Clinical trial NCT04329793: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2020-04-01
Enrollment: 23
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Ability and quality of walking.
timeFrame: Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention
Secondary outcomes:
measure: Functionality and autonomy
timeFrame: Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention
measure: Muscle strength
timeFrame: Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention
measure: Range of motion
timeFrame: Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention
measure: Spasticity
timeFrame: Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention
measure: Quality of walking: Edinburgh Visual Gait Scale
timeFrame: Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention
measure: Gait endurance
timeFrame: Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention
Other outcomes:
Locations:
city: Yecla
country: Spain
facility: Raquel Olmos Gómez
state: Murcia
Study officials:
References: