Spinal Cord InjuriesPhase 1NCT02803255
AAN Robotic Therapy in SCI
A Phase 1 study testing MAHI Exo-II in people with Spinal Cord Injuries, run by William Marsh Rice University at 2 sites in United States.
Trial summary
The purpose of this study is to demonstrate that a robot-aided rehabilitation protocol that follows the "assist-as needed" paradigm provide statistically significant improvements in arm and hand motor functions when compared to robot-aided protocols that passively move patients' arms along pre-defined trajectories, in… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- MAHI Exo-II
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2014to Sep 2015
- Phase
- Phase 1
- 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
Who may be able to join
- Providing written informed consent prior to any study related procedures;
- Age between 18-75 years;
- Diagnosis of chronic complete or incomplete spinal cord injury as defined by the American Spinal Injury Association Impairment scale classification and at least for 6 months;
- Not being involved in any specific exercise program (e.g., NMES, FES) within the previous 3 months;
- No planned alteration in upper-extremity therapy or medication for muscle tone during the course of the study;
- Eligibility for standard rehabilitation at the time of enrollment (i.e., absence medical comorbidities that would prevent standard rehabilitation);
- No condition (e.g., severe arthritis, extreme shoulder pain) that would interfere with valid administration of the measures or with interpreting motor testing;
Who cannot join
- Any joint contracture or severe spasticity in the affected upper extremity, as measured by a Modified Ashworth Score > than 3 out of 4;
- Subject who cannot provide self-transportation to the study location.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rice University
Houston, Texas, 77005
TIRR Memorial Hermann
Houston, Texas, 77030
About this study
Official title: Effect of Assist-as-needed Robot Aided Rehabilitation Strategies in Subjects With Incomplete Spinal Cord Injury
The purpose of this study is to demonstrate that a robot-aided rehabilitation protocol that follows the "assist-as needed" paradigm provide statistically significant improvements in arm and hand motor functions when compared to robot-aided protocols that passively move patients' arms along pre-defined trajectories, in patients with incomplete spinal cord injury (SCI).
- Conditions
- Spinal Cord Injuries
- Being tested
- MAHI Exo-II
- Keywords
- Injuries, Spinal Cord
- Medical subject headings
- Spinal Cord Injuries, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAHI Exo-IIDevice
Also called Robot-aided movement therapy
| Study group | Role | What they receive |
|---|---|---|
| Assist-As-Needed Control | Experimental | Subjects in this group will interact with a robotic exoskeleton, the MAHI Exo-II, programmed with an "adaptive mode". In this mode, the robot will continuously assist motion along pre-defined trajectories, but will employ an "assist-as-needed" protocol.
Here, the amount of assistance provided by the robot will not be always the 100% of that required to complete the task (as in the position control mode), but only a fraction of it. The robot will continuously estimate the residual movement capabilities of the subject, depending on the specific joint addressed in the movement, and will estimate the remaining contribution needed to complete the movement following a predefined trajectory, thus avoiding to over-support motion. Receives: Device: MAHI Exo-II |
| Subject-Triggered Control | Active comparator | Subjects in group B will interact with a robotic exoskeleton, the MAHI Exo-II, controlled via the subject-triggered mode, as in a previous clinical trial with the MAHI Exo II robotic system. In the subject triggered mode, the MAHIExo II is commanded to regulate joints motion following a position-control control scheme, and using as desired trajectories standardized single-joints profiles that require motion of one of the axes of the exoskeleton (i.e. elbow flexion and extension, forearm pronation and supination, wrist radial and ulnar deviation, wrist flexion and extension). The switch to position control of the exoskeleton is triggered by the application of sufficient force by the subject, in a previous phase where the robot implements a virtual wall. Receives: Device: MAHI Exo-II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ARAT score
Measured: Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
Secondary outcomes (5)
Change in Modified Ashworth Scale
Measured: Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
Change in Grip Pinch Strength Assessment
Measured: Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
Change in Graded Redefined Assessment of Strength, Sensibility and Prehension
Measured: Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
Change in Smoothness metrics
Measured via analysis of point-to-point reaching movements performed with the robot. Extracted measures include the movement-arrest-period-ratio, the spectral arc length, and the normalized average speed
Measured: Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
Change in smoothness metrics
Measured via analysis of point-to-point reaching movements performed with the robot. Extracted measures include the movement-arrest-period-ratio, the spectral arc length, and the normalized average speed
Measured: Difference between values measured i) treatment start day and ii) session 10 of the therapy program - 2-4 weeks after treatment start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startMay 2014
- Primary completionSep 2015
- Study completionSep 2015
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 Spinal Cord InjuriesStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- William Marsh Rice University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcia K. O'Malley, PhD, Principal investigator, William Marsh Rice University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02803255
- Sponsor's protocol ID
- 14-027F
- Status last verified
- May 2016
- First submitted
- 25 May 2016
- Last updated
- 16 Jun 2016
- Results posted
- No
Publications
Frullo JM, Elinger J, Pehlivan AU, Fitle K, Nedley K, Francisco GE, Sergi F, O'Malley MK. Effects of Assist-As-Needed Upper Extremity Robotic Therapy after Incomplete Spinal Cord Injury: A Parallel-Group Controlled Trial. Front Neurorobot. 2017 Jun 13;11:26. doi: 10.3389/fnbot.2017.00026. eCollection 2017.
PubMed 28659784
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Assist-as-needed Robot Aided Rehabilitation Strategies in Subjects With Incomplete Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02803255
- Acronym / sponsor ID
- 14-027F
- Conditions
- Spinal Cord Injuries
- Keywords
- Injuries, Spinal Cord
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- William Marsh Rice UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 16 Jun 2016 (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.
The purpose of this study is to demonstrate that a robot-aided rehabilitation protocol that follows the "assist-as needed" paradigm provide statistically significant improvements in arm and hand motor functions when compared to robot-aided protocols that passively move patients' arms along pre-defined trajectories, in patients with incomplete spinal cord injury (SCI).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Assist-As-Needed Control | Experimental | Device: MAHI Exo-IISubjects in this group will interact with a robotic exoskeleton, the MAHI Exo-II, programmed with an "adaptive mode". In this mode, the robot will continuously assist motion along pre-defined trajectories, but will employ an "assist-as-needed" protocol. Here, the amount of assistance provided by the robot will not be always the 100% of that required to complete the task (as in the position control mode), but only a fraction of it. The robot will continuously estimate the residual movement capabilities of the subject, depending on the specific joint addressed in the movement, and will estimate the remaining contribution needed to complete the movement following a predefined trajectory, thus avoiding to over-support motion. |
| Subject-Triggered Control | Active comparator | Device: MAHI Exo-IISubjects in group B will interact with a robotic exoskeleton, the MAHI Exo-II, controlled via the subject-triggered mode, as in a previous clinical trial with the MAHI Exo II robotic system. In the subject triggered mode, the MAHIExo II is commanded to regulate joints motion following a position-control control scheme, and using as desired trajectories standardized single-joints profiles that require motion of one of the axes of the exoskeleton (i.e. elbow flexion and extension, forearm pronation and supination, wrist radial and ulnar deviation, wrist flexion and extension). The switch to position control of the exoskeleton is triggered by the application of sufficient force by the subject, in a previous phase where the robot implements a virtual wall. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Providing written informed consent prior to any study related procedures;
- Age between 18-75 years;
- Diagnosis of chronic complete or incomplete spinal cord injury as defined by the American Spinal Injury Association Impairment scale classification and at least for 6 months;
- Not being involved in any specific exercise program (e.g., NMES, FES) within the previous 3 months;
- No planned alteration in upper-extremity therapy or medication for muscle tone during the course of the study;
Key exclusion criteria (2 listed)
- Any joint contracture or severe spasticity in the affected upper extremity, as measured by a Modified Ashworth Score > than 3 out of 4;
- Subject who cannot provide self-transportation to the study location.
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 |
|---|---|---|
| MAHI Exo-IIAlso: Robot-aided movement therapy | Device | Assist-As-Needed Control, Subject-Triggered Control |
Primary outcome
Change in ARAT score
Time frame: Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
5 secondary outcomes
Change in Modified Ashworth Scale
Time frame: Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
Change in Grip Pinch Strength Assessment
Time frame: Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
Change in Graded Redefined Assessment of Strength, Sensibility and Prehension
Time frame: Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
Change in Smoothness metrics
Time frame: Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
Change in smoothness metrics
Time frame: Difference between values measured i) treatment start day and ii) session 10 of the therapy program - 2-4 weeks after treatment start
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 16 Jun 2016.
- Derived from this study: PubMed 28659784Frullo JM, Elinger J, Pehlivan AU, Fitle K, Nedley K, Francisco GE, Sergi F, O'Malley MK. Effects of Assist-As-Needed Upper Extremity Robotic Therapy after Incomplete Spinal Cord Injury: A Parallel-Group Controlled Trial. Front Neurorobot. 2017 Jun 13;11:26. doi: 10.3389/fnbot.2017.00026. eCollection 2017.
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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.
Marcia K. O'Malley, PhD principal investigator
William Marsh Rice University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MAHI Exo-II in people with Spinal Cord Injuries, run by William Marsh Rice University at 2 sites 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 7 inclusion and 2 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 16 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in ARAT score (time frame: Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program). 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 NCT02803255, 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 16 Jun 2016.