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The Effect of Treadmill Back Walking Training on Balance and Function in Cerebral Palsy (CP)

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
walking training
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cerebral Palsy focused on measuring cerebral palsy, treadmill, backward walking, balance, spasticity

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Those who are between 6 and 18 years old and have a medical report on the diagnosis of cerebral palsy,
  • Classes classified as Level I and II by Gross Motor Function Classification System (GMFCS),
  • Lower extremity spasticity classified as 1st and 2nd degree according to Modified Modified Ashworth Scale,
  • To understand and apply verbal commands and instructions.
  • Volunteer to participate in the study,
  • Read and approve the informed consent form.

Exclusion Criteria:

  • Active epileptic seizures
  • Those with visual or auditory defects,
  • Those with fixed deformities in the lower extremities,
  • Patients with a history of surgery in the lower extremity musculoskeletal system in the last 6 months
  • Injection of Botulinum Toxin (BOTOX) for lower extremity within the last 6 months Spasticity drug users,
  • Those with mental and cognitive problems will be excluded from the study

Sites / Locations

  • Halkalı, Yükselen Başarı, Abı Hayat, Altın, Özlem and Çocuklarla Elele Education and Rehabilitation Center.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treadmill back walking training

Arm Description

15 minutes conventional walking training, 15 minutes of treadmill back walking training, 15-minute treadmill forward walking training

Outcomes

Primary Outcome Measures

The Pediatric Balance Scale
It can be considered as a simple, valid scale for studying functional balance capacity in children with spastic SP (Yi 2012). Pediatric Berg Balance Scale (PBBS) will be used to evaluate the functional balance of daily living activities. Higher scores mean a better outcome.

Secondary Outcome Measures

The Rivermead Visual Gait Assessment
RVGA allows rapid assessment and documentation of gait disturbances without equipment in the clinic and demonstration of clinical changes (Lord, et al. 1998). Visual parameters of walking in our study will be evaluated by The Rivermead Visual Gait Assessment (RVGA). Higher scores mean a worse outcome.

Full Information

First Posted
October 10, 2019
Last Updated
February 11, 2020
Sponsor
Istanbul Medipol University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04136678
Brief Title
The Effect of Treadmill Back Walking Training on Balance and Function in Cerebral Palsy
Acronym
CP
Official Title
The Effect of Treadmill Back Walking Training on Balance and Function in Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
November 15, 2018 (Actual)
Primary Completion Date
October 10, 2019 (Actual)
Study Completion Date
October 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study was to investigate the effect of treadmill back walking training on balance and function in cerebral palsy. In our study, scientific data will be prepared by clinical measurement tools in order to determine whether there is balance and walking effect of easy and practicable treadmill back walking training in the clinical setting in Cerebral Palsy.
Detailed Description
Measurements will be made at baseline and after each 8 weeks of physiotherapy program, the results will be compared. 30 minutes of the physiotherapy session, which we will apply for 2 days and 45 minutes; in the prone, supine, crawling and above knee positions; They will take physiotherapy training based on neurodevelopmental therapy consisting of fine motor activities, standing up, weight transfer, stretching, strengthening and balance exercises with mat activities such as rotation, weight transfer, sitting. Term: After the first measurements, the participants will take 8 minutes, 2 days a week, the regular physiotherapy session based on 30 minutes Neurodevelopmental Therapy as described above, as well as 15 minutes conventional walking training, then the measurements will be repeated. Term: After the second measurements, the participants will take 8 weeks, 2 days a week, the regular physiotherapy session based on 30 minutes of Neurodevelopmental Therapy as described above, as well as 15 minutes of treadmill back walking training, then the measurements will be repeated. Term: After the third measurements, the participants will take 8 weeks, 2 days a week, the regular physiotherapy session based on the 30 minute Neurodevelopmental Therapy described above, as well as the 15-minute treadmill walking forward training, then the measurements will be repeated. Statistical method (s) to be used: In the analysis of the results to be obtained in our study, SPS statistics 22.0 version of SPSS statistical package will be used under the Windows operating system Statistical Package for Social Sciences (SPSS). Descriptive statistical information will be shown as arithmetic mean ± Standard Deviation (x statistical ± Ss) or percentage (%) and the level of statistical significance will be considered as p≤0.05.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
cerebral palsy, treadmill, backward walking, balance, spasticity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Those who are between 6 and 18 years old and have a medical report on the diagnosis of cerebral palsy,
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
treadmill back walking training
Arm Type
Experimental
Arm Description
15 minutes conventional walking training, 15 minutes of treadmill back walking training, 15-minute treadmill forward walking training
Intervention Type
Other
Intervention Name(s)
walking training
Other Intervention Name(s)
conventional walking training, treadmill backward walking training, treadmill forward walking training
Intervention Description
15 minutes of conventional walking training 15 minutes of treadmill backward walking training 15 minutes of treadmil forward walking training
Primary Outcome Measure Information:
Title
The Pediatric Balance Scale
Description
It can be considered as a simple, valid scale for studying functional balance capacity in children with spastic SP (Yi 2012). Pediatric Berg Balance Scale (PBBS) will be used to evaluate the functional balance of daily living activities. Higher scores mean a better outcome.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
The Rivermead Visual Gait Assessment
Description
RVGA allows rapid assessment and documentation of gait disturbances without equipment in the clinic and demonstration of clinical changes (Lord, et al. 1998). Visual parameters of walking in our study will be evaluated by The Rivermead Visual Gait Assessment (RVGA). Higher scores mean a worse outcome.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Those who are between 6 and 18 years old and have a medical report on the diagnosis of cerebral palsy, Classes classified as Level I and II by Gross Motor Function Classification System (GMFCS), Lower extremity spasticity classified as 1st and 2nd degree according to Modified Modified Ashworth Scale, To understand and apply verbal commands and instructions. Volunteer to participate in the study, Read and approve the informed consent form. Exclusion Criteria: Active epileptic seizures Those with visual or auditory defects, Those with fixed deformities in the lower extremities, Patients with a history of surgery in the lower extremity musculoskeletal system in the last 6 months Injection of Botulinum Toxin (BOTOX) for lower extremity within the last 6 months Spasticity drug users, Those with mental and cognitive problems will be excluded from the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
H D Doğan, Pt
Organizational Affiliation
Istanbul Medipol University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Halkalı, Yükselen Başarı, Abı Hayat, Altın, Özlem and Çocuklarla Elele Education and Rehabilitation Center.
City
İ̇stanbul
ZIP/Postal Code
(535) 020-6774
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Treadmill Back Walking Training on Balance and Function in Cerebral Palsy

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