StrokeHOMEMUSICNCT04507542
Enriched Music-Supported Therapy to Restore Motor Deficits After Stroke
A study testing Enriched Music-Supported Therapy and Graded Repetitive Arm Supplementary Program in people with Stroke, run by University of Barcelona at 1 site in Spain.
Trial summary
Music-Supported Therapy (MST) is a rehabilitation technique to improve the upper extremity motor function of stroke patients through playing musical instruments. A modified version of the MST protocol has been created (hereafter, referred as enriched MST, eMST) to include (i) a home-based self-training program using… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Enriched Music-Supported Therapy and Graded Repetitive Arm Supplementary Program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2020to 1 Jul 2022
- 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
- Presence of mild-to-moderate paresis of the upper extremity after a stroke (having a score between 1 and 4 in the Medical Research Council Scale for Muscle Strength at the distal muscles of the upper extremity);
- More than 6 months post-stroke;
- Completion of formal rehabilitation programs.
Who cannot join
- Major language or cognitive deficits affecting comprehension (Mini-Mental State Examination < 24);
- Neurological or psychiatric co-morbidity;
- Other musculoskeletal condition affecting upper extremity motor function (e.g. fracture or arthritis).
Trial locations and contacts
1 site in 1 country.
Spain1 site
Bellvitge Biomedical Research Institute
L'Hospitalet de Llobregat, Barcelona, 08908
Research Office, +34932607411
About this study
Official title: Playing and Singing for the Recovering Brain: Efficacy of Enriched Social-Motivational Musical Interventions in Stroke Rehabilitation
Music-Supported Therapy (MST) is a rehabilitation technique to improve the upper extremity motor function of stroke patients through playing musical instruments. A modified version of the MST protocol has been created (hereafter, referred as enriched MST, eMST) to include (i) a home-based self-training program using an app for electronic tablets and (ii) weekly group sessions of musical playing strengthening the motivational and emotional components of music playing. A randomised controlled trial will be conducted to test the effectiveness of this enriched MST (eMST) protocol in improving motor functions, cognition, emotional well-being and quality of life when compared to a program of home-based exercises utilizing the Graded Repetitive Arm Supplementary Program (GRASP). Sixty stroke patients will be recruited and randomly allocated to an eMST group (n=30) or a control GRASP intervention group (n=30). Patients will be evaluated before and after a 10-week intervention, as well as at 3-month follow-up. The primary outcome of the study is the functionality of the paretic upper limb measured with the Action Research Arm Test. Secondary outcomes include other motor and cognitive functions, emotional well-being and quality of life measures as well as self-regulation and self-efficacy outcomes. We hypothesize that patients treated with eMST will show larger improvements in their motor and cognitive functions, emotional well-being and quality of life than patients treated with a home-based GRASP intervention.
- Conditions
- Stroke
- Being tested
- Enriched Music-Supported Therapy, Graded Repetitive Arm Supplementary Program
- Keywords
- stroke, rehabilitation, music therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enriched Music-Supported TherapyBehavioural
Also called Music-Supported Therapy
Home-based rehabilitation program for stroke patients aimed at improving the upper extremity motor function. The program is based on musical training, combining self-training sessions of music playing using an app for electronic tablets and music therapy group sessions.
Graded Repetitive Arm Supplementary ProgramBehavioural
Also called GRASP
Home-based rehabilitation program for stroke patients aimed at improving the upper extremity motor function. The program comprises self-training sessions of mass repetition of movements and task-specific exercises for the upper extremity.
| Study group | Role | What they receive |
|---|---|---|
| Enriched Music-Supported Therapy group | Experimental | Participants in the eMST-group will follow a 10-week program of Enriched Music-Supported Therapy. The program comprises 3 individual self-training sessions and 1 group session per week (total program duration: 40 hours). Receives: Behavioral: Enriched Music-Supported Therapy |
| Control group | Active comparator | Participants in the control intervention group will follow the Graded Repetitive Arm Supplementary Program (GRASP, Harris et al., 2009). They will be asked to complete 4 weekly one-hour session for 10 weeks (total program duration: 40 hours). Receives: Behavioral: Graded Repetitive Arm Supplementary Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Action Research Arm Test
Upper extremity function measure. The measure is a 19-item test divided into four subtests (grasp, grip, pinch and gross movement). For each item, the patient is asked to perform a simple task that involves a functional movement of the affected upper limb. Each task is rated using a 4-point ordinal scale. The maximum possible score is 57 and the minimal clinically important difference is 5.7 points.
Measured: immediately after the intervention
Change in Action Research Arm Test
Upper extremity function measure. The measure is a 19-item test divided into four subtests (grasp, grip, pinch and gross movement). For each item, the patient is asked to perform a simple task that involves a functional movement of the affected upper limb. Each task is rated using a 4-point ordinal scale. The maximum possible score is 57 and the minimal clinically important difference is 5.7 points.
Measured: 3 months after completing the intervention
Secondary outcomes (28)
Change in Fugl-Meyer Assessment of Motor Recovery after Stroke
Motor impairment measure. It comprises 33 items that evaluate motor impairment in the affected upper limb. The test is divided into 4 sections (shoulder, forearm and elbow, wrist, hand and coordination) assessing reflexes, flexor and extensor synergies, range of motion, and overall coordination and speed of the upper extremity. Each item is graded using an ordinal scale from 0 to 2. The maximum possible score is 66 and the minimal clinically important difference for chronic stroke patients is 5.2 points.
Measured: immediately after the intervention
Change in Fugl-Meyer Assessment of Motor Recovery after Stroke
Motor impairment measure. It comprises 33 items that evaluate motor impairment in the affected upper limb. The test is divided into 4 sections (shoulder, forearm and elbow, wrist, hand and coordination) assessing reflexes, flexor and extensor synergies, range of motion, and overall coordination and speed of the upper extremity. Each item is graded using an ordinal scale from 0 to 2. The maximum possible score is 66 and the minimal clinically important difference for chronic stroke patients is 5.2 points.
Measured: 3 months after completing the intervention
Change in Grip Strength in Kgs
Grip strength measure, Biometrics E-Link tool
Measured: immediately after the intervention
Change in Grip Strength in Kgs
Grip strength measure, Biometrics E-Link tool
Measured: 3 months after completing the intervention
Change in Box and Block Test
Gross manual dexterity measure
Measured: immediately after the intervention
Change in Box and Block Test
Gross manual dexterity measure
Measured: 3 months after completing the intervention
Change in Nine Hole Pegboard Test
Fine manual dexterity measure
Measured: immediately after the intervention
Change in Nine Hole Pegboard Test
Fine manual dexterity measure
Measured: 3 months after completing the intervention
Change in Chedoke Arm and Hand Activity Inventory
Motor performance in activities of daily living measure. The test is composed of 13 different tasks (i.e. open a jar of coffee, make a phone call, clean a pair of eyeglasses) and each task is graded using an ordinal scale from 1 to 7. Maximum score is 91, indicating good performance.
Measured: immediately after the intervention
Change in Chedoke Arm and Hand Activity Inventory
Motor performance in activities of daily living measure. The test is composed of 13 different tasks (i.e. open a jar of coffee, make a phone call, clean a pair of eyeglasses) and each task is graded using an ordinal scale from 1 to 7. Maximum score is 91, indicating good performance.
Measured: 3 months after completing the intervention
Change in Behaviour Rating Inventory of Executive Function
Executive function measure. It comprises 75 items describing various behaviours, and the participant is asked to report if the behaviour is never a problem, sometimes a problem or often a problem.
Measured: immediately after the intervention
Change in Behaviour Rating Inventory of Executive Function
Executive function measure. It comprises 75 items describing various behaviours, and the participant is asked to report if the behaviour is never a problem, sometimes a problem or often a problem.
Measured: 3 months after completing the intervention
Change in Sustained Attention to Response Task
Sustained attention measure
Measured: immediately after the intervention
Change in Sustained Attention to Response Task
Sustained attention measure
Measured: 3 months after completing the intervention
Change in Figural Memory Subtest
Visuospatial memory measure
Measured: immediately after the intervention
Change in Figural Memory Subtest
Visuospatial memory measure
Measured: 3 months after completing the intervention
Change in Rey Auditory Verbal Learning Test
Verbal learning measure
Measured: immediately after the intervention
Change in Rey Auditory Verbal Learning Test
Verbal learning measure
Measured: 3 months after completing the intervention
Change in Fluency Test
Verbal fluency measure
Measured: immediately after the intervention
Change in Fluency Test
Verbal fluency measure
Measured: 3 months after completing the intervention
Change in Beck Depression Inventory-II
Depression measure. It comprises 21 multiple-choice questions that are scored on a scale from 0 to 3. The participant is asked about feelings, thoughts and behaviours of the past week. Higher scores indicate depression severity and the maximum possible score of the measure is 63.
Measured: immediately after the intervention
Change in Beck Depression Inventory-II
Depression measure. It comprises 21 multiple-choice questions that are scored on a scale from 0 to 3. The participant is asked about feelings, thoughts and behaviours of the past week. Higher scores indicate depression severity and the maximum possible score of the measure is 63.
Measured: 3 months after completing the intervention
Change in Apathy Evaluation Scale
Apathy measure. The scale comprises a self and informant reports both consisting of 18 items that are scored on a 4-point Likert scale, where higher scores indicate more apathy.
Measured: immediately after the intervention
Change in Apathy Evaluation Scale
Apathy measure. The scale comprises a self and informant reports both consisting of 18 items that are scored on a 4-point Likert scale, where higher scores indicate more apathy.
Measured: 3 months after completing the intervention
Change in Profile of Mood States
Mood measure. The measure includes 65 items that are scored on a 5-point Likert scale ranging from 0 "not at all" to 4 "extremely".
Measured: immediately after the intervention
Change in Profile of Mood States
Mood measure. The measure includes 65 items that are scored on a 5-point Likert scale ranging from 0 "not at all" to 4 "extremely".
Measured: 3 months after completing the intervention
Change in Stroke Impact Scale
Quality of life measure. It is a 59-item self-report questionnaire that assesses muscle strength, hand function, basic and instrumental activities of daily living, global mobility, communication, emotion, memory and thinking, and participation.
Measured: immediately after the intervention
Change in Stroke Impact Scale
Quality of life measure. It is a 59-item self-report questionnaire that assesses muscle strength, hand function, basic and instrumental activities of daily living, global mobility, communication, emotion, memory and thinking, and participation.
Measured: 3 months after completing the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start1 Sep 2020 (estimated)
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A parallel-group randomised controlled trial will be conducted with participants being randomised to either an enriched Music-Supported Therapy group or to a control treatment group receiving the Graded Repetitive Arm Supplementary Program (GRASP, Harris et al., 2009).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Artificial Intelligence Research Institute, Spanish National Research Council, University of Helsinki
- Responsible party
- Principal investigator, Antoni Rodriguez Fornells, University of Barcelona
- Investigators
- Antoni Rodríguez Fornells, PhD, Principal investigator, Bellvitge Biomedical Research Institute, University of BarcelonaJennifer Grau Sánchez, PhD, Study director, Bellvitge Biomedical Research Institute, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04507542
- Sponsor's protocol ID
- 201729.30
- Acronym
- HOMEMUSIC
- Status last verified
- Aug 2020
- First submitted
- 3 Aug 2020
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Segura E, Grau-Sanchez J, Cerda-Company X, Porto MF, De la Cruz-Puebla M, Sanchez-Pinsach D, Cerquides J, Duarte E, Palumbo A, Turry A, Raghavan P, Sarkamo T, Munte TF, Arcos JL, Rodriguez-Fornells A. Enriched music-supported therapy for individuals with chronic stroke: a randomized controlled trial. J Neurol. 2024 Oct;271(10):6606-6617. doi: 10.1007/s00415-024-12570-3. Epub 2024 Aug 7.
PubMed 39112892Grau-Sanchez J, Segura E, Sanchez-Pinsach D, Raghavan P, Munte TF, Palumbo AM, Turry A, Duarte E, Sarkamo T, Cerquides J, Arcos JL, Rodriguez-Fornells A. Enriched Music-supported Therapy for chronic stroke patients: a study protocol of a randomised controlled trial. BMC Neurol. 2021 Jan 12;21(1):19. doi: 10.1186/s12883-020-02019-1.
PubMed 33435919
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Playing and Singing for the Recovering Brain: Efficacy of Enriched Social-Motivational Musical Interventions in Stroke Rehabilitation
- ClinicalTrials.gov ID
- NCT04507542
- Acronym / sponsor ID
- HOMEMUSIC / 201729.30
- Conditions
- Stroke
- Keywords
- stroke, rehabilitation, music therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Collaborators
- Artificial Intelligence Research Institute, Spanish National Research Council, University of Helsinki
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 11 Aug 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.
Music-Supported Therapy (MST) is a rehabilitation technique to improve the upper extremity motor function of stroke patients through playing musical instruments. A modified version of the MST protocol has been created (hereafter, referred as enriched MST, eMST) to include (i) a home-based self-training program using an app for electronic tablets and (ii) weekly group sessions of musical playing strengthening the motivational and emotional components of music playing. A randomised controlled trial will be conducted to test the effectiveness of this enriched MST (eMST) protocol in improving motor functions, cognition, emotional well-being and quality of life when compared to a program of home-based exercises utilizing the Graded Repetitive Arm Supplementary Program (GRASP). Sixty stroke patients will be recruited and randomly allocated to an eMST group (n=30) or a control GRASP intervention group (n=30). Patients will be evaluated before and after a 10-week intervention, as well as at 3-month follow-up. The primary outcome of the study is the functionality of the paretic upper limb measured with the Action Research Arm Test. Secondary outcomes include other motor and cognitive functions, emotional well-being and quality of life measures as well as self-regulation and self-efficacy outcomes. We hypothesize that patients treated with eMST will show larger improvements in their motor and cognitive functions, emotional well-being and quality of life than patients treated with a home-based GRASP intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A parallel-group randomised controlled trial will be conducted with participants being randomised to either an enriched Music-Supported Therapy group or to a control treatment group receiving the Graded Repetitive Arm Supplementary Program (GRASP, Harris et al., 2009).
| Arm | Type | Receives |
|---|---|---|
| Enriched Music-Supported Therapy group | Experimental | Behavioral: Enriched Music-Supported TherapyParticipants in the eMST-group will follow a 10-week program of Enriched Music-Supported Therapy. The program comprises 3 individual self-training sessions and 1 group session per week (total program duration: 40 hours). |
| Control group | Active comparator | Behavioral: Graded Repetitive Arm Supplementary ProgramParticipants in the control intervention group will follow the Graded Repetitive Arm Supplementary Program (GRASP, Harris et al., 2009). They will be asked to complete 4 weekly one-hour session for 10 weeks (total program duration: 40 hours). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Presence of mild-to-moderate paresis of the upper extremity after a stroke (having a score between 1 and 4 in the Medical Research Council Scale for Muscle Strength at the distal muscles of the upper extremity);
- More than 6 months post-stroke;
- Completion of formal rehabilitation programs.
Key exclusion criteria (3 listed)
- Major language or cognitive deficits affecting comprehension (Mini-Mental State Examination < 24);
- Neurological or psychiatric co-morbidity;
- Other musculoskeletal condition affecting upper extremity motor function (e.g. fracture or arthritis).
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 |
|---|---|---|
| Enriched Music-Supported TherapyAlso: Music-Supported TherapyHome-based rehabilitation program for stroke patients aimed at improving the upper extremity motor function. The program is based on musical training, combining self-training sessions of music playing using an app for electronic tablets and music therapy group sessions. | Behavioural | Enriched Music-Supported Therapy group |
| Graded Repetitive Arm Supplementary ProgramAlso: GRASPHome-based rehabilitation program for stroke patients aimed at improving the upper extremity motor function. The program comprises self-training sessions of mass repetition of movements and task-specific exercises for the upper extremity. | Behavioural | Control group |
Primary outcome
Change in Action Research Arm Test
Time frame: immediately after the intervention
Upper extremity function measure. The measure is a 19-item test divided into four subtests (grasp, grip, pinch and gross movement). For each item, the patient is asked to perform a simple task that involves a functional movement of the affected upper limb. Each task is rated using a 4-point ordinal scale. The maximum possible score is 57 and the minimal clinically important difference is 5.7 points.
Change in Action Research Arm Test
Time frame: 3 months after completing the intervention
Upper extremity function measure. The measure is a 19-item test divided into four subtests (grasp, grip, pinch and gross movement). For each item, the patient is asked to perform a simple task that involves a functional movement of the affected upper limb. Each task is rated using a 4-point ordinal scale. The maximum possible score is 57 and the minimal clinically important difference is 5.7 points.
28 secondary outcomes
Change in Fugl-Meyer Assessment of Motor Recovery after Stroke
Time frame: immediately after the intervention
Change in Fugl-Meyer Assessment of Motor Recovery after Stroke
Time frame: 3 months after completing the intervention
Change in Grip Strength in Kgs
Time frame: immediately after the intervention
Change in Grip Strength in Kgs
Time frame: 3 months after completing the intervention
Change in Box and Block Test
Time frame: immediately after the intervention
Change in Box and Block Test
Time frame: 3 months after completing the intervention
Change in Nine Hole Pegboard Test
Time frame: immediately after the intervention
Change in Nine Hole Pegboard Test
Time frame: 3 months after completing the intervention
Change in Chedoke Arm and Hand Activity Inventory
Time frame: immediately after the intervention
Change in Chedoke Arm and Hand Activity Inventory
Time frame: 3 months after completing the intervention
Change in Behaviour Rating Inventory of Executive Function
Time frame: immediately after the intervention
Change in Behaviour Rating Inventory of Executive Function
Time frame: 3 months after completing the intervention
Change in Sustained Attention to Response Task
Time frame: immediately after the intervention
Change in Sustained Attention to Response Task
Time frame: 3 months after completing the intervention
Change in Figural Memory Subtest
Time frame: immediately after the intervention
Change in Figural Memory Subtest
Time frame: 3 months after completing the intervention
Change in Rey Auditory Verbal Learning Test
Time frame: immediately after the intervention
Change in Rey Auditory Verbal Learning Test
Time frame: 3 months after completing the intervention
Change in Fluency Test
Time frame: immediately after the intervention
Change in Fluency Test
Time frame: 3 months after completing the intervention
Change in Beck Depression Inventory-II
Time frame: immediately after the intervention
Change in Beck Depression Inventory-II
Time frame: 3 months after completing the intervention
Change in Apathy Evaluation Scale
Time frame: immediately after the intervention
Change in Apathy Evaluation Scale
Time frame: 3 months after completing the intervention
Change in Profile of Mood States
Time frame: immediately after the intervention
Change in Profile of Mood States
Time frame: 3 months after completing the intervention
Change in Stroke Impact Scale
Time frame: immediately after the intervention
Change in Stroke Impact Scale
Time frame: 3 months after completing the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- Derived from this study: PubMed 39112892Segura E, Grau-Sanchez J, Cerda-Company X, Porto MF, De la Cruz-Puebla M, Sanchez-Pinsach D, Cerquides J, Duarte E, Palumbo A, Turry A, Raghavan P, Sarkamo T, Munte TF, Arcos JL, Rodriguez-Fornells A. Enriched music-supported therapy for individuals with chronic stroke: a randomized controlled trial. J Neurol. 2024 Oct;271(10):6606-6617. doi: 10.1007/s00415-024-12570-3. Epub 2024 Aug 7.
- Derived from this study: PubMed 33435919Grau-Sanchez J, Segura E, Sanchez-Pinsach D, Raghavan P, Munte TF, Palumbo AM, Turry A, Duarte E, Sarkamo T, Cerquides J, Arcos JL, Rodriguez-Fornells A. Enriched Music-supported Therapy for chronic stroke patients: a study protocol of a randomised controlled trial. BMC Neurol. 2021 Jan 12;21(1):19. doi: 10.1186/s12883-020-02019-1.
- Research group webpageLink provided by the sponsor.
- 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.
Antoni Rodríguez Fornells, PhD principal investigator
Bellvitge Biomedical Research Institute, University of Barcelona
Jennifer Grau Sánchez, PhD study director
Bellvitge Biomedical Research Institute, University of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enriched Music-Supported Therapy and Graded Repetitive Arm Supplementary Program in people with Stroke, run by University of Barcelona at 1 site in Spain.
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 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2020. 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 Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antoni Rodríguez Fornells, PhD (+34934020489, antoni.rodriguez@icrea.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Action Research Arm Test (time frame: immediately after the intervention). The study lists 2 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 NCT04507542, which also lists 2 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 11 Aug 2020.