Comparision Of The Effectiveness Of Physiotherapy Methods

NCT ID: NCT04328168

Last Updated: 2020-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-15
• Study Completion Date: 2017-01-15

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.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Group1

Conventional Physiotherapy

Group Type: ACTIVE_COMPARATOR

ROM exercises, stretching, positioning, gait training

Intervention Type: PROCEDURE

Group2

robot-assisted gait training

Group Type: ACTIVE_COMPARATOR

by two physiotherapist under the supervision of a doctor

Intervention Type: PROCEDURE

Interventions

ROM exercises, stretching, positioning, gait training

Intervention Type: PROCEDURE

by two physiotherapist under the supervision of a doctor

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kayseri Education and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. Ayşe Güç

Kayseri Education and Research State Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2016/442

Identifier Type: -

Identifier Source: org_study_id