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

NCT04329793 | Completed

• 1 other identifier: 2365/2019
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Ability and quality of walking.

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

  Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention

Secondary Outcomes (6)

• Functionality and autonomy

  Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention

• Muscle strength

  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

• Quality of walking: Edinburgh Visual Gait Scale

  Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention

Study Arms (2)

Intervention arm

EXPERIMENTAL

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

Device: Assisted gait training with Walkbot System; Other: Physical Therapy

Control arm

ACTIVE COMPARATOR

Their usual Physical Therapy.

Other: Physical Therapy

Interventions

Assisted gait training with Walkbot System 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.

Also known as: Physical Therapy

Intervention arm

Physical Therapy OTHER

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

Control arm; Intervention arm

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Murcia: lead

Study Sites (1)

Raquel Olmos Gómez

Yecla, Murcia, 30510, Spain

Location

Related Publications (1)

• 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.

  PMID: 39009990 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 7, 2020
• First Posted: April 1, 2020
• Study Start: April 8, 2019
• Primary Completion: March 14, 2021
• Study Completion: March 14, 2021
• Last Updated: May 4, 2021

Record last verified: 2021-05

Locations

ES (1)