StrokeNCT04756570
The Effect of Robot-Assisted Gait Training in Stroke Patients
A study testing Robotic Group 1 and Robotic Group 2 in people with Stroke, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
Stroke has been defined by the World Health Organization as a condition with rapid onset and vascular origin, leading to a focal or global deterioration in brain functions lasting 1 day or longer. Stroke is an important health problem affecting a large part of the society with its high frequency and mortality. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Robotic Group 1 and Robotic Group 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 1 Jan 2023
- 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
- Diagnosed with stroke
- Willing to participate
- Modified Ashworth Scale Score lower than "3"
- Able to walk 10 meter independently
Who cannot join
- Secondary neurological diseases
- Cognitive problems
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Abant Izzet Baysal University
Bolu, Merkez, 14100
About this study
Official title: The Effect of Robot-Assisted Gait Training Dose on Walking, Functional Recovery and Quality of Life in Stroke Patients
Stroke has been defined by the World Health Organization as a condition with rapid onset and vascular origin, leading to a focal or global deterioration in brain functions lasting 1 day or longer. Stroke is an important health problem affecting a large part of the society with its high frequency and mortality. Post-stroke disability reduces the patient's quality of life and causes socioeconomic and social problems. Post-stroke hemiplegia often causes a decrease in the ambulatory ability of the patient. As a result, the patient's independence to move inside and outside the home is negatively affected. Gait is one of the most affected sensorimotor functions in stroke patients. Although the majority of patients strive to walk independently, they cannot reach a level of independent walking sufficient to perform activities of daily living (ADL). Current studies emphasize that the intensive early rehabilitation program is effective in treating patients with gait and movement disorders. Rehabilitation programs with a multidisciplinary approach are the most effective options that can be applied to increase a patient's functional status and post-stroke independence. Robotic-assisted walking devices are one of the current and effective methods used to regain ambulation.
Read the detailed description
Robotic-assisted walking devices are used in the treatment of many neurological diseases such as spinal cord trauma, multiple sclerosis, post-stroke hemiplegia. In treatments applied with robotic walking devices, since accurate and equal weight transfer is provided in both lower extremities, sensorimotor learning of the patient is also supported. Thanks to the intense and repetitive simulation provided in every phase of the walk and the proprioceptive inputs taken, reorganization occurs in the cortical and sub-cortical regions. With the continuous facilitation of the walking cycle, neural transmission is regenerated or existing communication is strengthened between the motor areas of the brain and sensory pathways. The advantages of robotic systems can be listed as enabling longer and more intense treatments, ensuring that the patient feels better cognitively, adapting to exercise better, providing the opportunity to check the patient's condition objectively by monitoring and recording the patient's condition functionally. A recent systematic review showed that individuals with stroke who received robotic gait training combine with physiotherapy were more likely to achieve independent walking than those who received gait training without robotic gait training. Different studies on the effectiveness of robotic rehabilitation have reported that robot-assisted gait training should be applied together with a physiotherapy program. However, there is no clear information on the optimal dosage of Robot-Assisted Gait Training (RAGT) to achieve clinically meaningful functional recovery after a central nervous system injury. This study aims to investigate the effect of RAGT dosage on Functional Recovery and Quality of Life in patients with stroke.
- Conditions
- Stroke
- Being tested
- Control, Robotic Group 1, Robotic Group 2
- Keywords
- Rehabilitation, Robotic, Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Also called Conventional therapy
Individuals in this group will be randomly recruited from hospitalized stroke volunteers. Since these individuals receive routine rehabilitation 5 days a week, they will be evaluated at the beginning and end of 18 sessions over a total period of 6 weeks. Conventional physiotherapy will include normal joint movements, muscle strengthening exercises, balance and mobility exercises, and exercises to improve daily life activity.
Robotic Group 1Other
Individuals in this group will receive one session of robotic rehabilitation in addition to conventional therapy each week
Robotic Group 2Other
Individuals in this group will receive two sessions of robotic rehabilitation in addition to conventional therapy each week
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | 25 stroke patients between the ages of 18-80, stroke duration of less than 2 months and not more than 2 years whose Mini-Mental State Examination (MMSE) scores equal or above the 25 will be included in this study. Modified Ashworth Scale (MAS), Barthel Index, The Modified Rankin Scale, Berg Balance Scale , \&-min walk test, and Stroke-Specific Quality of Life Scale (SSQOL) assessments will be applied just before the rehabilitation program, after the application and at the end of 6 weeks Receives: Other: Control |
| Robotic 1 | Active comparator | 25 stroke patients between the ages of 18-80, stroke duration of less than 2 months and not more than 2 years whose MMSE scores equal or above the 25 will be included in this study. Modified Ashworth Scale (MAS), Barthel Index, The Modified Rankin Scale, Berg Balance Scale , \&-min walk test, and Stroke-Specific Quality of Life Scale assessments will be applied just before the rehabilitation program, after the application and at the end of 6 weeks Receives: Other: Robotic Group 1 |
| Robotic 2 | Active comparator | 25 stroke patients between the ages of 18-80, stroke duration of less than 2 months and not more than 2 years whose MMSE scores equal or above the 25 will be included in this study. Modified Ashworth Scale (MAS), Barthel Index, The Modified Rankin Scale, Berg Balance Scale , \&-min walk test, and Stroke-Specific Quality of Life Scale assessments will be applied just before the rehabilitation program, after the application and at the end of 6 weeks Receives: Other: Robotic Group 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
It is a scale that includes fourteen balance activities and scores between 0-4 by observing the patient's performance for each activity. This scale includes activities such as moving from a sitting position to a standing position, turning while standing, picking up objects while standing, rotating 360 degrees, standing on one foot. If the patient cannot do the activity, 0 points are given, and 4 points are given if the patient does the activity independently. Low scores indicate impaired balance. The highest total score is 56 and 0-20 points indicate an imbalance, 21-40 points indicate an acceptable balance, 41-56 points indicate the presence of a good balance.
Measured: Six weeks
Secondary outcomes (4)
The Barthel Index
The Barthel Index (BI) evaluates physical independence in activities of daily living in 10 items (transfer, ambulation / wheelchair use, climbing up and downstairs, feeding, dressing, self-care, bathing, toilet use, urinary continence, stool continence). Each item is scored separately as 0, 5, 10 or 15 points. The total score between 0-20 means fully dependent, 21-61 highly dependent, 62-90 moderately dependent, 91-99 mildly dependent and 100 fully independent. In our study, the version of the BI, which has been adapted to Turkish and whose validity and reliability study has been made, will be used.
Measured: Six weeks
Stroke-Specific Quality of Life Scale
Stroke-Specific Quality of Life Scale was used to assess the quality of life. SSQOL consists of 12 sub-sections including energy, family roles, language, mobility, mood, personality, self-care, social roles, thinking, upper limb function, vision, and work productivity and a total of 49 questions. It is graded with Likert type scoring ranging from 1 to 5. It was adapted to Turkish in 2009 by Hakverdioğlu et al. A question was removed from the original scale and the subsections were grouped under 8 headings. These subheadings are; activities, social and family roles, language, vision, energy, temperament, personality and thinking.
Measured: Six weeks
6-min walk test
6-min walk test is based on the patient walking for 6 minutes in a certain length of the corridor. Before, the patient is rested on a chair for 15 minutes. Patients are asked to walk as fast as possible at their walking speed for 6 minutes in a 30-meter straight corridor and the distance traveled is recorded.
Measured: Six weeks
Modified Rankin Scale
The Modified Rankin Scale (MRS) is used to evaluate the disability level of individuals after stroke. Points between 0 and 6 can be obtained. 0 points indicate no symptoms, 5 points indicate bedridden and continuous care, and 6 points indicate death.
Measured: Six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start1 Mar 2021
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
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.
- More trials run by Abant Izzet Baysal UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three groups with one control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramazan KURUL, Abant Izzet Baysal University
- Investigators
- Mustafa Fatih Yaşar, MD, Principal investigator, Bolu Abant Izzet Baylsa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04756570
- Sponsor's protocol ID
- Physical Med-3
- Status last verified
- Nov 2023
- First submitted
- 12 Feb 2021
- Last updated
- 9 Nov 2023
- 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 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Robot-Assisted Gait Training Dose on Walking, Functional Recovery and Quality of Life in Stroke Patients
- ClinicalTrials.gov ID
- NCT04756570
- Acronym / sponsor ID
- Physical Med-3
- Conditions
- Stroke
- Keywords
- Rehabilitation, Robotic, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 16 Feb 2021 (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.
Stroke has been defined by the World Health Organization as a condition with rapid onset and vascular origin, leading to a focal or global deterioration in brain functions lasting 1 day or longer. Stroke is an important health problem affecting a large part of the society with its high frequency and mortality. Post-stroke disability reduces the patient's quality of life and causes socioeconomic and social problems. Post-stroke hemiplegia often causes a decrease in the ambulatory ability of the patient. As a result, the patient's independence to move inside and outside the home is negatively affected. Gait is one of the most affected sensorimotor functions in stroke patients. Although the majority of patients strive to walk independently, they cannot reach a level of independent walking sufficient to perform activities of daily living (ADL). Current studies emphasize that the intensive early rehabilitation program is effective in treating patients with gait and movement disorders. Rehabilitation programs with a multidisciplinary approach are the most effective options that can be applied to increase a patient's functional status and post-stroke independence. Robotic-assisted walking devices are one of the current and effective methods used to regain ambulation.
Detailed description
Robotic-assisted walking devices are used in the treatment of many neurological diseases such as spinal cord trauma, multiple sclerosis, post-stroke hemiplegia. In treatments applied with robotic walking devices, since accurate and equal weight transfer is provided in both lower extremities, sensorimotor learning of the patient is also supported. Thanks to the intense and repetitive simulation provided in every phase of the walk and the proprioceptive inputs taken, reorganization occurs in the cortical and sub-cortical regions. With the continuous facilitation of the walking cycle, neural transmission is regenerated or existing communication is strengthened between the motor areas of the brain and sensory pathways. The advantages of robotic systems can be listed as enabling longer and more intense treatments, ensuring that the patient feels better cognitively, adapting to exercise better, providing the opportunity to check the patient's condition objectively by monitoring and recording the patient's condition functionally. A recent systematic review showed that individuals with stroke who received robotic gait training combine with physiotherapy were more likely to achieve independent walking than those who received gait training without robotic gait training. Different studies on the effectiveness of robotic rehabilitation have reported that robot-assisted gait training should be applied together with a physiotherapy program. However, there is no clear information on the optimal dosage of Robot-Assisted Gait Training (RAGT) to achieve clinically meaningful functional recovery after a central nervous system injury. This study aims to investigate the effect of RAGT dosage on Functional Recovery and Quality of Life in patients with stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Three groups with one control group
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Control25 stroke patients between the ages of 18-80, stroke duration of less than 2 months and not more than 2 years whose Mini-Mental State Examination (MMSE) scores equal or above the 25 will be included in this study. Modified Ashworth Scale (MAS), Barthel Index, The Modified Rankin Scale, Berg Balance Scale , \&-min walk test, and Stroke-Specific Quality of Life Scale (SSQOL) assessments will be applied just before the rehabilitation program, after the application and at the end of 6 weeks |
| Robotic 1 | Active comparator | Other: Robotic Group 125 stroke patients between the ages of 18-80, stroke duration of less than 2 months and not more than 2 years whose MMSE scores equal or above the 25 will be included in this study. Modified Ashworth Scale (MAS), Barthel Index, The Modified Rankin Scale, Berg Balance Scale , \&-min walk test, and Stroke-Specific Quality of Life Scale assessments will be applied just before the rehabilitation program, after the application and at the end of 6 weeks |
| Robotic 2 | Active comparator | Other: Robotic Group 225 stroke patients between the ages of 18-80, stroke duration of less than 2 months and not more than 2 years whose MMSE scores equal or above the 25 will be included in this study. Modified Ashworth Scale (MAS), Barthel Index, The Modified Rankin Scale, Berg Balance Scale , \&-min walk test, and Stroke-Specific Quality of Life Scale assessments will be applied just before the rehabilitation program, after the application and at the end of 6 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with stroke
- Willing to participate
- Modified Ashworth Scale Score lower than "3"
- Able to walk 10 meter independently
Key exclusion criteria (2 listed)
- Secondary neurological diseases
- Cognitive 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 |
|---|---|---|
| ControlAlso: Conventional therapyIndividuals in this group will be randomly recruited from hospitalized stroke volunteers. Since these individuals receive routine rehabilitation 5 days a week, they will be evaluated at the beginning and end of 18 sessions over a total period of 6 weeks. Conventional physiotherapy will include normal joint movements, muscle strengthening exercises, balance and mobility exercises, and exercises to improve daily life activity. | Other | Control |
| Robotic Group 1Individuals in this group will receive one session of robotic rehabilitation in addition to conventional therapy each week | Other | Robotic 1 |
| Robotic Group 2Individuals in this group will receive two sessions of robotic rehabilitation in addition to conventional therapy each week | Other | Robotic 2 |
Primary outcome
Berg Balance Scale
Time frame: Six weeks
It is a scale that includes fourteen balance activities and scores between 0-4 by observing the patient's performance for each activity. This scale includes activities such as moving from a sitting position to a standing position, turning while standing, picking up objects while standing, rotating 360 degrees, standing on one foot. If the patient cannot do the activity, 0 points are given, and 4 points are given if the patient does the activity independently. Low scores indicate impaired balance. The highest total score is 56 and 0-20 points indicate an imbalance, 21-40 points indicate an acceptable balance, 41-56 points indicate the presence of a good balance.
4 secondary outcomes
The Barthel Index
Time frame: Six weeks
Stroke-Specific Quality of Life Scale
Time frame: Six weeks
6-min walk test
Time frame: Six weeks
Modified Rankin Scale
Time frame: Six 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 9 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Mustafa Fatih Yaşar, MD principal investigator
Bolu Abant Izzet Baylsa University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic Group 1 and Robotic Group 2 in people with Stroke, run by Abant Izzet Baysal University 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 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 9 Nov 2023. 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. 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?
Berg Balance Scale (time frame: Six weeks). 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 9 Nov 2023.