Effectiveness of a Treatment With the Robot - Assisted Gait Training System Walkbot in Patients With Cerebral Palsy
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Assisted gait training with Walkbot System
Physical Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy
Eligibility Criteria
Inclusion Criteria:
- Cerebral palsy diagnosis (diplegia or tetraplegia)
- Ability to communicate even if not verbal (yes/not; gestures; pictograms; sounds)
- Levels II, III and IV in GMFCS
- Unsupported seating capacity
- Go on standing with or without help
- Not receiving therapy with a walking robot and not having received it in at least one year
Exclusion Criteria:
- Serious psychiatric problems
- Serious heart problems
- Active tumors
- Severe joint degenerative problems
- Degenerative diseases of the nervous system
- Mitochondrial diseases
- Recent surgeries
- Unbound fractures
- Severe osteoporosis
- Uncontrolled seizures
- Open wounds in the lower half of the body
- Extreme fear of being placed in robotic devices
- Anthropomorphic measures are below the minimum required to use the device
Sites / Locations
- Raquel Olmos Gómez
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention arm
Control arm
Arm Description
Assisted gait training with Walkbot System and their usual Physical Therapy.
Their usual Physical Therapy.
Outcomes
Primary Outcome Measures
Ability and quality of walking.
Changes in Gross Motor Function Measure-88 (dimensions IV y V)
Secondary Outcome Measures
Functionality and autonomy
Differences in the basic activities of daily life, measured with the PedsQL- Cerebral Palsy Module
Muscle strength
Differences in muscle strength of lower limbs, measured with dynamometer.
Range of motion
Analyze if the range of joint mobility is increased in those joints that are more limited, measured with goniometer.
Spasticity
Changes in spasticity values, measured with the modified Ashworth Scale. Higher scores mean worse outcome. Minimum value is 0. Maximum value is 4.
Quality of walking: Edinburgh Visual Gait Scale
Changes in Edinburgh Visual Gait Scale values. Higher scores mean worse outcome. Minimum value is 0. Maximum value is 34.
Gait endurance
Changes in 6 minutes walk test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04329793
Brief Title
Effectiveness of a Treatment With the Robot - Assisted Gait Training System Walkbot in Patients With Cerebral Palsy
Official Title
Effectiveness of a Treatment With the Robot - Assisted Gait Training System Walkbot in Patients With Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
April 8, 2019 (Actual)
Primary Completion Date
March 14, 2021 (Actual)
Study Completion Date
March 14, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Murcia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The improvement of walking capacity is a key objective of the rehabilitation of children with PC. There are different approaches from physiotherapy to address this need, including walking on the ground and on treadmill with partial weight support. Currently, there are robotic technologies adapted to the functional rehabilitation of patients. Assisted gait training with robotic devices such as the Walkbot allows a longer duration of training, at more variable speeds, and with a constant gait pattern adapted to the patient. This training, based on the intensity and repetition of the movement, has beneficial effects on the recovery and improvement of the patient's postural and locomotor functions.
There are some studies that evaluate walking interventions on treadmill with partial weight support, on the ground and in assisted walking robot in patients with PC.
Currently, there are no studies conducted that report the effectiveness of interventions performed with robotic walking training device Walkbot K on PC. However, studies in adults with Walkbot S, affected with neurological injury, have reported good results.
Assisted gait training with robotic devices such as the Walkbot, based on the intensity and repetition of the movement, has beneficial effects on the recovery and improvement of the patient's postural and locomotor functions. However, due to the little evidence that exists, it is necessary to know the effectiveness of the Walkbot assisted walking robot in these patients by means of a clinical trial that allows to firmly establish the scope of its benefits.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
Assisted gait training with Walkbot System and their usual Physical Therapy.
Arm Title
Control arm
Arm Type
Active Comparator
Arm Description
Their usual Physical Therapy.
Intervention Type
Device
Intervention Name(s)
Assisted gait training with Walkbot System
Other Intervention Name(s)
Physical Therapy
Intervention Description
The experimental group will receive at least 3 treatment sessions per week consisting of 40 minutes in robot-assisted gait training with Walkbot System in addition to their usual Physical therapy sessions. In total, the number of Walkbot sessions will be 20, in uninterrupted weeks.
Intervention Type
Other
Intervention Name(s)
Physical Therapy
Intervention Description
The control group will receive their usual Physical therapy sessions during 6 weeks.
Primary Outcome Measure Information:
Title
Ability and quality of walking.
Description
Changes in Gross Motor Function Measure-88 (dimensions IV y V)
Time Frame
Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention
Secondary Outcome Measure Information:
Title
Functionality and autonomy
Description
Differences in the basic activities of daily life, measured with the PedsQL- Cerebral Palsy Module
Time Frame
Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention
Title
Muscle strength
Description
Differences in muscle strength of lower limbs, measured with dynamometer.
Time Frame
Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention
Title
Range of motion
Description
Analyze if the range of joint mobility is increased in those joints that are more limited, measured with goniometer.
Time Frame
Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention
Title
Spasticity
Description
Changes in spasticity values, measured with the modified Ashworth Scale. Higher scores mean worse outcome. Minimum value is 0. Maximum value is 4.
Time Frame
Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention
Title
Quality of walking: Edinburgh Visual Gait Scale
Description
Changes in Edinburgh Visual Gait Scale values. Higher scores mean worse outcome. Minimum value is 0. Maximum value is 34.
Time Frame
Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention
Title
Gait endurance
Description
Changes in 6 minutes walk test
Time Frame
Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cerebral palsy diagnosis (diplegia or tetraplegia)
Ability to communicate even if not verbal (yes/not; gestures; pictograms; sounds)
Levels II, III and IV in GMFCS
Unsupported seating capacity
Go on standing with or without help
Not receiving therapy with a walking robot and not having received it in at least one year
Exclusion Criteria:
Serious psychiatric problems
Serious heart problems
Active tumors
Severe joint degenerative problems
Degenerative diseases of the nervous system
Mitochondrial diseases
Recent surgeries
Unbound fractures
Severe osteoporosis
Uncontrolled seizures
Open wounds in the lower half of the body
Extreme fear of being placed in robotic devices
Anthropomorphic measures are below the minimum required to use the device
Facility Information:
Facility Name
Raquel Olmos Gómez
City
Yecla
State/Province
Murcia
ZIP/Postal Code
30510
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of a Treatment With the Robot - Assisted Gait Training System Walkbot in Patients With Cerebral Palsy
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