NCT05614167

Brief Summary

Muscle strength can be defined as the ability of skeletal muscle to develop force for the purpose of providing stability and mobility within the musculoskeletal system, so that functional movement can take place.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

November 7, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 14, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2023

Completed
Last Updated

April 11, 2023

Status Verified

April 1, 2023

Enrollment Period

2 months

First QC Date

November 5, 2022

Last Update Submit

April 8, 2023

Conditions

Keywords

HemiplegiaCerebral Palsymuscle stengthgmfm

Outcome Measures

Primary Outcomes (2)

  • Gross motor function measure

    standing and walking domain

    3 months

  • Isometric muscle strength

    a handheld dynamometer

    3 months

Interventions

A total of 97 children with CP between the ages of six and 12 years participated in the study. Muscle strength was measured with a handheld dynamometer. Motor function in children with CP was classified with the Gross Motor Function Classification System (GMFCS), graded with the Gross Motor Function Measure (GMFM)

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Muscle weakness was found in children with CP, increasing with severity of gross motor function, approximately 50% of the predicted muscle strength was needed to be able to walk without aids.

You may qualify if:

  • Their age between 6 and 12 years old.
  • Grade 1and 2 according to the Modified Ashworth scale (RW and Smith, 1987).
  • They could walk with limitation or holding on according to GMFCS (level I, II) (Palisano et al., 1997).
  • They were able to understand and follow verbal instructions.

You may not qualify if:

  • Children with any visual or auditory problems.
  • Children with any surgical interference in the lower limb.
  • Children with any structural deformities in joints and bones of lower limbs.
  • Children with any special medications affecting muscle functions (anti-spastic drugs).
  • Children who suffer from other diseases or associated disorders that interfered with physical activity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Badr University

Cairo, 002, Egypt

Location

MeSH Terms

Conditions

HemiplegiaCerebral Palsy

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBrain Damage, ChronicBrain DiseasesCentral Nervous System Diseases

Study Officials

  • Omnya samy, PHD

    lecturer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, Department of Physical Therapy for Pediatrics and Pediatric Surgery, Faculty of Physical Therapy, Badr University in Cairo, Egypt.

Study Record Dates

First Submitted

November 5, 2022

First Posted

November 14, 2022

Study Start

November 7, 2022

Primary Completion

January 12, 2023

Study Completion

February 12, 2023

Last Updated

April 11, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

private

Locations