StrokeNCT04034069
Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial
A study testing Theta burst stimulation (TBS) and Robot-assisted training in people with Stroke, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
The aim of this study is to investigate the effects of intermittent theta burst stimulation primed with continous theta burst stimulation (cTBS), on top of a standard robot-assisted training (RAT) on improving the upper limb motor functions of stroke survivors and to explore potential sensorimotor neuroplasticity with… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Theta burst stimulation (TBS) and Robot-assisted training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteHong Kong
- Study dates
- 9 Sep 2019to 1 Aug 2021
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- with a diagnosis of a unilateral ischemic or hemorrhagic stroke;
- with stroke onset more than 6 months;
- from 18 to 75 years old;
- with mild to moderate impairment of upper limb functions due to stroke, measured using the Hong Kong Version of the Functional Test for the Hemiplegic Upper Extremity (FTHUE-HK) from level 2 to level 7;
- be able to understand verbal instruction and follow one-step commands;
- be able to give informed consent to participate;
Who cannot join
- any contraindications to rTMS/TBS, such as unstable medical condition, history of epileptic seizures, metal implants in vivo (eg, pacemaker, artificial cochlear, and implant brain stimulator), and a history of receiving craniotomy;
- previous diagnosis of any neurological disease excluding stroke;
- presence of any sign of cognitive problems (Abbreviated mental test Hong Kong version < 6/10);
- patients with extreme spasticity in any hemiplegic upper limb joint (Modified Ashworth score > 2) or severe pain that hinder the upper limb motor training;
- with other notable impairment of the upper limb affected by stroke, eg, recent fracture, severe osteoarthritis, congenital upper limb deformity
- any sign of anxiety or depression, as assessed by the Hospital Anxiety and Depression Scale.
- concurrent participation in an upper limb rehabilitation program or a medicine trial.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
The Hong Kong Polytechnic University, Department of Rehabilitation Sciences
Hong Kong
About this study
The aim of this study is to investigate the effects of intermittent theta burst stimulation primed with continous theta burst stimulation (cTBS), on top of a standard robot-assisted training (RAT) on improving the upper limb motor functions of stroke survivors and to explore potential sensorimotor neuroplasticity with electroencephalography (EEG).
Read the detailed description
Intermittent theta burst stimulation (iTBS) delivered to the affected primary motor cortex (M1) appears to enhance the brain response to rehabilitative intervention in patients with stroke. However, its clinical utility is highly affected by the response variability. New evidence has reported that preceding iTBS with a priming session of continuous theta burst stimulation (cTBS), may stabilize and even boost the facilitatory effect of iTBS on the stimulated M1, via metaplasticity. The aim of this study is to investigate the effects of iTBS primed with cTBS, on top of a standard robot-assisted training (RAT) on improving the upper limb motor functions of patients with chronic stroke and to explore potential sensorimotor neuroplasticity with electroencephalography (EEG). A three-arm randomized controlled trial (RCT) will be performed with an estimated total of 36 patients with subacute or chronic stroke. All participants will be randomly allocated to receive 10-session intervention of different TBS protocols (i.e., cTBS+iTBS, sham cTBS+iTBS and sham cTBS+sham iTBS), delivered for 3-5 sessions per week, lasting for 2-3 weeks. All participants will receive a 60-minute standard RAT after each stimulation session. Primary outcome will be Fugl-Meyer Assessment-Upper Extremity scores (FMA-UE). Secondary outcomes will be Action Research Arm Test (ARAT), kinematic outcomes generated during RAT as well as and EEG.
- Conditions
- Stroke
- Being tested
- Theta burst stimulation (TBS), Robot-assisted training
- Keywords
- stroke, theta burst stimulation, upper limb, metaplasticity, priming
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theta burst stimulation (TBS)Device
Also called Repetitive transcranial magnetic stimulation (rTMS)
Theta burst stimulation (TBS) is a potent form of repetitive transcranial magnetic stimulation (rTMS). Standard 600-pulse intermittent theta burst stimulation (iTBS) can enhance the corticomotor excitability, whereas standard 600-pulse continuous theta burst stimulation (cTBS) can suppress the corticomotor excitability. Sham stimulation uses an extreme low stimulation intensity which will not influence with corticomotor excitability. In the present study, real stimulation will be delivered in an intensity of 70% individual resting motor threshold while sham stimulation will be delivered in an intensity of 20% individual resting motor threshold.
Robot-assisted trainingBehavioural
Fourier M2 upper limb rehabilitation robot (Fourier Intelligence Co. Ltd., Shanghai, China), will be used for upper limb proximal joints training. Fourier M2 upper limb rehab robot is an end-effector robot-assisted device. The device targets (1) flexion and extension of shoulder joint, (2) flexion and extension of elbow, (3) internal and external rotation of shoulder joint, and (4) abduction and adduction of shoulder joint, supported by tailored interactive TV games in the device. HandyRehab hand robot (Zunosaki Company Ltd., Hong Kong SAR) will be used for upper limb distal joints training. It is an exoskeleton over the hand which provides power-driven extension and grasping force to the fingers and thumb in order to assist the patient to open and close the paretic hand by means of surface electromyography-triggered from the signals through the forearm extensors and flexors.
| Study group | Role | What they receive |
|---|---|---|
| cTBS + iTBS, in addition to robot-assisted training | Experimental | Participants will receive 10-session intervention of priming iTBS protocol (cTBS followed by iTBS, with an interval of 10 minutes). The stimulation will be delivered 3-5 sessions per week, lasting for 2-3 weeks. Participants will receive a 60-minute standard robot-assisted training after each stimulation session. Receives: Device: Theta burst stimulation (TBS); Behavioral: Robot-assisted training |
| Sham cTBS + iTBS, in addition to robot-assisted training | Active comparator | Participants will receive 10-session intervention of non-primed, standard iTBS (sham cTBS followed by iTBS, with an interval of 10 minutes). The stimulation will be delivered 3-5 sessions per week, lasting for 2-3 weeks. Participants will receive a 60-minute standard robot-assisted training after each stimulation session. Receives: Device: Theta burst stimulation (TBS); Behavioral: Robot-assisted training |
| Sham cTBS + sham iTBS, in addition to robot-assisted training | Sham comparator | Participants will receive 10-session intervention of sham stimulation (sham cTBS followed by sham iTBS, with an interval of 10 minutes). The stimulation will be delivered 3-5 sessions per week, lasting for 2-3 weeks. Participants will receive a 60-minute standard robot-assisted training after each stimulation session. Receives: Device: Theta burst stimulation (TBS); Behavioral: Robot-assisted training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment-Upper Extremity scores (FMA-UE)
FMA-UE is a standard upper limb motor impairment assessment for stroke survivors. FMA-UE assesses voluntary movement, reflex activity, grasp and coordination.
Measured: Baseline
Fugl-Meyer Assessment-Upper Extremity scores (FMA-UE)
FMA-UE is a standard upper limb motor impairment assessment for stroke survivors. FMA-UE assesses voluntary movement, reflex activity, grasp and coordination.
Measured: 1 week
Fugl-Meyer Assessment-Upper Extremity scores (FMA-UE)
FMA-UE is a standard upper limb motor impairment assessment for stroke survivors. FMA-UE assesses voluntary movement, reflex activity, grasp and coordination.
Measured: 2 weeks
Fugl-Meyer Assessment-Upper Extremity scores (FMA-UE)
FMA-UE is a standard upper limb motor impairment assessment for stroke survivors. FMA-UE assesses voluntary movement, reflex activity, grasp and coordination.
Measured: 2 weeks after the completion of training
Action Research Arm Test (ARAT)
ARAT is a standard upper limb functional performance assessment for stroke survivors. ARAT assesses a patient's ability to handle objects differing in size, weight and shape. ARAT consists of 19 items grouped into four subscales: grasp, grip, pinch, and gross movement.
Measured: Baseline
Action Research Arm Test (ARAT)
ARAT is a standard upper limb functional performance assessment for stroke survivors. ARAT assesses a patient's ability to handle objects differing in size, weight and shape. ARAT consists of 19 items grouped into four subscales: grasp, grip, pinch, and gross movement.
Measured: 1 week
Action Research Arm Test (ARAT)
ARAT is a standard upper limb functional performance assessment for stroke survivors. ARAT assesses a patient's ability to handle objects differing in size, weight and shape. ARAT consists of 19 items grouped into four subscales: grasp, grip, pinch, and gross movement.
Measured: 2 week
Action Research Arm Test (ARAT)
ARAT is a standard upper limb functional performance assessment for stroke survivors. ARAT assesses a patient's ability to handle objects differing in size, weight and shape. ARAT consists of 19 items grouped into four subscales: grasp, grip, pinch, and gross movement.
Measured: 2 weeks after the completion of training
Secondary outcomes (4)
Sensorimotor event-related desynchronization
Electroencephalographical assessment for cortical activation induced by movement and mirror visual feedback-based observation of movement
Measured: Baseline
Sensorimotor event-related desynchronization
Electroencephalographical assessment for cortical activation induced by movement and mirror visual feedback-based observation of movement
Measured: 2 weeks
Mean velocity
Mean velocity is a quantified assessment for movement efficiency during robot-assisted training with Fourier M2 device.
Measured: Baseline
Mean velocity
Mean velocity is a quantified assessment for movement efficiency during robot-assisted training with Fourier M2 device.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start9 Sep 2019
- Primary completion1 Jun 2021
- Study completion1 Aug 2021
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.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth N. K. Fong, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04034069
- Sponsor's protocol ID
- HSEARS20190718003
- Status last verified
- Aug 2021
- First submitted
- 23 Jul 2019
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be shared for research purpose upon reasonable request.
Publications
Zhang JJ, Bai Z, Fong KNK. Priming Intermittent Theta Burst Stimulation for Hemiparetic Upper Limb After Stroke: A Randomized Controlled Trial. Stroke. 2022 Jul;53(7):2171-2181. doi: 10.1161/STROKEAHA.121.037870. Epub 2022 Mar 23.
PubMed 35317611Zhang JJ, Fong KNK. Effects of priming intermittent theta burst stimulation on upper limb motor recovery after stroke: study protocol for a proof-of-concept randomised controlled trial. BMJ Open. 2020 Mar 8;10(3):e035348. doi: 10.1136/bmjopen-2019-035348.
PubMed 32152174
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04034069
- Acronym / sponsor ID
- HSEARS20190718003
- Conditions
- Stroke
- Keywords
- stroke, theta burst stimulation, upper limb, metaplasticity, priming
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 26 Jul 2019 (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 aim of this study is to investigate the effects of intermittent theta burst stimulation primed with continous theta burst stimulation (cTBS), on top of a standard robot-assisted training (RAT) on improving the upper limb motor functions of stroke survivors and to explore potential sensorimotor neuroplasticity with electroencephalography (EEG).
Detailed description
Intermittent theta burst stimulation (iTBS) delivered to the affected primary motor cortex (M1) appears to enhance the brain response to rehabilitative intervention in patients with stroke. However, its clinical utility is highly affected by the response variability. New evidence has reported that preceding iTBS with a priming session of continuous theta burst stimulation (cTBS), may stabilize and even boost the facilitatory effect of iTBS on the stimulated M1, via metaplasticity. The aim of this study is to investigate the effects of iTBS primed with cTBS, on top of a standard robot-assisted training (RAT) on improving the upper limb motor functions of patients with chronic stroke and to explore potential sensorimotor neuroplasticity with electroencephalography (EEG). A three-arm randomized controlled trial (RCT) will be performed with an estimated total of 36 patients with subacute or chronic stroke. All participants will be randomly allocated to receive 10-session intervention of different TBS protocols (i.e., cTBS+iTBS, sham cTBS+iTBS and sham cTBS+sham iTBS), delivered for 3-5 sessions per week, lasting for 2-3 weeks. All participants will receive a 60-minute standard RAT after each stimulation session. Primary outcome will be Fugl-Meyer Assessment-Upper Extremity scores (FMA-UE). Secondary outcomes will be Action Research Arm Test (ARAT), kinematic outcomes generated during RAT as well as and EEG.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cTBS + iTBS, in addition to robot-assisted training | Experimental | Device: Theta burst stimulation (TBS), Behavioral: Robot-assisted trainingParticipants will receive 10-session intervention of priming iTBS protocol (cTBS followed by iTBS, with an interval of 10 minutes). The stimulation will be delivered 3-5 sessions per week, lasting for 2-3 weeks. Participants will receive a 60-minute standard robot-assisted training after each stimulation session. |
| Sham cTBS + iTBS, in addition to robot-assisted training | Active comparator | Device: Theta burst stimulation (TBS), Behavioral: Robot-assisted trainingParticipants will receive 10-session intervention of non-primed, standard iTBS (sham cTBS followed by iTBS, with an interval of 10 minutes). The stimulation will be delivered 3-5 sessions per week, lasting for 2-3 weeks. Participants will receive a 60-minute standard robot-assisted training after each stimulation session. |
| Sham cTBS + sham iTBS, in addition to robot-assisted training | Sham comparator | Device: Theta burst stimulation (TBS), Behavioral: Robot-assisted trainingParticipants will receive 10-session intervention of sham stimulation (sham cTBS followed by sham iTBS, with an interval of 10 minutes). The stimulation will be delivered 3-5 sessions per week, lasting for 2-3 weeks. Participants will receive a 60-minute standard robot-assisted training after each stimulation session. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- with a diagnosis of a unilateral ischemic or hemorrhagic stroke;
- with stroke onset more than 6 months;
- from 18 to 75 years old;
- with mild to moderate impairment of upper limb functions due to stroke, measured using the Hong Kong Version of the Functional Test for the Hemiplegic Upper Extremity (FTHUE-HK) from level 2 to level 7;
- be able to understand verbal instruction and follow one-step commands;
Key exclusion criteria (7 listed)
- any contraindications to rTMS/TBS, such as unstable medical condition, history of epileptic seizures, metal implants in vivo (eg, pacemaker, artificial cochlear, and implant brain stimulator), and a history of receiving craniotomy;
- previous diagnosis of any neurological disease excluding stroke;
- presence of any sign of cognitive problems (Abbreviated mental test Hong Kong version < 6/10);
- patients with extreme spasticity in any hemiplegic upper limb joint (Modified Ashworth score > 2) or severe pain that hinder the upper limb motor training;
- with other notable impairment of the upper limb affected by stroke, eg, recent fracture, severe osteoarthritis, congenital upper limb deformity
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 |
|---|---|---|
| Theta burst stimulation (TBS)Also: Repetitive transcranial magnetic stimulation (rTMS)Theta burst stimulation (TBS) is a potent form of repetitive transcranial magnetic stimulation (rTMS). Standard 600-pulse intermittent theta burst stimulation (iTBS) can enhance the corticomotor excitability, whereas standard 600-pulse continuous theta burst stimulation (cTBS) can suppress the corticomotor excitability. Sham stimulation uses an extreme low stimulation intensity which will not influence with corticomotor excitability. In the present study, real stimulation will be delivered in an intensity of 70% individual resting motor threshold while sham stimulation will be delivered in an intensity of 20% individual resting motor threshold. | Device | Sham cTBS + iTBS, in addition to robot-assisted training, Sham cTBS + sham iTBS, in addition to robot-assisted training, cTBS + iTBS, in addition to robot-assisted training |
| Robot-assisted trainingFourier M2 upper limb rehabilitation robot (Fourier Intelligence Co. Ltd., Shanghai, China), will be used for upper limb proximal joints training. Fourier M2 upper limb rehab robot is an end-effector robot-assisted device. The device targets (1) flexion and extension of shoulder joint, (2) flexion and extension of elbow, (3) internal and external rotation of shoulder joint, and (4) abduction and adduction of shoulder joint, supported by tailored interactive TV games in the device. HandyRehab hand robot (Zunosaki Company Ltd., Hong Kong SAR) will be used for upper limb distal joints training. It is an exoskeleton over the hand which provides power-driven extension and grasping force to the fingers and thumb in order to assist the patient to open and close the paretic hand by means of surface electromyography-triggered from the signals through the forearm extensors and flexors. | Behavioural | Sham cTBS + iTBS, in addition to robot-assisted training, Sham cTBS + sham iTBS, in addition to robot-assisted training, cTBS + iTBS, in addition to robot-assisted training |
Primary outcome
Fugl-Meyer Assessment-Upper Extremity scores (FMA-UE)
Time frame: Baseline
FMA-UE is a standard upper limb motor impairment assessment for stroke survivors. FMA-UE assesses voluntary movement, reflex activity, grasp and coordination.
Fugl-Meyer Assessment-Upper Extremity scores (FMA-UE)
Time frame: 1 week
FMA-UE is a standard upper limb motor impairment assessment for stroke survivors. FMA-UE assesses voluntary movement, reflex activity, grasp and coordination.
Fugl-Meyer Assessment-Upper Extremity scores (FMA-UE)
Time frame: 2 weeks
FMA-UE is a standard upper limb motor impairment assessment for stroke survivors. FMA-UE assesses voluntary movement, reflex activity, grasp and coordination.
Fugl-Meyer Assessment-Upper Extremity scores (FMA-UE)
Time frame: 2 weeks after the completion of training
FMA-UE is a standard upper limb motor impairment assessment for stroke survivors. FMA-UE assesses voluntary movement, reflex activity, grasp and coordination.
Action Research Arm Test (ARAT)
Time frame: Baseline
ARAT is a standard upper limb functional performance assessment for stroke survivors. ARAT assesses a patient's ability to handle objects differing in size, weight and shape. ARAT consists of 19 items grouped into four subscales: grasp, grip, pinch, and gross movement.
Action Research Arm Test (ARAT)
Time frame: 1 week
ARAT is a standard upper limb functional performance assessment for stroke survivors. ARAT assesses a patient's ability to handle objects differing in size, weight and shape. ARAT consists of 19 items grouped into four subscales: grasp, grip, pinch, and gross movement.
Action Research Arm Test (ARAT)
Time frame: 2 week
ARAT is a standard upper limb functional performance assessment for stroke survivors. ARAT assesses a patient's ability to handle objects differing in size, weight and shape. ARAT consists of 19 items grouped into four subscales: grasp, grip, pinch, and gross movement.
Action Research Arm Test (ARAT)
Time frame: 2 weeks after the completion of training
ARAT is a standard upper limb functional performance assessment for stroke survivors. ARAT assesses a patient's ability to handle objects differing in size, weight and shape. ARAT consists of 19 items grouped into four subscales: grasp, grip, pinch, and gross movement.
4 secondary outcomes
Sensorimotor event-related desynchronization
Time frame: Baseline
Sensorimotor event-related desynchronization
Time frame: 2 weeks
Mean velocity
Time frame: Baseline
Mean velocity
Time frame: 2 weeks
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 30 Aug 2021.
- Derived from this study: PubMed 35317611Zhang JJ, Bai Z, Fong KNK. Priming Intermittent Theta Burst Stimulation for Hemiparetic Upper Limb After Stroke: A Randomized Controlled Trial. Stroke. 2022 Jul;53(7):2171-2181. doi: 10.1161/STROKEAHA.121.037870. Epub 2022 Mar 23.
- Derived from this study: PubMed 32152174Zhang JJ, Fong KNK. Effects of priming intermittent theta burst stimulation on upper limb motor recovery after stroke: study protocol for a proof-of-concept randomised controlled trial. BMJ Open. 2020 Mar 8;10(3):e035348. doi: 10.1136/bmjopen-2019-035348.
- Individual participant dataSharing planned: No. The data will be shared for research purpose upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theta burst stimulation (TBS) and Robot-assisted training in people with Stroke, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. 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. Some participants in this study may receive a placebo. 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?
Fugl-Meyer Assessment-Upper Extremity scores (FMA-UE) (time frame: Baseline). The study lists 8 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 NCT04034069, 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 30 Aug 2021.