Contralateral Isokinetic Training on Strength and Reaching Skill

Sponsor

Delta University for Science and Technology (Other)

Overall Status

Completed

CT.gov ID

NCT05718388

Collaborator

(none)

Enrollment

Location

Arms

8.7

Actual Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hemiplegic Cerebral Palsy	Other: Physical therapy exercises Other: Isokinetic training	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

Effect of Contralateral Isokinetic Training on Strength and Reaching Skill in Children With Spastic Hemiplegic Cerebral Palsy

Actual Study Start Date :

May 1, 2022

Actual Primary Completion Date :

Jan 20, 2023

Actual Study Completion Date :

Jan 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Control group (A) They received a physiotherapy program	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
Experimental: study Group (B) They 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	Other: 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.

Arm

Intervention/Treatment

Other: Control group (A)

They received a physiotherapy program

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

Experimental: study Group (B)

They 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

Other: 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.

Outcome Measures

Primary Outcome Measures

Concentric isokinetic shoulder abductors peak torque in Newton- meters and average power. [Change from Baseline Isokinetic dynamometer parameters at 2 months]
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

Secondary Outcome Measures

Modified functional scale for reaching [Change from Baseline Modified functional scale for reaching at 2 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 7 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Amira Hussin Mohammed	Gamasa		Egypt	35712

Sponsors and Collaborators

Delta University for Science and Technology

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Amira Hussin Hussin Mohammed, Assistant professor at faculty of physical therapy, Delta University for Science and Technology

ClinicalTrials.gov Identifier:

NCT05718388

Other Study ID Numbers:

contralateral isokinetic

First Posted:

Feb 8, 2023

Last Update Posted:

Feb 8, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cerebral Palsy

Study Results

No Results Posted as of Feb 8, 2023