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

NCT ID: NCT04329793

Last Updated: 2021-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-08
• Study Completion Date: 2021-03-14

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.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention arm

Assisted gait training with Walkbot System and their usual Physical Therapy.

Group Type: EXPERIMENTAL

Assisted gait training with Walkbot System

Intervention Type: DEVICE

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.

Physical Therapy

Intervention Type: OTHER

The control group will receive their usual Physical therapy sessions during 6 weeks.

Control arm

Their usual Physical Therapy.

Group Type: ACTIVE_COMPARATOR

Physical Therapy

Intervention Type: OTHER

The control group will receive their usual Physical therapy sessions during 6 weeks.

Interventions

Assisted gait training with Walkbot System

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: DEVICE

Physical Therapy

The control group will receive their usual Physical therapy sessions during 6 weeks.

Intervention Type: OTHER

Other Intervention Names

Physical Therapy

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Murcia

OTHER

Sponsor Role: lead

Responsible Party

Raquel Olmos Gómez

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Raquel Olmos Gómez

Yecla, Murcia, Spain

Countries

Spain

References

Olmos-Gomez R, Calvo-Munoz I, Gomez-Conesa A. Treatment with robot-assisted gait trainer Walkbot along with physiotherapy vs. isolated physiotherapy in children and adolescents with cerebral palsy. Experimental study. BMC Neurol. 2024 Jul 15;24(1):245. doi: 10.1186/s12883-024-03750-9.

Reference Type: DERIVED

PMID: 39009990 (View on PubMed)

Other Identifiers

2365/2019

Identifier Type: -

Identifier Source: org_study_id