Spinal Cord InjuryNCT02324322
Non-Ambulatory SCI Walk Using a Robotic Exoskeleton: Effect on Bone and Muscle
A study testing Exoskeleton Training, Muscle Biopsies and MRI in people with Spinal Cord Injury, run by Kessler Foundation at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate an exoskeleton device and mobility skills in the device. Read more about this study
- Who is it for?
- Ages 21 to 45 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Exoskeleton Training, Muscle Biopsies and MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Mar 2018
- 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 21 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Must be a non walker with a SCI greater than 1 year post injury
- Must have a neurological level between the C6-T10 level
- Must have a lower extremity score greater than 1 as defined by the neurological exam
- Must be between 21 and 45 years old
- Must be wheelchair reliant 100% of time
- Must have knee bone mineral density greater than .5755 gm/cm2 as determined by study staff
Show all 18Show fewer
- Must have a score on the Modified Ashworth Scale equal to or less than 3 as determined by the study staff
- Must be able to tolerate upright standing for up to 30 minutes
- Must have joint range of motion within normal functional limits for ambulation
- Must have sufficient upper body strength to balance using the walker while wearing the exoskeleton
- Must have a height between 62 inches or 74 inches
- Must weigh less than 220 lbs,(limitation of the devices)
- Must have no joint tightening of any extremity that limits movement during walking with the assistive devices
- Must have no medical issue that precludes full weight bearing, ambulation or exercise intolerance in the exoskeleton (e.g. orthopedic injuries, pain, severe spasticity)
- Must have no skin issues (e.g. pressure sores) that would prevent wearing the device
- Must have no memory and/or thinking disability (e.g. due to brain injury)
- Must be able to follow directions well and demonstrate learning capability
- Must be able to physically fit into the exoskeletal device
Who cannot join
- A woman who is pregnant, lactating, or post-menopausal
- Wearing an external device that supports the spinal column or the head, neck, or trunk
- Have persistent orthostatic hypotension (blood pressure drop of more than 30 millimeters of Mercury in robotic system)
- Have had a hospitalization for heart attack, heart surgery or acute heart failure within 3 months of enrollment in study or no presence of major cardiovascular or pulmonary disease, lower extremity deep vein thrombosis (within the last three months)
- Have been taking any medications known to influence bone metabolism
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kessler Foundation
West Orange, New Jersey, 07052
Gail F Forrest, Ph.D, 973-324-3518, gforrest@kesslerfoundation.org
About this study
The purpose of this research study is to evaluate an exoskeleton device and mobility skills in the device.
Read the detailed description
Currently, the treatment of muscle and bone deterioration after SCI is very limited; therefore, there is a definite need to further understand the mechanism of breakdown in the musculoskeletal system after a SCI, and, more importantly, find a clinical strategy that will treat muscle and bone loss.
This pilot research grant will collect results that will be used for the design of a multi-site randomized controlled clinical trial to determine whether a Robotic Exoskeleton training [100 sessions; 1hr/session; 4-5 sessions/week] can improve musculoskeletal outcomes more than other current interventions. If the overall objective is to use the progression of technology to enhance functional ambulation for persons with a spinal cord injury, then the investigators need to evaluate the health benefits associated with continual use of the device.
The study will be a prospective, single-group, repeated measure design using a 2 -month lead in to establish stability, 5-month intervention phase and 2 -month follow-up phase for retention will be performed. Each participant will be used as his or her own control. This project will be completed at two sites: Kessler Foundation will be the lead site that will be under the direction of Dr. Gail F Forrest (Principal Investigator) and Spinal Cord Damage Research Center, James J Peters VA Medical Center under the direction of Dr. Ann M. Spungen (collaborator). Both sites have exoskeletal-assisted walking programs.
- Conditions
- Spinal Cord Injury
- Being tested
- Exoskeleton Training, Muscle Biopsies, MRI
- Keywords
- Device: Robotic Exoskeleton
- 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.
Exoskeleton TrainingDevice
Also called Ekso
Exoskeleton Training (100 sessions - 1 hour, 4 - 5 sessions per week for 20 weeks) to enhance functional ambulation for persons with a spinal cord injury. To examine the effectiveness of exoskeleton assisted overground walking to induce positive changes in muscle volume and structure of the lower limbs for non-ambulatory persons with SCI.
Muscle BiopsiesOther
Also called Needle Biopsies
Needle Biopsies for Quadricep Muscles will be performed to define changes in BMD and Bone structure with intensive exoskeleton assisted walking. This procedure includes having a trained physician make a small skin incision, after numbing the area over the muscle, and then removing a tiny sliver of muscle to study under the microscope. Three separate biopsies for one incision will be obtained. The biopsies will be performed at baseline, 7 days, and after the intervention.
To define changes in biochemical markers of bone metabolism with intensive exoskeleton-assisted walking.
MRIOther
MRI's will provide accurate assessments of muscle CSA of each lower limb (from above the origin of the iliopsoas to the insertion of the achilles tendon) to determine individual's muscle thigh and shank volume.
| Study group | Role | What they receive |
|---|---|---|
| Exoskeleton training | Experimental | To examine the effectiveness of robotic exoskeleton-assisted over ground walking (5 hrs. p/wk, 100 sessions, 20 wks = 100 hrs) to induce positive changes in muscle volume and structure of the lower limbs for non-ambulatory persons with SCI. Combined with our current training protocol where people step 1500-2000/session we predict that the 2,000 lower extremity muscle contractions will be sufficient in our proposed exoskeletal study.
MRI's will be performed to accurately assess muscle CSA of each lower limb to determine individual's muscle thigh and shank volume.
Muscle Biopsies for the quadricep muscle will be performed to determine changes in BMD and bone structure due to intensive exoskeleton assisted walking. Receives: Device: Exoskeleton Training; Other: Muscle Biopsies; Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bilateral Muscle Volume (surrogate for strength)for thigh and shank will be the primary outcome measurement.
To examine the effectiveness of exoskeleton assisted overground walking (5 hours per week, 100 sessions, 20 weeks = 100 hours) to induce positive changes in muscle volume and structure of the lower limbs for non-ambulatory persons with SCI.
Measured: 100 hours
Secondary outcomes (1)
Muscle Activation
To examine the effect of exoskeletal assisted walking for 100 sessions in increasing further muscle volume through muscle activation to increase muscle size and strength and mitigate the secondary complications that follow SCI.
Measured: 100 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startOct 2013
- Primary completionDec 2017 (estimated)
- Study completionMar 2018 (estimated)
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.
- 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
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- New Jersey Commission on Spinal Cord Research
- Responsible party
- Principal investigator, Gail Forrest, Kessler Foundation
- Investigators
- Gail F Forrest, PhD, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02324322
- Sponsor's protocol ID
- CSCR131RG013
- Status last verified
- Mar 2017
- First submitted
- 3 Dec 2014
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Ambulatory SCI Walk Using a Robotic Exoskeleton: Effect on Bone and Muscle
- ClinicalTrials.gov ID
- NCT02324322
- Acronym / sponsor ID
- CSCR131RG013
- Conditions
- Spinal Cord Injury
- Keywords
- Device: Robotic Exoskeleton
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- New Jersey Commission on Spinal Cord Research
- Study start
- Oct 2013
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 24 Dec 2014 (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 research study is to evaluate an exoskeleton device and mobility skills in the device.
Detailed description
Currently, the treatment of muscle and bone deterioration after SCI is very limited; therefore, there is a definite need to further understand the mechanism of breakdown in the musculoskeletal system after a SCI, and, more importantly, find a clinical strategy that will treat muscle and bone loss.
This pilot research grant will collect results that will be used for the design of a multi-site randomized controlled clinical trial to determine whether a Robotic Exoskeleton training [100 sessions; 1hr/session; 4-5 sessions/week] can improve musculoskeletal outcomes more than other current interventions. If the overall objective is to use the progression of technology to enhance functional ambulation for persons with a spinal cord injury, then the investigators need to evaluate the health benefits associated with continual use of the device.
The study will be a prospective, single-group, repeated measure design using a 2 -month lead in to establish stability, 5-month intervention phase and 2 -month follow-up phase for retention will be performed. Each participant will be used as his or her own control. This project will be completed at two sites: Kessler Foundation will be the lead site that will be under the direction of Dr. Gail F Forrest (Principal Investigator) and Spinal Cord Damage Research Center, James J Peters VA Medical Center under the direction of Dr. Ann M. Spungen (collaborator). Both sites have exoskeletal-assisted walking programs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exoskeleton training | Experimental | Device: Exoskeleton Training, Other: Muscle Biopsies, Other: MRITo examine the effectiveness of robotic exoskeleton-assisted over ground walking (5 hrs. p/wk, 100 sessions, 20 wks = 100 hrs) to induce positive changes in muscle volume and structure of the lower limbs for non-ambulatory persons with SCI. Combined with our current training protocol where people step 1500-2000/session we predict that the 2,000 lower extremity muscle contractions will be sufficient in our proposed exoskeletal study. MRI's will be performed to accurately assess muscle CSA of each lower limb to determine individual's muscle thigh and shank volume. Muscle Biopsies for the quadricep muscle will be performed to determine changes in BMD and bone structure due to intensive exoskeleton assisted walking. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Must be a non walker with a SCI greater than 1 year post injury
- Must have a neurological level between the C6-T10 level
- Must have a lower extremity score greater than 1 as defined by the neurological exam
- Must be between 21 and 45 years old
- Must be wheelchair reliant 100% of time
Key exclusion criteria (5 listed)
- A woman who is pregnant, lactating, or post-menopausal
- Wearing an external device that supports the spinal column or the head, neck, or trunk
- Have persistent orthostatic hypotension (blood pressure drop of more than 30 millimeters of Mercury in robotic system)
- Have had a hospitalization for heart attack, heart surgery or acute heart failure within 3 months of enrollment in study or no presence of major cardiovascular or pulmonary disease, lower extremity deep vein thrombosis (within the last three months)
- Have been taking any medications known to influence bone metabolism
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 |
|---|---|---|
| Exoskeleton TrainingAlso: EksoExoskeleton Training (100 sessions - 1 hour, 4 - 5 sessions per week for 20 weeks) to enhance functional ambulation for persons with a spinal cord injury. To examine the effectiveness of exoskeleton assisted overground walking to induce positive changes in muscle volume and structure of the lower limbs for non-ambulatory persons with SCI. | Device | Exoskeleton training |
| Muscle BiopsiesAlso: Needle BiopsiesNeedle Biopsies for Quadricep Muscles will be performed to define changes in BMD and Bone structure with intensive exoskeleton assisted walking. This procedure includes having a trained physician make a small skin incision, after numbing the area over the muscle, and then removing a tiny sliver of muscle to study under the microscope. Three separate biopsies for one incision will be obtained. The biopsies will be performed at baseline, 7 days, and after the intervention. To define changes in biochemical markers of bone metabolism with intensive exoskeleton-assisted walking. | Other | Exoskeleton training |
| MRIMRI's will provide accurate assessments of muscle CSA of each lower limb (from above the origin of the iliopsoas to the insertion of the achilles tendon) to determine individual's muscle thigh and shank volume. | Other | Exoskeleton training |
Primary outcome
Bilateral Muscle Volume (surrogate for strength)for thigh and shank will be the primary outcome measurement.
Time frame: 100 hours
To examine the effectiveness of exoskeleton assisted overground walking (5 hours per week, 100 sessions, 20 weeks = 100 hours) to induce positive changes in muscle volume and structure of the lower limbs for non-ambulatory persons with SCI.
1 secondary outcome
Muscle Activation
Time frame: 100 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
- Individual participant dataSharing planned: Yes
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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.
Gail F Forrest, PhD principal investigator
Kessler Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exoskeleton Training, Muscle Biopsies and MRI in people with Spinal Cord Injury, run by Kessler Foundation 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 18 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 22 Mar 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gail F Forrest, PhD (973-324-3518 ext. 3518, gforrest@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bilateral Muscle Volume (surrogate for strength)for thigh and shank will be the primary outcome measurement. (time frame: 100 hours). 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 22 Mar 2017.