NCT05546164

Brief Summary

The contralateral hand deficits are often masked by the complex clinical presentation of the more affected hand in children with spastic hemiparesis. Thus, intervention targeting the contralateral hand is not often a component of the child's rehabilitation plan of care. The presence of bilateral hand deficits, even if subtle in the contralateral hand, may limit the transfer of unimanual gains following rehabilitation to bimanual activities of daily living tasks. However, conservation of upper-limb function of the less-affected side is highly important for individuals with hemiparesis, because this side is often employed as a compensatory 'tool' in performing activities of daily living . Therefore, the current study will be conducted to determine and compare the motor abilities of the less affected hand of children with hemiparesis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2022

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

September 15, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 19, 2022

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

12 months

First QC Date

September 15, 2022

Last Update Submit

November 16, 2023

Conditions

Keywords

Cerebral PalsyUnilateral cerebral palsygrip strengthpinch strengthupper limb dexterity

Outcome Measures

Primary Outcomes (3)

  • Hand grip strength

    Hand dynamometer will be used to measure grip strength. It is a reliable tool, by measuring the amount of pressure applied to the compressible bulb-shaped rubber handle (Innes, 1999).The child sit in chair with armrest, suitable back support, feet flat on the floor, shoulder adducted to side, elbow flexed to 90 degree and forearm in neutral position then teach the child how to apply pressure on bulb through grip or pinch pressure for 3 times and their mean was calculated.

    from October 2022 to September 2023

  • Hand pinch strength

    Hand dynamometer will be used to measure pinch strength. It is a reliable tool, by measuring the amount of pressure applied to the compressible bulb-shaped rubber handle (Innes, 1999).The child sit in chair with armrest, suitable back support, feet flat on the floor, shoulder adducted to side, elbow flexed to 90 degree and forearm in neutral position then teach the child how to apply pressure on bulb through grip or pinch pressure for 3 times and their mean was calculated.

    from October 2022 to September 2023

  • upper limb dexterity

    Functional dexterity test will be used for assessment of fine motor dexterity. it is a timed pegboard test that provides objective assessment of in-hand manipulation and tripod pinch, .It consists of 16 cylindrical pegs arranged on a peg board in 4 rows of 4 pegs. Participants are instructed to pick up each peg, turn it over in their hand while refraining from supinating or touching the table with the peg, and re-insert it into the pegboard as quickly as possible, beginning with the top row and proceeding in a zigzag fashion through all 4 rows. One complete practice trial is performed to allow the child to learn the task, and the second trial is timed. The time taken to complete the test is measured with a stopwatch..

    from October 2022 to September 2023

Study Arms (2)

Hemiparetic group

This group will contains 60 children with hemiparesis

Other: Assessment of hand grip strengthOther: Assessment of pinch strengthOther: Assessment of upper limb dexterity

Normal group

This group will contains 60 children with normal children

Other: Assessment of hand grip strengthOther: Assessment of pinch strengthOther: Assessment of upper limb dexterity

Interventions

Assessment of hand grip strength

Hemiparetic groupNormal group

Assessment of pinch strength

Hemiparetic groupNormal group

Assessment of upper limb dexterity

Hemiparetic groupNormal group

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

This study will include 120 children of both gender with age from 6 years to 10 years

You may qualify if:

  • Children will be recruited according to the following criteria:
  • Age range between 6 and 10 years.
  • Both sexes
  • The degree of spasticity rang from grade 1 to 1+ according to Modified Ashworth scale (Appendix II).
  • They can follow the order during the testing.

You may not qualify if:

  • Significant visual or auditory defect that may affect their performance.
  • Previous orthopedic surgery for upper extremity.
  • Injection with Botulinium toxin in the last 6 months.
  • Structural deformities in any joint or bone of the upper limbs.
  • Practicing any form of sports.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy, Cairo University

Giza, 12662, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Emam EL-Negamy, PhD

    Cairo University

    STUDY CHAIR
  • Amira Mahmoud, PhD

    Cairo University

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

September 15, 2022

First Posted

September 19, 2022

Study Start

October 1, 2022

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

November 18, 2023

Record last verified: 2023-11

Locations