Multiple SclerosisNCT03801473
Comparison of Robot-Assisted Gait Training and Conventional Therapy in Multiple Sclerosis Patients
A study testing robot assisted gait therapy and Conventional rehabilitation in people with Multiple Sclerosis, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare conventional neurorehabilitation with robot-assisted gait training program in terms of fatigue, anxiety, depression and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- robot assisted gait therapy and Conventional rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Feb 2019to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-70 years old Multiple Sclerosis patients
- EDSS score: 5.5-7.5
- Being oriented and cooperated
- Mini-mental score ≥24/30
Who cannot join
- Modified Ashworth >3 in lower extremity muscles
- Cognitive impairment
- Botox injection within last 6-months
- Having another neurological disease
- Pregnancy or breast-feeding
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sultan Abdulhamid Han Training and Research Hospital
Istanbul
About this study
The aim of this study is to compare conventional neurorehabilitation with robot-assisted gait training program in terms of fatigue, anxiety, depression and quality of life.
Read the detailed description
Gait disturbances are common in Multiple Sclerosis (MS) patients. Nowadays, gait training with robot assisted technology is used for rehabilitation. In several studies conventional rehabilitation was compared with robot assisted rehabilitation program, and they found no superior effects of robot assisted walking program. In this study we aimed to compare these modalities in terms of fatigue, anxiety and quality of life.
- Conditions
- Multiple Sclerosis
- Being tested
- robot assisted gait therapy, Conventional rehabilitation
- Keywords
- rehabilitation, robot assisted gait training
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robot assisted gait therapyOther
The Robogait is a fixed lower body hip-knee exoskeleton. The user's weight is supported by a combination of an overhead attached harness and the support from the exoskeleton.
Conventional rehabilitationOther
Conventional rehabilitation program. Exercise and walking education is performed by the physiotherapists.
| Study group | Role | What they receive |
|---|---|---|
| robot assisted training (RAT) | Experimental | RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities Receives: Other: robot assisted gait therapy |
| conventional training (CT) | Active comparator | Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker. Receives: Other: Conventional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Severity Score
Patient-reported outcome measure which is composed of 9 items and evaluates the severity of fatigue. The items are scored on a 7-point scale with 1=strongly disagree and 7=strongly agree. The minimum score is 9 and maximum possible score is 63. FSS score is calculated as total score/9. Higher score reflects greater fatigue severity.
Measured: baseline
Fatigue Severity Score
Patient-reported outcome measure which is composed of 9 items and evaluates the severity of fatigue. The items are scored on a 7-point scale with 1=strongly disagree and 7=strongly agree. The minimum score is 9 and maximum possible score is 63. FSS score is calculated as total score/9. Higher score reflects greater fatigue severity.
Measured: after treatment (4th week)
Fatigue Severity Score
Patient-reported outcome measure which is composed of 9 items and evaluates the severity of fatigue. The items are scored on a 7-point scale with 1=strongly disagree and 7=strongly agree. The minimum score is 9 and maximum possible score is 63. FSS score is calculated as total score/9. Higher score reflects greater fatigue severity.
Measured: 3 months after treatment
Hospital Anxiety Depression Scale-Depression Subscale (HADS-D)
Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D).
HADS-D sub-scale has seven items and each item is scored on a scale of 0 to 3. Total score ranged from 0 to 21. Higher scores reflects more severe depression.
Measured: Baseline
Hospital Anxiety Depression Scale- Depression Subscale (HADS-D)
Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D).
HADS-D sub-scale has seven items and each item is scored on a scale of 0 to 3. Total score ranged from 0 to 21. Higher scores reflects more severe depression.
Measured: After treatment (4th week)
Hospital Anxiety Depression Scale- Depression Subscale (HADS-D)
Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D).
HADS-D sub-scale has seven items and each item is scored on a scale of 0 to 3. Total score ranged from 0 to 21. Higher scores reflects more severe depression.
Measured: 3 months after treatment
Hospital Anxiety Depression Scale- Anxiety Subscale (HADS-A)
Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D).
HADS-A sub-scale has seven items and each item is scored on a scale of 0 to 3. Total sub-scale score ranged from 0 to 21. Higher score mean a worse outcome.
Measured: baseline
Hospital Anxiety Depression Scale-Anxiety Subscale (HADS-A)
Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D).
HADS-A sub-scale has seven items and each item is scored on a scale of 0 to 3. Total sub-scale score ranged from 0 to 21. Higher score mean a worse outcome.
Measured: After treatment (4th week)
Hospital Anxiety Depression Scale-Anxiety Subscale (HADS-A)
Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D).
HADS-A sub-scale has seven items and each item is scored on a scale of 0 to 3. Total sub-scale score ranged from 0 to 21. Higher score mean a worse outcome.
Measured: 3 months after treatment
Secondary outcomes (15)
Multiple Sclerosis Quality of Life-54 (MSQOL-54)-Physical Health
The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items.
This 54-item instrument generates 12 subscales along with two summary scores, and two additional single-item measures. The subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function.
The summary scores are the physical health composite summary and the mental health composite summary.
Each composite summary scored 0-100. Higher values indicate better QoL.
Measured: baseline
Multiple Sclerosis Quality of Life-54 (MSQOL-54)-Physical Health
The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items.
This 54-item instrument generates 12 subscales along with two summary scores, and two additional single-item measures. The subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function.
The summary scores are the physical health composite summary and the mental health composite summary.
Each composite summary scored 0-100. Higher values indicate better QoL.
Measured: after treatment (4th week)
Multiple Sclerosis Quality of Life-54 (MSQOL-54)- Physical Health
The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items.
This 54-item instrument generates 12 subscales along with two summary scores, and two additional single-item measures. The subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function.
The summary scores are the physical health composite summary and the mental health composite summary.
Each composite summary scored 0-100. Higher values indicate better QoL.
Measured: 3 months after treatment
Expanded Disability Status Scale (EDSS)
The EDSS assesses the disability status of MS patients on a scale range from 0 to 10 in 0.5 unit increments that represent higher levels of disability.
Measured: baseline
Expanded Disability Status Scale (EDSS)
The EDSS assesses the disability status of MS patients on a scale range from 0 to 10 in 0.5 unit increments that represent higher levels of disability.
Measured: after treatment (4th week)
Expanded Disability Status Scale (EDSS)
The EDSS assesses the disability status of MS patients on a scale range from 0 to 10 in 0.5 unit increments that represent higher levels of disability.
Measured: 3 months after treatment
Functional Ambulation Classification
scored 0 to 5 (non functional ambulator to independant ambulator)
Measured: baseline
Functional Ambulation Classification
scored 0 to 5 (non functional ambulator to independant ambulator)
Measured: after treatment (4th week)
Functional Ambulation Classification
scored 0 to 5 (non functional ambulator to independant ambulator)
Measured: 3 months after treatment
Walking Ability
The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.
Measured: baseline
Walking Ability
The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.
Measured: after treatment (4th week)
Walking Ability
The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.
Measured: 3 months after treatment
Berg Balance Test (BBT)
Berg Balance Test (BBT) is a functional test with 14 items. Each item is scored on a five point scale (0 to 4) which is determined by ability to perform the task. The total score ranged 0 to 56. A higher score reflects better functional balance.
Measured: Baseline
Berg Balance Test (BBT)
Berg Balance Test (BBT) is a functional test with 14 items. Each item is scored on a five point scale (0 to 4) which is determined by ability to perform the task. The total score ranged 0 to 56. A higher score reflects better functional balance.
Measured: After treatment (4th week)
Berg Balance Test (BBT)
Berg Balance Test (BBT) is a functional test with 14 items. Each item is scored on a five point scale (0 to 4) which is determined by ability to perform the task. The total score ranged 0 to 56. A higher score reflects better functional balance.
Measured: 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start4 Feb 2019
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03801473
- Sponsor's protocol ID
- Tugba Ozsoy
- Status last verified
- Apr 2021
- First submitted
- 9 Jan 2019
- Last updated
- 7 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lefeber N, Swinnen E, Kerckhofs E. The immediate effects of robot-assistance on energy consumption and cardiorespiratory load during walking compared to walking without robot-assistance: a systematic review. Disabil Rehabil Assist Technol. 2017 Oct;12(7):657-671. doi: 10.1080/17483107.2016.1235620. Epub 2016 Oct 20.
PubMed 27762641Straudi S, Manfredini F, Lamberti N, Zamboni P, Bernardi F, Marchetti G, Pinton P, Bonora M, Secchiero P, Tisato V, Volpato S, Basaglia N. The effectiveness of Robot-Assisted Gait Training versus conventional therapy on mobility in severely disabled progressIve MultiplE sclerosis patients (RAGTIME): study protocol for a randomized controlled trial. Trials. 2017 Feb 27;18(1):88. doi: 10.1186/s13063-017-1838-2.
PubMed 28241776Gandolfi M, Geroin C, Picelli A, Munari D, Waldner A, Tamburin S, Marchioretto F, Smania N. Robot-assisted vs. sensory integration training in treating gait and balance dysfunctions in patients with multiple sclerosis: a randomized controlled trial. Front Hum Neurosci. 2014 May 22;8:318. doi: 10.3389/fnhum.2014.00318. eCollection 2014.
PubMed 24904361Ozsoy-Unubol T, Ata E, Cavlak M, Demir S, Candan Z, Yilmaz F. Effects of Robot-Assisted Gait Training in Patients With Multiple Sclerosis: A Single-Blinded Randomized Controlled Study. Am J Phys Med Rehabil. 2022 Aug 1;101(8):768-774. doi: 10.1097/PHM.0000000000001913. Epub 2021 Oct 21.
PubMed 34686632
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Robot-Assisted Gait Training and Conventional Therapy in Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT03801473
- Acronym / sponsor ID
- Tugba Ozsoy
- Conditions
- Multiple Sclerosis
- Keywords
- rehabilitation, robot assisted gait training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 11 Jan 2019 (actual)
- Results
- Posted 2 Feb 2021
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 conventional neurorehabilitation with robot-assisted gait training program in terms of fatigue, anxiety, depression and quality of life.
Detailed description
Gait disturbances are common in Multiple Sclerosis (MS) patients. Nowadays, gait training with robot assisted technology is used for rehabilitation. In several studies conventional rehabilitation was compared with robot assisted rehabilitation program, and they found no superior effects of robot assisted walking program. In this study we aimed to compare these modalities in terms of fatigue, anxiety and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| robot assisted training (RAT) | Experimental | Other: robot assisted gait therapyRoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities |
| conventional training (CT) | Active comparator | Other: Conventional rehabilitationParticipants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-70 years old Multiple Sclerosis patients
- EDSS score: 5.5-7.5
- Being oriented and cooperated
- Mini-mental score ≥24/30
Key exclusion criteria (5 listed)
- Modified Ashworth >3 in lower extremity muscles
- Cognitive impairment
- Botox injection within last 6-months
- Having another neurological disease
- Pregnancy or breast-feeding
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 therapyThe Robogait is a fixed lower body hip-knee exoskeleton. The user's weight is supported by a combination of an overhead attached harness and the support from the exoskeleton. | Other | robot assisted training (RAT) |
| Conventional rehabilitationConventional rehabilitation program. Exercise and walking education is performed by the physiotherapists. | Other | conventional training (CT) |
Primary outcome
Fatigue Severity Score
Time frame: baseline
Patient-reported outcome measure which is composed of 9 items and evaluates the severity of fatigue. The items are scored on a 7-point scale with 1=strongly disagree and 7=strongly agree. The minimum score is 9 and maximum possible score is 63. FSS score is calculated as total score/9. Higher score reflects greater fatigue severity.
Fatigue Severity Score
Time frame: after treatment (4th week)
Patient-reported outcome measure which is composed of 9 items and evaluates the severity of fatigue. The items are scored on a 7-point scale with 1=strongly disagree and 7=strongly agree. The minimum score is 9 and maximum possible score is 63. FSS score is calculated as total score/9. Higher score reflects greater fatigue severity.
Fatigue Severity Score
Time frame: 3 months after treatment
Patient-reported outcome measure which is composed of 9 items and evaluates the severity of fatigue. The items are scored on a 7-point scale with 1=strongly disagree and 7=strongly agree. The minimum score is 9 and maximum possible score is 63. FSS score is calculated as total score/9. Higher score reflects greater fatigue severity.
Hospital Anxiety Depression Scale-Depression Subscale (HADS-D)
Time frame: Baseline
Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D). HADS-D sub-scale has seven items and each item is scored on a scale of 0 to 3. Total score ranged from 0 to 21. Higher scores reflects more severe depression.
Hospital Anxiety Depression Scale- Depression Subscale (HADS-D)
Time frame: After treatment (4th week)
Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D). HADS-D sub-scale has seven items and each item is scored on a scale of 0 to 3. Total score ranged from 0 to 21. Higher scores reflects more severe depression.
Hospital Anxiety Depression Scale- Depression Subscale (HADS-D)
Time frame: 3 months after treatment
Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D). HADS-D sub-scale has seven items and each item is scored on a scale of 0 to 3. Total score ranged from 0 to 21. Higher scores reflects more severe depression.
Hospital Anxiety Depression Scale- Anxiety Subscale (HADS-A)
Time frame: baseline
Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D). HADS-A sub-scale has seven items and each item is scored on a scale of 0 to 3. Total sub-scale score ranged from 0 to 21. Higher score mean a worse outcome.
Hospital Anxiety Depression Scale-Anxiety Subscale (HADS-A)
Time frame: After treatment (4th week)
Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D). HADS-A sub-scale has seven items and each item is scored on a scale of 0 to 3. Total sub-scale score ranged from 0 to 21. Higher score mean a worse outcome.
Hospital Anxiety Depression Scale-Anxiety Subscale (HADS-A)
Time frame: 3 months after treatment
Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D). HADS-A sub-scale has seven items and each item is scored on a scale of 0 to 3. Total sub-scale score ranged from 0 to 21. Higher score mean a worse outcome.
15 secondary outcomes
Multiple Sclerosis Quality of Life-54 (MSQOL-54)-Physical Health
Time frame: baseline
Multiple Sclerosis Quality of Life-54 (MSQOL-54)-Physical Health
Time frame: after treatment (4th week)
Multiple Sclerosis Quality of Life-54 (MSQOL-54)- Physical Health
Time frame: 3 months after treatment
Expanded Disability Status Scale (EDSS)
Time frame: baseline
Expanded Disability Status Scale (EDSS)
Time frame: after treatment (4th week)
Expanded Disability Status Scale (EDSS)
Time frame: 3 months after treatment
Functional Ambulation Classification
Time frame: baseline
Functional Ambulation Classification
Time frame: after treatment (4th week)
Functional Ambulation Classification
Time frame: 3 months after treatment
Walking Ability
Time frame: baseline
Walking Ability
Time frame: after treatment (4th week)
Walking Ability
Time frame: 3 months after treatment
Berg Balance Test (BBT)
Time frame: Baseline
Berg Balance Test (BBT)
Time frame: After treatment (4th week)
Berg Balance Test (BBT)
Time frame: 3 months after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27762641Lefeber N, Swinnen E, Kerckhofs E. The immediate effects of robot-assistance on energy consumption and cardiorespiratory load during walking compared to walking without robot-assistance: a systematic review. Disabil Rehabil Assist Technol. 2017 Oct;12(7):657-671. doi: 10.1080/17483107.2016.1235620. Epub 2016 Oct 20.
- Background: PubMed 28241776Straudi S, Manfredini F, Lamberti N, Zamboni P, Bernardi F, Marchetti G, Pinton P, Bonora M, Secchiero P, Tisato V, Volpato S, Basaglia N. The effectiveness of Robot-Assisted Gait Training versus conventional therapy on mobility in severely disabled progressIve MultiplE sclerosis patients (RAGTIME): study protocol for a randomized controlled trial. Trials. 2017 Feb 27;18(1):88. doi: 10.1186/s13063-017-1838-2.
- Background: PubMed 24904361Gandolfi M, Geroin C, Picelli A, Munari D, Waldner A, Tamburin S, Marchioretto F, Smania N. Robot-assisted vs. sensory integration training in treating gait and balance dysfunctions in patients with multiple sclerosis: a randomized controlled trial. Front Hum Neurosci. 2014 May 22;8:318. doi: 10.3389/fnhum.2014.00318. eCollection 2014.
- Derived from this study: PubMed 34686632Ozsoy-Unubol T, Ata E, Cavlak M, Demir S, Candan Z, Yilmaz F. Effects of Robot-Assisted Gait Training in Patients With Multiple Sclerosis: A Single-Blinded Randomized Controlled Study. Am J Phys Med Rehabil. 2022 Aug 1;101(8):768-774. doi: 10.1097/PHM.0000000000001913. Epub 2021 Oct 21.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 therapy and Conventional rehabilitation in people with Multiple Sclerosis, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey 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 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: finished, as of the sponsor's last update on 7 May 2021. 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?
Yes. Results are posted in the registry (first posted 2 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Fatigue Severity Score (time frame: baseline). The study lists 9 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 NCT03801473, which also lists 4 linked publications.
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 May 2021.