Comparision Of The Effectiveness Of Physiotherapy Methods

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Procedure: ROM exercises, stretching, positioning, gait training
* Procedure: by two physiotherapist under the supervision of a doctor


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Botulinum-toxin, cerebral-palsy, robot-assisted therapy