StrokeNCT03565185
Comparison Of Two Different Type Robot Assisted Gait Training In Rehabilitation Of Stroke
A study testing robot-assisted gait training in people with Stroke, run by Erenköy Physical Therapy and Rehabilitation Hospital at 1 site in Turkey (Türkiye).
Trial summary
Investigators aimed to compare the results of rehabilitation with an exoskeleton device(Robogait) and with an end-effector device(Lokohelp) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- robot-assisted gait training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2018to 1 Apr 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rehabilitation need for stroke
- Patients under FAC stage 4
- No contraindications for robotic rehabilitation
- Subacute stroke
Who cannot join
- The robot-orthosis does not fit the patient's body
- Inadequate body weight (obesity)
- Severe contractures
- Bone instability (nonstable spinal cord fracture and severe osteoporosis)
- Circulation problems
- Cardiac problems
Show all 16Show fewer
- 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
- Patients with long-term infusion therapy
- Hip, knee, ankle arthrodesis
- Epilepsy
- Patients with disproportionate limb or vertebrae, such as bone cartilage dysplasia
- Those with severe vascular problems of the lower extremity
- Conditions requiring rest or immobilization, such as osteomyelitis and other inflammatory/infectious diseases
- Severe respiratory diseases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erenkoy physical treatment and rehabilitation hospital
Istanbul, In the USA Or Canada, Please Select..., 34400
About this study
Official title: Comparison Of An Exoskeleton Device With An End-Effector Device In Robotic Gait Assesment Of Stroke
Investigators aimed to compare the results of rehabilitation with an exoskeleton device(Robogait) and with an end-effector device(Lokohelp)
Read the detailed description
There are different types of devices in robotic rehabilitation which has been used in recent years for stroke. Investigators aimed to compare the results of rehabilitation with an exoskeleton device(Robogait) and with an end-effector device(Lokohelp) in robot-assisted gait training of stroke rehabilitation
- Conditions
- Stroke
- Being tested
- robot-assisted gait training, placebo
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robot-assisted gait trainingOther
Investigators will use robot-assisted gait training for rehabilitation of stroke
placeboOther
Also called conventional treatment
Investigators will use only conventional treatment without robot-assisted gait training
| Study group | Role | What they receive |
|---|---|---|
| End-effector | Active comparator | For stroke rehabilitation 5 days a week in addition to conventional treatment methods robot-assisted gait training(end-effector type-Lokohelp) will be taken with 45 minutes a day for 3 days a week for 4 weeks.
Patients will be assessed with PASS, Rivermead mobility index, 10-meter walking test, 6-minute walking test, Barthel index, and FAC in terms of baseline and ending for posture, mobility, walking velocity, walking capacity, daily life activities and ambulance level. Receives: Other: robot-assisted gait training |
| Exoskeleton | Active comparator | For stroke rehabilitation 5 days a week in addition to conventional treatment methods robot-assisted gait training (exoskeleton type-Robogait) will be taken with 45 minutes a day for 3 days a week for 4 weeks.
Patients will be assessed with PASS, Rivermead mobility index, 10-meter walking test, 6-minute walking test, Barthel index, and FAC in terms of baseline and ending for posture, mobility, walking velocity, walking capacity, daily life activities and ambulance level. Receives: Other: robot-assisted gait training |
| conventional treatment | Placebo comparator | conventional treatment methods for stroke rehabilitation 5 days a week Patients will be assessed with PASS, Rivermead mobility index, 10-meter walking test, 6-minute walking test, Barthel index, and FAC in terms of baseline and ending for posture, mobility, walking velocity, walking capacity, daily life activities and ambulance level. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minute walk test
6 minute walk test for walking speed
Measured: 4 weeks
10 meter walking test
10 meter walking test for walking
Measured: 4 weeks
Postural Assessment Scale for Stroke(PASS)
Postural Assessment Scale for Stroke(PASS) will be used
Measured: 4 weeks
Secondary outcomes (2)
FAC(Functional Ambulation Classification)
FAC will be used for ambulation
Measured: 4 weeks
Barthel Index
Barthel Index will be used for daily living activities
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start30 Jun 2018
- Primary completion30 Mar 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 64 participants (actual)
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
- Aylin SARI, Study chair, Dr.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03565185
- Sponsor's protocol ID
- ErenkoyPTRH
- Status last verified
- May 2020
- First submitted
- 21 May 2018
- Last updated
- 13 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 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of An Exoskeleton Device With An End-Effector Device In Robotic Gait Assesment Of Stroke
- ClinicalTrials.gov ID
- NCT03565185
- Acronym / sponsor ID
- ErenkoyPTRH
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Erenköy Physical Therapy and Rehabilitation HospitalUniversity, hospital or other
- Study start
- 30 Jun 2018 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 21 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.
Investigators aimed to compare the results of rehabilitation with an exoskeleton device(Robogait) and with an end-effector device(Lokohelp)
Detailed description
There are different types of devices in robotic rehabilitation which has been used in recent years for stroke. Investigators aimed to compare the results of rehabilitation with an exoskeleton device(Robogait) and with an end-effector device(Lokohelp) in robot-assisted gait training of stroke rehabilitation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| End-effector | Active comparator | Other: robot-assisted gait trainingFor stroke rehabilitation 5 days a week in addition to conventional treatment methods robot-assisted gait training(end-effector type-Lokohelp) will be taken with 45 minutes a day for 3 days a week for 4 weeks. Patients will be assessed with PASS, Rivermead mobility index, 10-meter walking test, 6-minute walking test, Barthel index, and FAC in terms of baseline and ending for posture, mobility, walking velocity, walking capacity, daily life activities and ambulance level. |
| Exoskeleton | Active comparator | Other: robot-assisted gait trainingFor stroke rehabilitation 5 days a week in addition to conventional treatment methods robot-assisted gait training (exoskeleton type-Robogait) will be taken with 45 minutes a day for 3 days a week for 4 weeks. Patients will be assessed with PASS, Rivermead mobility index, 10-meter walking test, 6-minute walking test, Barthel index, and FAC in terms of baseline and ending for posture, mobility, walking velocity, walking capacity, daily life activities and ambulance level. |
| conventional treatment | Placebo comparator | Other: placeboconventional treatment methods for stroke rehabilitation 5 days a week Patients will be assessed with PASS, Rivermead mobility index, 10-meter walking test, 6-minute walking test, Barthel index, and FAC in terms of baseline and ending for posture, mobility, walking velocity, walking capacity, daily life activities and ambulance level. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Rehabilitation need for stroke
- Patients under FAC stage 4
- No contraindications for robotic rehabilitation
- Subacute stroke
Key exclusion criteria (16 listed)
- The robot-orthosis does not fit the patient's body
- Inadequate body weight (obesity)
- Severe contractures
- Bone instability (nonstable spinal cord fracture and severe osteoporosis)
- Circulation problems
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 trainingInvestigators will use robot-assisted gait training for rehabilitation of stroke | Other | End-effector, Exoskeleton |
| placeboAlso: conventional treatmentInvestigators will use only conventional treatment without robot-assisted gait training | Other | conventional treatment |
Primary outcome
6 minute walk test
Time frame: 4 weeks
6 minute walk test for walking speed
10 meter walking test
Time frame: 4 weeks
10 meter walking test for walking
Postural Assessment Scale for Stroke(PASS)
Time frame: 4 weeks
Postural Assessment Scale for Stroke(PASS) will be used
2 secondary outcomes
FAC(Functional Ambulation Classification)
Time frame: 4 weeks
Barthel Index
Time frame: 4 weeks
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 13 May 2020.
- Individual participant dataSharing planned: No
Related trials for Stroke
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The AHA Oneida Study
Oneida Nation Members
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Safety and Efficacy Evaluation of the iNstroke 4F Thromboaspiration Catheter in Patients With Acute Ischaemic Stroke Due to Primary Distal Medium Vessel Occlusions (DMVO)
Acute Ischemic Stroke
Active, not recruiting
Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
Ischemic Stroke, Systemic Embolism
RecruitingPhase 3
A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)
Atherosclerosis Cardiovascular Disease, Chronic Kidney Disease
Active, not recruiting
Brain Connectivity Analysis
Neural Injury
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.
Aylin 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 Stroke, 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 4 inclusion and 16 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 13 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?
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?
6 minute walk test (time frame: 4 weeks). 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 13 May 2020.