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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05718388
Other study ID # contralateral isokinetic
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2022
Est. completion date January 20, 2023

Study information

Verified date February 2023
Source Delta University for Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study aimed to ascertain how cross-education affected the activity of the paretic muscles in the upper limb and how that affected function in children with spastic hemiplegia and cerebral palsy. Additionally, it sought to determine how unilateral isokinetic resistance training affected children with spastic hemiplegia of the contralateral limb in terms of strength development.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date January 20, 2023
Est. primary completion date January 20, 2023
Accepts healthy volunteers No
Gender All
Age group 5 Years to 7 Years
Eligibility Inclusion Criteria: - hemiplegic CP children from both genders with age ranged from five to seven year - had mild to moderate spasticity according to the Modified Ashworth Scale - able to follow verbal instructions - able to stand unassisted and ambulate with abnormal pattern Exclusion Criteria: - children who had any visual or auditory problems, fixed deformities in upper limb that interfere with fine motor functions, with history of any surgical interference in upper limbs for less than one year, and un-cooperative children were excluded.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Physical therapy exercises
For two consecutive months, the children in control group underwent a physiotherapy program for 60min/ three sessions each week: it was based mainly on the neurodevelopment technique, directed toward inhibiting abnormal muscle tone facilitating normal patterns of postural control and hand functions training program
Isokinetic training
Children in study group received the same program given to control group (A) in addition to isokinetic resistance training of the less affected upper limb for shoulder abductors in concentric mode at the angular velocity of 180 degree/ second under full supervision on the Biodex isokinetic dynamometer three times per week for 8 weeks, making a total of 24 training sessions. Each child was trained in the seated position with the similar precaution of the testing protocol.

Locations

Country Name City State
Egypt Amira Hussin Mohammed Gamasa

Sponsors (1)

Lead Sponsor Collaborator
Delta University for Science and Technology

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Concentric isokinetic shoulder abductors peak torque in Newton- meters and average power. Isokinetic dynamometer was used to measure the concentric isokinetic shoulder abductors peak torque in Newton- meters and average power at an angular velocity of 180 degrees per second in concentric mode with gravity adjustment Change from Baseline Isokinetic dynamometer parameters at 2 months
Secondary Modified functional scale for reaching It was used to measure the ability of the child to perform the reaching skills. It was used to determine the level of performance and functional improvement in reaching skills. Each child was seated in front of a table, in a chair adjustable to his or her height. They were appropriately fitted and supported to avoid any substitution movement from the child's trunk. The target was positioned on the top of the table, beside the child. The child's elbow was passively placed at full extension and the writ in natural position. Each trail of the reaching task was begun with the child's arm straight and parallel to the patient's trunk. The child was asked to make accurate reaching to touch the target by the affected arm when the examiner gives the command. Change from Baseline Modified functional scale for reaching at 2 months
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