NCT06294444

Brief Summary

Hemiplegia in infants and children is a type of Cerebral Palsy that results from damage to the part (hemisphere) of the brain that controls muscle movements. This damage may occur before, during or shortly after birth. The term hemiplegia means that the paralysis is on one vertical half of the body. The aim of this study will be the to know the effect of mCIMT with and without mirror therapy on upper limb function in children with hemiplegic cerebral palsy. A randomized control trial will be conducted at Sheikh Zayed Hospital, RYK through convenience sampling technique on 30 patients which will be allocated through simple random sampling through sealed opaque enveloped into group A and group B. Group A will be treated with mCIMT and Group B will be treated with mCIMT and mirror therapy. Outcome measure will be conducted through pain and disability questionnaire after 6 weeks. Data will be analyzed using SPSS software version 21. After assessing normality of data by Shapiro - wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups. mCIMT with and without mirror therapy will be applied in patients with hemiplegic cerebral palsy to see the effect on upper limb function.

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 Dec 2023

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

Study Start

First participant enrolled

December 1, 2023

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

December 26, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 5, 2024

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2024

Completed
Last Updated

May 7, 2024

Status Verified

May 1, 2024

Enrollment Period

4 months

First QC Date

December 26, 2023

Last Update Submit

May 6, 2024

Conditions

Keywords

mCIMT, Hemiplegia, Mirror therapy

Outcome Measures

Primary Outcomes (1)

  • fine motor skills

    The Melbourne Assessment 2 (MA2): a test of quality of unilateral upper limb function. Is a criterion-referenced test for children aged 2.5 to 15 years with neurological impairments providing measurement of four elements of upper limb movement quality: range of movement, accuracy, dexterity and fluency. FHGT: The subject holds the dynamometer in the hand to be tested, with the arm at right angles and the elbow by the side of the body. The handle of the dynamometer is adjusted if required - the base should rest on the first metacarpal (heel of palm), while the handle should rest on middle of the four fingers. When ready the subject squeezes the dynamometer with maximum isometric effort, which is maintained for about 5 seconds. No other body movement is allowed. The subject should be strongly encouraged to give a maximum effort. MMT: Manual Muscle Testing Grades 0-5

    6weeks

Study Arms (2)

Constraint induced Movement Therapy

EXPERIMENTAL

Group of 15 members will be given constraint induced movement therapy for 6 weeks.

Other: Constraint Induced Movement Therapy

Mirror therapy group

EXPERIMENTAL

Group of 15 members will be given modified constraint induced movement therapy with mirror theray for 6 weeks.

Other: Mirror therapy

Interventions

Group A: This group patients will be treated with mCIMT, the forced use of the affected arm by restraining the unaffected arm, with a sling or a hand splint, during dedicated exercise sections or usual ADLs (90% of waking hours).Massed practice (eight hours of exercise) of the affected arm through a shaping method, where shaping involves a commonly operant conditioning method in which a behavioural objective (in this case 'movement') is approached in small steps of progressively increasing difficulty. The participant is rewarded with enthusiastic approval for improvement, but never blamed or punished for failure. This therapy will be given 4hrs daily for 6 weeks. The results will be based upon pre and post evaluation.

Also known as: Mirror Therapy
Constraint induced Movement Therapy

Group B: These patients will be treated with mCIMT and mirror therapy. Children were taught repetitive symmetrical upper limbs exercises: with modelling-clay in each hand to elicit bilateral thumb-finger pinch and grasping. They performed these during a 15-minute daily routine at home with mCIMT (forced use of arm and massed practice 4hrs of exercise of affected arm). This combination of therapy will be given for 6 weeks. The results will be seen through pre and post evaluation.

Mirror therapy group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Medically diagnosed with Hemiplegic CP
  • Age ranges btween3-12 years
  • Hemiplegic CP with motor disability
  • No major contractures of upper limb muscle
  • Both genders were included
  • Able to follow command
  • No orthopedic surgery during the previous six months(8)

You may not qualify if:

  • Functional limb
  • Patients with contracture
  • Patient with sensory,cognitive and perceptual disorders
  • Patient with seizures
  • Patient with orthopedic surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Imran Amjad

Lahore, Punjab Province, 54000, Pakistan

Location

Riphah International University

Lahore, Punjab Province, Pakistan

Location

Related Publications (1)

  • Oliva-Sierra M, Rios-Leon M, Abuin-Porras V, Martin-Casas P. [Effectiveness of mirror therapy and action observation therapy in infantile cerebral palsy: a systematic review]. An Sist Sanit Navar. 2022 Aug 16;45(2):e1003. doi: 10.23938/ASSN.1003. Spanish.

    PMID: 35972309BACKGROUND

MeSH Terms

Conditions

Hemiplegia

Interventions

Constraint Induced Movement TherapyMirror Movement Therapy

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyPhysical Therapy ModalitiesTherapeuticsRehabilitation

Study Officials

  • Hurriya Sehar, MS*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will get separate treatment protocol and possible efforts will be put to mask the both groups about their treatment
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Randomized Control Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2023

First Posted

March 5, 2024

Study Start

December 1, 2023

Primary Completion

March 15, 2024

Study Completion

March 15, 2024

Last Updated

May 7, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations