Effects of Mirror Therapy on Lower Extremity in CP Children

NCT06673823 | Recruiting DMC

• 1 other identifier: REC/RCR/AHA/24/sharmeen arif
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebral Palsy

Keywords

lower limb, mirror therapy, conventional therapy, spastic CP

Outcome Measures

Primary Outcomes (2)

• Selective Control Assessment of Lower Extremity scale (SCALE):

  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.

  12 weeks

• Pediatric Balance Scale (PBS);

  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.

  12 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

In the Experimental Group, Mirror Therapy will be applied by covering any birthmarks or scars on the less affected lower extremity (LE) if they obstruct the child's view. The therapy will take place in a distraction-free environment to help each child maintain focus and concentration. A mirror, at least 35 × 25 inches in size, will be placed between both LEs, with the more affected LE concealed behind a black curtain, allowing a clear reflection of the less affected LE. The child will be instructed to observe the mirror image of their more affected LE for one to two minutes. To begin, the therapist will visually demonstrate the technique.

Device: Mirror therapy

Control group

ACTIVE COMPARATOR

In the Control Group, conventional therapy will include exercises such as stride standing to allow weight shifting between extremities, single leg standing, stooping and recovering from a standing position, standing on a balance board, and various balance training exercises. Additionally, the program will incorporate stretching exercises for the hip flexors, adductors, hamstrings, and calf muscles, along with gait training exercises conducted in an open environment.

Other: conventional therapy

Interventions

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.

Experimental group

conventional therapy OTHER

conventional therapy

Control group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (1)

• Morris C. Definition and classification of cerebral palsy: a historical perspective. Dev Med Child Neurol Suppl. 2007 Feb;109:3-7. doi: 10.1111/j.1469-8749.2007.tb12609.x.

  PMID: 17370476 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Rehabilitation; Therapeutics

Study Officials

• Sharmeen Arif, MS*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, PhD

CONTACT

: 9233224390125; Imran.amjad@riphah.edu.pk

Muhammad Asif Javed, MS

CONTACT

03224209422; a.javed@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will get separate treatment protocols and possible efforts will be put to mask the both group about the treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized controlled trial will be conducted to investigate the effects of mirror therapy in children with hemiplegic cerebral palsy. 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

Study Record Dates

• First Submitted: November 3, 2024
• First Posted: November 5, 2024
• Study Start: October 29, 2024
• Primary Completion: January 30, 2025
• Study Completion: February 15, 2025
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)