Back to resultsComparision Of The Effectiveness Of Physiotherapy Methods
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ROM exercises, stretching, positioning, gait training
by two physiotherapist under the supervision of a doctor
Sponsored by
About this trial
This is an interventional health services research trial for Cerebral Palsy focused on measuring Botulinum-toxin, cerebral-palsy, robot-assisted therapy
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group1
Group2
Arm Description
Conventional Physiotherapy
robot-assisted gait training
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04328168
First Posted
March 21, 2020
Last Updated
March 28, 2020
Sponsor
Kayseri Education and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04328168
Brief Title
Comparision Of The Effectiveness Of Physiotherapy Methods
Official Title
Comparision Of The Effectiveness Of Conventional Physiotherapy After Botulinum Toxin Injection In Children With Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
August 15, 2016 (Actual)
Primary Completion Date
October 15, 2016 (Actual)
Study Completion Date
January 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kayseri Education and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Botulinum-toxin, cerebral-palsy, robot-assisted therapy
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
Participant
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group1
Arm Type
Active Comparator
Arm Description
Conventional Physiotherapy
Arm Title
Group2
Arm Type
Active Comparator
Arm Description
robot-assisted gait training
Intervention Type
Procedure
Intervention Name(s)
ROM exercises, stretching, positioning, gait training
Intervention Type
Procedure
Intervention Name(s)
by two physiotherapist under the supervision of a doctor
Primary Outcome Measure Information:
Title
The Gross Motor Function Classification System (GMFCS)
Description
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.
Time Frame
3 weeks
Title
The Edinburgh Visual Gait Scale (EVGS)
Description
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.
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
individual participant data (IPD) is not be available to other researchers.
Learn more about this trial
Comparision Of The Effectiveness Of Physiotherapy Methods
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