StrokeNCT05447754
Comparison of the Effects of Robotic Rehabilitation Versus Traditional Balance Training on Balance and Fear of Falling in Stroke Patients
A study testing Combined RAGT and TBT and balance exercises in people with Stroke and Stroke Rehabilitation, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
In the literature, it has been observed that traditional balance training (TBT) and robot-assisted walking training (RAGT) in stroke patients stimulate the balance mechanism by supporting the spinal muscles symmetrically and functionally. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke, Stroke Rehabilitation, Robotic Exoskeleton
- What is being tested?
- Combined RAGT and TBT and balance exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 May 2022to 13 Apr 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being 18 years or older
- Volunteering to participate in the study
- Having been diagnosed with stroke (at least 3 months)
- Age range 18 ≥ or 75 <
- Being able to walk independently (Functional Ambulation Scale> 3)
- Modified Ashworth Scale ≤ 2 spasticity value
Who cannot join
- Being under the age of 18
- Having severe visual and cognitive impairment
- Having severe cardiovascular disease
- Having experienced musculoskeletal injuries (osteoarthritis, contracture, osteoporosis, etc. in the joints of the lower extremities) or any skin problem (such as pressure sores)
- Being involved in a robotic rehabilitation program before
Trial locations and contacts
1 site in 1 country.
About this study
In the literature, it has been observed that traditional balance training (TBT) and robot-assisted walking training (RAGT) in stroke patients stimulate the balance mechanism by supporting the spinal muscles symmetrically and functionally. However, it is seen that there is no clear protocol for RAGT in the chronic period. Combined RAGT and TBT approaches over ten weeks have been shown to be more effective than TBT alone for the acute and subacute period. However, there is no definite expression for chronic period effects. No study was found in the literature in which an objective measuring device was used for balance assessment of patients receiving TBT and RAGT. If changes are detected between the two treatment groups in balance education in stroke patients as a result of objective evaluation, our study will lead to the necessity of including these changes in the treatment. Considering the effect of balance on activities of daily living, we believe that objective evaluation of the changes in balance after TBT and RAGT in stroke patients and shaping the treatment according to the evaluation results will contribute to the literature.
- Conditions
- Stroke, Stroke Rehabilitation, Robotic Exoskeleton
- Being tested
- Combined RAGT and TBT, balance exercises
- Keywords
- Stroke, Stroke Rehabilitation, Robot assisted gait training, Balance training, Fear of falling
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined RAGT and TBTOther
Combined RAGT and TBT: Participants will be treated with Lokomat for 40 minutes, twice a week for 5 weeks, and RAGT with a body weight support system and combined TBT for 40 minutes each session 3 times a week. During RAGT, 30-40% of each participant's body weight will be taken with the body weight support system. In patients without drop foot and knee instability in the sessions after the first session, the body weight will be reduced by 10% and progression will be achieved. The speed of the treadmill will be adjusted between 1.2-2.6 km/h and the maximum speed tolerated by the patient will be reached during the sessions. TBT exercises 3 times a week for 40 minutes (weight transfer to the paretic leg during sitting and standing, weight transfer during sitting and standing with or without an assistive device) will be personalized according to the patient. Progression of exercises will be provided by adding upper extremity and trunk activities in addition to exercises.
balance exercisesOther
TBT
| Study group | Role | What they receive |
|---|---|---|
| Combined RAGT and TBT | Experimental | Participants will be treated with Lokomat for 40 minutes, twice a week for 5 weeks, and RAGT with a body weight support system and combined TBT for 40 minutes each session 3 times a week. During RAGT, 30-40% of each participant's body weight will be taken with the body weight support system. In patients without drop foot and knee instability in the sessions after the first session, the body weight will be reduced by 10% and progression will be achieved. The speed of the treadmill will be adjusted between 1.2-2.6 km/h and the maximum speed tolerated by the patient will be reached during the sessions. TBT exercises 3 times a week for 40 minutes (weight transfer to the paretic leg during sitting and standing, weight transfer during sitting and standing with or without an assistive device) will be personalized according to the patient. Progression of exercises will be provided by adding upper extremity and trunk activities in addition to exercises. Receives: Other: Combined RAGT and TBT |
| TBT Only | Active comparator | Participants were given balance exercises (weight transfer to the paretic leg during sitting and standing, weight transfer during sitting and standing without an assistive device, walking on a flat surface to the forward and sideways) for 5 weeks, 5 times a week and for 40 minutes in each session. lying down while sitting and standing) will be applied. Receives: Other: balance exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
It is used to evaluate postural control and to determine fall risk. It consists of 14 questions with parameters such as standing up from sitting, standing, transfers, taking a step, turning. A score of 0-4 is given for each question and the time the person performs the desired activity is recorded. At the end of the test, the total score received by the subject is calculated.
Measured: 5 weeks
EncephaLog by Montfort® App
The phone, which is fixed to the sternum of the participant, evaluates the static and dynamic balance with the integration of accelerometer and gyroscope. Static balance is evaluated in a neutral stance with feet open, feet together, feet together and eyes closed, in tandem stance for 10 seconds for each test. Starts the dynamic balance assessment with a 5 second countdown followed by a short audible tone and vibration. Participants stand up without any assistance or arm support and walk at their natural speed towards a cone positioned on the ground 3 m from their chair, then turn around the cone and walk back and sit. It provides objective data by recording the walking time and the test is repeated twice.
Measured: 5 weeks
International Fall Efficiency Scale (FES-I)
It was developed to assess the fear of falling. The cut-off point is 24 to distinguish between people who have a fear of falling and those who do not. The participant is asked to rate his/her concern about the possibility of falling while performing activities of daily living. Fear of falling is determined by adding the scores between 1-4 obtained from each question after completing 16 questions.
Measured: 5 weeks
Timed Get Up and Go Test
It is a measure for assessing balance and functional mobility. A chair and a stopwatch are required to administer the test. The shoes that are always used during the test are used and the test is continued with the assistive device if used. The person is asked to get up from a chair, walk 3 meters, turn around, walk back and sit, and the score is calculated by measuring how many seconds he or she completes the test. Completing the test in more than 12 seconds indicates that the risk of falling is high.
Measured: 5 weeks
Secondary outcomes (4)
Foot Posture Index
In this index, the medial and lateral palpation of the distal talus, the inequality in submalleolar and supramalleolar recesses, the position of the calcaneus, the medial protrusion of the navicular region in posterior observation, the evaluation of MLA, and the number of fingers visible medially or laterally when viewed from the posterior are evaluated. The regions examined are evaluated for each item up to (+2) according to the degree of pronation and (-2) according to the degree of supination, and the total score is determined as the sum of these values.
Measured: 5 weeks
Functional Ambulation Scale
In this classification system, 6 functional levels are defined. This classification system is widely used to evaluate the outcome or effectiveness of rehabilitation and functional level in individuals recovering from stroke.
Measured: 5 weeks
Modified Ashworth Scale
It is a 6-item scale that focuses on the subjective clinical assessment of muscle tone. It measures the level of resistance to passive movement, but cannot assess the speed of passive joint movement, the angle of contraction swing, or potential tendon retraction. MAS is effective in clinical practice due to its ease of use and speed.
Measured: 5 weeks
Fugl-Meyer Test- Lower Extremity
The lower extremity section with a score of 34 including 17 items was used. Evaluates reflexes, synergy-dependent or synergy-independent voluntary movement, coordination and speed. Each item is evaluated out of 2 as follows; 0: cannot complete the movement/ no active movement, 1: partial movement, 2: the movement is completed / movements can be performed normally.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start13 May 2022
- Primary completion13 Jan 2023 (estimated)
- Study completion13 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rüstem Mustafaoğlu, Istanbul University - Cerrahpasa
- Investigators
- Rüstem Mustafaoğlu, PhD, Study chair, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05447754
- Sponsor's protocol ID
- 2022/18
- Status last verified
- Jul 2022
- First submitted
- 1 Jul 2022
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gunduz MS, Mustafaoglu R, Ural IH. Effects of Robot-Assisted Gait Training on Balance and Fear of Falling in Patients With Stroke: A Randomized Controlled Clinical Trial. Am J Phys Med Rehabil. 2025 Jun 1;104(6):558-566. doi: 10.1097/PHM.0000000000002674. Epub 2024 Dec 3.
PubMed 39642346
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Robotic Rehabilitation Versus Traditional Balance Training on Balance and Fear of Falling in Stroke Patients
- ClinicalTrials.gov ID
- NCT05447754
- Acronym / sponsor ID
- 2022/18
- Conditions
- Stroke, Stroke Rehabilitation, Robotic Exoskeleton
- Keywords
- Stroke, Stroke Rehabilitation, Robot assisted gait training, Balance training, Fear of falling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 13 May 2022 (actual)
- Primary completion
- 13 Jan 2023 (estimated)
- Study completion
- 13 Apr 2023 (estimated)
- First posted
- 7 Jul 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.
In the literature, it has been observed that traditional balance training (TBT) and robot-assisted walking training (RAGT) in stroke patients stimulate the balance mechanism by supporting the spinal muscles symmetrically and functionally. However, it is seen that there is no clear protocol for RAGT in the chronic period. Combined RAGT and TBT approaches over ten weeks have been shown to be more effective than TBT alone for the acute and subacute period. However, there is no definite expression for chronic period effects. No study was found in the literature in which an objective measuring device was used for balance assessment of patients receiving TBT and RAGT. If changes are detected between the two treatment groups in balance education in stroke patients as a result of objective evaluation, our study will lead to the necessity of including these changes in the treatment. Considering the effect of balance on activities of daily living, we believe that objective evaluation of the changes in balance after TBT and RAGT in stroke patients and shaping the treatment according to the evaluation results will contribute to the literature.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined RAGT and TBT | Experimental | Other: Combined RAGT and TBTParticipants will be treated with Lokomat for 40 minutes, twice a week for 5 weeks, and RAGT with a body weight support system and combined TBT for 40 minutes each session 3 times a week. During RAGT, 30-40% of each participant's body weight will be taken with the body weight support system. In patients without drop foot and knee instability in the sessions after the first session, the body weight will be reduced by 10% and progression will be achieved. The speed of the treadmill will be adjusted between 1.2-2.6 km/h and the maximum speed tolerated by the patient will be reached during the sessions. TBT exercises 3 times a week for 40 minutes (weight transfer to the paretic leg during sitting and standing, weight transfer during sitting and standing with or without an assistive device) will be personalized according to the patient. Progression of exercises will be provided by adding upper extremity and trunk activities in addition to exercises. |
| TBT Only | Active comparator | Other: balance exercisesParticipants were given balance exercises (weight transfer to the paretic leg during sitting and standing, weight transfer during sitting and standing without an assistive device, walking on a flat surface to the forward and sideways) for 5 weeks, 5 times a week and for 40 minutes in each session. lying down while sitting and standing) will be applied. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Being 18 years or older
- Volunteering to participate in the study
- Having been diagnosed with stroke (at least 3 months)
- Age range 18 ≥ or 75 <
- Being able to walk independently (Functional Ambulation Scale> 3)
Key exclusion criteria (5 listed)
- Being under the age of 18
- Having severe visual and cognitive impairment
- Having severe cardiovascular disease
- Having experienced musculoskeletal injuries (osteoarthritis, contracture, osteoporosis, etc. in the joints of the lower extremities) or any skin problem (such as pressure sores)
- Being involved in a robotic rehabilitation program before
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 |
|---|---|---|
| Combined RAGT and TBTCombined RAGT and TBT: Participants will be treated with Lokomat for 40 minutes, twice a week for 5 weeks, and RAGT with a body weight support system and combined TBT for 40 minutes each session 3 times a week. During RAGT, 30-40% of each participant's body weight will be taken with the body weight support system. In patients without drop foot and knee instability in the sessions after the first session, the body weight will be reduced by 10% and progression will be achieved. The speed of the treadmill will be adjusted between 1.2-2.6 km/h and the maximum speed tolerated by the patient will be reached during the sessions. TBT exercises 3 times a week for 40 minutes (weight transfer to the paretic leg during sitting and standing, weight transfer during sitting and standing with or without an assistive device) will be personalized according to the patient. Progression of exercises will be provided by adding upper extremity and trunk activities in addition to exercises. | Other | Combined RAGT and TBT |
| balance exercisesTBT | Other | TBT Only |
Primary outcome
Berg Balance Scale
Time frame: 5 weeks
It is used to evaluate postural control and to determine fall risk. It consists of 14 questions with parameters such as standing up from sitting, standing, transfers, taking a step, turning. A score of 0-4 is given for each question and the time the person performs the desired activity is recorded. At the end of the test, the total score received by the subject is calculated.
EncephaLog by Montfort® App
Time frame: 5 weeks
The phone, which is fixed to the sternum of the participant, evaluates the static and dynamic balance with the integration of accelerometer and gyroscope. Static balance is evaluated in a neutral stance with feet open, feet together, feet together and eyes closed, in tandem stance for 10 seconds for each test. Starts the dynamic balance assessment with a 5 second countdown followed by a short audible tone and vibration. Participants stand up without any assistance or arm support and walk at their natural speed towards a cone positioned on the ground 3 m from their chair, then turn around the cone and walk back and sit. It provides objective data by recording the walking time and the test is repeated twice.
International Fall Efficiency Scale (FES-I)
Time frame: 5 weeks
It was developed to assess the fear of falling. The cut-off point is 24 to distinguish between people who have a fear of falling and those who do not. The participant is asked to rate his/her concern about the possibility of falling while performing activities of daily living. Fear of falling is determined by adding the scores between 1-4 obtained from each question after completing 16 questions.
Timed Get Up and Go Test
Time frame: 5 weeks
It is a measure for assessing balance and functional mobility. A chair and a stopwatch are required to administer the test. The shoes that are always used during the test are used and the test is continued with the assistive device if used. The person is asked to get up from a chair, walk 3 meters, turn around, walk back and sit, and the score is calculated by measuring how many seconds he or she completes the test. Completing the test in more than 12 seconds indicates that the risk of falling is high.
4 secondary outcomes
Foot Posture Index
Time frame: 5 weeks
Functional Ambulation Scale
Time frame: 5 weeks
Modified Ashworth Scale
Time frame: 5 weeks
Fugl-Meyer Test- Lower Extremity
Time frame: 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
- Derived from this study: PubMed 39642346Gunduz MS, Mustafaoglu R, Ural IH. Effects of Robot-Assisted Gait Training on Balance and Fear of Falling in Patients With Stroke: A Randomized Controlled Clinical Trial. Am J Phys Med Rehabil. 2025 Jun 1;104(6):558-566. doi: 10.1097/PHM.0000000000002674. Epub 2024 Dec 3.
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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.
Rüstem Mustafaoğlu, PhD study chair
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined RAGT and TBT and balance exercises in people with Stroke and Stroke Rehabilitation, run by Istanbul University - Cerrahpasa 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 6 inclusion and 5 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 Jul 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?
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?
Berg Balance Scale (time frame: 5 weeks). The study lists 4 primary outcomes in all. 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 NCT05447754, which also lists 1 linked publication.
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 Jul 2022.