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

Hemiplegic Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05787977
• Other study ID #: Asma001-04
• Status: Completed
• Phase: N/A
• Start date: December 20, 2022
• Est. completion date: March 22, 2024

Study information

• Verified date: March 2024
• Source: Sehat Medical Complex
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 22, 2024
• Est. primary completion date: February 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Hemiplegic Cerebral Palsy
• Paralysis

Intervention

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.

Locations

Country	Name	City	State
Pakistan	Sehat Medical Complex, Lahore	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Sehat Medical Complex

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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