Skip to main content
Clinical Trials/NCT04329793
NCT04329793
Completed
Not Applicable

Effectiveness of a Treatment With the Robot - Assisted Gait Training System Walkbot in Patients With Cerebral Palsy

Universidad de Murcia1 site in 1 country23 target enrollmentApril 8, 2019
ConditionsCerebral Palsy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
Universidad de Murcia
Enrollment
23
Locations
1
Primary Endpoint
Ability and quality of walking.
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 8, 2019
End Date
March 14, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Raquel Olmos Gómez

Principal investigator

Universidad de Murcia

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

Outcomes

Primary Outcomes

Ability and quality of walking.

Time Frame: Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention

Changes in Gross Motor Function Measure-88 (dimensions IV y V)

Secondary Outcomes

  • Muscle strength(Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention)
  • Functionality and autonomy(Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention)
  • Quality of walking: Edinburgh Visual Gait Scale(Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention)
  • Range of motion(Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention)
  • Spasticity(Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention)
  • Gait endurance(Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention)

Study Sites (1)

Loading locations...

Similar Trials