Comparision Of The Effectiveness Of Physiotherapy Methods

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04328168
• Other study ID #: 2016/442
• Status: Completed
• Phase: N/A
• Start date: August 15, 2016
• Est. completion date: January 15, 2017

Study information

• Verified date: March 2020
• Source: Kayseri Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: January 15, 2017
• Est. primary completion date: October 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Procedure:
• ROM exercises, stretching, positioning, gait training

• by two physiotherapist under the supervision of a doctor

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kayseri Education and Research Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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