Clinical trial NCT05304676: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Jebsen Hand Function Test
timeFrame: 4 weeks
measure: Minnesota Hand Skill Test
timeFrame: 4 Week
measure: Goniometer
timeFrame: 4Week
Secondary outcomes:
measure: Manual Ability Classification System
timeFrame: 4Weeks
measure: Gross Motor Function Classification System
timeFrame: 4Weeks
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: National Institute of Rehabilitation and Medicine
city: Rawalpindi
country: Pakistan
facility: Misbah Ghous
Study officials:
affiliation: Riphah college of Rehabilitation and Allied Health sciences Islamabad
name: Misbah Ghous, MSNMPT
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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
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.