NCT06234215

Brief Summary

The aims of the study are to:

  1. 1.Investigate the combined effect of functional task training with electrical stimulation of bilateral hip abductor muscles on balance in children with diplegia.
  2. 2.Investigate the combined effect of functional task training with electrical stimulation of bilateral hip abductor muscles on motor abilities in children with diplegia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

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

January 17, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 5, 2024

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 31, 2024

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

8 months

First QC Date

January 5, 2024

Last Update Submit

January 29, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Humac balance system

    static and dynamic balance when values inscrease the results are better.

    two months

Secondary Outcomes (1)

  • Growth motor functional scale

    two months

Study Arms (2)

control group had functional task training

ACTIVE COMPARATOR

this group doing functional task training exercise for 50 min 3 times per week for two months

Other: functional task training

study group had functional task training combined with electrical stimulation

EXPERIMENTAL

this group doing functional task training exercise combined with electrical stimulation for 50 min 3 times per week for two months

Device: functional electrical stimulationOther: functional task training

Interventions

electrical stimulation during function

study group had functional task training combined with electrical stimulation

functional exercise

control group had functional task trainingstudy group had functional task training combined with electrical stimulation

Eligibility Criteria

Age7 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Their ages will range from 7-11 years.
  • Both genders will be included.
  • Their degree of spasticity will range from 1 to 1+ according to Modified Ashworth Scale (Meseguer-Henarejos et al., 2018).
  • Their motor function will be at level I \& II according to Gross Motor Function --- -Classification system (Palisano et al., 2008).
  • They will be understanding instructions.

You may not qualify if:

  • Children will be excluded from the study if they have any of the following criteria:
  • Musculoskeletal fixed deformities in upper limb, lower limb or spine.
  • Visual or hearing problems.
  • Epilepsy.
  • Botulinium toxin therapy or orthopedic surgery within the past 6months or within the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

‪Randa Adel‬

Ītāy al Bārūd, El-beheira, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • ‪Randa Adel‬, master

    Cairo University

    PRINCIPAL INVESTIGATOR

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
PRINCIPAL INVESTIGATOR
PI Title
specialist physiotherapy Randa Adel Mousa Mostafa Mousa

Study Record Dates

First Submitted

January 5, 2024

First Posted

January 31, 2024

Study Start

January 17, 2023

Primary Completion

September 12, 2023

Study Completion

November 25, 2023

Last Updated

January 31, 2024

Record last verified: 2024-01

Locations