StrokeSRTINCT03641651
New Technologies in the Rehabilitation of Chronic Stroke
A study testing Rehabilitation technology in people with Stroke and Hemiplegia, run by Markus Wirz at 4 sites in Switzerland.
Trial summary
The objective of the current study is to develop and investigate training concepts involving rehabilitation technology, which aim at exploiting the potential for regaining the ability to perform skilled movements by maximizing training intensity and keeping the motivation of patients high. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Stroke, Hemiplegia
- What is being tested?
- Rehabilitation technology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 4 sitesSwitzerland
- Study dates
- 31 Aug 2018to 31 May 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with residual hemiparesis after cerebrovascular accident
- Up to 12 months after the event
- Primary rehabilitation terminated
- Able to cognitively comprehend the aim of the project with at least 22 points in the Montreal Cognitive Assessment (MoCA)
- General health condition allows for intensive rehabilitative training with limited supervision i.e. clearance and prescription of responsible physician
- Understand written and spoken German language
Who cannot join
- Patients with any signs and symptoms showing that the participant is unwilling to participate in the study will result in the patient being excluded from participation Any medical condition preventing participation such as Severe respiratory disease Severe OR unstable cardio-circulatory conditions Orthopaedic conditions, especially in extremities targeted for rehabilitation such as
- fixed joint contractures limiting range of motion
- non-consolidated fractures Neuro-psychological conditions including cognitive deficits limiting communication or non-cooperation like (self-) aggressive behaviour Infections or inflammatory diseases, like osteomyelitis
- Specific absolute contraindication for the training with any of the respective devices:
- Improper fit of the device, including its harness to relevant extremity(ies)
- Contraindicated training position (standing, sitting)
- Device specific contraindications will be respected and will lead to the exclusion of the device for that patient.
Trial locations and contacts
4 sites in 1 country.
Switzerland4 sites
Reha Rheinfelden
Rheinfelden, 4310
Kliniken Valens
Valens, 7317
Rehakliniken Zihlschlacht
Zihlschlacht, 8588
Klinik Lengg AG
Zurich, 8008
About this study
Official title: Feasibility and Cost Description of Intensive Rehabilitation Involving New Technologies in Patients With Sub-acute Stroke:A Multicenter Single Arm Trial of the Swiss RehabTech Initiative
The objective of the current study is to develop and investigate training concepts involving rehabilitation technology, which aim at exploiting the potential for regaining the ability to perform skilled movements by maximizing training intensity and keeping the motivation of patients high.
The evaluation focuses on feasibility and cost-benefit analyses
Read the detailed description
This feasibility project aims to establish an efficient setting for intensive rehabilitation with new technology in four trailblazer clinics. This will enable them to provide intensive therapy to the patients in accordance with the study protocol. If this setting is integrated into the clinical routine, the investigators will be able to collect data to get some first insight into economic and functional data required to calculate changes in socioeconomic costs
- Conditions
- Stroke, Hemiplegia
- Being tested
- Rehabilitation technology
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation technologyOther
Also called Lokomat, Erigo, Andago, Armeo (Boom, Senseo, Spring, Power)
- Series of tailored rehabilitative training with the use of new technology which provide feedback and allow for a targeted and intensive and dense training.
- With supervision based on patients preconditions and therapy device (e.g. patient/ therapist ratio= 3/1).
- A training series lasts four weeks and comprises 3-5 training-days per week. Maximum training break of 7 days.
Five sessions of training with duration of 45 min per session, and up to four hours each day are foreseen.
- The training can take place in an outpatient or inpatient setting.
- Training will be organized in individual one-to-one or group session
| Study group | Role | What they receive |
|---|---|---|
| Technology arm | Experimental | 4 Weeks intervention of intensive rehabilitation using rehabilitation technology, 3-5 h per day, within a 5d week in-or outpatient setting. Receives: Other: Rehabilitation technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation Between Scheduled and Performed Trainings
Adherence was operationalized by correlating planned trainings with trainings which were carried out by the participants. Due to the small sample size Spearman's rank correlation was used.
Measured: 4 weeks
Secondary outcomes (7)
Functional Independence Measurement (FIM) Generic Functional Performance
observer based measurement of the subject performing basic functional tests, e.g. sitting-up from lying position, stand-up from sitting, walking, stair-climbing etc. Observer rate on a scale from 1 to 7 (1= totally dependent on aid, 7= totally independent) for each activity 18 items, that would led to a score from 18 (totally dependent) to 126 (totally independent)
Measured: Baseline and 4 weeks
Stroke Impact Scale (SIS) Recovery
Questionnaire to be completed by the patient, regarding different parts in daily life: 1. physical problems: 4 items, 2. memory and thinking: 7 items, 3. mood and emotional control: 9 items, 4. communication and understanding: 7 items, 5.daily activities: 10 items, 6. mobility at home and community: 9 items, 7. hand function: 5 items, 8. participation in life: 8 items.
each item should be rated on on 5-point Lickert scale with 1= extremely difficult OR can't do at all OR no strength at all OR all the time AND 5 means: a lot of strength OR not difficult at all OR none of the time OR Question 9 regarding "recovery from stroke" rated on a scale from 0 - 100 (0= no recovery, 100= full recovery)
Measured: Baseline and 4 weeks
Box and Block Test
Measures broader motoric function of the arm and hand as a performance test. Subjects are required to grab and sort wooden blocks from one side of a small dividing wall set up on a table in front of the sitting subject to another side.
The unit of the measure is the amount of blocks transferred within 60 seconds.
Measured: Baseline and 4 weeks
Functional Ambulation Categories (FAC)
Observer based measurement to rate the ability to walk independently. Rated from 0 to 6 (0= not able to walk independently, 6= can walk independently in every situation)
Measured: Baseline and 4 weeks
10m Walk Test= TMT Comfortable
time needed to walk 10 m with Comfortable walking speed
Measured: Baseline and 4 weeks
Walking Index of the Chedoke-McMaster Stroke Assessment Measure (CMSA)
The Walking Index consists of the 5 following items:
Walking indoors Walking outdoors, over rough ground, ramps, and curbs Walking outdoors several blocks Stairs Age and sex appropriate walking distance in meters for 2 minutes
scored on a 7-point scale (Stage 1 through 7, most impairment through to no impairment, respectively) score from 5 to 35 points, the more points the better
Measured: Baseline and 4 weeks
Berg Balance Scale (BBS)
Observer based measurement of walking, standing and balance with 14 items/task to perform by the subject and rated each on scale from 0 to 4 (0= not able to do without help, 4 = can do safely and independently) score between 0 to 56, the more the better
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start31 Aug 2018
- Primary completion31 May 2020
- Study completion31 May 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 (35)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Markus Wirz
- Sponsor type
- University, hospital or other
- Collaborators
- Klinik Lengg, Zurich, Reha Rheinfelden, Klinik Valens, Rehaklinik Zihlschlacht AG
- Responsible party
- Sponsor-investigator, Markus Wirz, Zurich University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03641651
- Sponsor's protocol ID
- ZHAW-SRTI
- Acronym
- SRTI
- Status last verified
- Sep 2022
- First submitted
- 13 Aug 2018
- Last updated
- 27 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Pollock A, Baer G, Campbell P, Choo PL, Forster A, Morris J, Pomeroy VM, Langhorne P. Physical rehabilitation approaches for the recovery of function and mobility following stroke. Cochrane Database Syst Rev. 2014 Apr 22;2014(4):CD001920. doi: 10.1002/14651858.CD001920.pub3.
PubMed 24756870Veerbeek JM, van Wegen E, van Peppen R, van der Wees PJ, Hendriks E, Rietberg M, Kwakkel G. What is the evidence for physical therapy poststroke? A systematic review and meta-analysis. PLoS One. 2014 Feb 4;9(2):e87987. doi: 10.1371/journal.pone.0087987. eCollection 2014.
PubMed 24505342Langhorne P, Wagenaar R, Partridge C. Physiotherapy after stroke: more is better? Physiother Res Int. 1996;1(2):75-88. doi: 10.1002/pri.6120010204.
PubMed 9238725Hornby TG, Holleran CL, Hennessy PW, Leddy AL, Connolly M, Camardo J, Woodward J, Mahtani G, Lovell L, Roth EJ. Variable Intensive Early Walking Poststroke (VIEWS): A Randomized Controlled Trial. Neurorehabil Neural Repair. 2016 Jun;30(5):440-50. doi: 10.1177/1545968315604396. Epub 2015 Sep 3.
PubMed 26338433Knecht S, Rossmuller J, Unrath M, Stephan KM, Berger K, Studer B. Old benefit as much as young patients with stroke from high-intensity neurorehabilitation: cohort analysis. J Neurol Neurosurg Psychiatry. 2016 May;87(5):526-30. doi: 10.1136/jnnp-2015-310344. Epub 2015 Jun 11.
PubMed 26069298Kwakkel G, Wagenaar RC, Twisk JW, Lankhorst GJ, Koetsier JC. Intensity of leg and arm training after primary middle-cerebral-artery stroke: a randomised trial. Lancet. 1999 Jul 17;354(9174):191-6. doi: 10.1016/S0140-6736(98)09477-X.
PubMed 10421300Feys H, De Weerdt W, Verbeke G, Steck GC, Capiau C, Kiekens C, Dejaeger E, Van Hoydonck G, Vermeersch G, Cras P. Early and repetitive stimulation of the arm can substantially improve the long-term outcome after stroke: a 5-year follow-up study of a randomized trial. Stroke. 2004 Apr;35(4):924-9. doi: 10.1161/01.STR.0000121645.44752.f7. Epub 2004 Mar 4.
PubMed 15001789Jette DU, Warren RL, Wirtalla C. The relation between therapy intensity and outcomes of rehabilitation in skilled nursing facilities. Arch Phys Med Rehabil. 2005 Mar;86(3):373-9. doi: 10.1016/j.apmr.2004.10.018.
PubMed 15759214Lohse KR, Lang CE, Boyd LA. Is more better? Using metadata to explore dose-response relationships in stroke rehabilitation. Stroke. 2014 Jul;45(7):2053-8. doi: 10.1161/STROKEAHA.114.004695. Epub 2014 May 27.
PubMed 24867924Birkenmeier RL, Prager EM, Lang CE. Translating animal doses of task-specific training to people with chronic stroke in 1-hour therapy sessions: a proof-of-concept study. Neurorehabil Neural Repair. 2010 Sep;24(7):620-35. doi: 10.1177/1545968310361957. Epub 2010 Apr 27.
PubMed 20424192Kwakkel G, van Peppen R, Wagenaar RC, Wood Dauphinee S, Richards C, Ashburn A, Miller K, Lincoln N, Partridge C, Wellwood I, Langhorne P. Effects of augmented exercise therapy time after stroke: a meta-analysis. Stroke. 2004 Nov;35(11):2529-39. doi: 10.1161/01.STR.0000143153.76460.7d. Epub 2004 Oct 7.
PubMed 15472114Teasell R, Bitensky J, Salter K, Bayona NA. The role of timing and intensity of rehabilitation therapies. Top Stroke Rehabil. 2005 Summer;12(3):46-57. doi: 10.1310/ETDP-6DR4-D617-VMVF.
PubMed 16110427Andrews AW, Li D, Freburger JK. Association of Rehabilitation Intensity for Stroke and Risk of Hospital Readmission. Phys Ther. 2015 Dec;95(12):1660-7. doi: 10.2522/ptj.20140610. Epub 2015 Jun 18.
PubMed 26089042Krakauer JW, Carmichael ST, Corbett D, Wittenberg GF. Getting neurorehabilitation right: what can be learned from animal models? Neurorehabil Neural Repair. 2012 Oct;26(8):923-31. doi: 10.1177/1545968312440745. Epub 2012 Mar 30.
PubMed 22466792De Wit L, Putman K, Dejaeger E, Baert I, Berman P, Bogaerts K, Brinkmann N, Connell L, Feys H, Jenni W, Kaske C, Lesaffre E, Leys M, Lincoln N, Louckx F, Schuback B, Schupp W, Smith B, De Weerdt W. Use of time by stroke patients: a comparison of four European rehabilitation centers. Stroke. 2005 Sep;36(9):1977-83. doi: 10.1161/01.STR.0000177871.59003.e3. Epub 2005 Aug 4.
PubMed 16081860
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Cost Description of Intensive Rehabilitation Involving New Technologies in Patients With Sub-acute Stroke:A Multicenter Single Arm Trial of the Swiss RehabTech Initiative
- ClinicalTrials.gov ID
- NCT03641651
- Acronym / sponsor ID
- SRTI / ZHAW-SRTI
- Conditions
- Stroke, Hemiplegia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Markus WirzUniversity, hospital or other
- Collaborators
- Klinik Lengg, Zurich, Reha Rheinfelden, Klinik Valens, Rehaklinik Zihlschlacht AG
- Study start
- 31 Aug 2018 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 22 Aug 2018 (actual)
- Results
- Posted 27 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the current study is to develop and investigate training concepts involving rehabilitation technology, which aim at exploiting the potential for regaining the ability to perform skilled movements by maximizing training intensity and keeping the motivation of patients high.
The evaluation focuses on feasibility and cost-benefit analyses
Detailed description
This feasibility project aims to establish an efficient setting for intensive rehabilitation with new technology in four trailblazer clinics. This will enable them to provide intensive therapy to the patients in accordance with the study protocol. If this setting is integrated into the clinical routine, the investigators will be able to collect data to get some first insight into economic and functional data required to calculate changes in socioeconomic costs
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Technology arm | Experimental | Other: Rehabilitation technology4 Weeks intervention of intensive rehabilitation using rehabilitation technology, 3-5 h per day, within a 5d week in-or outpatient setting. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients with residual hemiparesis after cerebrovascular accident
- Up to 12 months after the event
- Primary rehabilitation terminated
- Able to cognitively comprehend the aim of the project with at least 22 points in the Montreal Cognitive Assessment (MoCA)
- General health condition allows for intensive rehabilitative training with limited supervision i.e. clearance and prescription of responsible physician
Key exclusion criteria (7 listed)
- Patients with any signs and symptoms showing that the participant is unwilling to participate in the study will result in the patient being excluded from participation Any medical condition preventing participation such as Severe respiratory disease Severe OR unstable cardio-circulatory conditions Orthopaedic conditions, especially in extremities targeted for rehabilitation such as
- fixed joint contractures limiting range of motion
- non-consolidated fractures Neuro-psychological conditions including cognitive deficits limiting communication or non-cooperation like (self-) aggressive behaviour Infections or inflammatory diseases, like osteomyelitis
- Improper fit of the device, including its harness to relevant extremity(ies)
- Contraindicated training position (standing, sitting)
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 |
|---|---|---|
| Rehabilitation technologyAlso: Lokomat, Erigo, Andago, Armeo (Boom, Senseo, Spring, Power)* Series of tailored rehabilitative training with the use of new technology which provide feedback and allow for a targeted and intensive and dense training. * With supervision based on patients preconditions and therapy device (e.g. patient/ therapist ratio= 3/1). * A training series lasts four weeks and comprises 3-5 training-days per week. Maximum training break of 7 days. Five sessions of training with duration of 45 min per session, and up to four hours each day are foreseen. * The training can take place in an outpatient or inpatient setting. * Training will be organized in individual one-to-one or group session | Other | Technology arm |
Primary outcome
Correlation Between Scheduled and Performed Trainings
Time frame: 4 weeks
Adherence was operationalized by correlating planned trainings with trainings which were carried out by the participants. Due to the small sample size Spearman's rank correlation was used.
7 secondary outcomes
Functional Independence Measurement (FIM) Generic Functional Performance
Time frame: Baseline and 4 weeks
Stroke Impact Scale (SIS) Recovery
Time frame: Baseline and 4 weeks
Box and Block Test
Time frame: Baseline and 4 weeks
Functional Ambulation Categories (FAC)
Time frame: Baseline and 4 weeks
10m Walk Test= TMT Comfortable
Time frame: Baseline and 4 weeks
Walking Index of the Chedoke-McMaster Stroke Assessment Measure (CMSA)
Time frame: Baseline and 4 weeks
Berg Balance Scale (BBS)
Time frame: Baseline and 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24756870Pollock A, Baer G, Campbell P, Choo PL, Forster A, Morris J, Pomeroy VM, Langhorne P. Physical rehabilitation approaches for the recovery of function and mobility following stroke. Cochrane Database Syst Rev. 2014 Apr 22;2014(4):CD001920. doi: 10.1002/14651858.CD001920.pub3.
- Background: PubMed 24505342Veerbeek JM, van Wegen E, van Peppen R, van der Wees PJ, Hendriks E, Rietberg M, Kwakkel G. What is the evidence for physical therapy poststroke? A systematic review and meta-analysis. PLoS One. 2014 Feb 4;9(2):e87987. doi: 10.1371/journal.pone.0087987. eCollection 2014.
- Background: PubMed 9238725Langhorne P, Wagenaar R, Partridge C. Physiotherapy after stroke: more is better? Physiother Res Int. 1996;1(2):75-88. doi: 10.1002/pri.6120010204.
- Background: PubMed 26338433Hornby TG, Holleran CL, Hennessy PW, Leddy AL, Connolly M, Camardo J, Woodward J, Mahtani G, Lovell L, Roth EJ. Variable Intensive Early Walking Poststroke (VIEWS): A Randomized Controlled Trial. Neurorehabil Neural Repair. 2016 Jun;30(5):440-50. doi: 10.1177/1545968315604396. Epub 2015 Sep 3.
- Background: PubMed 26069298Knecht S, Rossmuller J, Unrath M, Stephan KM, Berger K, Studer B. Old benefit as much as young patients with stroke from high-intensity neurorehabilitation: cohort analysis. J Neurol Neurosurg Psychiatry. 2016 May;87(5):526-30. doi: 10.1136/jnnp-2015-310344. Epub 2015 Jun 11.
- Background: PubMed 10421300Kwakkel G, Wagenaar RC, Twisk JW, Lankhorst GJ, Koetsier JC. Intensity of leg and arm training after primary middle-cerebral-artery stroke: a randomised trial. Lancet. 1999 Jul 17;354(9174):191-6. doi: 10.1016/S0140-6736(98)09477-X.
- Background: PubMed 15001789Feys H, De Weerdt W, Verbeke G, Steck GC, Capiau C, Kiekens C, Dejaeger E, Van Hoydonck G, Vermeersch G, Cras P. Early and repetitive stimulation of the arm can substantially improve the long-term outcome after stroke: a 5-year follow-up study of a randomized trial. Stroke. 2004 Apr;35(4):924-9. doi: 10.1161/01.STR.0000121645.44752.f7. Epub 2004 Mar 4.
- Background: PubMed 15759214Jette DU, Warren RL, Wirtalla C. The relation between therapy intensity and outcomes of rehabilitation in skilled nursing facilities. Arch Phys Med Rehabil. 2005 Mar;86(3):373-9. doi: 10.1016/j.apmr.2004.10.018.
- Background: PubMed 24867924Lohse KR, Lang CE, Boyd LA. Is more better? Using metadata to explore dose-response relationships in stroke rehabilitation. Stroke. 2014 Jul;45(7):2053-8. doi: 10.1161/STROKEAHA.114.004695. Epub 2014 May 27.
- Background: PubMed 20424192Birkenmeier RL, Prager EM, Lang CE. Translating animal doses of task-specific training to people with chronic stroke in 1-hour therapy sessions: a proof-of-concept study. Neurorehabil Neural Repair. 2010 Sep;24(7):620-35. doi: 10.1177/1545968310361957. Epub 2010 Apr 27.
- Background: PubMed 15472114Kwakkel G, van Peppen R, Wagenaar RC, Wood Dauphinee S, Richards C, Ashburn A, Miller K, Lincoln N, Partridge C, Wellwood I, Langhorne P. Effects of augmented exercise therapy time after stroke: a meta-analysis. Stroke. 2004 Nov;35(11):2529-39. doi: 10.1161/01.STR.0000143153.76460.7d. Epub 2004 Oct 7.
- Background: PubMed 16110427Teasell R, Bitensky J, Salter K, Bayona NA. The role of timing and intensity of rehabilitation therapies. Top Stroke Rehabil. 2005 Summer;12(3):46-57. doi: 10.1310/ETDP-6DR4-D617-VMVF.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation technology in people with Stroke and Hemiplegia, run by Markus Wirz at 4 sites 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 6 inclusion and 7 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 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Yes. Results are posted in the registry (first posted 27 Sep 2022). 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?
Correlation Between Scheduled and Performed Trainings (time frame: 4 weeks). 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 NCT03641651, which also lists 35 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 27 Sep 2022.