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

NCT05787977 | Completed DMC

• 1 other identifier: Asma001-04
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Hemiplegic Cerebral Palsy

Keywords

Treadmill training; Visual Feedback and Rhythmic Auditory cue; Gait and Balance; Hemiplegic Cerebral palsy

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Interventional Group

EXPERIMENTAL

Treadmil Training with visual feedback and rhythmic Auditory Cue

Other: Visual Feedback and Rhythmic Auditory Cue

Control Group

NO INTERVENTION

No intervention

Interventions

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.

Interventional Group

Eligibility Criteria

• Age: 5 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children having GMF level 1 and 2,
• willing to participate,
• Pediatric subjects Diagnosed with cerebral palsy, receiving Neurodevelopmental
• Rehabilitation program regularly.

You may not qualify if:

• Child using any sort of auditory aid
• Children with visual limitation,
• Child using orthosis for lower extremity

Sponsors & Collaborators

• Sehat Medical Complex: lead

Study Sites (1)

Sehat Medical Complex, Lahore

Lahore, Punjab Province, 55201, Pakistan

Location

MeSH Terms

Interventions

Feedback, Sensory

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological; Feedback, Physiological; Homeostasis; Physiological Phenomena

Study Officials

• Momina Mehmood

  University of Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: March 28, 2023
• Study Start: December 20, 2022
• Primary Completion: February 22, 2024
• Study Completion: March 22, 2024
• Last Updated: March 26, 2024

Record last verified: 2024-03

Locations

PA (1)