measure Information:
Title
Jebsen Hand Function Test
Description
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
Time Frame
4 weeks
Title
Minnesota Hand Skill Test
Description
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
Time Frame
4 Week
Title
Goniometer
Description
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
Time Frame
4Week
Secondary Outcome Measure Information:
Title
Manual Ability Classification System
Description
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
Time Frame
4Weeks
Title
Gross Motor Function Classification System
Description
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
Time Frame
4Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Misbah Ghous, MSNMPT
Organizational Affiliation
Riphah college of Rehabilitation and Allied Health sciences Islamabad
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute of Rehabilitation and Medicine
City
Islamabad
ZIP/Postal Code
46000
Country
Pakistan
Facility Name
Misbah Ghous
City
Rawalpindi
ZIP/Postal Code
46000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16780624
Citation
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.
Results Reference
background
PubMed Identifier
16272660
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
26428444
Citation
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.
Results Reference
background
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Additional Effects of Kinesiotape and Neuromuscular Electrical Stimulation on the Hand Activity.
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