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

Sponsor
Sehat Medical Complex (Other)
Overall Status
Recruiting
CT.gov ID
NCT05787977
Collaborator
(none)
30
1
2
4.3
6.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Visual Feedback and Rhythmic Auditory Cue
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
The Effect of Treadmill Training With Visual Feedback and Rhythmic Auditory Cue on Gait and Balance in Hemiplegic Cerebral Palsy
Actual Study Start Date :
Dec 20, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Interventional Group

Treadmil Training with visual feedback and rhythmic Auditory Cue

Other: Visual Feedback and Rhythmic Auditory Cue
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.

No Intervention: Control Group

No intervention

Outcome Measures

Primary Outcome Measures

  1. 6 Minutes Walk Test [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 11 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sehat Medical Complex, Lahore Lahore Punjab Pakistan 55201

Sponsors and Collaborators

  • Sehat Medical Complex

Investigators

  • Principal Investigator: Momina Mehmood, University of Lahore

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sehat Medical Complex
ClinicalTrials.gov Identifier:
NCT05787977
Other Study ID Numbers:
  • Asma001-04
First Posted:
Mar 28, 2023
Last Update Posted:
Mar 28, 2023
Last Verified:
Feb 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sehat Medical Complex
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 28, 2023