Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05546164
Other study ID # No: p.T. R E C /012 /003789
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2022
Est. completion date September 30, 2023

Study information

Verified date November 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

An impairment of the less affected hand of hemiparetic cerebral palsy children can be detrimental to the development of bimanual skills. It would be beneficial to identify and quantify the severity of any impairment of the less affected hand of hemiparetic cerebral palsy children. Hemiparetic cerebral palsy may present with substantial deficits in hand function, because bimanual activities involve the ability to use the affected and contralateral hands together for grasp and stabilization. Several authors have evaluated bimanual involvement in cerebral palsy but these studies have not compared the contralateral hand with norms. The less affected hand is widely regarded as "normal" or "unaffected" and is consequently rarely evaluated. Several authors have reported incidental findings of subtle deficits in the less affected extremity, noted that hemiparetic children "also presented motor impairments in their non-paretic hand, especially in dexterity. The purpose of this study is to assess the grip ,pinch strength and dexterity of less affected hand of hemiparetic cerebral palsy children and compare with dominant hand of normal peers


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date September 30, 2023
Est. primary completion date September 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 10 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria:Children will be excluded from the study if they had any of the following criteria; - 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt Faculty of Physical Therapy, Cairo University Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Recruiting NCT05317234 - Genetic Predisposition in Cerebral Palsy N/A
Recruiting NCT05576948 - Natural History of Cerebral Palsy Prospective Study
Completed NCT04119063 - Evaluating Wearable Robotic Assistance on Gait Early Phase 1
Completed NCT03264339 - The Small Step Program - Early Intervention for Children With High Risk of Developing Cerebral Palsy N/A
Completed NCT05551364 - Usability and Effectiveness of the ATLAS2030 Exoskeleton in Children With Cerebral Palsy N/A
Completed NCT03902886 - Independent Walking Onset of Children With Cerebral Palsy
Recruiting NCT05571033 - Operant Conditioning of the Soleus Stretch Reflex in Adults With Cerebral Palsy N/A
Not yet recruiting NCT04081675 - Compliance in Children With Cerebral Palsy Supplied With AFOs
Completed NCT02167022 - Intense Physiotherapies to Improve Function in Young Children With Cerebral Palsy N/A
Completed NCT04012125 - The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy N/A
Enrolling by invitation NCT05619211 - Piloting Movement-to-Music With Arm-based Sprint-Intensity Interval Training Among Children With Physical Disabilities Phase 1
Completed NCT04489498 - Comparison of Somatometric Characteristics Between Cerebral Palsy and Normal Children, Cross-sectional, Multi Center Study
Completed NCT03677193 - Biofeedback-enhanced Interactive Computer-play for Youth With Cerebral Palsy N/A
Recruiting NCT06450158 - Robot-assisted Training in Children With CP N/A
Completed NCT04093180 - Intensive Neurorehabilitation for Cerebral Palsy N/A
Completed NCT02909127 - The Pediatric Eating Assessment Tool
Not yet recruiting NCT06377982 - Human Umbilical Cord Blood Infusion in Patients With Cerebral Palsy Phase 1
Not yet recruiting NCT06007885 - Examining Capacity Building of Youth With Physical Disabilities to Pursue Participation Following the PREP Intervention. N/A
Not yet recruiting NCT03183427 - Corpus Callosum Size in Patients With Pineal Cyst N/A
Active, not recruiting NCT03078621 - Bone Marrow-Derived Stem Cell Transplantation for the Treatment of Cerebral Palsy Phase 1/Phase 2