The Effect of Treadmill Training With Visual Feedback and Rhythmic Auditory Cue on Gait and Balance in Hemiplegic Cerebral Palsy
Primary Purpose
Hemiplegic Cerebral Palsy
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Visual Feedback and Rhythmic Auditory Cue
Sponsored by
About this trial
This is an interventional treatment trial for Hemiplegic Cerebral Palsy focused on measuring Treadmill training, Visual Feedback and Rhythmic Auditory cue, Gait and Balance, Hemiplegic Cerebral palsy
Eligibility Criteria
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
Sites / Locations
- Sehat Medical Complex, LahoreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Interventional Group
Control Group
Arm Description
Treadmil Training with visual feedback and rhythmic Auditory Cue
No intervention
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05787977
First Posted
February 20, 2023
Last Updated
March 27, 2023
Sponsor
Sehat Medical Complex
1. Study Identification
Unique Protocol Identification Number
NCT05787977
Brief Title
The Effect of Treadmill Training With Visual Feedback and Rhythmic Auditory Cue on Gait and Balance in Hemiplegic Cerebral Palsy
Official Title
The Effect of Treadmill Training With Visual Feedback and Rhythmic Auditory Cue on Gait and Balance in Hemiplegic Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 20, 2022 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sehat Medical Complex
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegic Cerebral Palsy
Keywords
Treadmill training, Visual Feedback and Rhythmic Auditory cue, Gait and Balance, Hemiplegic Cerebral palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interventional Group
Arm Type
Experimental
Arm Description
Treadmil Training with visual feedback and rhythmic Auditory Cue
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Other
Intervention Name(s)
Visual Feedback and Rhythmic Auditory Cue
Intervention Description
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.
Primary Outcome Measure Information:
Title
6 Minutes Walk Test
Description
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.
Time Frame
Change from baseline at 8th week
Title
Pediatric Balance scale
Description
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.
Time Frame
Change from baseline at 8th Week
Title
Berg Balance Scale
Description
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.
Time Frame
Change from baseline at 8th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Ghafoor
Phone
03344292887
Email
imran.ghafoor64@gamil.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Momina Mehmood
Organizational Affiliation
University of Lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sehat Medical Complex, Lahore
City
Lahore
State/Province
Punjab
ZIP/Postal Code
55201
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Waseem Javaid
Phone
04235410037
Email
info.hw@smc.uol.edu.pk
12. IPD Sharing Statement
Learn more about this trial
The Effect of Treadmill Training With Visual Feedback and Rhythmic Auditory Cue on Gait and Balance in Hemiplegic Cerebral Palsy
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