Cerebral PalsyNCT05304676
Additional Effects of Kinesiotape and Neuromuscular Electrical Stimulation on the Hand Activity.
A study testing Experimental: KTT group and Active Comparator: conventional treatment in people with Cerebral Palsy, run by Riphah International University at 2 sites in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 15 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Experimental: KTT group and Active Comparator: conventional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesPakistan
- Study dates
- 15 Mar 2022to 30 Jun 2022
- 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 3 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
National Institute of Rehabilitation and Medicine
Islamabad, 46000
Misbah Ghous
Rawalpindi, 46000
About this study
Official title: 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
Read the 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
- Conditions
- Cerebral Palsy
- Being tested
- Experimental: KTT group, Active Comparator: conventional treatment
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: KTT groupOther
This group will receive neurodevelopmental treatment along with kinesotape and neuromuscular electrical stimulation
Active Comparator: conventional treatmentOther
Group B will receive neurodevelopment treatment along with neuromuscular electrical stimulation.
| Study group | Role | What they receive |
|---|---|---|
| KTT group | Experimental | 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. Receives: Other: Experimental: KTT group |
| Conventional treatment | Active comparator | Group B will receive neurodevelopment treatment along with neuromuscular electrical stimulation. Receives: Other: Active Comparator: conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
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
Measured: 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
Measured: 4Week
Secondary outcomes (2)
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
Measured: 4Weeks
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
Measured: 4Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start15 Mar 2022
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Misbah Ghous, MSNMPT, Principal investigator, Riphah college of Rehabilitation and Allied Health sciences Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05304676
- Sponsor's protocol ID
- REC/01039 Umair
- Status last verified
- Dec 2022
- First submitted
- 21 Jan 2022
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16780624Sankar C, Mundkur N. Cerebral palsy-definition, classification, etiology and early diagnosis. Indian J Pediatr. 2005 Oct;72(10):865-8. doi: 10.1007/BF02731117.
PubMed 16272660Acıkbas 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.
PubMed 26428444
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additional Effects of Kinesio Tape and Neuromuscular Electrical Stimulation on the Hand Activity in Hemiplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05304676
- Acronym / sponsor ID
- REC/01039 Umair
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 31 Mar 2022 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KTT group | Experimental | Other: Experimental: KTT groupThis group will receive neurodevelopmental treatment along with kinesotape and neuromuscular electrical stimulation. Children will be treated for 3 days a week over 4 weeks. |
| Conventional treatment | Active comparator | Other: Active Comparator: conventional treatmentGroup B will receive neurodevelopment treatment along with neuromuscular electrical stimulation. |
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- • Age: 3 year to 15 year
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Experimental: KTT groupThis group will receive neurodevelopmental treatment along with kinesotape and neuromuscular electrical stimulation | Other | KTT group |
| Active Comparator: conventional treatmentGroup B will receive neurodevelopment treatment along with neuromuscular electrical stimulation. | Other | Conventional treatment |
Primary outcome
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
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
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
2 secondary outcomes
Manual Ability Classification System
Time frame: 4Weeks
Gross Motor Function Classification System
Time frame: 4Weeks
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 12 Dec 2022.
- Background: PubMed 16780624Ozer 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.
- Background: PubMed 16272660Sankar C, Mundkur N. Cerebral palsy-definition, classification, etiology and early diagnosis. Indian J Pediatr. 2005 Oct;72(10):865-8. doi: 10.1007/BF02731117.
- BackgroundAcıkbas 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
- Background: PubMed 26428444Kitai 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.
- Individual participant dataSharing planned: No
Related trials for Cerebral Palsy
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
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.
Misbah Ghous, MSNMPT principal investigator
Riphah college of Rehabilitation and Allied Health sciences Islamabad
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: KTT group and Active Comparator: conventional treatment in people with Cerebral Palsy, run by Riphah International University at 2 sites in Pakistan.
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 7 inclusion and 4 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 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. 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?
Jebsen Hand Function Test (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05304676, which also lists 4 linked publications.
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 12 Dec 2022.