Skip to main content
OpenTrials
Completed

NCT Number: NCT04329793

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Raquel Olmos Gómez

Yecla, Murcia, 30510, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Physical Therapy

Physical Therapy

Other

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

Primary outcomes

  1. 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

  1. Functionality and autonomy

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

    Differences in the basic activities of daily life, measured with the PedsQL- Cerebral Palsy Module

  2. Muscle strength

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

    Differences in muscle strength of lower limbs, measured with dynamometer.

  3. Range of motion

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

    Analyze if the range of joint mobility is increased in those joints that are more limited, measured with goniometer.

  4. Spasticity

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

    Changes in spasticity values, measured with the modified Ashworth Scale. Higher scores mean worse outcome. Minimum value is 0. Maximum value is 4.

  5. Quality of walking: Edinburgh Visual Gait Scale

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

    Changes in Edinburgh Visual Gait Scale values. Higher scores mean worse outcome. Minimum value is 0. Maximum value is 34.

  6. Gait endurance

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

    Changes in 6 minutes walk test

Sponsors and collaborators

Lead sponsor

Universidad de Murcia

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 1, 2020
Registry last updated
May 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.