NCT05718388

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

May 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 21, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

9 months

First QC Date

January 21, 2023

Last Update Submit

February 6, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Modified functional scale for reaching

    Change from Baseline Modified functional scale for reaching at 2 months

Study Arms (2)

Control group (A)

OTHER

They received a physiotherapy program

Other: Physical therapy exercises

study Group (B)

EXPERIMENTAL

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

Interventions

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

Control group (A)

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.

study Group (B)

Eligibility Criteria

Age5 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amira Hussin Mohammed

Gamasa, 35712, Egypt

Location

MeSH Terms

Interventions

Exercise Therapy

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor at faculty of physical therapy

Study Record Dates

First Submitted

January 21, 2023

First Posted

February 8, 2023

Study Start

May 1, 2022

Primary Completion

January 20, 2023

Study Completion

January 20, 2023

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations