Skip to main content
OpenTrials
Completed

NCT Number: NCT04136678

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Istanbul, (535) 020-6774, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Walking training

Other

15 minutes of conventional walking training 15 minutes of treadmill backward walking training 15 minutes of treadmil forward walking training

Other names: conventional walking training, treadmill backward walking training, treadmill forward walking training

Primary outcomes

  1. The Pediatric Balance Scale

    Time frame: 8 weeks

    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 outcomes

  1. The Rivermead Visual Gait Assessment

    Time frame: 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Acronym: CP

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 23, 2019
Registry last updated
Feb 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.