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

Cerebral Palsy Clinical Trial

— CP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04136678
• Other study ID #: halisdogan
• Status: Completed
• Phase: N/A
• Start date: November 15, 2018
• Est. completion date: October 10, 2019

Study information

• Verified date: October 2019
• Source: Istanbul Medipol University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

1. 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.

2. 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.

3. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 10, 2019
• Est. primary completion date: October 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

Other:
• walking training
15 minutes of conventional walking training 15 minutes of treadmill backward walking training 15 minutes of treadmil forward walking training

Locations

Country	Name	City	State
Turkey	Halkali, Yükselen Basari, Abi Hayat, Altin, Özlem and Çocuklarla Elele Education and Rehabilitation Center.	I?stanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks
Secondary	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.	8 weeks