NCT04695639

Brief Summary

Identification of musculoskeletal and neuromuscular factors that affect the integrity and functional performance in children with cerebral palsy is very essential as it enables multidisciplinary rehabilitation team to design the proper intervention to improve functional performance and independence for those children.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
27 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2021

Completed
Last Updated

May 11, 2021

Status Verified

May 1, 2021

Enrollment Period

3 months

First QC Date

January 3, 2021

Last Update Submit

May 8, 2021

Conditions

Keywords

Cerebral palsselective voluntary motor controlupper extremity functionhand grip strength

Outcome Measures

Primary Outcomes (1)

  • Test of Arm Selective Control

    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 Outcomes (2)

  • Hand Held Dynamometer

    1/2/2021 to 30/4/2021

  • Quality of Upper Extremity Skill Test

    1/2/2021 to 30/4/2021

Study Arms (1)

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.

Other: Test of Arm Selective ControlOther: Hand Held DynamometerOther: Quality of Upper Extremity Skill Test

Interventions

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

cohort group

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.

cohort group

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.

cohort group

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Participants will be recruited from the Outpatient Clinic of Faculty of Physical Therapy, Cairo University, Abo El-reesh Hospital and the Outpatient Clinic of Al-Minya General Hospital, Al-Minya Governorate.

You may qualify if:

  • 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 .

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of physical therapy, Cairo university

Giza, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Maya Galal, Phd

    Cairo University

    STUDY DIRECTOR
  • Radwa Gomaa

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

January 3, 2021

First Posted

January 5, 2021

Study Start

February 1, 2021

Primary Completion

April 30, 2021

Study Completion

May 5, 2021

Last Updated

May 11, 2021

Record last verified: 2021-05

Locations