Spinal Cord InjuriesNCT03544398
Comparison of an Exoskeleten With an End-effector for Assisted Gait Training in Spinal Cord Injury
A study testing robot assisted gait training in people with Spinal Cord Injuries, run by Erenköy Physical Therapy and Rehabilitation Hospital at 1 site in Turkey (Türkiye).
Trial summary
Aim is to compare exoskeleton assisted gait training with end-effector assisted gait training in Spinal Cord Rehabilitation Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- robot assisted gait training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 30 Jun 2020
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of spinal cord injury Applying to the hospital for a rehabilitation program
Who cannot join
- Inadequate body weight (obesity) Severe contractures Bone instability ( nonstable spinal cord fracture, and severe osteoporosis) Circulation problems Cardiac nonconformity Open wounds on the lower extremities or in the body where they will come into contact with the orthosis Uncoordinated, psychotic or aggressive patients Serious cognitive disorders Long-term infusion therapy Hip, knee, ankle arthrodesis Epilepsy Disproportionate limb or vertebrae, such as bone cartilage dysplasia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Aylin Sari
Istanbul, In the USA Or Canada, Please Select..., 3440
AYLİN SARI, 05058396368, mdaylinsari@gmail.com
About this study
Official title: Comparison of Exoskeleten Assisted Gait Training With End-effector Assisted Gait Training in Spinal Cord Injury
Aim is to compare exoskeleton assisted gait training with end-effector assisted gait training in Spinal Cord Rehabilitation
Read the detailed description
It was planned to evaluate patients aged between 18 and 80 years who will admit to the robotic rehabilitation program due to spinal cord injury. Patients will divide into three groups as Exoskeleton, End-effector and conventional therapy. Exoskeleton and End-effector group will receive robotic therapy 4 days a week besides conventional treatment for 6 weeks. All groups will be evaluated at the start and end of the treatment.
- Conditions
- Spinal Cord Injuries
- Being tested
- robot assisted gait training
- 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.
robot assisted gait trainingOther
we use two types of robot assisted gait training and we will compare two groups.
| Study group | Role | What they receive |
|---|---|---|
| exoskeleton | Active comparator | We will use exoskeleton type robot assisted gait training for spinal cord injury rehabilitation Receives: Other: robot assisted gait training |
| end-effector | Active comparator | We will use end-effector type robot assisted gait training for spinal cord injury rehabilitation Receives: Other: robot assisted gait training |
| conventional physiotherapy | Placebo comparator | Not described Receives: Other: robot assisted gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
FAC
functional ambulational classification scale
Measured: Change from baseline FAC class to 6th week of therapy
6MWT
6 minute walking test
Measured: Change from baseline 6MWT class to 6th week of therapy
10MWT
10 meter walking test
Measured: Change from baseline 10MWT class to 6th week of therapy
Secondary outcomes (2)
ASIA
ASIA impairment scale
Measured: Change Of ASIA scale from the beginnig to the 6th week of the therapy
SCIM
Spinal cord independence measure
Measured: Change Of SCIM from the beginnig to the 6th week of the therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start1 Jan 2020
- Primary completion15 Jun 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erenköy Physical Therapy and Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AYLİN SARI, Erenköy Physical Therapy and Rehabilitation Hospital
- Investigators
- unsal SARI, Study chair, Dr.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03544398
- Sponsor's protocol ID
- Erenkoy
- Status last verified
- May 2020
- First submitted
- 22 May 2018
- Last updated
- 18 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Exoskeleten Assisted Gait Training With End-effector Assisted Gait Training in Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT03544398
- Acronym / sponsor ID
- Erenkoy
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Erenköy Physical Therapy and Rehabilitation HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 15 Jun 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 1 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.
Aim is to compare exoskeleton assisted gait training with end-effector assisted gait training in Spinal Cord Rehabilitation
Detailed description
It was planned to evaluate patients aged between 18 and 80 years who will admit to the robotic rehabilitation program due to spinal cord injury. Patients will divide into three groups as Exoskeleton, End-effector and conventional therapy. Exoskeleton and End-effector group will receive robotic therapy 4 days a week besides conventional treatment for 6 weeks. All groups will be evaluated at the start and end of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| exoskeleton | Active comparator | Other: robot assisted gait trainingWe will use exoskeleton type robot assisted gait training for spinal cord injury rehabilitation |
| end-effector | Active comparator | Other: robot assisted gait trainingWe will use end-effector type robot assisted gait training for spinal cord injury rehabilitation |
| conventional physiotherapy | Placebo comparator | Other: robot assisted gait training |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of spinal cord injury Applying to the hospital for a rehabilitation program
Key exclusion criteria (1 listed)
- Inadequate body weight (obesity) Severe contractures Bone instability ( nonstable spinal cord fracture, and severe osteoporosis) Circulation problems Cardiac nonconformity Open wounds on the lower extremities or in the body where they will come into contact with the orthosis Uncoordinated, psychotic or aggressive patients Serious cognitive disorders Long-term infusion therapy Hip, knee, ankle arthrodesis Epilepsy Disproportionate limb or vertebrae, such as bone cartilage dysplasia
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 |
|---|---|---|
| robot assisted gait trainingwe use two types of robot assisted gait training and we will compare two groups. | Other | conventional physiotherapy, end-effector, exoskeleton |
Primary outcome
FAC
Time frame: Change from baseline FAC class to 6th week of therapy
functional ambulational classification scale
6MWT
Time frame: Change from baseline 6MWT class to 6th week of therapy
6 minute walking test
10MWT
Time frame: Change from baseline 10MWT class to 6th week of therapy
10 meter walking test
2 secondary outcomes
ASIA
Time frame: Change Of ASIA scale from the beginnig to the 6th week of the therapy
SCIM
Time frame: Change Of SCIM from the beginnig to the 6th week of the therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2020.
- Individual participant dataSharing planned: No
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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.
unsal SARI study chair
Dr.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing robot assisted gait training in people with Spinal Cord Injuries, run by Erenköy Physical Therapy and Rehabilitation Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 18 May 2020. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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 AYLİN SARI (05058396368, mdaylinsari@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FAC (time frame: Change from baseline FAC class to 6th week of therapy). The study lists 3 primary outcomes in all. 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 18 May 2020.