Clinical trial NCT04136678: The Effect of Treadmill Back Walking Training on Balance and Function in Cerebral Palsy
Official title: The Effect of Treadmill Back Walking Training on Balance and Function in Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: cerebral palsy
treadmill
backward walking
balance
spasticity
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2019-10-23
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Those who are between 6 and 18 years old and have a medical report on the diagnosis of cerebral palsy,
Primary purpose: OTHER

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.

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.

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

Primary outcomes:
measure: The Pediatric Balance Scale
timeFrame: 8 weeks
Secondary outcomes:
measure: The Rivermead Visual Gait Assessment
timeFrame: 8 weeks
Other outcomes:
Locations:
city: İ̇stanbul
country: Turkey
facility: Halkalı, Yükselen Başarı, Abı Hayat, Altın, Özlem and Çocuklarla Elele Education and Rehabilitation Center.
Study officials:
affiliation: Istanbul Medipol University Hospital
name: H D Doğan, Pt
role: PRINCIPAL_INVESTIGATOR
References: