NCT04246645

Brief Summary

Background: Impaired upper extremity is the major disability facing the children with hemiplegia as the inability to use hands for reach; grasp and manipulation affect their daily life activities. little attention has been given to gain perspective about abnormal movements that are detectable in hemiplegic cerebral palsy that are related to one's level of core stability and how they affect their hand functions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

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

First Submitted

Initial submission to the registry

January 21, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

January 22, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 29, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2020

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

January 28, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

January 21, 2020

Last Update Submit

January 26, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Jebsen Taylor Test

    scale used to asses gross manual dexterity

    Jebsen Taylor Test used to assess gross manual dexterity before the intervention and after three months of the intervention . the loweest score indicate improvement

Secondary Outcomes (2)

  • Box and Block Test

    Box and Block Test used to asses gross manual dexterity pre and after 3 months of intervension

  • Quality Upper Extremity Skill Test

    Quality Upper Extremity Skill Test scale used to asses skills of the upper extremity pre and after 3 months of intervension

Study Arms (2)

CONTROL GROUP

NO INTERVENTION

received the selective physiotherapy exercises

STUDY GROUP

EXPERIMENTAL

received the same selective physiotherapy exercises program in addition to core stability exercises three times/week for 60 min for 12 weeks

Other: CORE STABILITY EXERCISES

Interventions

SELECTED CORE EXERCISES

STUDY GROUP

Eligibility Criteria

Age6 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • The level of gross motor function ranged from II to III, according to Gross Motor Function Classification System
  • All participants are cognitively capable and competent of interpreting and following instructions

You may not qualify if:

  • if they had fixed contractures or deformities of the spine, upper or lower extremities,
  • visual or respiratory disorders, orthopedic surgery on their involved upper extremity;
  • dorsal rhizotomy;
  • botulinum toxin therapy in the upper extremity musculature during the past 6 months
  • who wished to receive it within the period of study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Badr Univesity in Cairo (BUC)

Cairo, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
lecturer in the deparment of pediatrics and peditaric surgery , faculty of phyical therapy

Study Record Dates

First Submitted

January 21, 2020

First Posted

January 29, 2020

Study Start

January 22, 2020

Primary Completion

March 20, 2020

Study Completion

March 31, 2020

Last Updated

January 28, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations