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

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 helped to investigates the effect of treadmill training with visual feedback and rhythmic auditory cue (VF+RAC) for walking symmetry and balance ability. Participants were chosen from Sehat medical complex and they were randomly allocated to either the VF+RAC or the Control group. The VF+RAC group received treadmill training with VF and RAC, and the Control group undergo treadmill training without any visual and auditory stimulation. VF+RAC and Control groups was trained five times per week for eight weeks. After eight weeks of training the gait pattern and balance were evaluated by the gait parameters, 6min Walk test, Pediatric Balance Scale and Berg balance scale.

Study Overview

• Status: Completed
• Conditions: Hemiplegic Cerebral Palsy
• Intervention / Treatment: Other: Visual Feedback and Rhythmic Auditory Cue

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 55201
      • Sehat Medical Complex, Lahore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 11 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Sehat Medical Complex
• Investigators: Principal Investigator: Momina Mehmood, University of Lahore

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2022
• Primary Completion (Actual): February 22, 2024
• Study Completion (Actual): March 22, 2024

Study Registration Dates

• First Submitted: February 20, 2023
• First Submitted That Met QC Criteria: March 27, 2023
• First Posted (Actual): March 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Treadmill training; Gait and Balance; Hemiplegic Cerebral palsy; Visual Feedback and Rhythmic Auditory cue
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: Asma001-04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No