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

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Other: walking training

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İ̇stanbul, Turkey, (535) 020-6774
    • Halkalı, Yükselen Başarı, Abı Hayat, Altın, Özlem and Çocuklarla Elele Education and Rehabilitation Center.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treadmill back walking training; 15 minutes conventional walking training, 15 minutes of treadmill back walking training, 15-minute treadmill forward walking training	Other: walking training; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital
• Investigators: Principal Investigator: H D Doğan, Pt, Istanbul Medipol University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2018
• Primary Completion (Actual): October 10, 2019
• Study Completion (Actual): October 10, 2019

Study Registration Dates

• First Submitted: October 10, 2019
• First Submitted That Met QC Criteria: October 22, 2019
• First Posted (Actual): October 23, 2019

Study Record Updates

• Last Update Posted (Actual): February 12, 2020
• Last Update Submitted That Met QC Criteria: February 11, 2020
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: spasticity; cerebral palsy; balance; treadmill; backward walking
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: halisdogan

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No