NCT04136678

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 23, 2019

Completed
Last Updated

February 12, 2020

Status Verified

October 1, 2019

Enrollment Period

11 months

First QC Date

October 10, 2019

Last Update Submit

February 11, 2020

Conditions

Keywords

cerebral palsytreadmillbackward walkingbalancespasticity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The Rivermead Visual Gait Assessment

    8 weeks

Study Arms (1)

treadmill back walking training

EXPERIMENTAL

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

Other: walking training

Interventions

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

Also known as: conventional walking training, treadmill backward walking training, treadmill forward walking training
treadmill back walking training

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

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

Location

MeSH Terms

Conditions

Cerebral PalsyMuscle Spasticity

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • H D Doğan, Pt

    Istanbul Medipol University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Those who are between 6 and 18 years old and have a medical report on the diagnosis of cerebral palsy,
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

October 10, 2019

First Posted

October 23, 2019

Study Start

November 15, 2018

Primary Completion

October 10, 2019

Study Completion

October 10, 2019

Last Updated

February 12, 2020

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations