Comparision Of The Effectiveness Of Physiotherapy Methods

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

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

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Procedure: ROM exercises, stretching, positioning, gait training; Procedure: by two physiotherapist under the supervision of a doctor

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group1; Conventional Physiotherapy	Procedure: ROM exercises, stretching, positioning, gait training
Active Comparator: Group2; robot-assisted gait training	Procedure: by two physiotherapist under the supervision of a doctor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Gross Motor Function Classification System (GMFCS)	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.	3 weeks
The Edinburgh Visual Gait Scale (EVGS)	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.	3 weeks

Collaborators and Investigators

• Sponsor: Kayseri Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2016
• Primary Completion (Actual): October 15, 2016
• Study Completion (Actual): January 15, 2017

Study Registration Dates

• First Submitted: March 21, 2020
• First Submitted That Met QC Criteria: March 28, 2020
• First Posted (Actual): March 31, 2020

Study Record Updates

• Last Update Posted (Actual): March 31, 2020
• Last Update Submitted That Met QC Criteria: March 28, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Botulinum-toxin, cerebral-palsy, robot-assisted therapy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 2016/442

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: individual participant data (IPD) is not be available to other researchers.

Drug and device information, study documents

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