Mobility LimitationsNCT02077049
Are Serious Games Promoting Mobility an Attractive Alternative to Conventional Self-training for Elderly People?
A study testing serious games and Conventional self-training in people with Mobility Limitations and Geriatric Disorder, run by Klinik Valens at 1 site in Switzerland.
Trial summary
The main objective of this study is to determine whether elderly people in rehabilitation setting show higher adherence to self-training when using computer-based-learning games (i.e. the so called serious games) than when performing conventional exercises. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mobility Limitations, Geriatric Disorder
- What is being tested?
- serious games and Conventional self-training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2014to Dec 2015
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- +65 years old
- Ability to walk independently over 20meters, with or without walking aids.
- Self-training prescribed by the doctor
- sufficient written and spoken knowledge of German to fill out questionnaires, with or without help.
- Informed consent
Who cannot join
- Cognitive impairment, defined as a Mini-Mental-State Examination (MMSE) score < 26.
- Other limiting disorders hampering the practice of computer-based games (e.g. visual impairment, numbness, vertigo)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Walenstadtberg Klinik
Walenstadtberg, Canton of St. Gallen, 8881
About this study
Official title: Are Serious Games Promoting Mobility an Attractive Alternative to Conventional Self-training for Elderly People? A Randomized Controlled Trial.
The main objective of this study is to determine whether elderly people in rehabilitation setting show higher adherence to self-training when using computer-based-learning games (i.e. the so called serious games) than when performing conventional exercises. Secondly the study explores to which extend balance and mobility performances vary according to the mode of self-training.
The primary study hypothesis is that elderly people practice longer and more frequently with serious games than with a conventional exercise booklet. The secondary hypothesis is that patients experience a significant higher improvement in their balance capacity by using serious games compared to patients performing conventional exercises.
Read the detailed description
Background:
The Swiss population, and in Europe in general, is getting older. Due to this evolving demographic trend, the need to develop specific healthcare services for this age group is becoming crucial. From the international literature, evidence-based findings have demonstrated that physical abilities of elderly people can be increased, and institutional placement and mortality can be reduced through specific inpatient rehabilitation programs (Bachmann, Finger et al. 2010).
Adults 65 years and older should carry out aerobic physical activities for at least 150 minutes of moderate intensity or for 75 minutes of high intensity in a week. Besides it is strongly recommended that senior adults perform strengthening exercises minimum twice a week and activities promoting balance minimum thrice a week (WHO 2010; NIH 2013).
In order to increase the training intensity and thus the independence in activities of daily living, older patients admitted in Kliniken Valens are instructed with a customized self-training program, in addition to the usual rehabilitation services. As for therapist-assisted sessions, this self-training program leads to significant improvement of patient's physical performance (Olney, Nymark et al. 2006) and represents therefore a proven, efficient and cost-effective intervention for inpatient settings. However, the compliance of elderly people to execute self-training exercises varies considerably. These programs are often considered as tedious and boring, and so prematurely stopped (Phillips, Schneider et al. 2004). An alternative to increase patient's motivation could be through serious games practice. Kliniken Valens has already experienced promising results with computer-based games such as the Nintendo Wii® (Schnurr and Oesch 2012).
Methods:
In this study participants are categorized in 4 strata according to their Berg Balance Score (BBS) (≤ 44 or ≥45) and their computer skills. Subsequently they are allocated randomly either in the intervention group or in the control group. In addition to the usual rehabilitation services provided in the clinic, participants of both groups are entitled to 2 additional time-slots (2 x 30 min/day) devoted to self-training and this during the 10 days of the intervention period. This protocol ensures the same conditions for each participant to perform or not self-training exercises. For safety measures, participants with a low BBS (<45) perform the program in siting, whereas those with a higher BBS (≥45) practice in standing position (in front of a bench). The time frame of the intervention phase (from t1 to t2) lasts 10 working days and starts after self-training exercises have been instructed. In other words, t1 equates to approximately day 4 after the patient's admission in the clinic and t2 is 10 working days later, i.e. approximately day 16 after admission.
Intervention group:
The participants are instructed by experienced physiotherapists on serious games with Kinect®. Additionally, participants wear the Fit Bit® (an activity tracker device) and are encouraged to walk and climb stairs instead of using the escalator. Finally participants are asked to write down in a logbook, the frequency and duration of their self-training sessions.
Control group:
As in the usual rehabilitation services, experienced physiotherapists arrange a customized self-training program, instruct the exercises and deliver a hand-out. Additionally, patients are encouraged to walk and climb stairs instead of using the escalator. Finally participants are asked to write down in a logbook, the frequency and duration of their self-training sessions.
Data collection:
Data on self-training's intensity (primary outcome) are extracted from the logbook at post-intervention (t2) i.e. after the 10 working days of the intervention phase. The Berg Balance Scale and the Falls Efficacy Scale (secondary outcomes) are completed by a blinded researcher at pre- and post-intervention (before t1 and after t2) i.e. approximately at day 1-2 after admission and day 16-17 after admission.
Data analysis:
Data are analyzed using the statistical software for social sciences (SPSS). The statistical analysis of the two groups is performed following a normal distribution of data, with an unmatched t-test. For non-normal distributions, the Mann-Whitney U test is used.
- Conditions
- Mobility Limitations, Geriatric Disorder
- Being tested
- serious games, Conventional self-training
- Keywords
- elderly, exercise program, self-training, mobility, computer-based learning games, serious game, balance, training adherence, training compliance, Kinect ®, Fit Bit ®
- Medical subject headings
- Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serious gamesDevice
Also called Kinect®, Xbox®, Windows®, Fit Bit®
Execution of computer-based games that stimulate patient's mobility. The game is displayed on a Television (TV) screen and the patient's movements are detected by the sensors of the Kinect® camera, requiring therefore no game console.
The Fit Bit®, a mobility tracker device, is attached at the patient's belt the whole day and measure all the trips performed and stairs climbed.
This serious games program is instructed individually by experienced physiotherapists.
Conventional self-trainingOther
Also called gymnastic exercises, home exercises, physical exercises
Participants perform conventional physical exercises that train their balance capabilities. There are instructed by experienced physiotherapists and are adapted to each patient's physical abilities. Detailed handouts are distributed to each participants.
| Study group | Role | What they receive |
|---|---|---|
| serious games self-training program | Experimental | Serious games are played, using Kinect® and Fit Bit®. This program is performed during the 10 days of the intervention on a self-training basis and 2 specific time-slot (2x30 min) per day are allocated for this program. Receives: Device: serious games |
| Conventional self-training program | Active comparator | conventional physical exercises are performed during the 10 days of the intervention, on a self-training basis and 2 specific time-slot (2x30 min) per day are allocated for this program. Receives: Other: Conventional self-training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of self-training
Self-training intensity is defined as the frequency of training sessions (f) multiplied by the duration (T) of each training session. The training intensity (f x T) of the 10-days intervention are summated.
These data are recorded daily in a logbook by the patient himself from t1 (which equates to approximately day 4 after admission) till the end of the intervention (t2) i.e. 10 workings days later. The logbook is then collected for data extraction at the end of the intervention (t2), which equates to approximately day 16-17 after patient's admission in the clinic.
Measured: The intensity of self-training is recorded every day and thus from the begining (t1) till the end (t2) of the intervention phase ie. during 10 working days.
Secondary outcomes (3)
Berg Balance Scale
The intervention lasts 10 working days (from t1 to t2), starting from day 4 of the patient's admission in the rehabilitation center.
The Berg Balance Scale is a clinical test for static and dynamic balance abilities. It is assessed before the start of the intervention (t1), i.e. approximately at day 1-2 after admission and again at the end of the intervention phase (t2) 10 working days later, i.e. approximately at day 16-17 after admission.
Measured: The test is performed at the before the start of the intervention (t1) and again at after the end of the intervention (t2) i.e. after 10 working days
Falls Efficacy Scale - International version
The intervention phase lasts 10 working days (from t1 to t2), starting from day 4 of the patient's admission in the rehabilitation center.
The Falls Efficacy Scale is a questionnaire measuring the fear of falling. It is assessed before the start of the intervention (t1), i.e. approximately at day 1-2 after admission and again at the end of the intervention phase (t2) 10 working days later, i.e. approximately at day 16-17 after admission.
Measured: The questionnaire is completed at the before the start of the intervention (t1) and again at after the end of the intervention (t2) i.e. after 10 working days
Local dynamic stability
Local Dynamic Stability (LDS), a non-linear gait stability index, has been advocated as an early indicator of risk for falls. LDS is measured with a tri-axial accelerometer and quantified by calculating Lyapunov exponent.
Measured: The test is performed at the before the start of the intervention (t1) and again at after the end of the intervention (t2) i.e. after 10 working days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Mobility LimitationsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinik Valens
- Sponsor type
- University, hospital or other
- Collaborators
- State Secretariat for Education Research and Innovation, Switzerland, Office Ambient Assisted Living
- Responsible party
- Principal investigator, Dr. Peter Oesch, Klinik Valens
- Investigators
- Peter Oesch, PhD PT, Principal investigator, Kliniken Valens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02077049
- Sponsor's protocol ID
- KlinikenValens_Oesch_RCT-2013
- Other IDs
- EKSG 13/081/1B
- Status last verified
- Feb 2019
- First submitted
- 6 Feb 2014
- Last updated
- 28 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schnurr B, & Oesch P. Sind Nintendo Wii-Balancespiele eine machbare Alternative zum herkömmlichen Selbsttraining des Gleichgewichts nach Schlaganfall? Ergoscience (4): 147-156, 2012.
Bachmann S, Finger C, Huss A, Egger M, Stuck AE, Clough-Gorr KM. Inpatient rehabilitation specifically designed for geriatric patients: systematic review and meta-analysis of randomised controlled trials. BMJ. 2010 Apr 20;340:c1718. doi: 10.1136/bmj.c1718.
PubMed 20406866Global Recommendations on Physical Activity for Health. Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK305057/
PubMed 26180873Phillips EM, Schneider JC, Mercer GR. Motivating elders to initiate and maintain exercise. Arch Phys Med Rehabil. 2004 Jul;85(7 Suppl 3):S52-7; quiz S58-9. doi: 10.1016/j.apmr.2004.03.012.
PubMed 15221728Olney SJ, Nymark J, Brouwer B, Culham E, Day A, Heard J, Henderson M, Parvataneni K. A randomized controlled trial of supervised versus unsupervised exercise programs for ambulatory stroke survivors. Stroke. 2006 Feb;37(2):476-81. doi: 10.1161/01.STR.0000199061.85897.b7. Epub 2006 Jan 12.
PubMed 16410482Oesch P, Kool J, Fernandez-Luque L, Brox E, Evertsen G, Civit A, Hilfiker R, Bachmann S. Exergames versus self-regulated exercises with instruction leaflets to improve adherence during geriatric rehabilitation: a randomized controlled trial. BMC Geriatr. 2017 Mar 23;17(1):77. doi: 10.1186/s12877-017-0467-7.
PubMed 28330455Hasselmann V, Oesch P, Fernandez-Luque L, Bachmann S. Are exergames promoting mobility an attractive alternative to conventional self-regulated exercises for elderly people in a rehabilitation setting? Study protocol of a randomized controlled trial. BMC Geriatr. 2015 Sep 7;15:108. doi: 10.1186/s12877-015-0106-0.
PubMed 26346751
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Serious Games Promoting Mobility an Attractive Alternative to Conventional Self-training for Elderly People? A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02077049
- Acronym / sponsor ID
- KlinikenValens_Oesch_RCT-2013
- Conditions
- Mobility Limitations, Geriatric Disorder
- Keywords
- elderly, exercise program, self-training, mobility, computer-based learning games, serious game, balance, training adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Klinik ValensUniversity, hospital or other
- Collaborators
- State Secretariat for Education Research and Innovation, Switzerland, Office Ambient Assisted Living
- Study start
- Feb 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 4 Mar 2014 (estimated)
- 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 main objective of this study is to determine whether elderly people in rehabilitation setting show higher adherence to self-training when using computer-based-learning games (i.e. the so called serious games) than when performing conventional exercises. Secondly the study explores to which extend balance and mobility performances vary according to the mode of self-training.
The primary study hypothesis is that elderly people practice longer and more frequently with serious games than with a conventional exercise booklet. The secondary hypothesis is that patients experience a significant higher improvement in their balance capacity by using serious games compared to patients performing conventional exercises.
Detailed description
Background:
The Swiss population, and in Europe in general, is getting older. Due to this evolving demographic trend, the need to develop specific healthcare services for this age group is becoming crucial. From the international literature, evidence-based findings have demonstrated that physical abilities of elderly people can be increased, and institutional placement and mortality can be reduced through specific inpatient rehabilitation programs (Bachmann, Finger et al. 2010).
Adults 65 years and older should carry out aerobic physical activities for at least 150 minutes of moderate intensity or for 75 minutes of high intensity in a week. Besides it is strongly recommended that senior adults perform strengthening exercises minimum twice a week and activities promoting balance minimum thrice a week (WHO 2010; NIH 2013).
In order to increase the training intensity and thus the independence in activities of daily living, older patients admitted in Kliniken Valens are instructed with a customized self-training program, in addition to the usual rehabilitation services. As for therapist-assisted sessions, this self-training program leads to significant improvement of patient's physical performance (Olney, Nymark et al. 2006) and represents therefore a proven, efficient and cost-effective intervention for inpatient settings. However, the compliance of elderly people to execute self-training exercises varies considerably. These programs are often considered as tedious and boring, and so prematurely stopped (Phillips, Schneider et al. 2004). An alternative to increase patient's motivation could be through serious games practice. Kliniken Valens has already experienced promising results with computer-based games such as the Nintendo Wii® (Schnurr and Oesch 2012).
Methods:
In this study participants are categorized in 4 strata according to their Berg Balance Score (BBS) (≤ 44 or ≥45) and their computer skills. Subsequently they are allocated randomly either in the intervention group or in the control group. In addition to the usual rehabilitation services provided in the clinic, participants of both groups are entitled to 2 additional time-slots (2 x 30 min/day) devoted to self-training and this during the 10 days of the intervention period. This protocol ensures the same conditions for each participant to perform or not self-training exercises. For safety measures, participants with a low BBS (<45) perform the program in siting, whereas those with a higher BBS (≥45) practice in standing position (in front of a bench). The time frame of the intervention phase (from t1 to t2) lasts 10 working days and starts after self-training exercises have been instructed. In other words, t1 equates to approximately day 4 after the patient's admission in the clinic and t2 is 10 working days later, i.e. approximately day 16 after admission.
Intervention group:
The participants are instructed by experienced physiotherapists on serious games with Kinect®. Additionally, participants wear the Fit Bit® (an activity tracker device) and are encouraged to walk and climb stairs instead of using the escalator. Finally participants are asked to write down in a logbook, the frequency and duration of their self-training sessions.
Control group:
As in the usual rehabilitation services, experienced physiotherapists arrange a customized self-training program, instruct the exercises and deliver a hand-out. Additionally, patients are encouraged to walk and climb stairs instead of using the escalator. Finally participants are asked to write down in a logbook, the frequency and duration of their self-training sessions.
Data collection:
Data on self-training's intensity (primary outcome) are extracted from the logbook at post-intervention (t2) i.e. after the 10 working days of the intervention phase. The Berg Balance Scale and the Falls Efficacy Scale (secondary outcomes) are completed by a blinded researcher at pre- and post-intervention (before t1 and after t2) i.e. approximately at day 1-2 after admission and day 16-17 after admission.
Data analysis:
Data are analyzed using the statistical software for social sciences (SPSS). The statistical analysis of the two groups is performed following a normal distribution of data, with an unmatched t-test. For non-normal distributions, the Mann-Whitney U test is used.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| serious games self-training program | Experimental | Device: serious gamesSerious games are played, using Kinect® and Fit Bit®. This program is performed during the 10 days of the intervention on a self-training basis and 2 specific time-slot (2x30 min) per day are allocated for this program. |
| Conventional self-training program | Active comparator | Other: Conventional self-trainingconventional physical exercises are performed during the 10 days of the intervention, on a self-training basis and 2 specific time-slot (2x30 min) per day are allocated for this program. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- +65 years old
- Ability to walk independently over 20meters, with or without walking aids.
- Self-training prescribed by the doctor
- sufficient written and spoken knowledge of German to fill out questionnaires, with or without help.
- Informed consent
Key exclusion criteria (2 listed)
- Cognitive impairment, defined as a Mini-Mental-State Examination (MMSE) score < 26.
- Other limiting disorders hampering the practice of computer-based games (e.g. visual impairment, numbness, vertigo)
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 |
|---|---|---|
| serious gamesAlso: Kinect®, Xbox®, Windows®, Fit Bit®Execution of computer-based games that stimulate patient's mobility. The game is displayed on a Television (TV) screen and the patient's movements are detected by the sensors of the Kinect® camera, requiring therefore no game console. The Fit Bit®, a mobility tracker device, is attached at the patient's belt the whole day and measure all the trips performed and stairs climbed. This serious games program is instructed individually by experienced physiotherapists. | Device | serious games self-training program |
| Conventional self-trainingAlso: gymnastic exercises, home exercises, physical exercisesParticipants perform conventional physical exercises that train their balance capabilities. There are instructed by experienced physiotherapists and are adapted to each patient's physical abilities. Detailed handouts are distributed to each participants. | Other | Conventional self-training program |
Primary outcome
Intensity of self-training
Time frame: The intensity of self-training is recorded every day and thus from the begining (t1) till the end (t2) of the intervention phase ie. during 10 working days.
Self-training intensity is defined as the frequency of training sessions (f) multiplied by the duration (T) of each training session. The training intensity (f x T) of the 10-days intervention are summated. These data are recorded daily in a logbook by the patient himself from t1 (which equates to approximately day 4 after admission) till the end of the intervention (t2) i.e. 10 workings days later. The logbook is then collected for data extraction at the end of the intervention (t2), which equates to approximately day 16-17 after patient's admission in the clinic.
3 secondary outcomes
Berg Balance Scale
Time frame: The test is performed at the before the start of the intervention (t1) and again at after the end of the intervention (t2) i.e. after 10 working days
Falls Efficacy Scale - International version
Time frame: The questionnaire is completed at the before the start of the intervention (t1) and again at after the end of the intervention (t2) i.e. after 10 working days
Local dynamic stability
Time frame: The test is performed at the before the start of the intervention (t1) and again at after the end of the intervention (t2) i.e. after 10 working days.
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 28 Feb 2019.
- BackgroundSchnurr B, & Oesch P. Sind Nintendo Wii-Balancespiele eine machbare Alternative zum herkömmlichen Selbsttraining des Gleichgewichts nach Schlaganfall? Ergoscience (4): 147-156, 2012.
- Background: PubMed 20406866Bachmann S, Finger C, Huss A, Egger M, Stuck AE, Clough-Gorr KM. Inpatient rehabilitation specifically designed for geriatric patients: systematic review and meta-analysis of randomised controlled trials. BMJ. 2010 Apr 20;340:c1718. doi: 10.1136/bmj.c1718.
- Background: PubMed 26180873Global Recommendations on Physical Activity for Health. Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK305057/
- Background: PubMed 15221728Phillips EM, Schneider JC, Mercer GR. Motivating elders to initiate and maintain exercise. Arch Phys Med Rehabil. 2004 Jul;85(7 Suppl 3):S52-7; quiz S58-9. doi: 10.1016/j.apmr.2004.03.012.
- Background: PubMed 16410482Olney SJ, Nymark J, Brouwer B, Culham E, Day A, Heard J, Henderson M, Parvataneni K. A randomized controlled trial of supervised versus unsupervised exercise programs for ambulatory stroke survivors. Stroke. 2006 Feb;37(2):476-81. doi: 10.1161/01.STR.0000199061.85897.b7. Epub 2006 Jan 12.
- Derived from this study: PubMed 28330455Oesch P, Kool J, Fernandez-Luque L, Brox E, Evertsen G, Civit A, Hilfiker R, Bachmann S. Exergames versus self-regulated exercises with instruction leaflets to improve adherence during geriatric rehabilitation: a randomized controlled trial. BMC Geriatr. 2017 Mar 23;17(1):77. doi: 10.1186/s12877-017-0467-7.
- Derived from this study: PubMed 26346751Hasselmann V, Oesch P, Fernandez-Luque L, Bachmann S. Are exergames promoting mobility an attractive alternative to conventional self-regulated exercises for elderly people in a rehabilitation setting? Study protocol of a randomized controlled trial. BMC Geriatr. 2015 Sep 7;15:108. doi: 10.1186/s12877-015-0106-0.
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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.
Peter Oesch, PhD PT principal investigator
Kliniken Valens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing serious games and Conventional self-training in people with Mobility Limitations and Geriatric Disorder, run by Klinik Valens at 1 site in Switzerland.
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 5 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 28 Feb 2019. 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 Switzerland. 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?
Intensity of self-training (time frame: The intensity of self-training is recorded every day and thus from the begining (t1) till the end (t2) of the intervention phase ie. during 10 working days.). 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 NCT02077049, which also lists 7 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 28 Feb 2019.