Spinal Cord InjuryNCT02342080
Effects of System Suspended Robotic Lokomat Gait in Patients With Incomplete Spinal Cord Injury
A study testing Training sessions and Lokomat system (Hocoma AG Switzerland) in people with Spinal Cord Injury, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Patients with incomplete spinal cord injury Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Training sessions and Lokomat system (Hocoma AG Switzerland)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2013to Feb 2015
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Clinical and radiological diagnosis of incomplete spinal cord injury of traumatic origin
- Injury time from 1 to 36 months
- Stability verified in clinical medical evaluation
- ASIA C or D
- Absence of severe psychiatric amendment requiring psychiatric evaluations
- Present functional recovery of the upper limb compatible with stages III and IV of Brunnstrom
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- Patients cannot use a cardiac pacemaker ; have unstable angina or other decompensated heart disease; have chronic obstructive pulmonary disease; dysreflexia without having autonomic control; have some fracture of the bones of the lower limbs; tracheostomy; presenting deformity and stiffness of the hip joint, knee (20 ° or more of flexion ) and ankle ( 10 or more plantar flexion ) and pressure ulcers.
- Absence of illicit drug use
- Grant writing the informed consent to participate in the study
Who cannot join
- Lack of resistance
- Disabling fatigue
- Worsening of spasticity which prevents the movement
- Body weight in excess of 150Kg
- Risk of osteoporosis with pathological fracture
- Asymmetry in the lower limbs greater than 2 cm
- Skin lesions and / or pressure ulcers in areas where the orthosis Lokomat pressuring
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Centro de Pesquisa Clínica do Instituto de Medicina Física e Reabilitação do HCFMUSP
São Paulo, São Paulo, 04116-040
About this study
Patients with incomplete spinal cord injury
Read the detailed description
The objective of this project is to verify the effects of suspended robotic gait training (Lokomat) in recovery of functional capacity of the lower limbs patients with incomplete spinal cord injury.
- Conditions
- Spinal Cord Injury
- Being tested
- Training sessions, Lokomat system (Hocoma AG Switzerland)
- Keywords
- Rehabilitation, Walking, Robotics, Neuronal Plasticity
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training sessionsOther
A group with spinal cord injury will be trained in a 30-minute session 5 times weekly for 6 weeks. Each session will be supervised by qualified staff. Patients will undergo training with gradual increase in load and speed, according to the tolerance of each patient. The body weight support progression will start at 50 % of the patient body weight. It will be changed every 2 weeks and the load will decrease 10%. The progression of speed may be accompanied during the training period.
Lokomat system (Hocoma AG Switzerland)Device
For the robot locomotion therapy, the Lokomat system (Hocoma AG Switzerland) will be used.
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | A group with spinal cord injury will be trained in a 30-minute session 5 times weekly for 6 weeks. Each session will be supervised by qualified staff. Patients will undergo training with gradual increase in load and speed, according to the tolerance of each patient. The body weight support progression will start at 50 % of the patient body weight. It will be changed every 2 weeks and the load will decrease 10%. The progression of speed may be accompanied during the training period. For the robot locomotion therapy, the Lokomat system (Hocoma AG Switzerland) will be used. Receives: Other: Training sessions; Device: Lokomat system (Hocoma AG Switzerland) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking Index for Spinal Cord Injury II
Measured: 6 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startMar 2013
- Primary completionJun 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linamara Rizzo Battistella, MD PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02342080
- Sponsor's protocol ID
- 0718.0.015.000-11
- Status last verified
- May 2015
- First submitted
- 14 Jan 2015
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of System Suspended Robotic Lokomat Gait in Patients With Incomplete Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02342080
- Acronym / sponsor ID
- 0718.0.015.000-11
- Conditions
- Spinal Cord Injury
- Keywords
- Rehabilitation, Walking, Robotics, Neuronal Plasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 19 Jan 2015 (estimated)
- 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.
Patients with incomplete spinal cord injury
Detailed description
The objective of this project is to verify the effects of suspended robotic gait training (Lokomat) in recovery of functional capacity of the lower limbs patients with incomplete spinal cord injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Other: Training sessions, Device: Lokomat system (Hocoma AG Switzerland)A group with spinal cord injury will be trained in a 30-minute session 5 times weekly for 6 weeks. Each session will be supervised by qualified staff. Patients will undergo training with gradual increase in load and speed, according to the tolerance of each patient. The body weight support progression will start at 50 % of the patient body weight. It will be changed every 2 weeks and the load will decrease 10%. The progression of speed may be accompanied during the training period. For the robot locomotion therapy, the Lokomat system (Hocoma AG Switzerland) will be used. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Clinical and radiological diagnosis of incomplete spinal cord injury of traumatic origin
- Injury time from 1 to 36 months
- Stability verified in clinical medical evaluation
- ASIA C or D
- Absence of severe psychiatric amendment requiring psychiatric evaluations
Key exclusion criteria (7 listed)
- Lack of resistance
- Disabling fatigue
- Worsening of spasticity which prevents the movement
- Body weight in excess of 150Kg
- Risk of osteoporosis with pathological fracture
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 |
|---|---|---|
| Training sessionsA group with spinal cord injury will be trained in a 30-minute session 5 times weekly for 6 weeks. Each session will be supervised by qualified staff. Patients will undergo training with gradual increase in load and speed, according to the tolerance of each patient. The body weight support progression will start at 50 % of the patient body weight. It will be changed every 2 weeks and the load will decrease 10%. The progression of speed may be accompanied during the training period. | Other | Interventional group |
| Lokomat system (Hocoma AG Switzerland)For the robot locomotion therapy, the Lokomat system (Hocoma AG Switzerland) will be used. | Device | Interventional group |
Primary outcome
Walking Index for Spinal Cord Injury II
Time frame: 6 weeks after treatment
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 12 May 2015.
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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.
Linamara Rizzo Battistella, MD PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training sessions and Lokomat system (Hocoma AG Switzerland) in people with Spinal Cord Injury, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 9 inclusion and 7 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 12 May 2015. 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 Brazil. 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?
Walking Index for Spinal Cord Injury II (time frame: 6 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2015.