Effects of Mirror Therapy on Lower Extremity in CP Children

NCT ID: NCT06673823

Last Updated: 2024-11-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-29
• Study Completion Date: 2025-02-15

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.

Detailed Description

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.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental group

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.

Group Type: EXPERIMENTAL

Mirror therapy

Intervention Type: 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.

Control group

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.

Group Type: ACTIVE_COMPARATOR

conventional therapy

Intervention Type: OTHER

conventional therapy

Interventions

Mirror therapy

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.

Intervention Type: DEVICE

conventional therapy

conventional therapy

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sharmeen Arif, MS*

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Riphah International University

Lahore, Punjab Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Imran Amjad, PhD

Role: CONTACT

Imran.amjad@riphah.edu.pk

: 9233224390125

Muhammad Asif Javed, MS

Role: CONTACT

a.javed@riphah.edu.pk

03224209422

Facility Contacts

Imran Amjad

Role: primary

Imran.amjad@riphah.edu.pk

33224390125

Muhammad Asif Javed, MS

Role: backup

a.javed@riphah.edu.pk

03224209422

References

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.

Reference Type: BACKGROUND

PMID: 17370476 (View on PubMed)

Other Identifiers

REC/RCR/AHA/24/sharmeen arif

Identifier Type: -

Identifier Source: org_study_id