Comparision Of The Effectiveness Of Physiotherapy Methods

Not Applicable

Completed

• Conditions: Cerebral Palsy
• Interventions: Procedure: ROM exercises, stretching, positioning, gait training; Procedure: by two physiotherapist under the supervision of a doctor

• Registration Number: NCT04328168
• Lead Sponsor: Kayseri Education and Research Hospital

Brief Summary

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

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 Timeline

• Study Start: 2016-08-15
• Primary Completion: 2016-10-15
• Study Completion: 2017-01-15
• Status Verified: 2020-03
• Study First Submitted: 2020-03-21
• Study First Submitted QC: 2020-03-28
• Last Update Submitted: 2020-03-28
• Study First Posted: 2020-03-31
• Last Update Posted: 2020-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group1	ROM exercises, stretching, positioning, gait training	Conventional Physiotherapy
Group2	by two physiotherapist under the supervision of a doctor	robot-assisted gait training

Primary Outcome Measures

Name	Time	Method
The Gross Motor Function Classification System (GMFCS)	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)	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.