The Effect of Treadmill Training With Visual Feedback and Rhythmic Auditory Cue on Gait and Balance in Hemiplegic Cerebral Palsy

Study Overview
=================
Brief Summary
-----------------
The development of efficient and independent walking is an important therapeutic goal for many children with cerebral palsy (CP). Consequently, there has been growing interest in determining the effects of treadmill training programs for these children. This study will help to investigates the effect of treadmill training with visual feedback and rhythmic auditory cue (VF+RAC) for walking symmetry and balance ability. Participants will be chosen from sehat medical complex and they will be randomly allocate to either the VF+RAC or the Control group. The VF+RAC group will receive treadmill training with VF and RAC, and the Control group will undergo treadmill training without any visual and auditory stimulation. VF+RAC and Control groups will be trained five times per week for eight weeks. After eight weeks of training the gait pattern and balance will be evaluated by the gait parameters, 6min Walk test, Pediatric Balance Scale and Berg balance scale.

Detailed Description
-----------------
Cerebral palsy is the most common cause of childhood-onset, lifelong physical disability in most countries, affecting about 1 in 500 neonates with an estimated prevalence of 17 million people worldwide. Cerebral palsy is a non-progressive brain injury or lesion acquired during the antenatal, perinatal or early postnatal period. The clinical manifestations of cerebral palsy vary greatly in the type of movement disorder, the degree of functional ability and limitation and the affected parts of the body. Auditory entrainment can influence gait performance in movement disorders. The entrainment can incite neurophysiological and musculoskeletal changes to enhance motor execution. Biofeedback systems have been extensively used in walking exercises for gait improvement.

Official Title
-----------------
The Effect of Treadmill Training With Visual Feedback and Rhythmic Auditory Cue on Gait and Balance in Hemiplegic Cerebral Palsy

Conditions
-----------------
Hemiplegic Cerebral Palsy

Intervention / Treatment
-----------------
* Other: Visual Feedback and Rhythmic Auditory Cue


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children having GMF level 1 and 2, willing to participate, Pediatric subjects Diagnosed with cerebral palsy, receiving Neurodevelopmental Rehabilitation program regularly. Exclusion Criteria Child using any sort of auditory aid Children with visual limitation, Child using orthosis for lower extremity

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 11 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional Group<br>Treadmil Training with visual feedback and rhythmic Auditory Cue | Other: Visual Feedback and Rhythmic Auditory Cue<br>* Patients will be trained five times per week for eight weeks. After eight weeks of training the gait pattern and balance will be evaluated by the gait parameters, 6min Walk test, Pediatric Balance Scale and Berg balance scale.<br>|
| No Intervention: Control Group<br>No intervention | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 Minutes Walk Test | The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. | Change from baseline at 8th week | 
| Pediatric Balance scale | The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points. | Change from baseline at 8th Week | 
| Berg Balance Scale | The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait. | Change from baseline at 8th week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Treadmill training, Visual Feedback and Rhythmic Auditory cue, Gait and Balance, Hemiplegic Cerebral palsy