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

Not Applicable

Completed

• Conditions: Cerebral Palsy
• Interventions: Device: Assisted gait training with Walkbot System; Other: Physical Therapy

• Registration Number: NCT04329793
• Lead Sponsor: Universidad de Murcia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-08
• Study First Submitted: 2020-03-07
• Study First Submitted QC: 2020-03-31
• Study First Posted: 2020-04-01
• Primary Completion: 2021-03-14
• Study Completion: 2021-03-14
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-02
• Last Update Posted: 2021-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention arm	Assisted gait training with Walkbot System	Assisted gait training with Walkbot System and their usual Physical Therapy.
Intervention arm	Physical Therapy	Assisted gait training with Walkbot System and their usual Physical Therapy.
Control arm	Physical Therapy	Their usual Physical Therapy.

Primary Outcome Measures

Name	Time	Method
Ability and quality of walking.	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 Outcome Measures

Name	Time	Method
Muscle strength	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.
Range of motion	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.
Functionality and autonomy	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
Quality of walking: Edinburgh Visual Gait Scale	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.
Spasticity	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.
Gait endurance	Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention	Changes in 6 minutes walk test

Trial Locations

Locations (1)

Raquel Olmos Gómez; 🇪🇸 Yecla, Murcia, Spain