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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Pakistan1 site
  • Hayatabad Medical Complex

    Peshawar, KPK

Other trials in Pakistan

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.
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 groups in NCT04635930
Study groupRoleWhat they receive
Taping plus Traditional exercisesExperimentalkinesio 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 exercisesActive comparatorStretching 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.

  1. 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)
  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.

  1. First posted19 Nov 2020
  2. Study start8 Sep 2020
  3. Primary completion30 Jan 2021
  4. Study completion30 Jan 2021

Resources

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)
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 20095955
  • Kassee 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 28582885
  • Camerota 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 24087981
  • Wang 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

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.

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