Cerebral PalsyNCT04329793
Effectiveness of a Treatment With the Robot - Assisted Gait Training System Walkbot in Patients With Cerebral Palsy
A study testing Assisted gait training with Walkbot System and Physical Therapy in people with Cerebral Palsy, run by Universidad de Murcia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Assisted gait training with Walkbot System and Physical Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSpain
- Study dates
- 8 Apr 2019to 14 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Serious psychiatric problems
- Serious heart problems
- Active tumors
- Severe joint degenerative problems
- Degenerative diseases of the nervous system
- Mitochondrial diseases
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Assisted gait training with Walkbot System, Physical Therapy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assisted gait training with Walkbot SystemDevice
Also called Physical Therapy
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 TherapyOther
The control group will receive their usual Physical therapy sessions during 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Assisted gait training with Walkbot System and their usual Physical Therapy. Receives: Device: Assisted gait training with Walkbot System; Other: Physical Therapy |
| Control arm | Active comparator | Their usual Physical Therapy. Receives: Other: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability and quality of walking.
Changes in Gross Motor Function Measure-88 (dimensions IV y V)
Measured: Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention
Secondary outcomes (6)
Functionality and autonomy
Differences in the basic activities of daily life, measured with the PedsQL- Cerebral Palsy Module
Measured: Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention
Muscle strength
Differences in muscle strength of lower limbs, measured with dynamometer.
Measured: Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention
Range of motion
Analyze if the range of joint mobility is increased in those joints that are more limited, measured with goniometer.
Measured: Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention
Spasticity
Changes in spasticity values, measured with the modified Ashworth Scale. Higher scores mean worse outcome. Minimum value is 0. Maximum value is 4.
Measured: Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention
Quality of walking: Edinburgh Visual Gait Scale
Changes in Edinburgh Visual Gait Scale values. Higher scores mean worse outcome. Minimum value is 0. Maximum value is 34.
Measured: Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention
Gait endurance
Changes in 6 minutes walk test
Measured: Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start8 Apr 2019
- Primary completion14 Mar 2021
- Study completion14 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raquel Olmos Gómez, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04329793
- Sponsor's protocol ID
- 2365/2019
- Status last verified
- May 2021
- First submitted
- 7 Mar 2020
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39009990
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Treatment With the Robot - Assisted Gait Training System Walkbot in Patients With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04329793
- Acronym / sponsor ID
- 2365/2019
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 14 Mar 2021 (actual)
- Study completion
- 14 Mar 2021 (actual)
- First posted
- 1 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Device: Assisted gait training with Walkbot System, Other: Physical TherapyAssisted gait training with Walkbot System and their usual Physical Therapy. |
| Control arm | Active comparator | Other: Physical TherapyTheir usual Physical Therapy. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- Serious psychiatric problems
- Serious heart problems
- Active tumors
- Severe joint degenerative problems
- Degenerative diseases of the nervous system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assisted gait training with Walkbot SystemAlso: Physical TherapyThe 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. | Device | Intervention arm |
| Physical TherapyThe control group will receive their usual Physical therapy sessions during 6 weeks. | Other | Control arm, Intervention arm |
Primary outcome
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)
6 secondary outcomes
Functionality and autonomy
Time frame: Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention
Muscle strength
Time frame: Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention
Range of motion
Time frame: Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention
Spasticity
Time frame: Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention
Quality of walking: Edinburgh Visual Gait Scale
Time frame: Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention
Gait endurance
Time frame: Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
- Derived from this study: PubMed 39009990Olmos-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assisted gait training with Walkbot System and Physical Therapy in people with Cerebral Palsy, run by Universidad de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability and quality of walking. (time frame: Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04329793, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2021.