Spinal Cord InjuriesDENCT00127439
Effects of Robotic Versus Manually-Assisted Locomotor Training for Individuals With Incomplete Spinal Cord Injury
A study testing Manually Assisted Locomotor Training and Robotic Assisted Locomotor Training in people with Spinal Cord Injuries, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The purpose of this study is to collect data comparing two means of providing locomotor training: manual and robotic and the possible differential effects it may have on walking ability for persons with spinal cord injury (SCI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Manually Assisted Locomotor Training and Robotic Assisted Locomotor Training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Apr 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults at least 18 years of age
- Spinal cord injury (SCO) at least 6 months since injury
- Motor I-SCI, upper motor neuron lesion only at cervical or thoracic levels
- A diagnosis of first time SCI including etiology from trauma, vascular, or orthopedic pathology
- SCI as defined by the American ASIA Impairment Scale categories C or D
- Medically stable condition that is asymptomatic for bladder infection, decubiti, osteoporosis, cardiopulmonary disease, pain, contractures or other significant medical complications that would prohibit or interfere with testing of walking function and training or alter compliance with the training protocol
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- Documented medical approval from the participant's personal physician verifying the participant's medical status at time of enrollment
- Ability to walk a minimum of 30 feet with or without an assistive device, independently or with minimal assistance
- Over ground gait speed < 0.8 m/s
- Persons using anti-spasticity medication must maintain stable medication dosage during the study
- Able to give informed consent
Who cannot join
- Current participation in a rehabilitation program/research protocol that could interfere or influence the outcome measures of the current study
- History of congenital SCI (e.g. myelomeningocele, intraspinal neoplasm, Friedreich's ataxia) or other degenerative spinal disorders (e.g. spinocerebellar degeneration, syringomyelia) that may complicate the protocol
- Inappropriate or unsafe fit of the harness or robotic trainer due to the participant's body size and/or joint contractures or severe spasticity that would prohibit the safe provision of either training modality
Trial locations and contacts
1 site in 1 country.
United States1 site
North Florida/South Georgia Veterans Health System
Gainesville, Florida, 32608
About this study
Official title: Differential Effects of Robotic vs. Manually-Assisted Locomotor Training
The purpose of this study is to collect data comparing two means of providing locomotor training: manual and robotic and the possible differential effects it may have on walking ability for persons with spinal cord injury (SCI).
Read the detailed description
Spinal cord injury (SCI) is one of the most disabling health problems facing adults today, with one of the consequences often being inability to walk or difficulty walking. Recent studies suggest that intensive step training on a treadmill using body-weight support (BWS) and manual assistance that provides repetitive task-specific sensory cues to the neural axis can improve the recovery of walking for persons with incomplete SCI. More recently, robotics have been developed as an alternative to manually-assisted training. Robotic-assisted training may allow for increased intensity of training, improve the reproducibility and consistency of training, and reduce the personnel needed to implement the training. However, the effects of robotic-assisted training compared to manually-assisted training are not known. An improved understanding of these differential effects and the mechanisms of improvement in walking can facilitate continued advances in evidenced-based practice of neuro-rehabilitation, therefore improving the treatment of persons with SCI.
The primary objective of this project is to assess and compare the effects of robotic-assisted versus manually-assisted locomotor training (LT) using the body-weight support (BWS) on sub-tasks of walking. Specifically, we believe that at least four sub-tasks of walking are differentially affected by the robotic-assisted training when compared to manually-assisted training (propulsion, transition from stance to step, stepping, and equilibrium). The investigators hypothesize that robotic-assisted training will have a greater effect on improving propulsion, transition and equilibrium. The effect of these two modalities on adaptability, a fifth sub-task of walking, is unclear; therefore, a development component of the pilot project will involve establishing a quantitative measure of adaptability and assessing differential effects of training. Participants will be randomized to one of two training groups: robotic-assisted or manually-assisted, and evaluated for performance on sub-tasks of walking.
- Conditions
- Spinal Cord Injuries
- Being tested
- Manually Assisted Locomotor Training, Robotic Assisted Locomotor Training
- Keywords
- Ambulatory Disability, Disability Ambulation, Locomotion Disorders, Motor Activity, Rehabilitation, Spinal Cord Injury
- Medical subject headings
- Spinal Cord Injuries, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manually Assisted Locomotor TrainingProcedure or surgery
Also called manually assisted body-weight supported treadmill training
The total program is 45 sessions, 5x/week with total locomotor training (LT) duration of 30 stepping minutes/day. 1) BWS is initiated at 40% and gradually decreasing to 0%, 2) treadmill speed is set at normal walking speeds and increased as tolerated, and 3) manual assistance given when the subject is unable to independently step or control upright posture, and decreased as participant progresses. Trainers assist via verbal cues and manual assistance to achieve good stepping. The goal for endurance is 20 mins of continuous, independent, coordinated stepping on the treadmill at 0% BWS. Participants are encouraged to assist and/or independently maintain an upright posture, weight shift onto the loaded limb, flex or extend their legs, and to swing their arms in coordination with the legs.
Robotic Assisted Locomotor TrainingOther
Also called robotic assisted body-weight supported treadmill training
The total program is 45 sessions, 5x/week with total locomotor training (LT) duration of 30 stepping minutes/day. 1) BWS is initiated at 40% and gradually decreasing to 0%, 2) treadmill speed is set at normal walking speeds and increased as tolerated, and 3) manual assistance given when the subject is unable to independently step or control upright posture, and decreased as participant progresses. Trainers assist via verbal cues and manual assistance to achieve good stepping. The goal for endurance is 20 mins of continuous, independent, coordinated stepping on the treadmill at 0% BWS. Participants are encouraged to assist and/or independently maintain an upright posture, weight shift onto the loaded limb, flex or extend their legs, and to swing their arms in coordination with the legs.
| Study group | Role | What they receive |
|---|---|---|
| Robotic Assisted Locomotor Training | Experimental | A robotic stepping device in concert with a body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. The robotic device provides the appropriate kinematics associated with standing and stepping. Receives: Other: Robotic Assisted Locomotor Training |
| Manually Assisted Locomotor Training | Experimental | A body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. Therapists and trainers promote the appropriate kinematics associated with standing and stepping. Receives: Procedure: Manually Assisted Locomotor Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self Selected Velocity on Treadmill
Subjects walk on a treadmill with overhead safety mounted to laboratory ceiling while wearing a harness. Treadmill speeds adjusted to lower than overground walking speeds and adjusted to patient reaches a comfortable speed.
Measured: 12 weeks
Stepping: Foot Trajectory Toe-Off
Foot angle in a global reference frame at the start of swing phase during treadmill walking at self-selected speed. The kinematic outcomes were first standardized as deviations from control subjects who walk at similar speed (i.e., deviation from the control mean divided by SD among control). Stepping was quantified by the change in orientation of the foot angle (in a global reference frame) from the beginning to the end of the swing phase (i.e., foot-off to foot-down). The values will be identified from the processed 3-D kinematics for each walking cycle and average across steps.
Measured: 12 weeks
Stepping: Foot Trajectory Toe-off % Cycle
The outcome measure is the percentage of the gait cycle (%) for the occurrence of toe off. Foot trajectory toe-off was identified as indicated in the prior primary outcome (#2). The occurrence of toe-off was then identified relative to the percent of a complete gait cycle and thus the end point of the stance component of the gait cycle and the point of initiation for the swing component of the gait cycle. This outcome is reported in per cent of gait cycle.
Measured: 12 weeks
Foot Trajectory Initial Contact
Foot trajectory initial contact is the foot angle in a global reference frame at the end of swing (start of stance phase) during treadmill walking at self-selected speed when the foot contacts the ground (i.e. heel strike, foot contact, initial contact). The kinematic outcomes were first standardized as deviations from control subjects who walk at similar speed (i.e. deviation from the control mean divided by the SD among control). Foot trajectory initial contact (heel strike) was quantified by the orientation of the foot angle (in a global reference frame) at foot down (initial contact or heel strike). The values will be identified from the process 3-D kinematics for each walking cycle and averaged across steps. The outcome measurement is in degrees.
Measured: 12 weeks
Foot Trajectory Range (Toe Off to Heel Strike)
Range of foot trajectory from toe off to heel strike in degrees. The kinematic outcomes were first standardized as deviations from control subjects who walk at similar speed (i.e., deviation from the control mean divided by SD among control).
Measured: 12 weeks
Propulsion: Propulsive Impulse
Push-off force at toe off in N-s during treadmill stepping
Measured: 12 weeks
Kinematics: Minimum Thigh Angle
Greatest thigh angle for hip flexion during stepping
Measured: 12 weeks
Kinematics: Minimum Hip Angle - Extension
Hip angle at maximal hip extension during stepping
Measured: 12 weeks
Kinematics: Trunk Angle Mid-Stance
Trunk Angle Mid-Stance - position in degrees
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2005 (estimated)
- Study startJun 2005
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Andrea Behrman, PT PhD, Principal investigator, North Florida/South Georgia Veterans Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00127439
- Sponsor's protocol ID
- B4024-I
- Acronym
- DE
- Status last verified
- Jan 2018
- First submitted
- 3 Aug 2005
- Last updated
- 24 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Behrman AL, Harkema SJ. Locomotor training after human spinal cord injury: a series of case studies. Phys Ther. 2000 Jul;80(7):688-700.
PubMed 10869131Barbeau H, Norman K, Fung J, Visintin M, Ladouceur M. Does neurorehabilitation play a role in the recovery of walking in neurological populations? Ann N Y Acad Sci. 1998 Nov 16;860:377-92. doi: 10.1111/j.1749-6632.1998.tb09063.x.
PubMed 9928326Hesse S, Uhlenbrock D. A mechanized gait trainer for restoration of gait. J Rehabil Res Dev. 2000 Nov-Dec;37(6):701-8.
PubMed 11321006Colombo G, Joerg M, Schreier R, Dietz V. Treadmill training of paraplegic patients using a robotic orthosis. J Rehabil Res Dev. 2000 Nov-Dec;37(6):693-700.
PubMed 11321005Hornby TG, Zemon DH, Campbell D. Robotic-assisted, body-weight-supported treadmill training in individuals following motor incomplete spinal cord injury. Phys Ther. 2005 Jan;85(1):52-66.
PubMed 15623362Trimble MH, Behrman AL, Flynn SM, Thigpen MT, Thompson FJ. Acute effects of locomotor training on overground walking speed and H-reflex modulation in individuals with incomplete spinal cord injury. J Spinal Cord Med. 2001 Summer;24(2):74-80. doi: 10.1080/10790268.2001.11753558.
PubMed 11587422Day KV, Kautz SA, Wu SS, Suter SP, Behrman AL. Foot placement variability as a walking balance mechanism post-spinal cord injury. Clin Biomech (Bristol). 2012 Feb;27(2):145-50. doi: 10.1016/j.clinbiomech.2011.09.001. Epub 2011 Oct 14.
PubMed 22000699
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Effects of Robotic vs. Manually-Assisted Locomotor Training
- ClinicalTrials.gov ID
- NCT00127439
- Acronym / sponsor ID
- DE / B4024-I
- Conditions
- Spinal Cord Injuries
- Keywords
- Ambulatory Disability, Disability Ambulation, Locomotion Disorders, Motor Activity, Rehabilitation, Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Jun 2005
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 5 Aug 2005 (estimated)
- Results
- Posted 24 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to collect data comparing two means of providing locomotor training: manual and robotic and the possible differential effects it may have on walking ability for persons with spinal cord injury (SCI).
Detailed description
Spinal cord injury (SCI) is one of the most disabling health problems facing adults today, with one of the consequences often being inability to walk or difficulty walking. Recent studies suggest that intensive step training on a treadmill using body-weight support (BWS) and manual assistance that provides repetitive task-specific sensory cues to the neural axis can improve the recovery of walking for persons with incomplete SCI. More recently, robotics have been developed as an alternative to manually-assisted training. Robotic-assisted training may allow for increased intensity of training, improve the reproducibility and consistency of training, and reduce the personnel needed to implement the training. However, the effects of robotic-assisted training compared to manually-assisted training are not known. An improved understanding of these differential effects and the mechanisms of improvement in walking can facilitate continued advances in evidenced-based practice of neuro-rehabilitation, therefore improving the treatment of persons with SCI.
The primary objective of this project is to assess and compare the effects of robotic-assisted versus manually-assisted locomotor training (LT) using the body-weight support (BWS) on sub-tasks of walking. Specifically, we believe that at least four sub-tasks of walking are differentially affected by the robotic-assisted training when compared to manually-assisted training (propulsion, transition from stance to step, stepping, and equilibrium). The investigators hypothesize that robotic-assisted training will have a greater effect on improving propulsion, transition and equilibrium. The effect of these two modalities on adaptability, a fifth sub-task of walking, is unclear; therefore, a development component of the pilot project will involve establishing a quantitative measure of adaptability and assessing differential effects of training. Participants will be randomized to one of two training groups: robotic-assisted or manually-assisted, and evaluated for performance on sub-tasks of walking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic Assisted Locomotor Training | Experimental | Other: Robotic Assisted Locomotor TrainingA robotic stepping device in concert with a body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. The robotic device provides the appropriate kinematics associated with standing and stepping. |
| Manually Assisted Locomotor Training | Experimental | Procedure: Manually Assisted Locomotor TrainingA body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. Therapists and trainers promote the appropriate kinematics associated with standing and stepping. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adults at least 18 years of age
- Spinal cord injury (SCO) at least 6 months since injury
- Motor I-SCI, upper motor neuron lesion only at cervical or thoracic levels
- A diagnosis of first time SCI including etiology from trauma, vascular, or orthopedic pathology
- SCI as defined by the American ASIA Impairment Scale categories C or D
Key exclusion criteria (3 listed)
- Current participation in a rehabilitation program/research protocol that could interfere or influence the outcome measures of the current study
- History of congenital SCI (e.g. myelomeningocele, intraspinal neoplasm, Friedreich's ataxia) or other degenerative spinal disorders (e.g. spinocerebellar degeneration, syringomyelia) that may complicate the protocol
- Inappropriate or unsafe fit of the harness or robotic trainer due to the participant's body size and/or joint contractures or severe spasticity that would prohibit the safe provision of either training modality
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 |
|---|---|---|
| Manually Assisted Locomotor TrainingAlso: manually assisted body-weight supported treadmill trainingThe total program is 45 sessions, 5x/week with total locomotor training (LT) duration of 30 stepping minutes/day. 1) BWS is initiated at 40% and gradually decreasing to 0%, 2) treadmill speed is set at normal walking speeds and increased as tolerated, and 3) manual assistance given when the subject is unable to independently step or control upright posture, and decreased as participant progresses. Trainers assist via verbal cues and manual assistance to achieve good stepping. The goal for endurance is 20 mins of continuous, independent, coordinated stepping on the treadmill at 0% BWS. Participants are encouraged to assist and/or independently maintain an upright posture, weight shift onto the loaded limb, flex or extend their legs, and to swing their arms in coordination with the legs. | Procedure or surgery | Manually Assisted Locomotor Training |
| Robotic Assisted Locomotor TrainingAlso: robotic assisted body-weight supported treadmill trainingThe total program is 45 sessions, 5x/week with total locomotor training (LT) duration of 30 stepping minutes/day. 1) BWS is initiated at 40% and gradually decreasing to 0%, 2) treadmill speed is set at normal walking speeds and increased as tolerated, and 3) manual assistance given when the subject is unable to independently step or control upright posture, and decreased as participant progresses. Trainers assist via verbal cues and manual assistance to achieve good stepping. The goal for endurance is 20 mins of continuous, independent, coordinated stepping on the treadmill at 0% BWS. Participants are encouraged to assist and/or independently maintain an upright posture, weight shift onto the loaded limb, flex or extend their legs, and to swing their arms in coordination with the legs. | Other | Robotic Assisted Locomotor Training |
Primary outcome
Self Selected Velocity on Treadmill
Time frame: 12 weeks
Subjects walk on a treadmill with overhead safety mounted to laboratory ceiling while wearing a harness. Treadmill speeds adjusted to lower than overground walking speeds and adjusted to patient reaches a comfortable speed.
Stepping: Foot Trajectory Toe-Off
Time frame: 12 weeks
Foot angle in a global reference frame at the start of swing phase during treadmill walking at self-selected speed. The kinematic outcomes were first standardized as deviations from control subjects who walk at similar speed (i.e., deviation from the control mean divided by SD among control). Stepping was quantified by the change in orientation of the foot angle (in a global reference frame) from the beginning to the end of the swing phase (i.e., foot-off to foot-down). The values will be identified from the processed 3-D kinematics for each walking cycle and average across steps.
Stepping: Foot Trajectory Toe-off % Cycle
Time frame: 12 weeks
The outcome measure is the percentage of the gait cycle (%) for the occurrence of toe off. Foot trajectory toe-off was identified as indicated in the prior primary outcome (#2). The occurrence of toe-off was then identified relative to the percent of a complete gait cycle and thus the end point of the stance component of the gait cycle and the point of initiation for the swing component of the gait cycle. This outcome is reported in per cent of gait cycle.
Foot Trajectory Initial Contact
Time frame: 12 weeks
Foot trajectory initial contact is the foot angle in a global reference frame at the end of swing (start of stance phase) during treadmill walking at self-selected speed when the foot contacts the ground (i.e. heel strike, foot contact, initial contact). The kinematic outcomes were first standardized as deviations from control subjects who walk at similar speed (i.e. deviation from the control mean divided by the SD among control). Foot trajectory initial contact (heel strike) was quantified by the orientation of the foot angle (in a global reference frame) at foot down (initial contact or heel strike). The values will be identified from the process 3-D kinematics for each walking cycle and averaged across steps. The outcome measurement is in degrees.
Foot Trajectory Range (Toe Off to Heel Strike)
Time frame: 12 weeks
Range of foot trajectory from toe off to heel strike in degrees. The kinematic outcomes were first standardized as deviations from control subjects who walk at similar speed (i.e., deviation from the control mean divided by SD among control).
Propulsion: Propulsive Impulse
Time frame: 12 weeks
Push-off force at toe off in N-s during treadmill stepping
Kinematics: Minimum Thigh Angle
Time frame: 12 weeks
Greatest thigh angle for hip flexion during stepping
Kinematics: Minimum Hip Angle - Extension
Time frame: 12 weeks
Hip angle at maximal hip extension during stepping
Kinematics: Trunk Angle Mid-Stance
Time frame: 12 weeks
Trunk Angle Mid-Stance - position in degrees
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10869131Behrman AL, Harkema SJ. Locomotor training after human spinal cord injury: a series of case studies. Phys Ther. 2000 Jul;80(7):688-700.
- Background: PubMed 9928326Barbeau H, Norman K, Fung J, Visintin M, Ladouceur M. Does neurorehabilitation play a role in the recovery of walking in neurological populations? Ann N Y Acad Sci. 1998 Nov 16;860:377-92. doi: 10.1111/j.1749-6632.1998.tb09063.x.
- Background: PubMed 11321006Hesse S, Uhlenbrock D. A mechanized gait trainer for restoration of gait. J Rehabil Res Dev. 2000 Nov-Dec;37(6):701-8.
- Background: PubMed 11321005Colombo G, Joerg M, Schreier R, Dietz V. Treadmill training of paraplegic patients using a robotic orthosis. J Rehabil Res Dev. 2000 Nov-Dec;37(6):693-700.
- Background: PubMed 15623362Hornby TG, Zemon DH, Campbell D. Robotic-assisted, body-weight-supported treadmill training in individuals following motor incomplete spinal cord injury. Phys Ther. 2005 Jan;85(1):52-66.
- Background: PubMed 11587422Trimble MH, Behrman AL, Flynn SM, Thigpen MT, Thompson FJ. Acute effects of locomotor training on overground walking speed and H-reflex modulation in individuals with incomplete spinal cord injury. J Spinal Cord Med. 2001 Summer;24(2):74-80. doi: 10.1080/10790268.2001.11753558.
- Results publication: PubMed 22000699Day KV, Kautz SA, Wu SS, Suter SP, Behrman AL. Foot placement variability as a walking balance mechanism post-spinal cord injury. Clin Biomech (Bristol). 2012 Feb;27(2):145-50. doi: 10.1016/j.clinbiomech.2011.09.001. Epub 2011 Oct 14.
- Click here for more information about this study: Differential Effects of Robotic vs. Manually-Assisted Locomotor TrainingLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Andrea Behrman, PT PhD principal investigator
North Florida/South Georgia Veterans Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manually Assisted Locomotor Training and Robotic Assisted Locomotor Training in people with Spinal Cord Injuries, run by VA Office of Research and Development at 1 site in United States.
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 11 inclusion and 3 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 24 Jan 2018. 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 United States. 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?
Yes. Results are posted in the registry (first posted 24 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Self Selected Velocity on Treadmill (time frame: 12 weeks). The study lists 9 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 NCT00127439, which also lists 7 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 24 Jan 2018.