Central Nervous System Diseasesi-ACTNCT04692311
Pilot Study Concerning an Intelligent Activity-based Client-centred Training System in Neurorehabilitation
A study testing an intelligent client-centred task-oriented training and Semi-structured interview in people with Central Nervous System Diseases and Neurological Rehabilitation, run by PXL University College.
Trial summary
The pilot study was performed to evaluate the usability, credibility and expectancy of an intelligent, activity-based client-centred training system (i-ACT), and the motivation towards its use in neurological rehabilitation over a short period of time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Nervous System Diseases, Neurological Rehabilitation
- What is being tested?
- an intelligent client-centred task-oriented training and Semi-structured interview
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 4 Jan 2016to 31 Aug 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age over 18 years old
- a medical diagnosis of central nervous system disease
- dysfunction in upper limb and/or core stability
- Persons with multiple sclerosis (MS) had to be free of treatment with corticosteroids for one month.
- Persons with stroke or spinal cord injury, had to be at least three months post injury.
Who cannot join
- severe spasticity (when spasticity impedes movement)
- severe cognitive impairment (person is not able to understand and follow instructions)
- severe communicative impairment (person is not able to answer questions)
- severe visual impairment (person is not able to see the television screen)
- persons who use an electric wheelchair
About this study
Official title: Motivation, Usability and Functionality of an Intelligent Activity-based Client-centred Training System in Neurological Rehabilitation: a Pilot Study
The pilot study was performed to evaluate the usability, credibility and expectancy of an intelligent, activity-based client-centred training system (i-ACT), and the motivation towards its use in neurological rehabilitation over a short period of time.
Read the detailed description
A mixed-method study was performed in four rehabilitation centres in Belgium. An homogenous convenience sample was recruited among persons with central nervous system disorders.
Participants received 3 x 45 minutes of training with the i-ACT system during six weeks, additional to conventional care. The Canadian Occupational Performance Measure (COPM) was used to collect and evaluate patients' individual goals towards rehabilitation. These goals were discussed with the therapists before implementing movements and exercises for each patient in the i-ACT system.
The following demographic data were obtained from the medical files: age, gender, and diagnosis. Outcomes measures were collected at baseline (T0), after 2 (T1), 4 (T2) and 6 (T3) weeks of training and at 9 weeks follow-up (T4).
The primary outcome measures were the Intrinsic Motivation Inventory (IMI), the System Usability Scale (SUS), Credibility/Expectancy Questionnaire (CEQ), the Canadian Occupational Performance Measure (COPM), and Wolf Motor Function Test (WMFT). The secondary measures were the Manual Ability Measure-36 (MAM-36), Modified Fatigue Impact Scale (MFIS), Trunk Impairment Scale (TIS), and Active Range of Motion (AROM).
After final training with i-ACT, a semi-structured interview was performed to gather more information about the participants' perception towards i-ACT.
For quantitative data, within-group differences of all the assessments were analysed using Friedman's ANOVA and Wilcoxon signed-rank test. Alpha was set at 0.05; No Bonferroni correction was applied as it is not compulsory in an exploratory study and furthermore, results are regarded as hypothesis for further investigations.
The qualitative data was collected and recorded with a voice recorder. No specific analysis was used as the interview collected data to support or oppose the findings of the quantitative data.
- Being tested
- an intelligent client-centred task-oriented training, Semi-structured interview
- Medical subject headings
- Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
an intelligent client-centred task-oriented trainingDevice
Also called i-ACT
3 x 45min of training with i-ACT system
Semi-structured interviewOther
Participants, patients and therapists, were invited to a semi-structured interview after training period.
| Study group | Role | What they receive |
|---|---|---|
| Persons with central nervous system diseases | Experimental | Persons with central nervous system diseases received additional training with i-ACT during 6 weeks. After final training, a semi-structured interview was performed. And at six weeks follow-up, a final assessment took place. Receives: Device: an intelligent client-centred task-oriented training; Other: Semi-structured interview |
| Occupational therapists | Other | Occupational therapists were invited to a semi-structured interview to gather information about their professional opinion regarding i-ACT. Receives: Other: Semi-structured interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intrinsic Motivation Inventory
Motivation towards a therapy, in this i-ACT
Measured: 2 weeks
Intrinsic Motivation Inventory
Motivation towards a therapy, in this i-ACT
Measured: 4 weeks
Intrinsic Motivation Inventory
Motivation towards a therapy, in this i-ACT
Measured: 6 weeks
Intrinsic Motivation Inventory
Motivation towards a therapy, in this i-ACT
Measured: 12 weeks (i.e. 6 weeks follow-up)
System Usability Scale
Usability of a system, in this i-ACT. Range of scores from 0 (negative) to 100 (positive).
Measured: 2 weeks
System Usability Scale
Usability of a system, in this i-ACT. Range of scores from 0 (negative) to 100 (positive).
Measured: 4 weeks
System Usability Scale
Usability of a system, in this i-ACT. Range of scores from 0 (negative) to 100 (positive).
Measured: 6 weeks
System Usability Scale
Usability of a system, in this i-ACT. Range of scores from 0 (negative) to 100 (positive).
Measured: 12 weeks (i.e. 6 weeks follow-up)
Credibility/Expectancy Questionnaire
Credibility and expectancy of a training system, in this i-ACT. The range of scores on each subscale (i.e. credibility and expectancy) is 27.
Measured: 2 weeks
Credibility/Expectancy Questionnaire
Credibility and expectancy of a training system, in this i-ACT. The range of scores on each subscale (i.e. credibility and expectancy) is 27.
Measured: 4 weeks
Credibility/Expectancy Questionnaire
Credibility and expectancy of a training system, in this i-ACT. The range of scores on each subscale (i.e. credibility and expectancy) is 27.
Measured: 6 weeks
Credibility/Expectancy Questionnaire
Credibility and expectancy of a training system, in this i-ACT. The range of scores on each subscale (i.e. credibility and expectancy) is 27.
Measured: 12 weeks (i.e. 6 weeks follow-up)
Canadian Occupational Performance Measure
By means of a semi-structured interview, participants are asked to identify their 5 main goals in self-care, productivity and/or leisure.
Scores range from 0 to 10 (best score) in each defined goal.
Measured: Baseline
Canadian Occupational Performance Measure
By means of a semi-structured interview, participants are asked to identify their 5 main goals in self-care, productivity and/or leisure.
Scores range from 0 to 10 (best score) in each defined goal.
Measured: 4 weeks
Canadian Occupational Performance Measure
By means of a semi-structured interview, participants are asked to identify their 5 main goals in self-care, productivity and/or leisure.
Scores range from 0 to 10 (best score) in each defined goal.
Measured: 6 weeks
Canadian Occupational Performance Measure
By means of a semi-structured interview, participants are asked to identify their 5 main goals in self-care, productivity and/or leisure.
Scores range from 0 to 10 (best score) in each defined goal.
Measured: 12 weeks (i.e. 6 weeks follow-up)
Wolf Motor Function Test
Arm-hand functioning. The test contains 17 items and are scored from 0 (not able to perform tesk) to 5 (normal performance).
Measured: Baseline
Wolf Motor Function Test
Arm-hand functioning. The test contains 17 items and are scored from 0 (not able to perform tesk) to 5 (normal performance).
Measured: 2 weeks
Wolf Motor Function Test
Arm-hand functioning. The test contains 17 items and are scored from 0 (not able to perform tesk) to 5 (normal performance).
Measured: 4 weeks
Wolf Motor Function Test
Arm-hand functioning. The test contains 17 items and are scored from 0 (not able to perform tesk) to 5 (normal performance).
Measured: 6 weeks
Wolf Motor Function Test
Arm-hand functioning. The test contains 17 items and are scored from 0 (not able to perform tesk) to 5 (normal performance).
Measured: 12 weeks (i.e. 6 weeks follow-up)
Secondary outcomes (20)
Manual Ability Measure-36
Manual ability. Scores range from 0 (impossible to perform) to 4 (easy to perform)
Measured: Baseline
Manual Ability Measure-36
Manual ability. Scores range from 0 (impossible to perform) to 4 (easy to perform)
Measured: 2 weeks
Manual Ability Measure-36
Manual ability. Scores range from 0 (impossible to perform) to 4 (easy to perform)
Measured: 4 Weeks
Manual Ability Measure-36
Manual ability. Scores range from 0 (impossible to perform) to 4 (easy to perform)
Measured: 6 weeks
Manual Ability Measure-36
Manual ability. Scores range from 0 (impossible to perform) to 4 (easy to perform)
Measured: 12 weeks (i.e. 6 weeks follow-up)
Modified Fatigue Impact Scale
Fatigue. Twenty-one items ar scored on a 5-point Likert scale (range from 0, never, to 4, almost always). The higher the score the most impact fatigue has on the life of the person. .
Measured: Baseline
Modified Fatigue Impact Scale
Fatigue. Twenty-one items ar scored on a 5-point Likert scale (range from 0, never, to 4, almost always). The higher the score the most impact fatigue has on the life of the person. .
Measured: 2 weeks
Modified Fatigue Impact Scale
Fatigue. Twenty-one items ar scored on a 5-point Likert scale (range from 0, never, to 4, almost always). The higher the score the most impact fatigue has on the life of the person. .
Measured: 4 weeks
Modified Fatigue Impact Scale
Fatigue. Twenty-one items ar scored on a 5-point Likert scale (range from 0, never, to 4, almost always). The higher the score the most impact fatigue has on the life of the person. .
Measured: 6 weeks
Modified Fatigue Impact Scale
Fatigue. Twenty-one items ar scored on a 5-point Likert scale (range from 0, never, to 4, almost always). The higher the score the most impact fatigue has on the life of the person. .
Measured: 12 weeks (i.e. 6 weeks follow-up)
Trunk Impairment Scale
Trunk impairment. Scores range from 0 (minimum) to 23. The higher the score the less motor impairment is present in the trunk.
Measured: Baseline
Trunk Impairment Scale
Trunk impairment. Scores range from 0 (minimum) to 23. The higher the score the less motor impairment is present in the trunk.
Measured: 2 weeks
Trunk Impairment Scale
Trunk impairment. Scores range from 0 (minimum) to 23. The higher the score the less motor impairment is present in the trunk.
Measured: 4 weeks
Trunk Impairment Scale
Trunk impairment. Scores range from 0 (minimum) to 23. The higher the score the less motor impairment is present in the trunk.
Measured: 6 weeks
Trunk Impairment Scale
Trunk impairment. Scores range from 0 (minimum) to 23. The higher the score the less motor impairment is present in the trunk.
Measured: 12 weeks (i.e. 6 weeks follow-up)
Active Range of Motion
Active range of motion
Measured: Baseline
Active Range of Motion
Active range of motion
Measured: 2 weeks
Active Range of Motion
Active range of motion
Measured: 4 weeks
Active Range of Motion
Active range of motion
Measured: 6 weeks
Active Range of Motion
Active range of motion
Measured: 12 weeks (i.e. 6 weeks follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start4 Jan 2016
- Primary completion31 Aug 2016
- Study completion31 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System DiseasesStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Mixed-method pilot study in which persons with central nervous system diseases and occupational therapists were included
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- PXL University College
- Sponsor type
- University, hospital or other
- Collaborators
- Hasselt University, Hogeschool West-Vlaanderen, Jessa Hospital, Ziekenhuis Oost-Limburg, Revalidatie & MS Centrum Overpelt, Universitaire Ziekenhuizen KU Leuven
- Responsible party
- Principal investigator, Els Knippenberg, PXL University College
- Investigators
- Annemie Spooren, Prof.Dr, Study chair, PXL University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04692311
- Sponsor's protocol ID
- i-ACT pilot
- Acronym
- i-ACT
- Status last verified
- Dec 2020
- First submitted
- 21 Dec 2020
- Last updated
- 31 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Upon reasonable request, the data (in Dutch) can be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivation, Usability and Functionality of an Intelligent Activity-based Client-centred Training System in Neurological Rehabilitation: a Pilot Study
- ClinicalTrials.gov ID
- NCT04692311
- Acronym / sponsor ID
- i-ACT / i-ACT pilot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- PXL University CollegeUniversity, hospital or other
- Collaborators
- Hasselt University, Hogeschool West-Vlaanderen, Jessa Hospital, Ziekenhuis Oost-Limburg, Revalidatie & MS Centrum Overpelt, Universitaire Ziekenhuizen KU Leuven
- Study start
- 4 Jan 2016 (actual)
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 31 Aug 2016 (actual)
- First posted
- 31 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The pilot study was performed to evaluate the usability, credibility and expectancy of an intelligent, activity-based client-centred training system (i-ACT), and the motivation towards its use in neurological rehabilitation over a short period of time.
Detailed description
A mixed-method study was performed in four rehabilitation centres in Belgium. An homogenous convenience sample was recruited among persons with central nervous system disorders.
Participants received 3 x 45 minutes of training with the i-ACT system during six weeks, additional to conventional care. The Canadian Occupational Performance Measure (COPM) was used to collect and evaluate patients' individual goals towards rehabilitation. These goals were discussed with the therapists before implementing movements and exercises for each patient in the i-ACT system.
The following demographic data were obtained from the medical files: age, gender, and diagnosis. Outcomes measures were collected at baseline (T0), after 2 (T1), 4 (T2) and 6 (T3) weeks of training and at 9 weeks follow-up (T4).
The primary outcome measures were the Intrinsic Motivation Inventory (IMI), the System Usability Scale (SUS), Credibility/Expectancy Questionnaire (CEQ), the Canadian Occupational Performance Measure (COPM), and Wolf Motor Function Test (WMFT). The secondary measures were the Manual Ability Measure-36 (MAM-36), Modified Fatigue Impact Scale (MFIS), Trunk Impairment Scale (TIS), and Active Range of Motion (AROM).
After final training with i-ACT, a semi-structured interview was performed to gather more information about the participants' perception towards i-ACT.
For quantitative data, within-group differences of all the assessments were analysed using Friedman's ANOVA and Wilcoxon signed-rank test. Alpha was set at 0.05; No Bonferroni correction was applied as it is not compulsory in an exploratory study and furthermore, results are regarded as hypothesis for further investigations.
The qualitative data was collected and recorded with a voice recorder. No specific analysis was used as the interview collected data to support or oppose the findings of the quantitative data.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Mixed-method pilot study in which persons with central nervous system diseases and occupational therapists were included
| Arm | Type | Receives |
|---|---|---|
| Persons with central nervous system diseases | Experimental | Device: an intelligent client-centred task-oriented training, Other: Semi-structured interviewPersons with central nervous system diseases received additional training with i-ACT during 6 weeks. After final training, a semi-structured interview was performed. And at six weeks follow-up, a final assessment took place. |
| Occupational therapists | Other | Other: Semi-structured interviewOccupational therapists were invited to a semi-structured interview to gather information about their professional opinion regarding i-ACT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age over 18 years old
- a medical diagnosis of central nervous system disease
- dysfunction in upper limb and/or core stability
- Persons with multiple sclerosis (MS) had to be free of treatment with corticosteroids for one month.
- Persons with stroke or spinal cord injury, had to be at least three months post injury.
Key exclusion criteria (5 listed)
- severe spasticity (when spasticity impedes movement)
- severe cognitive impairment (person is not able to understand and follow instructions)
- severe communicative impairment (person is not able to answer questions)
- severe visual impairment (person is not able to see the television screen)
- persons who use an electric wheelchair
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 |
|---|---|---|
| an intelligent client-centred task-oriented trainingAlso: i-ACT3 x 45min of training with i-ACT system | Device | Persons with central nervous system diseases |
| Semi-structured interviewParticipants, patients and therapists, were invited to a semi-structured interview after training period. | Other | Occupational therapists, Persons with central nervous system diseases |
Primary outcome
Intrinsic Motivation Inventory
Time frame: 2 weeks
Motivation towards a therapy, in this i-ACT
Intrinsic Motivation Inventory
Time frame: 4 weeks
Motivation towards a therapy, in this i-ACT
Intrinsic Motivation Inventory
Time frame: 6 weeks
Motivation towards a therapy, in this i-ACT
Intrinsic Motivation Inventory
Time frame: 12 weeks (i.e. 6 weeks follow-up)
Motivation towards a therapy, in this i-ACT
System Usability Scale
Time frame: 2 weeks
Usability of a system, in this i-ACT. Range of scores from 0 (negative) to 100 (positive).
System Usability Scale
Time frame: 4 weeks
Usability of a system, in this i-ACT. Range of scores from 0 (negative) to 100 (positive).
System Usability Scale
Time frame: 6 weeks
Usability of a system, in this i-ACT. Range of scores from 0 (negative) to 100 (positive).
System Usability Scale
Time frame: 12 weeks (i.e. 6 weeks follow-up)
Usability of a system, in this i-ACT. Range of scores from 0 (negative) to 100 (positive).
Credibility/Expectancy Questionnaire
Time frame: 2 weeks
Credibility and expectancy of a training system, in this i-ACT. The range of scores on each subscale (i.e. credibility and expectancy) is 27.
Credibility/Expectancy Questionnaire
Time frame: 4 weeks
Credibility and expectancy of a training system, in this i-ACT. The range of scores on each subscale (i.e. credibility and expectancy) is 27.
Credibility/Expectancy Questionnaire
Time frame: 6 weeks
Credibility and expectancy of a training system, in this i-ACT. The range of scores on each subscale (i.e. credibility and expectancy) is 27.
Credibility/Expectancy Questionnaire
Time frame: 12 weeks (i.e. 6 weeks follow-up)
Credibility and expectancy of a training system, in this i-ACT. The range of scores on each subscale (i.e. credibility and expectancy) is 27.
Canadian Occupational Performance Measure
Time frame: Baseline
By means of a semi-structured interview, participants are asked to identify their 5 main goals in self-care, productivity and/or leisure. Scores range from 0 to 10 (best score) in each defined goal.
Canadian Occupational Performance Measure
Time frame: 4 weeks
By means of a semi-structured interview, participants are asked to identify their 5 main goals in self-care, productivity and/or leisure. Scores range from 0 to 10 (best score) in each defined goal.
Canadian Occupational Performance Measure
Time frame: 6 weeks
By means of a semi-structured interview, participants are asked to identify their 5 main goals in self-care, productivity and/or leisure. Scores range from 0 to 10 (best score) in each defined goal.
Canadian Occupational Performance Measure
Time frame: 12 weeks (i.e. 6 weeks follow-up)
By means of a semi-structured interview, participants are asked to identify their 5 main goals in self-care, productivity and/or leisure. Scores range from 0 to 10 (best score) in each defined goal.
Wolf Motor Function Test
Time frame: Baseline
Arm-hand functioning. The test contains 17 items and are scored from 0 (not able to perform tesk) to 5 (normal performance).
Wolf Motor Function Test
Time frame: 2 weeks
Arm-hand functioning. The test contains 17 items and are scored from 0 (not able to perform tesk) to 5 (normal performance).
Wolf Motor Function Test
Time frame: 4 weeks
Arm-hand functioning. The test contains 17 items and are scored from 0 (not able to perform tesk) to 5 (normal performance).
Wolf Motor Function Test
Time frame: 6 weeks
Arm-hand functioning. The test contains 17 items and are scored from 0 (not able to perform tesk) to 5 (normal performance).
Wolf Motor Function Test
Time frame: 12 weeks (i.e. 6 weeks follow-up)
Arm-hand functioning. The test contains 17 items and are scored from 0 (not able to perform tesk) to 5 (normal performance).
20 secondary outcomes
Manual Ability Measure-36
Time frame: Baseline
Manual Ability Measure-36
Time frame: 2 weeks
Manual Ability Measure-36
Time frame: 4 Weeks
Manual Ability Measure-36
Time frame: 6 weeks
Manual Ability Measure-36
Time frame: 12 weeks (i.e. 6 weeks follow-up)
Modified Fatigue Impact Scale
Time frame: Baseline
Modified Fatigue Impact Scale
Time frame: 2 weeks
Modified Fatigue Impact Scale
Time frame: 4 weeks
Modified Fatigue Impact Scale
Time frame: 6 weeks
Modified Fatigue Impact Scale
Time frame: 12 weeks (i.e. 6 weeks follow-up)
Trunk Impairment Scale
Time frame: Baseline
Trunk Impairment Scale
Time frame: 2 weeks
Trunk Impairment Scale
Time frame: 4 weeks
Trunk Impairment Scale
Time frame: 6 weeks
Trunk Impairment Scale
Time frame: 12 weeks (i.e. 6 weeks follow-up)
Active Range of Motion
Time frame: Baseline
Active Range of Motion
Time frame: 2 weeks
Active Range of Motion
Time frame: 4 weeks
Active Range of Motion
Time frame: 6 weeks
Active Range of Motion
Time frame: 12 weeks (i.e. 6 weeks follow-up)
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 31 Dec 2020.
- Individual participant dataSharing planned: No. Upon reasonable request, the data (in Dutch) can be shared with other researchers.
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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.
Annemie Spooren, Prof.Dr study chair
PXL University College
Questions about this trial
What is this clinical trial studying?
A study testing an intelligent client-centred task-oriented training and Semi-structured interview in people with Central Nervous System Diseases and Neurological Rehabilitation, run by PXL University College.
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 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 31 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Intrinsic Motivation Inventory (time frame: 2 weeks). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2020.