NCT06082115

Brief Summary

The purpose of the study is to compare the effect between mirror therapy and task-oriented training on hand function in children with unilateral cerebral palsy.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Status
unknown

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

October 8, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 13, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

October 20, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2024

Completed
Last Updated

October 13, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

October 8, 2023

Last Update Submit

October 8, 2023

Conditions

Keywords

Mirror TherapyTask Oriented TrainingHand FunctionUnilateral Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

  • Grip Strength

    Hand-held dynamometer will be used to measure hand grip strength. It is a valid and reliable device used to measure isometric grip strength.

    Up to 12 weeks

Secondary Outcomes (3)

  • Range of Motion

    Up to 12 weeks

  • Upper Extremity Skills

    Up to 12 weeks

  • Hand Dexetrity

    Up to 12 weeks

Study Arms (3)

Selected Physical and Occupational Therapy Program

EXPERIMENTAL

Unilateral cerebral palsy children will receive selected physical and occupational therapy program for 1 hour. The duration of treatment will be 3 times/week for 12 weeks.

Other: Selected Physical and Occupational Therapy Program

Mirror Therapy

EXPERIMENTAL

Unilateral cerebral palsy children will receive selected physical and occupational therapy program for 1 hour in addition to mirror therapy for 30 minutes. The duration of treatment will be 3 times/week for 12 weeks.

Other: Selected Physical and Occupational Therapy ProgramOther: Mirror Therapy

Task Oriented Training

EXPERIMENTAL

Unilateral cerebral palsy children will receive selected physical and occupational therapy program for 1 hour in addition to task oriented training for 30 minutes. The duration of treatment will be 3 times/week for 12 weeks.

Other: Selected Physical and Occupational Therapy ProgramOther: Task-Oriented Training

Interventions

The selected physical and occupational therapy program include:- A-Physical therapy program contains neurodevelopmental technique for U.L \& L.L (U.L \& L.L approximation, U.L \& L.L weight bearing exercises), stretching exercises for U.L \& L.L muscles, strengthening exercises for antispastic group of U.L \& L.L muscles, facilitation of postural reactions, facilitation of gait training and, ascending and descending stairs. B-Occupational therapy program contains transfer cube from one hand to hand, reaching to mouth (eating lollipop), throwing and catching ball and, clapping with both hands.

Mirror TherapySelected Physical and Occupational Therapy ProgramTask Oriented Training

The mirror therapy program include tasks of manipulative and grasping skills that performed by the non-affected hand in-front of mirror while the affected hand behind the mirror. These tasks contain building towers, rolling dough, transferring cup from one place to another place, turning cards, moving keys, drawing circle and, grasps various objects with different size, shape and weight (ball, markers, pegs and brushes).

Mirror Therapy

The task-oriented training program include tasks of manipulative and grasping skills that performed by the affected hand based on repetition practice. These tasks contain building towers, rolling dough, transferring cup from one place to another place, turning cards, moving keys, drawing circle and, grasps various objects with different size, shape and weight (ball, markers, pegs and brushes).

Task Oriented Training

Eligibility Criteria

Age5 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children ages will be ranged from 5 to 8 years old.
  • Wrist flexor spasticity ranged from grade 1 to 1+ according to Modified Aswarth scale.
  • Capacity to handle objects without continuous assistance (level I or II in accordance with the Manual Ability Classification System).
  • Ability to sit alone.
  • Sufficient cognition to follow simple verbal instructions.

You may not qualify if:

  • Fixed contracture or deformities in the upper limb.
  • Visual or auditory defects.
  • Botulinuim toxin injection in the last 6 months before the study.
  • Previous surgical intervention in the upper limb.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Mirror Movement Therapy

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesRehabilitationTherapeutics

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Selected Physical Therapy Program, Mirror Therapy, Task Oriented Training
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

October 8, 2023

First Posted

October 13, 2023

Study Start

October 20, 2023

Primary Completion

January 20, 2024

Study Completion

January 20, 2024

Last Updated

October 13, 2023

Record last verified: 2023-10