- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04695639
Selective Motor Control and Upper Extremity Functions in Children With Hemiparetic Cerebral Palsy
Correlation Between Selective Motor Control and Upper Extremity Functions in Children With Hemiparetic Cerebral Palsy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Limited literature is available regarding the relation between selective voluntary motor control and motor functions in children with cerebral palsy. Up to our knowledge this is the first study intending to investigate the influence of selective voluntary motor control on upper extremity function in children with spastic cerebral palsy. Therefore, the current study will be conducted to investigate the correlation between selective voluntary motor control and upper extremity functions in children with spastic hemiparetic cerebral palsy.
It is hypothesized that:-
- There is no relation between SVMC and upper limb function in children with spastic hemiparetic CP.
- There is no relation between upper extremity SVMC and hand grip strength in children with spastic hemiparetic CP.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Giza, Egypt
- Faculty of physical therapy, Cairo University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ranges from 4 to 8 years.
- Both genders.
- Diagnosis of spastic hemiparetic cerebral palsy.
- Level I-IV on Manual Ability Classification System.
- Spasticity grade 1 to 2 on Modified Ashworth Scale.
- Level I-III on Gross Motor Classification System .
Exclusion Criteria:
- Significant mental or psychological problems.
- Significant visual/auditory problem.
- Botox injection and/or surgery of the upper limb in the past 12 months.
- Fixed deformities in the affected upper extremity.
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
cohort group
A convenient sample of children with spastic hemiparetic CP of both genders will participate in this study.
To avoid type II error, sample size calculation was performed prior to the study, based on data of pilot study, using G*POWER statistical software (version 3.1.9.2; Franz Faul, Universitat Kiel, Germany) [Exact tests- correlational study, α=0.05, β=0.2, and effect size = 0.4] and revealed that the appropriate sample size for this study is N=46.
|
It will be used to assess selective voluntary motor control.
It is a reliable and valid evaluation tool used to quantify and describe selective voluntary motor control in children with spastic cerebral palsy.
The goal of the assessment is to systematically evaluate a person's ability to move the upper extremity with selective voluntary motor control by observing movement control, coordination, fluency, mirroring, and speed at each joint, and then assigning a grade, all in 'real time.
Clinically this measure may guide the selection of medical, surgical, or therapy interventions and may improve outcome prognosis after brief training.
Raters demonstrated excellent reliability in assessing upper extremity SVMC in a group of children with hemiplegic, diplegic, and quadriplegic CP using the Ttest of arm selective control
Hand held dynamometer (Camry Digital Hand Dynamometer Grip Strength, Model EH101-37, China) will be used to assess hand grip strength of the affected upper extremity.
It is generally small, portable and relatively cheap reliable measurement instruments to measure muscle strength of the arm and hand in children with spastic cerebral pasly.
It is used to measure strength; maximal voluntary isometric contraction; objectively in kilograms, pounds or newtons.
Such devices have been proven to have good to excellent reliability in different populations.
It represents an easily accessible way to assess muscle weakness in children with cerebral palsy and the overall reliability is considered to be good.
It will be used to assess function of the affected upper extremity.
It is a reliable and valid outcome measure designed to evaluate movement patterns and hand function in children with cerebral palsy.
It is designed to be used with children who have neuromotor dysfunction with spasticity and has been validated with children from 18 months to 8 years of age.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Test of Arm Selective Control
Time Frame: 1/2/2021 to 30/4/2021
|
The goal of the assessment is to systematically evaluate a person's ability to move the upper extremity with selective voluntary motor control by observing movement control, coordination, fluency, mirroring, and speed at each joint, and then assigning a grade.
Each joint is scored as a 0, 1, or 2. The joints of the affected limb are summed for a limb score for a total score.
The maximum score is 16 per side, or 32 points in total (in hemiplegia assess the affected side only) with higher score indicates better performance.
Admiration of the teat items and scoring will be conducted according to the scale user instructions.
|
1/2/2021 to 30/4/2021
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hand Held Dynamometer
Time Frame: 1/2/2021 to 30/4/2021
|
to evaluate hand grip strength
|
1/2/2021 to 30/4/2021
|
|
Quality of Upper Extremity Skill Test
Time Frame: 1/2/2021 to 30/4/2021
|
to assess upper limb function
|
1/2/2021 to 30/4/2021
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Maya Galal, Phd, Cairo University
- Principal Investigator: Radwa Gomaa, Cairo University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Selective Motor Control
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cerebral Palsy
-
Ankara City Hospital BilkentRecruitingCerebral Palsy (CP) | Cerebral Palsy, Spastic, Diplegic | Diplegic Cerebral Palsy With Spasticity | Transcranial Magnetic StimilationTurkey (Türkiye)
-
Lahore University of Biological and Applied SciencesRecruiting
-
Suleyman Demirel UniversityCompletedCerebral Palsy | Hemiplegic Cerebral Palsy | Spastic Diplegia Cerebral PalsyTurkey (Türkiye)
-
Holland Bloorview Kids Rehabilitation HospitalCanadian Institutes of Health Research (CIHR)RecruitingCerebral Palsy (CP) | Hemiplegic Cerebral PalsyCanada
-
Cairo UniversityCompletedCerebral Palsy (CP) | Unilateral Cerebral PalsyEgypt
-
University of California, San FranciscoNot yet recruitingCerebral Palsy | Cerebral Palsy (CP) | Infant | Cerebral Palsy InfantileUnited States
-
Lahore University of Biological and Applied SciencesNot yet recruitingSpastic Diplegia Cerebral PalsyPakistan
-
IRCCS Fondazione Stella MarisNot yet recruitingCerebral Palsy (CP) | EEG | Unilateral Cerebral Palsy | Action ObservationItaly
-
IRCCS Fondazione Stella MarisUniversity of Siena, ItalyRecruitingCerebral Palsy (CP) | Motor Imagery | CP (Cerebral Palsy) | Action ObservationItaly
-
Gazi UniversityCompletedCerebral Palsy | Cerebral Palsy, Spastic | Cerebral Palsy Spastic Diplegia | Cerebral Palsy Quadriplegic | Cerebral Palsy, MonoplegicTurkey
Clinical Trials on Test of Arm Selective Control
-
State University of New York at BuffaloCompletedMultiple SclerosisUnited States
-
SightGlass Vision, Inc.RecruitingMyopia | Myopia Progression | Juvenile MyopiaUnited States
-
University of Missouri, Kansas CityNational Institute on Minority Health and Health Disparities (NIMHD)Active, not recruitingCOVID-19 Testing BehaviorsUnited States
-
Göteborg UniversityVastra Gotaland Region; Assar Gabrielsson Cancer Foundation, SwedenCompletedCervical Intraepithelial Neoplasia
-
CLASSYS Inc.Chung-Ang University Hosptial, Chung-Ang University College of MedicineRecruiting
-
Liverpool Heart and Chest Hospital NHS Foundation...WithdrawnCystic FibrosisUnited Kingdom
-
Centre Leon BerardNational Cancer Institute, France; Fondation de France; Cancéropôle Lyon Auvergne... and other collaboratorsCompletedImpact of Nutritional Intervention in Women With Breast Cancer Under Adjuvant Chemotherapy (PASAPAS)Breast Cancer | Adequate Physical ConditionFrance
-
Kaiser PermanenteCompletedAdolescent Behavior | Mental Health IssueUnited States
-
Heart of England NHS TrustAstraZenecaUnknown
-
American Hip InstituteArthrex, Inc.RecruitingFemoro Acetabular ImpingementUnited States