Interventional StudyLokophysioNCT04035122
Physiological Responses in Robotic Neurorehabilitation
A study testing Robotic Treatment and Conventional Treatment in people with Interventional Study, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
Trial summary
Robotic rehabilitation is very useful for improving functional recovery in neurological patients, there is not much evidence on its role in improving physiological responses (i.e. intestinal motility, orthostatic pressure), which are often abnormal in these patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Interventional Study
- What is being tested?
- Robotic Treatment and Conventional Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Aug 2019to 31 Jul 2020
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion criteria: diagnosis of neurological disease; age between 18 and 75; and Caucasian ethnicity; a FIM motor score equal to or greater than 30.
Exclusion criteria: patients with a history of concomitant brain surgery; severe cognitive or language impairment; systemic, bone or joint disorders; presence of disabling sensory alterations; concomitant medical and psychiatric illness that could interfere with VR training.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Neurolesi
Messina, Sicily, 98124
Rocco S Calabrò
About this study
Official title: Effects of Robotic Neurorehabilitation With Lokomat on Physiological Responses in Neurological Patients: a Randomized Controlled Trial
Robotic rehabilitation is very useful for improving functional recovery in neurological patients, there is not much evidence on its role in improving physiological responses (i.e. intestinal motility, orthostatic pressure), which are often abnormal in these patients.
To this end, we designed a randomized controlled experimental study on neurological patients, with the aim of evaluating the effects of robotic neurorehabilitation using Lokomat on physiological responses, compared to traditional therapy.
- Conditions
- Interventional Study
- Being tested
- Robotic Treatment, Conventional Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic TreatmentOther
Also called Lokomatdevice
The Lokomat is a robotic device, consisting of a powered gait orthosis with integrated computer-controlled linear actuators at each hip and knee joint, a body weight support, and a treadmill. During the Lokomat training, the patients completed at least 30 min of treatment session.
Conventional TreatmentOther
Also called control group
The standard physical treatment program consisted of general conditioning exercises, including warming up (e.g. calf, shoulder, and hand passive range of motion exercises), lower and upper extremity strengthening, postural control exercises. During the conventional training, the patients completed at least 30 min of treatment session.
| Study group | Role | What they receive |
|---|---|---|
| Robotic Treatment | Experimental | The Lokomat is a robotic device. For treatment with the robotic system, the amount of body weight supported will initially set at 70% of every patient's weight, then decreasing in accordance with load tolerance, although not providing less than 20% support. The selected speed will be adapted to the patient's working comfort under the supervision of a trained physiotherapist. The rehabilitation protocol consists of 40 training sessions (3 sessions per week lasting 45 minutes). Receives: Other: Robotic Treatment |
| Conventional Treatment | Active comparator | The CG will perform traditional overgroung gait rehabilitation. Exercises in this program are designed with gradual increments to meet each patient's abilities and were supervised by a physical therapist. The rehabilitation protocol consists of 40 training sessions (3 sessions per week lasting 45 minutes). Receives: Other: Conventional Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constipation Scoring System
Constipation Scoring System (CSS) is an eight-element self-report measure designed to assess the prevalence and severity of constipation. The authors used a pathophysiological definition of constipation. The scoring system is based on eight variables (frequency of bowel movements; difficult or painful evacuation; completeness of evacuation; abdominal pain; time per attempt; assistance including laxatives; digits or enemas; number of failed evacuation attempts in a period of 24 hours and duration of constipation). The CSS consists of seven objects that are marked using a five-point Likert scale ranging from 0 (no time) to 4 (all the time) and an article evaluated on a 0-2 scale. A total score can range from 0 (normal) to 30 (severe constipation). A limit score of 15 suggests constipation.
Measured: 8 months
Delta of variation in maximum and minimum blood pressure
Orthostatic pressure derives from systolic pressure and / or diastolic blood pressure (BP) (about 10 mm / Hg) from supine to vertical. It is evaluated by delta of variation in maximum and minimum blood pressure.
Measured: 8 months
Secondary outcomes (2)
The 12-Item Short Form Health Survey
The SF-12 Health Survey (SF-12) is a 12-article questionnaire used to assess general health outcomes from a patient's perspective. SF-12 assesses health-related quality of life, including the impact of all diseases on a wide range of functional domains. SF-12 consists of a subset of 12 articles dealing with physical functioning, physical role, physical pain, general health, vitality, social functioning, emotional role and mental health.
Measured: 8 months
Functional Independence Measure
The FIM scale is a questionnaire that evaluates 18 activities of daily life (13 motor-sphincteric, 5 cognitive). Each activity can receive a variable score between 1 (complete dependence on others) and 7 (complete self-sufficiency). The cumulative score and the profile of the scores in the different items represent standard indicators that are now very common in the world of rehabilitation. The applications range from the measurement of the appropriateness and effectiveness of the rehabilitation intervention on the individual case, to the forecast of hospitalization times, care interviews and health costs in single operational units or on the network, or in longitudinal "path" rehabilitation studies. The cumulative scores produce a quantitative index of the person's disability.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start1 Aug 2019
- Primary completion31 May 2020 (estimated)
- Study completion31 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Interventional StudyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a parallel-group randomized clinical trial using a double-blind study design. The enrolled patients will be randomly assigned to the 2 groups using an automated computerized randomization program. Patients will be informed about the research and will be asked to fill in the informed consent form. The patient's basic characteristics (age, sex, duration of the illness, marital status and educational background) will be recorded. Randomization will be performed using a randomization list, so patients will be randomized in a 1:1 ratio in the intervention or control group.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro Neurolesi Bonino Pulejo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rocco Salvatore Calabrò, IRCCS Centro Neurolesi Bonino Pulejo
- Investigators
- Rocco S Calabrò, MD, Principal investigator, IRCCS Centro Neurolesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04035122
- Sponsor's protocol ID
- IRCCSME:15/2019
- Acronym
- Lokophysio
- Status last verified
- Feb 2020
- First submitted
- 25 Jul 2019
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Calabro RS, Russo M, Naro A, De Luca R, Leo A, Tomasello P, Molonia F, Dattola V, Bramanti A, Bramanti P. Robotic gait training in multiple sclerosis rehabilitation: Can virtual reality make the difference? Findings from a randomized controlled trial. J Neurol Sci. 2017 Jun 15;377:25-30. doi: 10.1016/j.jns.2017.03.047. Epub 2017 Mar 29.
PubMed 28477702Calabro RS, Cacciola A, Berte F, Manuli A, Leo A, Bramanti A, Naro A, Milardi D, Bramanti P. Robotic gait rehabilitation and substitution devices in neurological disorders: where are we now? Neurol Sci. 2016 Apr;37(4):503-14. doi: 10.1007/s10072-016-2474-4. Epub 2016 Jan 18.
PubMed 26781943
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Robotic Neurorehabilitation With Lokomat on Physiological Responses in Neurological Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04035122
- Acronym / sponsor ID
- Lokophysio / IRCCSME:15/2019
- Conditions
- Interventional Study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS Centro Neurolesi Bonino PulejoUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 May 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 29 Jul 2019 (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.
Robotic rehabilitation is very useful for improving functional recovery in neurological patients, there is not much evidence on its role in improving physiological responses (i.e. intestinal motility, orthostatic pressure), which are often abnormal in these patients.
To this end, we designed a randomized controlled experimental study on neurological patients, with the aim of evaluating the effects of robotic neurorehabilitation using Lokomat on physiological responses, compared to traditional therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study is a parallel-group randomized clinical trial using a double-blind study design. The enrolled patients will be randomly assigned to the 2 groups using an automated computerized randomization program. Patients will be informed about the research and will be asked to fill in the informed consent form. The patient's basic characteristics (age, sex, duration of the illness, marital status and educational background) will be recorded. Randomization will be performed using a randomization list, so patients will be randomized in a 1:1 ratio in the intervention or control group.
| Arm | Type | Receives |
|---|---|---|
| Robotic Treatment | Experimental | Other: Robotic TreatmentThe Lokomat is a robotic device. For treatment with the robotic system, the amount of body weight supported will initially set at 70% of every patient's weight, then decreasing in accordance with load tolerance, although not providing less than 20% support. The selected speed will be adapted to the patient's working comfort under the supervision of a trained physiotherapist. The rehabilitation protocol consists of 40 training sessions (3 sessions per week lasting 45 minutes). |
| Conventional Treatment | Active comparator | Other: Conventional TreatmentThe CG will perform traditional overgroung gait rehabilitation. Exercises in this program are designed with gradual increments to meet each patient's abilities and were supervised by a physical therapist. The rehabilitation protocol consists of 40 training sessions (3 sessions per week lasting 45 minutes). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Robotic TreatmentAlso: LokomatdeviceThe Lokomat is a robotic device, consisting of a powered gait orthosis with integrated computer-controlled linear actuators at each hip and knee joint, a body weight support, and a treadmill. During the Lokomat training, the patients completed at least 30 min of treatment session. | Other | Robotic Treatment |
| Conventional TreatmentAlso: control groupThe standard physical treatment program consisted of general conditioning exercises, including warming up (e.g. calf, shoulder, and hand passive range of motion exercises), lower and upper extremity strengthening, postural control exercises. During the conventional training, the patients completed at least 30 min of treatment session. | Other | Conventional Treatment |
Primary outcome
Constipation Scoring System
Time frame: 8 months
Constipation Scoring System (CSS) is an eight-element self-report measure designed to assess the prevalence and severity of constipation. The authors used a pathophysiological definition of constipation. The scoring system is based on eight variables (frequency of bowel movements; difficult or painful evacuation; completeness of evacuation; abdominal pain; time per attempt; assistance including laxatives; digits or enemas; number of failed evacuation attempts in a period of 24 hours and duration of constipation). The CSS consists of seven objects that are marked using a five-point Likert scale ranging from 0 (no time) to 4 (all the time) and an article evaluated on a 0-2 scale. A total score can range from 0 (normal) to 30 (severe constipation). A limit score of 15 suggests constipation.
Delta of variation in maximum and minimum blood pressure
Time frame: 8 months
Orthostatic pressure derives from systolic pressure and / or diastolic blood pressure (BP) (about 10 mm / Hg) from supine to vertical. It is evaluated by delta of variation in maximum and minimum blood pressure.
2 secondary outcomes
The 12-Item Short Form Health Survey
Time frame: 8 months
Functional Independence Measure
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Results publication: PubMed 28477702Calabro RS, Russo M, Naro A, De Luca R, Leo A, Tomasello P, Molonia F, Dattola V, Bramanti A, Bramanti P. Robotic gait training in multiple sclerosis rehabilitation: Can virtual reality make the difference? Findings from a randomized controlled trial. J Neurol Sci. 2017 Jun 15;377:25-30. doi: 10.1016/j.jns.2017.03.047. Epub 2017 Mar 29.
- Results publication: PubMed 26781943Calabro RS, Cacciola A, Berte F, Manuli A, Leo A, Bramanti A, Naro A, Milardi D, Bramanti P. Robotic gait rehabilitation and substitution devices in neurological disorders: where are we now? Neurol Sci. 2016 Apr;37(4):503-14. doi: 10.1007/s10072-016-2474-4. Epub 2016 Jan 18.
- Individual participant dataSharing planned: No
Related trials for Interventional Study
Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction
Recruiting
Momentary Coping Prompts and Hair Steroids in College Students
Emotional Regulation, Alcohol Drinking in College
Recruiting
Individually Tailored, Supervised, Remote Exercise Intervention to Improve Physical Function for Stage I-III Gastroesophageal Cancer Survivors, PRECISE Trial
Clinical Stage I Esophageal Adenocarcinoma American Joint Committee on Cancer (AJCC) v8, Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8
Active, not recruitingObservational study
Spatial Needle Placement Strategies and Pathological Concordance in Prostate Biopsy: A National Multicenter Retrospective Cohort Study
Prostate Cancer, Prostatic Neoplasms
Recruiting
MI-CBTech: A Mobile Intervention for Community Integration in Homeless-Experienced Veterans With SMI
Schizophrenia Spectrum Disorders, Psychotic Affective Disorders
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.
Rocco S Calabrò, MD principal investigator
IRCCS Centro Neurolesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic Treatment and Conventional Treatment in people with Interventional Study, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 17 Feb 2020. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rocco S Calabrò, MD (+3909060128166, salbro77@tiscali.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constipation Scoring System (time frame: 8 months). The study lists 2 primary outcomes in all. 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 NCT04035122, which also lists 2 linked publications.
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 17 Feb 2020.