Skip to main content
OpenTrials
Completed

NCT Number: NCT05787977

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hemiplegic Cerebral Palsy

Age range

5 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sehat Medical Complex, Lahore

Lahore, Punjab Province, 55201, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Visual Feedback and Rhythmic Auditory Cue

Other

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.

Primary outcomes

  1. 6 Minutes Walk Test

    Time frame: Change from baseline at 8th week

    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.

  2. Pediatric Balance scale

    Time frame: Change from baseline at 8th Week

    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.

  3. Berg Balance Scale

    Time frame: Change from baseline at 8th week

    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.

Sponsors and collaborators

Lead sponsor

Sehat Medical Complex

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 28, 2023
Registry last updated
Mar 26, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.