HemiplegiaNCT05492097
The Effect of Robot-assisted Walking Training on Hemiplegic Individuals
A study testing Exercise Therapy and Exercise Therapy and Robotic Walking Training in people with Hemiplegia and Gait, Hemiplegic, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the effects of robotic rehabilitation on balance, body control, mobility, spasticity, motor function and depression compared to traditional therapy in individuals with chronic stroke. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Hemiplegia, Gait, Hemiplegic, Motor Function
- What is being tested?
- Exercise Therapy and Exercise Therapy and Robotic Walking Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Feb 2022to 21 Dec 2022
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having had a stroke once and associated hemiplegia,
- At least 1 year has passed since the stroke,
- Stage 3 and above in terms of lower extremity recovery level according to the Brunnstrom motor staging scale,
- Level 2 and above according to the Functional Ambulation Classification
Who cannot join
- Concomitant peripheral nerve lesion or lower motor neuron disease;
- Presence of other neurological disorders such as ataxia, dyskinesia, dystonia;
- Any circulatory disorder
- Presence of advanced osteoporosis, arrhythmia, or serious heart condition;
- Advanced spasticity, peripheral lesion, pressure sore, advanced muscle atrophy, obesity, skin irritation, presence of cardiac pacemaker;
- Surgery or botulinum toxin administration in the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Robot-assisted Walking Training on Balance, Trunk Control, Mobility, Spasticity and Motor Function in Hemiplegic Individuals
The aim of this study is to compare the effects of robotic rehabilitation on balance, body control, mobility, spasticity, motor function and depression compared to traditional therapy in individuals with chronic stroke. Patients aged between 40-70 years, who applied to the Private Avrasya Hospital Physical Therapy and Rehabilitation Clinic, were diagnosed with hemiplegia based on an epicrisis medical board report, were included in the study on a voluntary basis, regardless of gender. After recording the demographic and clinical information of the participants, based on the physician's decision, they were included in 2 groups: conventional treatment combined with robotic rehabilitation (n=20) and conventional treatment only (n=20).
While one of the groups received traditional treatment, the other group received robotic walking training in addition to conventional treatment. Traditional treatment includes strengthening, balance, range of motion exercises and gait training applied 3 days a week for 4 weeks. Robot-assisted walking training was planned for 20 minutes, 3 days a week.
As assessment methods, number of steps, the 10m Walk Test, Brunnstrom motor staging, Functional Ambulation Classification, Fugl Meyer Rating Scale (lower extremity section), Modified Ashworth Scale, Beck Depression Scale, Tinetti Balance and Gait Test, Postural Assessment Scale in Stroke Patients and Stroke Impact Scale were used. Gender, age and duration of illness showed homogeneous distribution between the groups.
Read the detailed description
More than 80% of stroke survivors have impaired walking ability, but most regain their ability to walk. While 40% of them need help while walking, 60% of the group do not have the ability to move independently outside the home. Balance disorder is the most common problem after stroke. Decreased muscle strength and joint range of motion and impaired coordination and sensory organization mechanism prevent balance. 80% of individuals who have had a stroke for the first time have balance disorder in the subacute phase. As a result of restricted balance, postural control deteriorates, the risk of falling increases and mobility decreases.
Interventions to improve gait function should be intense, repetitive, and task-oriented. Intensive efforts of more than one physiotherapist are required in patients who do not have independent gait. Robot assisted walking devices; provides high-intensity, repetitive, task-specific therapy. It both reduces the workload of physiotherapists and improves gait quality, functional results (walking speed and capacity) and motor performance with multi-sensory stimulation.
- Conditions
- Hemiplegia, Gait, Hemiplegic, Motor Function, Balance; Distorted
- Being tested
- Exercise Therapy, Exercise Therapy and Robotic Walking Training
- Medical subject headings
- Hemiplegia, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise TherapyBehavioural
Traditional exercise therapy and NMES
Exercise Therapy and Robotic Walking TrainingBehavioural
Traditional exercise therapy and Robotic Walking Training
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | For the patients in this group, 3 days a week for 4 weeks; various exercises and walking training will be given in sitting, crawling, kneeling, half-kneeling and standing positions and 20 minutes NMES will be applied. Receives: Behavioral: Exercise Therapy |
| Exercise and Robotic Group | Experimental | In addition to the exercise group treatment, patients will receive gait training for 4 weeks, 3 sessions a week, with the last effector fixed robot Lokohelp. Receives: Behavioral: Exercise Therapy and Robotic Walking Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 10-meter walking test
The 10-meter walking test will be performed in the 16-meter walking area without looking at the first and last 3 meters. The stopwatch will be started after the patient walks for the first 3 meters and the time will be stopped after the 10 meters are completed. The time to complete the 10 meters will be determined in seconds.
Measured: 0-4 weeks
Number of Steps
Calculation of the number of steps in one minute.
Measured: 0-4 weeks
The Fugl Meyer Rating Scale
The Fugl Meyer Rating Scale is a scale used to evaluate sensorimotor impairment in individuals with stroke. The maximum score is 226, which corresponds to full sensory-motor recovery. It is an ordinal scale with 3 points for each item. A given task is given 0 points if it cannot be done, 1 point if it is partially done, and 2 points if it is done completely. Reflex activity is measured using only 2 points, 0 points are given if there is no reflex, and 2 points are given if there is. In the study, the 34-point part of the scale for the lower extremity will used.
Measured: 0-4 weeks
The Postural Rating Scale in Stroke Patients
The Postural Rating Scale for Stroke Patients (PASS-Turk) will be used to assess trunk control. This scale helps to predict prognosis, shape treatment, and monitor time-dependent improvement. It is advantageous in that it is comprehensive, sensitive in evaluating changes in patients, and can be used even in patients with low physical capacity. The scale consists of 12 questions and each question is scored between 0-3 (0 = unable to do, 3 = able to do without assistance).
Measured: 0-4 weeks
Tineti Balance and Gait Assessment
The scale consists of 2 subtests: the first 9 questions are about balance and the next 7 questions are about walking. In 16 questions, the movements during ADL are questioned. If the movement is done correctly, 2 points are given, if the movement is made with adaptations, 1 point is given, if it cannot be done, 0 points are given. If the total score is 18 and below, the risk of falling is high, if it is 19-24, the risk of falling is moderate, and if it is 24 and above, the risk of falling is high.
Measured: 0-4 weeks
The Stroke Impact Scale
The Stroke Impact Scale will be used as a stroke-specific health status measure in the assessment of quality of life. It consists of a total of 59 items and 8 subsections: strength, hand function, activities of daily living, mobility, communication, emotion, memory and thinking, participation. If the patient cannot complete the item, he will be asked to give 1 point, if he has no difficulty in completing it, he will be asked to give 5 points. At the end of the scale, the visual analog scale (0: No recovery, 100: Complete recovery) will evaluate the perception of general recovery after stroke.
Measured: 0-4 weeks
Brunnstrom motor staging
Brunnstrom motor staging is a test that measures motor progress in parts of the central nervous system that regulate motor performance in patients with hemiplegia. The degree of recovery of the central nervous system is evaluated by enabling the patient to perform selected motor actions that require progressively better neuromuscular control. There are 6 stages for the lower extremity
Measured: 0-4 weeks
Functional Ambulation Scale
The amount of physical support that patients need during walking will be determined by the Functional Ambulation Scale. Evaluation is made out of 6 points between 0-5 (0=Cannot ambulatory alone, 5=Can walk independently on all kinds of surfaces).
Measured: 0-4 weeks
The Modified Ashworth Scale
The Modified Ashworth Scale is the most commonly used assessment method for spasticity in the international arena (10). The patient is examined in a supine and relaxed position. The joint is moved passively, repetitively and rapidly, and is scored between 0 and 4 according to the resistance of the joint to movement (0 = no increase in tone, 4 = the affected extremity is rigid in flexion and extension).
Measured: 0-4 weeks
Beck Depression Scale
Emotional symptoms such as hopelessness and guilt and physical symptoms such as weight loss, fatigue and insomnia are also examined in the questions in the scale. There are 21 questions, points are given between 0-3. According to the total score, it is evaluated as follows: 0 to 9 points = minimal depressive symptoms, 10 to 16 points = mild depressive symptoms, 17 to 29 points = moderate depressive symptoms, 30 to 63 points = severe depressive symptoms .
Measured: 0-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start14 Feb 2022
- Primary completion12 Dec 2022
- Study completion21 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiplegiaStudies of the same condition, open and under way.
- More trials run by Medipol 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Controlled study
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülay Aras, Medipol University
- Investigators
- Gülay Aras Bayram, PhD, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05492097
- Sponsor's protocol ID
- E-10840098-772.02-667
- Status last verified
- Dec 2022
- First submitted
- 4 Aug 2022
- Last updated
- 22 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Robot-assisted Walking Training on Balance, Trunk Control, Mobility, Spasticity and Motor Function in Hemiplegic Individuals
- ClinicalTrials.gov ID
- NCT05492097
- Acronym / sponsor ID
- E-10840098-772.02-667
- Conditions
- Hemiplegia, Gait, Hemiplegic, Motor Function, Balance; Distorted
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 12 Dec 2022 (actual)
- Study completion
- 21 Dec 2022 (actual)
- First posted
- 8 Aug 2022 (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.
The aim of this study is to compare the effects of robotic rehabilitation on balance, body control, mobility, spasticity, motor function and depression compared to traditional therapy in individuals with chronic stroke. Patients aged between 40-70 years, who applied to the Private Avrasya Hospital Physical Therapy and Rehabilitation Clinic, were diagnosed with hemiplegia based on an epicrisis medical board report, were included in the study on a voluntary basis, regardless of gender. After recording the demographic and clinical information of the participants, based on the physician's decision, they were included in 2 groups: conventional treatment combined with robotic rehabilitation (n=20) and conventional treatment only (n=20).
While one of the groups received traditional treatment, the other group received robotic walking training in addition to conventional treatment. Traditional treatment includes strengthening, balance, range of motion exercises and gait training applied 3 days a week for 4 weeks. Robot-assisted walking training was planned for 20 minutes, 3 days a week.
As assessment methods, number of steps, the 10m Walk Test, Brunnstrom motor staging, Functional Ambulation Classification, Fugl Meyer Rating Scale (lower extremity section), Modified Ashworth Scale, Beck Depression Scale, Tinetti Balance and Gait Test, Postural Assessment Scale in Stroke Patients and Stroke Impact Scale were used. Gender, age and duration of illness showed homogeneous distribution between the groups.
Detailed description
More than 80% of stroke survivors have impaired walking ability, but most regain their ability to walk. While 40% of them need help while walking, 60% of the group do not have the ability to move independently outside the home. Balance disorder is the most common problem after stroke. Decreased muscle strength and joint range of motion and impaired coordination and sensory organization mechanism prevent balance. 80% of individuals who have had a stroke for the first time have balance disorder in the subacute phase. As a result of restricted balance, postural control deteriorates, the risk of falling increases and mobility decreases.
Interventions to improve gait function should be intense, repetitive, and task-oriented. Intensive efforts of more than one physiotherapist are required in patients who do not have independent gait. Robot assisted walking devices; provides high-intensity, repetitive, task-specific therapy. It both reduces the workload of physiotherapists and improves gait quality, functional results (walking speed and capacity) and motor performance with multi-sensory stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Controlled study
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Behavioral: Exercise TherapyFor the patients in this group, 3 days a week for 4 weeks; various exercises and walking training will be given in sitting, crawling, kneeling, half-kneeling and standing positions and 20 minutes NMES will be applied. |
| Exercise and Robotic Group | Experimental | Behavioral: Exercise Therapy and Robotic Walking TrainingIn addition to the exercise group treatment, patients will receive gait training for 4 weeks, 3 sessions a week, with the last effector fixed robot Lokohelp. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Having had a stroke once and associated hemiplegia,
- At least 1 year has passed since the stroke,
- Stage 3 and above in terms of lower extremity recovery level according to the Brunnstrom motor staging scale,
- Level 2 and above according to the Functional Ambulation Classification
Key exclusion criteria (6 listed)
- Concomitant peripheral nerve lesion or lower motor neuron disease;
- Presence of other neurological disorders such as ataxia, dyskinesia, dystonia;
- Any circulatory disorder
- Presence of advanced osteoporosis, arrhythmia, or serious heart condition;
- Advanced spasticity, peripheral lesion, pressure sore, advanced muscle atrophy, obesity, skin irritation, presence of cardiac pacemaker;
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 |
|---|---|---|
| Exercise TherapyTraditional exercise therapy and NMES | Behavioural | Exercise Group |
| Exercise Therapy and Robotic Walking TrainingTraditional exercise therapy and Robotic Walking Training | Behavioural | Exercise and Robotic Group |
Primary outcome
The 10-meter walking test
Time frame: 0-4 weeks
The 10-meter walking test will be performed in the 16-meter walking area without looking at the first and last 3 meters. The stopwatch will be started after the patient walks for the first 3 meters and the time will be stopped after the 10 meters are completed. The time to complete the 10 meters will be determined in seconds.
Number of Steps
Time frame: 0-4 weeks
Calculation of the number of steps in one minute.
The Fugl Meyer Rating Scale
Time frame: 0-4 weeks
The Fugl Meyer Rating Scale is a scale used to evaluate sensorimotor impairment in individuals with stroke. The maximum score is 226, which corresponds to full sensory-motor recovery. It is an ordinal scale with 3 points for each item. A given task is given 0 points if it cannot be done, 1 point if it is partially done, and 2 points if it is done completely. Reflex activity is measured using only 2 points, 0 points are given if there is no reflex, and 2 points are given if there is. In the study, the 34-point part of the scale for the lower extremity will used.
The Postural Rating Scale in Stroke Patients
Time frame: 0-4 weeks
The Postural Rating Scale for Stroke Patients (PASS-Turk) will be used to assess trunk control. This scale helps to predict prognosis, shape treatment, and monitor time-dependent improvement. It is advantageous in that it is comprehensive, sensitive in evaluating changes in patients, and can be used even in patients with low physical capacity. The scale consists of 12 questions and each question is scored between 0-3 (0 = unable to do, 3 = able to do without assistance).
Tineti Balance and Gait Assessment
Time frame: 0-4 weeks
The scale consists of 2 subtests: the first 9 questions are about balance and the next 7 questions are about walking. In 16 questions, the movements during ADL are questioned. If the movement is done correctly, 2 points are given, if the movement is made with adaptations, 1 point is given, if it cannot be done, 0 points are given. If the total score is 18 and below, the risk of falling is high, if it is 19-24, the risk of falling is moderate, and if it is 24 and above, the risk of falling is high.
The Stroke Impact Scale
Time frame: 0-4 weeks
The Stroke Impact Scale will be used as a stroke-specific health status measure in the assessment of quality of life. It consists of a total of 59 items and 8 subsections: strength, hand function, activities of daily living, mobility, communication, emotion, memory and thinking, participation. If the patient cannot complete the item, he will be asked to give 1 point, if he has no difficulty in completing it, he will be asked to give 5 points. At the end of the scale, the visual analog scale (0: No recovery, 100: Complete recovery) will evaluate the perception of general recovery after stroke.
Brunnstrom motor staging
Time frame: 0-4 weeks
Brunnstrom motor staging is a test that measures motor progress in parts of the central nervous system that regulate motor performance in patients with hemiplegia. The degree of recovery of the central nervous system is evaluated by enabling the patient to perform selected motor actions that require progressively better neuromuscular control. There are 6 stages for the lower extremity
Functional Ambulation Scale
Time frame: 0-4 weeks
The amount of physical support that patients need during walking will be determined by the Functional Ambulation Scale. Evaluation is made out of 6 points between 0-5 (0=Cannot ambulatory alone, 5=Can walk independently on all kinds of surfaces).
The Modified Ashworth Scale
Time frame: 0-4 weeks
The Modified Ashworth Scale is the most commonly used assessment method for spasticity in the international arena (10). The patient is examined in a supine and relaxed position. The joint is moved passively, repetitively and rapidly, and is scored between 0 and 4 according to the resistance of the joint to movement (0 = no increase in tone, 4 = the affected extremity is rigid in flexion and extension).
Beck Depression Scale
Time frame: 0-4 weeks
Emotional symptoms such as hopelessness and guilt and physical symptoms such as weight loss, fatigue and insomnia are also examined in the questions in the scale. There are 21 questions, points are given between 0-3. According to the total score, it is evaluated as follows: 0 to 9 points = minimal depressive symptoms, 10 to 16 points = mild depressive symptoms, 17 to 29 points = moderate depressive symptoms, 30 to 63 points = severe depressive symptoms .
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 22 Dec 2022.
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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.
Gülay Aras Bayram, PhD principal investigator
Medipol 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 Exercise Therapy and Exercise Therapy and Robotic Walking Training in people with Hemiplegia and Gait, Hemiplegic, run by Medipol 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 6 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 22 Dec 2022. 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?
The 10-meter walking test (time frame: 0-4 weeks). The study lists 10 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 22 Dec 2022.