NCT05396053

Brief Summary

The aim is to investigate the effect of mirror therapy on hand functions in children with hemiplegic cerebral palsy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

May 25, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

May 26, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 31, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2022

Completed
Last Updated

January 9, 2024

Status Verified

January 1, 2024

Enrollment Period

3 months

First QC Date

May 25, 2022

Last Update Submit

January 6, 2024

Conditions

Hemiplegic Cerebral PalsyMirror Hands

Keywords

Mirror therapyHand functionGrip strength

Outcome Measures

Primary Outcomes (3)

  • Hand grip strength

    Change of hand strength by using Hand Dynamometer

    12 weeks

  • Hand function

    Change of hand function skills by using Box and block test

    12 weeks

  • Fine Motor skills

    Change of fine motor skills score by using Peabody

    12 weeks

Study Arms (3)

Control

ACTIVE COMPARATOR

A traditional physical therapy program

Other: Physical therapy exercises

Study 1

EXPERIMENTAL

Mirror therapy plus traditional physical therapy program

Other: Physical therapy exercisesOther: Mirror therapy

Study 2

EXPERIMENTAL

Constraint-induced movement therapy plus traditional

Other: Physical therapy exercisesOther: Constraint Induced Movement Therapy

Interventions

Physical therapy exercisesOTHER

Three times a week for 12 weeks.

ControlStudy 1Study 2
Mirror therapyOTHER

Three times a week for 12 weeks.

Study 1
Constraint Induced Movement TherapyOTHER

Three times a week for 12 weeks.

Study 2

Eligibility Criteria

Age5 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Spasticity grade 1 or 1+ based on the modified Ashworth scale
  • Able to understand and follow instructions

You may not qualify if:

  • Cognitive impairment
  • Orthopedic dysfunction
  • Impairment in visual acuity
  • Children who are unable to pay attention during the treatment period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Batterjee Medical College

Jeddah, Saudi Arabia

Location

Local physical rehabilitation centers

Jeddah, Saudi Arabia

Location

MeSH Terms

Interventions

Exercise TherapyMirror Movement TherapyConstraint Induced Movement Therapy

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • Mohamed A Abdel Ghafar, Ph.D

    Batterjee Medical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Study (2 groups) and control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 25, 2022

First Posted

May 31, 2022

Study Start

May 26, 2022

Primary Completion

August 15, 2022

Study Completion

October 10, 2022

Last Updated

January 9, 2024

Record last verified: 2024-01

Locations

SA(2)