Hemiplegic Cerebral PalsyCPNCT04635930
Taping and Traditional Exercises in Upper Limb Function in Hemiplegic
A study testing Taping plus Traditional exercises in people with Hemiplegic Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this research is to determine the Effects of taping verse traditional exercises on scapular stabilization and upper limb function in hemiplegic cerebral palsy.Taping and traditional exercises effects on scapular stabilization and support upper limb fuction in Hemiplegic cerebral palsy patients. Read more about this study
- Who is it for?
- Ages 6 to 8 years
- Conditions the study is for
- Hemiplegic Cerebral Palsy
- What is being tested?
- Taping plus Traditional exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 8 Sep 2020to 30 Jan 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 6 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients diagnosed as hemiplegic cerebral palsy.
- Age group 7 to 14 years.
- Both males and females.
- Hemiplegic patients demonstrating weakness of scapular muscles i.e., less than grade 3 on manual muscle testing scale.
- Hemiplegics who understand and follow verbal commands.
Who cannot join
- Hemiplegic patient with cognitive and perceptual disorders.
- Hemiplegic patient having sensory, behavioral dysfunction and emotional liability.
- Hemiplegic patient who is having any associated history of trauma and other medical disorders of hemiplegic upper extremity.
- Any musculoskeletal structural disorder impeding upper limb function.
- Participating in any experimental rehabilitation or drug studies.
- Excessive spasticity that is score of >3 on modified Ashworth spasticity scale
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Taping Verses Traditional Exercises on Scapular Stabilization and Upper Limb Function in Hemiplegic Cerebral Palsy.
The aim of this research is to determine the Effects of taping verse traditional exercises on scapular stabilization and upper limb function in hemiplegic cerebral palsy.Taping and traditional exercises effects on scapular stabilization and support upper limb fuction in Hemiplegic cerebral palsy patients. A randomized controlled trial will be done at hayatabad Medical Complex Peshawar. The sample size is 26. The Participants will be divided into two groups, 13 participants in group A and 13 in Group B. The study duration will 6 months. Sampling technique will purposive non probability sampling technique. Only 6 to 8 years participants with Hemiplegic cerebral palsy will be included. Tools will be used in this study are Quality of upper extremity skill test, The Functional Independence Measure for Children (WeeFIM): Data will be analyzed through Statistical Package of Social Sciences version23.
Read the detailed description
Cerebral palsy (CP) is a non-progressive group of developmental motor disorders that may result in spasticity, paralysis, or abnormal posture. Muscle weakness has been recognized as a primary clinical feature in CP. It is the most common cause of physical disability in children, with a prevalence of 2 to 2.5 per 1000 live births in Western countries . 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. There are several sub-types of CP, one of which is spastic hemiplegic CP, which occurs in approximately23%ofchildren with spastic CP. Because CP is a lifelong condition, all aspects of an individual's development and independence are impacted. The upper limb is usually more severely involved than lower one. This limits reaching, grasping and object manipulation, interfering also with exploration, play, self-care and other activities of daily living. Children with hemiplegic cerebral palsy often have marked hand involvement with excessive thumb adduction and flexion and limited active wrist extension from infancy. Deficits in upper limb motor function can affect a 53 child's participation in self-care and play, and thus interfere with development in 54 multiple domains. Chronic hemiplegic patient with residual scapular weakness has the spasticity of some of the scapular muscles, which disturb the proximal stability of the scapulothoracic joint.This limits reaching, grasping and object manipulation, interfering also with exploration, play, self-care and other activities of daily living. Becoming independent in activities of daily living requires amongst others a smooth coordination between both hands
- Though motor deficits have been emphasized, sensory dysfunction may exist and may contribute to diminished use of the affected hand. Several studies have emphasized the impact that sensory deficits may have on hand function, because precise motor ability is dependent on sensory input. Common treatments include botulinum toxin, orthopedic surgery constraint induced movement therapy, pharmacotherapy for muscle tone, occupational therapy and traditional physiotherapy. As impairments in these children involve a variable range of functions, the children need comprehensive rehabilitation therapy
- A study conducted on ''Neuromuscular taping for the upper limb in Cerebral Palsy'' discussed that, the data showed that, after the intervention, the movement of the affected arm was faster, in particular in the adjusting and returning phase. The movement was also smoother and with a more physiological range of motion at shoulder and elbow. After the taping removal, Researcher found in fact a reduction of the adjusting and returning phase duration, a lower value of average jerk parameter and improved upper limb ranges of motion if compared to pre-test condition . A study on ''the effect of taping on scapular stability and upper limb function in recovering hemiplegics with scapular weakness'' shows that scapular taping has improved the functional outcome in upper extremity hemiplegics with scapular weakness. Scapular taping has improved the alignment of the scapula by inhibiting the hyperactive upper trapezius and facilitating the weak serratus anterior muscle by altering length-tension properties of muscles and providing kinesthetic awareness of scapular position during rest and movement of upper extremity. A study on Functional Impact of Shoulder Taping in the Hemiplegic Upper Extremity reported relief of pain symptoms immediately after being taped. Reduction in the patient's subjective sense of pain was associated with improvements in the ability to perform activities of daily living (ADL) and in range of motion (ROM). The patient showed improvements in the ability to dress, toilet, and bathe himself following shoulder taping and concomitant reduction in pain. The reported changes in ROM were less dramatic than the ADL improvement .A systematic review on the effects of elastic therapeutic taping on motor function in children with motor impairments. From the studies analyzed, it appears that interest in the use of elastic therapeutic taping as an adjunct and assistance resource to conventional treatment has grown over the last decade.
- Conditions
- Hemiplegic Cerebral Palsy
- Being tested
- Taping plus Traditional exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taping plus Traditional exercisesOther
The children will be taped 6 days per week for a total a period of 08 weeks. The tape will be used and keep the scapula in position for 3 days and the region will then be left to rest for 24 hours. Kinesio Taping will then be re-applied by the same experienced research assistants for another 3 days.
| Study group | Role | What they receive |
|---|---|---|
| Taping plus Traditional exercises | Experimental | kinesio tape for improving the alignment of the scapula by inhibiting the hyperactive upper trapezius and facilitating the weak serratus anterior muscleStretching of the tight muscles of upper limb.
* Reaching forward sidewise and backward.
* Strengthening of the weak muscles by resisted exercise. 2-3 sets of 8-12 repetition, 4 times per week (ACSM guidelines).
* Prone lying weight bearing on elbows (four point kneeling)
* side sitting with weight bearing on the effected side, for 5 minutes.
* Wall pushups.
* Catching and throwing of ball Receives: Other: Taping plus Traditional exercises |
| Traditional exercises | Active comparator | Stretching of the tight muscles of upper limb.
* Reaching forward sidewise and backward.
* Strengthening of the weak muscles by resisted exercise. 2-3 sets of 8-12 repetition, 4 times per week (ACSM guidelines).
* Prone lying weight bearing on elbows (four point kneeling)
* side sitting with weight bearing on the effected side, for 5 minutes.
* Wall pushups.
* Catching and throwing of ball Receives: Other: Taping plus Traditional exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of upper extremity skills test
The Quality of upper extremity skills test (QUEST) This measures the upper limb function in four domains, dissociated movements grasp of hand, weight bearing of upper limb and protective extension of upper limb including 33 items. Each item comprises, however, several sub items and both left and right upper extremity is assessed, so a total of 174. This is designed to be used with children who exhibit neuromotor dysfunction with spasticity and has been validated with children 18 months to 8 years.
Measured: 8 weeks
Secondary outcomes (1)
The Functional Independence Measure for Children (WeeFIM):
WeeFIM is an 18-item, 7-level ordinal scale instrument that measures a child's consistent performance in essential daily functional skills. The method measures functional performance in three domains: self-care, mobility, and cognition. The lowest total score is 18 and the highest total score 126.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start8 Sep 2020
- Primary completion30 Jan 2021
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hemiplegic Cerebral PalsyStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saira Waqqar, Phd*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04635930
- Sponsor's protocol ID
- REC/00685 Mahnoor Ayaz
- Acronym
- CP
- Status last verified
- Apr 2022
- First submitted
- 15 Nov 2020
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Peters C, Chang A, Morales A, Barnes K, Allegretti A. An integrative review of assessments used in occupational therapy interventions for children with cerebral palsy. Brazilian J Occup Ther. 2019;27(1):168-85.
Klingels K, De Cock P, Molenaers G, Desloovere K, Huenaerts C, Jaspers E, Feys H. Upper limb motor and sensory impairments in children with hemiplegic cerebral palsy. Can they be measured reliably? Disabil Rehabil. 2010;32(5):409-16. doi: 10.3109/09638280903171469.
PubMed 20095955Kassee C, Hunt C, Holmes MWR, Lloyd M. Home-based Nintendo Wii training to improve upper-limb function in children ages 7 to 12 with spastic hemiplegic cerebral palsy. J Pediatr Rehabil Med. 2017 May 17;10(2):145-154. doi: 10.3233/PRM-170439.
PubMed 28582885Camerota F, Galli M, Cimolin V, Celletti C, Ancillao A, Blow D, Albertini G. Neuromuscular taping for the upper limb in Cerebral Palsy: A case study in a patient with hemiplegia. Dev Neurorehabil. 2014 Dec;17(6):384-7. doi: 10.3109/17518423.2013.830152. Epub 2013 Oct 2.
PubMed 24087981Wang TN, Liang KJ, Liu YC, Shieh JY, Chen HL. Psychometric and Clinimetric Properties of the Melbourne Assessment 2 in Children With Cerebral Palsy. Arch Phys Med Rehabil. 2017 Sep;98(9):1836-1841. doi: 10.1016/j.apmr.2017.01.024. Epub 2017 Feb 28.
PubMed 28254639
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Taping Verses Traditional Exercises on Scapular Stabilization and Upper Limb Function in Hemiplegic Cerebral Palsy.
- ClinicalTrials.gov ID
- NCT04635930
- Acronym / sponsor ID
- CP / REC/00685 Mahnoor Ayaz
- Conditions
- Hemiplegic Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 19 Nov 2020 (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.
The aim of this research is to determine the Effects of taping verse traditional exercises on scapular stabilization and upper limb function in hemiplegic cerebral palsy.Taping and traditional exercises effects on scapular stabilization and support upper limb fuction in Hemiplegic cerebral palsy patients. A randomized controlled trial will be done at hayatabad Medical Complex Peshawar. The sample size is 26. The Participants will be divided into two groups, 13 participants in group A and 13 in Group B. The study duration will 6 months. Sampling technique will purposive non probability sampling technique. Only 6 to 8 years participants with Hemiplegic cerebral palsy will be included. Tools will be used in this study are Quality of upper extremity skill test, The Functional Independence Measure for Children (WeeFIM): Data will be analyzed through Statistical Package of Social Sciences version23.
Detailed description
Cerebral palsy (CP) is a non-progressive group of developmental motor disorders that may result in spasticity, paralysis, or abnormal posture. Muscle weakness has been recognized as a primary clinical feature in CP. It is the most common cause of physical disability in children, with a prevalence of 2 to 2.5 per 1000 live births in Western countries . 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. There are several sub-types of CP, one of which is spastic hemiplegic CP, which occurs in approximately23%ofchildren with spastic CP. Because CP is a lifelong condition, all aspects of an individual's development and independence are impacted. The upper limb is usually more severely involved than lower one. This limits reaching, grasping and object manipulation, interfering also with exploration, play, self-care and other activities of daily living. Children with hemiplegic cerebral palsy often have marked hand involvement with excessive thumb adduction and flexion and limited active wrist extension from infancy. Deficits in upper limb motor function can affect a 53 child's participation in self-care and play, and thus interfere with development in 54 multiple domains. Chronic hemiplegic patient with residual scapular weakness has the spasticity of some of the scapular muscles, which disturb the proximal stability of the scapulothoracic joint.This limits reaching, grasping and object manipulation, interfering also with exploration, play, self-care and other activities of daily living. Becoming independent in activities of daily living requires amongst others a smooth coordination between both hands
- Though motor deficits have been emphasized, sensory dysfunction may exist and may contribute to diminished use of the affected hand. Several studies have emphasized the impact that sensory deficits may have on hand function, because precise motor ability is dependent on sensory input. Common treatments include botulinum toxin, orthopedic surgery constraint induced movement therapy, pharmacotherapy for muscle tone, occupational therapy and traditional physiotherapy. As impairments in these children involve a variable range of functions, the children need comprehensive rehabilitation therapy
- A study conducted on ''Neuromuscular taping for the upper limb in Cerebral Palsy'' discussed that, the data showed that, after the intervention, the movement of the affected arm was faster, in particular in the adjusting and returning phase. The movement was also smoother and with a more physiological range of motion at shoulder and elbow. After the taping removal, Researcher found in fact a reduction of the adjusting and returning phase duration, a lower value of average jerk parameter and improved upper limb ranges of motion if compared to pre-test condition . A study on ''the effect of taping on scapular stability and upper limb function in recovering hemiplegics with scapular weakness'' shows that scapular taping has improved the functional outcome in upper extremity hemiplegics with scapular weakness. Scapular taping has improved the alignment of the scapula by inhibiting the hyperactive upper trapezius and facilitating the weak serratus anterior muscle by altering length-tension properties of muscles and providing kinesthetic awareness of scapular position during rest and movement of upper extremity. A study on Functional Impact of Shoulder Taping in the Hemiplegic Upper Extremity reported relief of pain symptoms immediately after being taped. Reduction in the patient's subjective sense of pain was associated with improvements in the ability to perform activities of daily living (ADL) and in range of motion (ROM). The patient showed improvements in the ability to dress, toilet, and bathe himself following shoulder taping and concomitant reduction in pain. The reported changes in ROM were less dramatic than the ADL improvement .A systematic review on the effects of elastic therapeutic taping on motor function in children with motor impairments. From the studies analyzed, it appears that interest in the use of elastic therapeutic taping as an adjunct and assistance resource to conventional treatment has grown over the last decade.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Taping plus Traditional exercises | Experimental | Other: Taping plus Traditional exerciseskinesio tape for improving the alignment of the scapula by inhibiting the hyperactive upper trapezius and facilitating the weak serratus anterior muscleStretching of the tight muscles of upper limb. * Reaching forward sidewise and backward. * Strengthening of the weak muscles by resisted exercise. 2-3 sets of 8-12 repetition, 4 times per week (ACSM guidelines). * Prone lying weight bearing on elbows (four point kneeling) * side sitting with weight bearing on the effected side, for 5 minutes. * Wall pushups. * Catching and throwing of ball |
| Traditional exercises | Active comparator | Other: Taping plus Traditional exercisesStretching of the tight muscles of upper limb. * Reaching forward sidewise and backward. * Strengthening of the weak muscles by resisted exercise. 2-3 sets of 8-12 repetition, 4 times per week (ACSM guidelines). * Prone lying weight bearing on elbows (four point kneeling) * side sitting with weight bearing on the effected side, for 5 minutes. * Wall pushups. * Catching and throwing of ball |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patients diagnosed as hemiplegic cerebral palsy.
- Age group 7 to 14 years.
- Both males and females.
- Hemiplegic patients demonstrating weakness of scapular muscles i.e., less than grade 3 on manual muscle testing scale.
- Hemiplegics who understand and follow verbal commands.
Key exclusion criteria (6 listed)
- Hemiplegic patient with cognitive and perceptual disorders.
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 |
|---|---|---|
| Taping plus Traditional exercisesThe children will be taped 6 days per week for a total a period of 08 weeks. The tape will be used and keep the scapula in position for 3 days and the region will then be left to rest for 24 hours. Kinesio Taping will then be re-applied by the same experienced research assistants for another 3 days. | Other | Taping plus Traditional exercises, Traditional exercises |
Primary outcome
Quality of upper extremity skills test
Time frame: 8 weeks
The Quality of upper extremity skills test (QUEST) This measures the upper limb function in four domains, dissociated movements grasp of hand, weight bearing of upper limb and protective extension of upper limb including 33 items. Each item comprises, however, several sub items and both left and right upper extremity is assessed, so a total of 174. This is designed to be used with children who exhibit neuromotor dysfunction with spasticity and has been validated with children 18 months to 8 years.
1 secondary outcome
The Functional Independence Measure for Children (WeeFIM):
Time frame: 8 weeks
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 15 Apr 2022.
- BackgroundPeters C, Chang A, Morales A, Barnes K, Allegretti A. An integrative review of assessments used in occupational therapy interventions for children with cerebral palsy. Brazilian J Occup Ther. 2019;27(1):168-85.
- Background: PubMed 20095955Klingels K, De Cock P, Molenaers G, Desloovere K, Huenaerts C, Jaspers E, Feys H. Upper limb motor and sensory impairments in children with hemiplegic cerebral palsy. Can they be measured reliably? Disabil Rehabil. 2010;32(5):409-16. doi: 10.3109/09638280903171469.
- Background: PubMed 28582885Kassee C, Hunt C, Holmes MWR, Lloyd M. Home-based Nintendo Wii training to improve upper-limb function in children ages 7 to 12 with spastic hemiplegic cerebral palsy. J Pediatr Rehabil Med. 2017 May 17;10(2):145-154. doi: 10.3233/PRM-170439.
- Background: PubMed 24087981Camerota F, Galli M, Cimolin V, Celletti C, Ancillao A, Blow D, Albertini G. Neuromuscular taping for the upper limb in Cerebral Palsy: A case study in a patient with hemiplegia. Dev Neurorehabil. 2014 Dec;17(6):384-7. doi: 10.3109/17518423.2013.830152. Epub 2013 Oct 2.
- Background: PubMed 28254639Wang TN, Liang KJ, Liu YC, Shieh JY, Chen HL. Psychometric and Clinimetric Properties of the Melbourne Assessment 2 in Children With Cerebral Palsy. Arch Phys Med Rehabil. 2017 Sep;98(9):1836-1841. doi: 10.1016/j.apmr.2017.01.024. Epub 2017 Feb 28.
- 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.
Saira Waqqar, Phd* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Taping plus Traditional exercises in people with Hemiplegic Cerebral Palsy, run by Riphah International University at 1 site 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 5 inclusion and 6 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 15 Apr 2022. 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 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?
Quality of upper extremity skills test (time frame: 8 weeks). 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 NCT04635930, which also lists 5 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 15 Apr 2022.