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NCT Number: NCT06673823

Effects of Mirror Therapy on Lower Extremity in CP Children

A non-progressive condition that harms the developing brain both during and after birth is cerebral palsy (CP). It is a multifaceted syndrome marked by abnormalities in movement and posture, along with concomitant sensory-motor, cognitive, and behavioral impairments and seizures. CP can be divided into three types based on neurological classification: spastic, athetoid, and ataxic, impairments in motor skills and posture are hallmarks of cerebral palsy. Various strategies have been employed in motor skill improvement interventions. One of them, mirror-mediated treatment, works by stimulating mirror neurons in a specific region of the brain cortex. Mirror-mediated therapy involves the patient observing movement of his or her own limb reflected in a mirror, which activates mirror neurons. The application of mirror treatment improved gait capacity by elevating physical perception and balance ability. The purpose of the study will be to evaluate the effects of mirror therapy in lower limb hemiplegic cerebral palsy.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

A randomized controlled trial will be conducted to investigate the effects of mirror therapy in children with hemiplegic cerebral palsy. Data will be collected at the National Institute of Rehabilitation Medicine in Islamabad following ethical clearance. 26 patients will be enrolled in the study based on inclusion criteria. Patients will be randomly assigned into 2 equal groups for the study. Children in the control group will receive conventional therapy for 60 minutes, while Children in the experimental group will receive 30 minutes of mirror therapy and 30 minutes of conventional therapy, for 12 weeks, 3 days every week. The primary outcome will be measured by Selective Control Assessment of Lower Extremity scale (SCALE), while the secondary outcome will be measured by the Pediatric Balance Scale (PBS). All gait parameters (stride length, step length, step width, cadence and foot angle) will be measured before and after the application of intervention. Data will be analyzed using SPSS 27.0.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 6-12 years.
  • Motor tone of effected lower extremity is 1 to 2 according to modified Ashworth scale.
  • Patient with enough cognition to understand and follow instructions

Exclusion criteria

  • Patients with any other neurological illness affecting their lower extremities (e.g., MS, Parkinson's, peripheral neuropathy).
  • Patients with prior fractures of the lower limb (ankle or foot).
  • Patients with other forms of musculoskeletal diseases such as severe arthritis, ankle surgery, leg length difference.

Treatment and study plan

Mirror Therapy

Device

Mirror Therapy (MT) is a non-invasive treatment method aimed at addressing unilateral conditions impacting either the upper or lower limbs. This technique involves placing a mirror along the patient's sagittal plane, allowing the reflection of the unaffected limb to visually overlay the affected limb.

Conventional Therapy

Other

conventional therapy

Primary outcomes

  1. Selective Control Assessment of Lower Extremity scale (SCALE):

    Time frame: 12 weeks

    The Selective Control Assessment of the Lower Extremity (SCALE) is a clinical tool used to measure motor control in individuals with cerebral palsy. In this assessment, participants perform specific isolated movements at each joint, and each joint is scored to produce a total score per limb, with a maximum of 10 points per limb. SCALE demonstrates high interrater reliability, with intraclass correlation coefficients between 0.88 and 0.915. The assessment requires minimal training and takes approximately 10 to 15 minutes to complete.

  2. Pediatric Balance Scale (PBS);

    Time frame: 12 weeks

    The Pediatric Balance Scale is an adaptation of the Berg Balance Scale, designed to evaluate functional balance skills in children. It includes 14 items, each scored from 0 (indicating lowest function) to 4 (indicating highest function), with a maximum possible score of 56 points.

Study contacts

Contact information is provided by the study sponsor or research team.

Imran Amjad, PhD

CONTACT

[email protected]

: 9233224390125

Muhammad Asif Javed, MS

CONTACT

[email protected]

03224209422

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects Of Lower Extremity Mirror Therapy On Gait Parameters In Children With Hemiplegic Cerebral Palsy.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 5, 2024
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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