Comparision Of The Effectiveness Of Phy… | Clinical Trial

Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

7 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

A total of 28 patients who were followed-up in our clinic and received botulinum toxin injection of lower extremities in the last month were randomized to two groups in the study. Group 1 received conventional physiotherapy and Group 2 received robot-assisted gait training. The treatment period was 30 min/day, five sessions in a week, 15 sessions in total, for both groups. The study population was evaluated using range of joint motion evaluation chart, the Modified Ashworth Scale, The Gross Motor Function Classification System, The Berg Balance Scale, the functional independence measure for children, and the Edinburgh Visual Gait Score.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Aged 4>, <16 with CP diagnosis
Walking diffculties due to the spasticity of lower extremities,
Level I-IV on the Gross Motor Function Classification System.

Exclusion criteria

MAS Level IV spasticity, contractures, or rigidity in the lower extremities,
A limb length inequality of >2 cm,
Hypotonic CP,
Having drug-related refractory epilepsy,
Undergoing intrathecal baclofen pump surgery,
Surgical interventions in the lower extremities in the last year,
Scoliosis angle of >30°,
Complicated osteoporosis (nontraumatic fracture...),
Cardiovascular instability,
GMFCS Level V,
Metabolic disorder, genetic disease, neurodegenerative and neuromuscular diseases.

Treatment and study plan

ROM exercises, stretching, positioning, gait training

Procedure

by two physiotherapist under the supervision of a doctor

Procedure

Primary outcomes

The Gross Motor Function Classification System (GMFCS)

Time frame: 3 weeks

The Gross Motor Function Classification System or GMFCS is a 5 level clinical classification system that describes the gross motor function of people with cerebral palsy on the basis of self-initiated movement abilities.
The Edinburgh Visual Gait Scale (EVGS)

Time frame: 3 weeks

The Edinburgh visual gait score is an evaluative tool that uses software and video cameras to provide 3D video gait analysis as well as onscreen drawing and measurement tools to evaluate each portion of gait. The software will then generate a EVGS report, with illustrative images from the video if desired, in PDF format.

Sponsors and collaborators

Lead sponsor

Kayseri Education and Research Hospital

Other Gov

Registry information

Official study title

Comparision Of The Effectiveness Of Conventional Physiotherapy After Botulinum Toxin Injection In Children With Cerebral Palsy

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2017
First posted: Mar 31, 2020
Registry last updated: Mar 31, 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.

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

Completed