Spinal Cord InjuriesNCT03548649
The Efficacy and Safety of a New Power Exoskeleton Robot for Improving Walking Ability in Spinal Cord Injury Patients
A study testing exoskeleton robot training in people with Spinal Cord Injuries and Complete Spinal Cord Injury, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
In Taiwan, there are more than 23,000 individuals with spinal cord injuries (SCI, mean age: 27 years), with an increment of new 1,200 SCI individuals each year. Recovery of ambulatory function is among the most important therapeutic goals because 92% of the individuals with SCI have to use the wheelchair for the rest… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injuries, Complete Spinal Cord Injury, Incomplete Spinal Cord Injury
- What is being tested?
- exoskeleton robot training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Aug 2017to 31 Dec 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Spinal cord injury patients whose injury levels range from C7 to L5, ASIA impairment scale A to D, can use forearm crutch and can't walk without an assistive device.
- In a stable condition, for example, at least 3 months after first injury/onset, or with stable spine, or had been corrected (internal fixation).
- Age between 18-70.
- height between 150-190cm; weight less than 100kg; thigh length between 32-47cm; leg length (from lateral epicondyle of femur to sole) between 23-59cm.
- Normal joint range of motion(ROM) of both lower extremities and upper extremities or ROM limitation will not affect ambulation.
- Can maintain trunk stability with or without hand support in sitting position for 60s.
Who cannot join
- Combine other neurological diseases, for example, stroke, cerebral palsy, Parkinson's disease,... etc.
- Femoral T-score <-2.5. (Doctor's approval must be obtained for those who with femoral t-score between -2.5 and -3).
- Other medical conditions which will affect weight bearing or ambulation.
- Medical history including fracture(due to osteoporosis in the past 2 years), heart failure, myocardial infarction.
- Skin conditions including allergy, pressure sore, infection, ...etc.
- Impaired mental or cognitive conditions that will affect training or evaluation.
Show all 12Show fewer
- Severe contracture or limited joint range of motion of lower extremities.
- Severe spasticity which will impede the movement of exoskeleton robot.
- Heterotopic ossification.
- non-union fracture or open wound.
- pregnancy.
- other conditions that is not applicable for use the exoskeleton robot.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Research for Exoskeleton Robot
In Taiwan, there are more than 23,000 individuals with spinal cord injuries (SCI, mean age: 27 years), with an increment of new 1,200 SCI individuals each year. Recovery of ambulatory function is among the most important therapeutic goals because 92% of the individuals with SCI have to use the wheelchair for the rest of their lives.
The lower limb powered exoskeleton robot, FREE Walk, used for training in this research was developed by FREE Bionics Inc. The main purpose of this research is to test the safety and feasibility of FREE Walk exoskeleton robot. In addition, the research will further investigate the range of injury levels for the intended SCI users and the learning time needed for the users to independently operate the exoskeleton robot.
Read the detailed description
Individuals with SCI who meet the inclusion criteria will be referred to the investigators. Participants will be given consent forms and explained the research before participating. The participants must pass the initial evaluation described below in order to go through robot training: (1) medical history, (2) bone density, (3) joint range of motion, ROM (4) strength (manual muscle test, MMT), (5) muscle tone (modified Ashworth scale, MAS).
The training program consists of 5-min preparation, 50-min of functional activities training including weight shifting, sit-down, stand-up, stepping and walking, and 5-min training feedback. Every participant will receive at least 20 training sessions (1 hour per session, 2-5 sessions per week) and an post-training evaluation after completion of training. The post-training evaluation includes the following tests: timed up-and-go test, 10-meter walk test, and 6-minute walk test.
- Being tested
- exoskeleton robot training
- Keywords
- spinal cord injury, complete spinal cord injury, incomplete spinal cord injury, exoskeleton robot, gait training, security testing, functional testing
- 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 robot trainingDevice
Also called gait training
subjects will learn to independently use the exoskeleton robot to perform functional activities (including stand-up, sit-down, stepping forward, and walking).
| Study group | Role | What they receive |
|---|---|---|
| exoskeleton robot training group | Experimental | subjects will receive exoskeleton robot training for 20 sessions (1 hr/session). Receives: Device: exoskeleton robot training |
What is being measured
The primary outcome is the main question the study is designed to answer.
10 meters walking test
Subjects walk with exoskeleton for 10 metres, with the time measured for the intermediate 6 metres to allow for acceleration and deceleration.
Measured: Test will be held before starting the first training session and after completing 20 training sessions.(1 hour per session)
Secondary outcomes (2)
timed up-and-go test
Record the time needed to perform timed up-and-go test wearing exoskeleton robot
Measured: Test will be held before starting the first training session and after completing 20 training sessions.(1 hour per session)
6-minutes walking test
Record the distance covered to perform 6-min walk test wearing exoskeleton robot. Rate of Perceived Exertion will be recorded at the end of the 6-min walk test to evaluate users' endurance.
Measured: Test will be held before starting the first training session and after completing 20 training sessions.(1 hour per session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2018
- Study start30 Aug 2017
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 Taipei Veterans General Hospital, TaiwanThe 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
- Model description
- AIS A-D SCI patients with injury level C7-L5
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Collaborators
- The Industrial Technology Research Institute
- Responsible party
- Sponsor
- Investigators
- Yun-An Tsai, MD, Study chair, 0938-592-575
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03548649
- Sponsor's protocol ID
- 2017-03-012C
- Status last verified
- Jun 2018
- First submitted
- 5 Aug 2017
- Last updated
- 7 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.
PubMed 1991946van Hedel HJ, Wirz M, Dietz V. Assessing walking ability in subjects with spinal cord injury: validity and reliability of 3 walking tests. Arch Phys Med Rehabil. 2005 Feb;86(2):190-6. doi: 10.1016/j.apmr.2004.02.010.
PubMed 15706542Harada ND, Chiu V, Stewart AL. Mobility-related function in older adults: assessment with a 6-minute walk test. Arch Phys Med Rehabil. 1999 Jul;80(7):837-41. doi: 10.1016/s0003-9993(99)90236-8.
PubMed 10414771
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research for Exoskeleton Robot
- ClinicalTrials.gov ID
- NCT03548649
- Acronym / sponsor ID
- 2017-03-012C
- Keywords
- spinal cord injury, complete spinal cord injury, incomplete spinal cord injury, exoskeleton robot, gait training, security testing, functional testing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Collaborators
- The Industrial Technology Research Institute
- Study start
- 30 Aug 2017 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 7 Jun 2018 (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.
In Taiwan, there are more than 23,000 individuals with spinal cord injuries (SCI, mean age: 27 years), with an increment of new 1,200 SCI individuals each year. Recovery of ambulatory function is among the most important therapeutic goals because 92% of the individuals with SCI have to use the wheelchair for the rest of their lives.
The lower limb powered exoskeleton robot, FREE Walk, used for training in this research was developed by FREE Bionics Inc. The main purpose of this research is to test the safety and feasibility of FREE Walk exoskeleton robot. In addition, the research will further investigate the range of injury levels for the intended SCI users and the learning time needed for the users to independently operate the exoskeleton robot.
Detailed description
Individuals with SCI who meet the inclusion criteria will be referred to the investigators. Participants will be given consent forms and explained the research before participating. The participants must pass the initial evaluation described below in order to go through robot training: (1) medical history, (2) bone density, (3) joint range of motion, ROM (4) strength (manual muscle test, MMT), (5) muscle tone (modified Ashworth scale, MAS).
The training program consists of 5-min preparation, 50-min of functional activities training including weight shifting, sit-down, stand-up, stepping and walking, and 5-min training feedback. Every participant will receive at least 20 training sessions (1 hour per session, 2-5 sessions per week) and an post-training evaluation after completion of training. The post-training evaluation includes the following tests: timed up-and-go test, 10-meter walk test, and 6-minute walk test.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- AIS A-D SCI patients with injury level C7-L5
| Arm | Type | Receives |
|---|---|---|
| exoskeleton robot training group | Experimental | Device: exoskeleton robot trainingsubjects will receive exoskeleton robot training for 20 sessions (1 hr/session). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Spinal cord injury patients whose injury levels range from C7 to L5, ASIA impairment scale A to D, can use forearm crutch and can't walk without an assistive device.
- In a stable condition, for example, at least 3 months after first injury/onset, or with stable spine, or had been corrected (internal fixation).
- Age between 18-70.
- height between 150-190cm; weight less than 100kg; thigh length between 32-47cm; leg length (from lateral epicondyle of femur to sole) between 23-59cm.
- Normal joint range of motion(ROM) of both lower extremities and upper extremities or ROM limitation will not affect ambulation.
Key exclusion criteria (12 listed)
- Combine other neurological diseases, for example, stroke, cerebral palsy, Parkinson's disease,... etc.
- Femoral T-score <-2.5. (Doctor's approval must be obtained for those who with femoral t-score between -2.5 and -3).
- Other medical conditions which will affect weight bearing or ambulation.
- Medical history including fracture(due to osteoporosis in the past 2 years), heart failure, myocardial infarction.
- Skin conditions including allergy, pressure sore, infection, ...etc.
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 robot trainingAlso: gait trainingsubjects will learn to independently use the exoskeleton robot to perform functional activities (including stand-up, sit-down, stepping forward, and walking). | Device | exoskeleton robot training group |
Primary outcome
10 meters walking test
Time frame: Test will be held before starting the first training session and after completing 20 training sessions.(1 hour per session)
Subjects walk with exoskeleton for 10 metres, with the time measured for the intermediate 6 metres to allow for acceleration and deceleration.
2 secondary outcomes
timed up-and-go test
Time frame: Test will be held before starting the first training session and after completing 20 training sessions.(1 hour per session)
6-minutes walking test
Time frame: Test will be held before starting the first training session and after completing 20 training sessions.(1 hour per session)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2018.
- Background: PubMed 1991946Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.
- Background: PubMed 15706542van Hedel HJ, Wirz M, Dietz V. Assessing walking ability in subjects with spinal cord injury: validity and reliability of 3 walking tests. Arch Phys Med Rehabil. 2005 Feb;86(2):190-6. doi: 10.1016/j.apmr.2004.02.010.
- Background: PubMed 10414771Harada ND, Chiu V, Stewart AL. Mobility-related function in older adults: assessment with a 6-minute walk test. Arch Phys Med Rehabil. 1999 Jul;80(7):837-41. doi: 10.1016/s0003-9993(99)90236-8.
- World Health OrganizationLink provided by the sponsor.
- foundation of spinal cord injury, R.O.CLink 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.
Yun-An Tsai, MD study chair
0938-592-575
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 robot training in people with Spinal Cord Injuries and Complete Spinal Cord Injury, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 6 inclusion and 12 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 7 Jun 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 Taiwan. 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?
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?
10 meters walking test (time frame: Test will be held before starting the first training session and after completing 20 training sessions.(1 hour per session)). 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 NCT03548649, which also lists 3 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 7 Jun 2018.