StrokePhase 3NCT02749591
Comparative Hybrid Effects of Combining BoNT-A With Robot-assisted or Mirror Therapy for U/E Spasticity Stroke Patients
A Phase 3 study testing Botulinum Toxin Type A, Robot-assisted therapy and Mirror therapy in people with Stroke, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The aim of this study will be to determine and compare the immediate and longer-term effects of combination of BoNT-A injection and mirror therapy vs combination of BoNT-A injection and robot-assisted therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Botulinum Toxin Type A, Robot-assisted therapy and Mirror therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 May 2016to Nov 2017
- Phase
- Phase 3
- 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
- Willing to provide written informed consent
- Clinical and imagine diagnosis of a first or recurrent unilateral stroke ≥ 3 months
- Upper limb spasticity (Modified Ashworth scale of ≥ 2)
- Moderate to severe movement impairment of U/E (FMA score ranging from 18 to 56)
- No serious cognitive impairment (i.e., Mini Mental State Exam score > 18)
- Age ≥ 18 years
Who cannot join
- Pregnant
- Bilateral hemispheric or cerebellar lesions
- Significant visual field deficits or hemineglect
- Contraindication for BoNT-A injection
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Rehabilitation, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan
Kaohsiung City, 833
About this study
Official title: Comparative Hybrid Effects of Combining Botulinum Toxin Type A With Robot-assisted Training v.s. With Mirror Therapy for Stroke Patients With Upper Extremity Spasticity: A Randomized Controlled Study
The aim of this study will be to determine and compare the immediate and longer-term effects of combination of BoNT-A injection and mirror therapy vs combination of BoNT-A injection and robot-assisted therapy.
Read the detailed description
The purpose of this project is to examine and compare the immediate and long-term effects of combined Botulinum toxin type A injection with mirror therapy (MT) and with bilateral robot-assisted (RT) in patients with spastic hemiplegic stroke. Spasticity, a common impairment after stroke, has a profound impact on activity and participation for patients. BoNT-A injection combined with rehabilitation training is recommended to enhance functional recovery for stroke patients with spasticity. Although the positive combination effects of BoNT-A with stretch, RT, and constraint-induced movement therapy were reported, the quality of the evidence was weak due to methodology limitations. In addition, patients with spasticity usually have lower motor function and worse sensory deficits than patients without spasticity. Designing the post BoNT-A injection rehabilitation program should consider the above issues. RT and MT are two interventions providing sensorimotor input for patient with low level of motor function. It is unknown whether combining BoNT-A injection with RT or with MT have positive effects and engenders differential effects on motor and related functional performance.
At least 60 participants with chronic spastic hemiplegic stroke will be recruited and randomly assigned to one of 3 groups: BoNT-A injection with RT, BoNT-A injection with MT, and BoNT-A injection with control intervention (CI). All the post-injection interventions will be implemented 60 minutes/day, 3 days/week, for 8 weeks. The RT group will receive 30-minute RT, followed by 30-minute functional training. The MT group will receive 30-minute MT, followed by 30-minute functional training. The CI group will receive 60-minute rehabilitation program, such as bilateral arm training and functional task practice. Body function and structures outcome measures include Fugl-Meyer Assessment, Modified Ashworth Scale, Medical Research Council scale, myometer (Myoton-3), actigraph, and Pittsburgh Sleep Quality Index. Activity and participation measures include Wolf Motor Function Test, Ten meter walk test, Motor Activity Log, Nottingham Extended Activities of Daily Living Scale, and Canadian Occupational Performance Measure. In addition, to directly reflect a patient's unique needs and goals, Goal Attainment Scaling will be assessed. Evaluators will be blind to group allocation. The outcome will be measured at pre-treatment, post-treatment, and 3-month follow-up.
This comparative efficacy study will be the first to examine and compare the immediate and long-term combination effects of BoNT injection with RT, MT, or CI. The follow-up assessments will provide the long-term effects of different treatments on health-related outcomes, which are crucial for community reentry. In addition, the results of objective assessments and patient-reported outcomes may lead to individualized upper limb training following BoNT-A injection for patients with spastic hemiplegic stroke.
- Conditions
- Stroke
- Being tested
- Botulinum Toxin Type A, Robot-assisted therapy, Mirror therapy, Control intervention
- Keywords
- stroke rehabilitation, spasticity, Botulinum toxin type A injection, robot-assisted therapy, mirror therapy, randomized controlled trial
- Medical subject headings
- Stroke, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Botulinum Toxin
To inject Botulinum toxin type A on the spasticity upper extremity for stroke patients.Doses and muscles selected for BoNT-A injection are individualized on the basis of a number of factors, including the spasticity patterns, severity of spasticity, and treatment goals
Robot-assisted therapyOther
After injecting Botulinum toxin type A on the spasticity upper extremity, the RT group will receive a 45 minutes of robotic training and 30 minutes of training in functional training.
Mirror therapyOther
After injecting Botulinum toxin type A on the spasticity upper extremity, the MT group will receive a 45-minute MT per session followed by 30 minutes of task-oriented functional training.
Control interventionOther
After injecting Botulinum toxin type A on the spasticity upper extremity, the CI group will receive 75-minute rehabilitation program, focusing on upper extremity training and including neurodevelopmental techniques, trunk-arm control, weight bearing by the affected arm, fine motor tasks practice, functional task practice, and practice on compensatory strategies for daily activities.
| Study group | Role | What they receive |
|---|---|---|
| Robot-assisted therapy (RT) | Experimental | After injection with Botulinum Toxin Type A, a schedule of robot-assisted therapy appointments will be established. Each intervention includes 45 minutes of robotic training and 30 minutes of training in functional activities. Receives: Drug: Botulinum Toxin Type A; Other: Robot-assisted therapy |
| Mirror therapy (MT) | Experimental | After injection with Botulinum Toxin Type A, a schedule of mirror therapy appointments will be established.The MT group will receive a 45-minute MT per session followed by 30 minutes of task-oriented functional training. Receives: Drug: Botulinum Toxin Type A; Other: Mirror therapy |
| Control Intervention (CI) | Active comparator | After injection with Botulinum Toxin Type A, a schedule of control intervention appointments will be established.The CI group will receive 75-minute rehabilitation program, focusing on upper extremity training and including neurodevelopmental techniques, trunk-arm control, weight bearing by the affected arm, fine motor tasks practice, functional task practice, and practice on compensatory strategies for daily activities. Receives: Drug: Botulinum Toxin Type A; Other: Control intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor function assessed on Fugl-Meyer Assessment (FMA)
The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.
Measured: Change from baseline at 5 months
Secondary outcomes (13)
Muscle power assessed on Medical Research Council Scale (MRC)
The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.
Measured: Change from baseline at 5 months
Muscle tone assessed on Modified Ashworth Scale (MAS)
The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.
Measured: Change from baseline at 5 months
The functional state assessed on Myometer Assessment
The outcome will be measured at 4 time points: 0 week, 1 week, 8 weeks, and 5 months after recruitment.
Measured: Change from baseline at 5 months
The amount of movement assessed on Actigraph Assessment
The outcome will be measured at 2 time points: 0 week, and 8 weeks after recruitment.
Measured: Change from baseline at 2 months
The quality of sleep assessed on Pittsburgh Sleep Quality Index (PSQI)
The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.
Measured: Change from baseline at 5 months
Walking speed assessed on Ten Meter Walk Test (10MWT)
The outcome will be measured at 2 time points: 0 week, and 8 weeks after recruitment.
Measured: Change from baseline at 2 months
The upper extremity motor ability assessed on Wolf Motor Function Test (WMFT)
The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.
Measured: Change from baseline at 5 months
The quality of movement and amount of use assessed on Motor Activity Log (MAL)
The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.
Measured: Change from baseline at 5 months
The instrumental activities of daily living assessed on Nottingham Extended Activities of Daily Living Scale (NEADL)
The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.
Measured: Change from baseline at 5 months
The participant's perception of the performance assessed on Canadian Occupational Performance Measure (COPM)
The outcome will be measured at 3 time points: 0 week, 1week, and 8 weeks after recruitment.
Measured: Change from baseline at 2 months
The participants' individual goals assessed on Goal attainment scale (GAS)
The outcome will be measured at 4 time points: 0 week, 1 week, 8 weeks, and 5 months after recruitment.
Measured: Change from baseline at 5 months
Revised Notttingham Sensory Assessment (RNSA)
The outcome will be measured at 3 time points: 0 week, 1week, and 8 weeks after recruitment.
Measured: Change from baseline at 2 months
Stroke Impact Scale (SIS)
The outcome will be measured at 4 time points: 0 week, 1 week, 8 weeks, and 5 months after recruitment.
Measured: Change from baseline at 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study start2 May 2016
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jen-Wen Hung, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02749591
- Sponsor's protocol ID
- 104-9732A3
- Status last verified
- May 2017
- First submitted
- 7 Apr 2016
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ada L, O'Dwyer N, O'Neill E. Relation between spasticity, weakness and contracture of the elbow flexors and upper limb activity after stroke: an observational study. Disabil Rehabil. 2006 Jul 15-30;28(13-14):891-7. doi: 10.1080/09638280500535165.
PubMed 16777777Amano S, Takebayashi T, Hanada K, Umeji A, Marumoto K, Furukawa K, Domen K. Constraint-Induced Movement Therapy After Injection of Botulinum Toxin Type A for a Patient With Chronic Stroke: One-Year Follow-up Case Report. Phys Ther. 2015 Jul;95(7):1039-45. doi: 10.2522/ptj.20140329. Epub 2015 Jan 15.
PubMed 25592185Bhakta BB, Cozens JA, Chamberlain MA, Bamford JM. Impact of botulinum toxin type A on disability and carer burden due to arm spasticity after stroke: a randomised double blind placebo controlled trial. J Neurol Neurosurg Psychiatry. 2000 Aug;69(2):217-21. doi: 10.1136/jnnp.69.2.217.
PubMed 10896696Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.
PubMed 3809245
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Hybrid Effects of Combining Botulinum Toxin Type A With Robot-assisted Training v.s. With Mirror Therapy for Stroke Patients With Upper Extremity Spasticity: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02749591
- Acronym / sponsor ID
- 104-9732A3
- Conditions
- Stroke
- Keywords
- stroke rehabilitation, spasticity, Botulinum toxin type A injection, robot-assisted therapy, mirror therapy, randomized controlled trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 2 May 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 25 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study will be to determine and compare the immediate and longer-term effects of combination of BoNT-A injection and mirror therapy vs combination of BoNT-A injection and robot-assisted therapy.
Detailed description
The purpose of this project is to examine and compare the immediate and long-term effects of combined Botulinum toxin type A injection with mirror therapy (MT) and with bilateral robot-assisted (RT) in patients with spastic hemiplegic stroke. Spasticity, a common impairment after stroke, has a profound impact on activity and participation for patients. BoNT-A injection combined with rehabilitation training is recommended to enhance functional recovery for stroke patients with spasticity. Although the positive combination effects of BoNT-A with stretch, RT, and constraint-induced movement therapy were reported, the quality of the evidence was weak due to methodology limitations. In addition, patients with spasticity usually have lower motor function and worse sensory deficits than patients without spasticity. Designing the post BoNT-A injection rehabilitation program should consider the above issues. RT and MT are two interventions providing sensorimotor input for patient with low level of motor function. It is unknown whether combining BoNT-A injection with RT or with MT have positive effects and engenders differential effects on motor and related functional performance.
At least 60 participants with chronic spastic hemiplegic stroke will be recruited and randomly assigned to one of 3 groups: BoNT-A injection with RT, BoNT-A injection with MT, and BoNT-A injection with control intervention (CI). All the post-injection interventions will be implemented 60 minutes/day, 3 days/week, for 8 weeks. The RT group will receive 30-minute RT, followed by 30-minute functional training. The MT group will receive 30-minute MT, followed by 30-minute functional training. The CI group will receive 60-minute rehabilitation program, such as bilateral arm training and functional task practice. Body function and structures outcome measures include Fugl-Meyer Assessment, Modified Ashworth Scale, Medical Research Council scale, myometer (Myoton-3), actigraph, and Pittsburgh Sleep Quality Index. Activity and participation measures include Wolf Motor Function Test, Ten meter walk test, Motor Activity Log, Nottingham Extended Activities of Daily Living Scale, and Canadian Occupational Performance Measure. In addition, to directly reflect a patient's unique needs and goals, Goal Attainment Scaling will be assessed. Evaluators will be blind to group allocation. The outcome will be measured at pre-treatment, post-treatment, and 3-month follow-up.
This comparative efficacy study will be the first to examine and compare the immediate and long-term combination effects of BoNT injection with RT, MT, or CI. The follow-up assessments will provide the long-term effects of different treatments on health-related outcomes, which are crucial for community reentry. In addition, the results of objective assessments and patient-reported outcomes may lead to individualized upper limb training following BoNT-A injection for patients with spastic hemiplegic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Robot-assisted therapy (RT) | Experimental | Drug: Botulinum Toxin Type A, Other: Robot-assisted therapyAfter injection with Botulinum Toxin Type A, a schedule of robot-assisted therapy appointments will be established. Each intervention includes 45 minutes of robotic training and 30 minutes of training in functional activities. |
| Mirror therapy (MT) | Experimental | Drug: Botulinum Toxin Type A, Other: Mirror therapyAfter injection with Botulinum Toxin Type A, a schedule of mirror therapy appointments will be established.The MT group will receive a 45-minute MT per session followed by 30 minutes of task-oriented functional training. |
| Control Intervention (CI) | Active comparator | Drug: Botulinum Toxin Type A, Other: Control interventionAfter injection with Botulinum Toxin Type A, a schedule of control intervention appointments will be established.The CI group will receive 75-minute rehabilitation program, focusing on upper extremity training and including neurodevelopmental techniques, trunk-arm control, weight bearing by the affected arm, fine motor tasks practice, functional task practice, and practice on compensatory strategies for daily activities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Willing to provide written informed consent
- Clinical and imagine diagnosis of a first or recurrent unilateral stroke ≥ 3 months
- Upper limb spasticity (Modified Ashworth scale of ≥ 2)
- Moderate to severe movement impairment of U/E (FMA score ranging from 18 to 56)
- No serious cognitive impairment (i.e., Mini Mental State Exam score > 18)
Key exclusion criteria (4 listed)
- Pregnant
- Bilateral hemispheric or cerebellar lesions
- Significant visual field deficits or hemineglect
- Contraindication for BoNT-A injection
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 |
|---|---|---|
| Botulinum Toxin Type AAlso: Botulinum ToxinTo inject Botulinum toxin type A on the spasticity upper extremity for stroke patients.Doses and muscles selected for BoNT-A injection are individualized on the basis of a number of factors, including the spasticity patterns, severity of spasticity, and treatment goals | Drug | Control Intervention (CI), Mirror therapy (MT), Robot-assisted therapy (RT) |
| Robot-assisted therapyAfter injecting Botulinum toxin type A on the spasticity upper extremity, the RT group will receive a 45 minutes of robotic training and 30 minutes of training in functional training. | Other | Robot-assisted therapy (RT) |
| Mirror therapyAfter injecting Botulinum toxin type A on the spasticity upper extremity, the MT group will receive a 45-minute MT per session followed by 30 minutes of task-oriented functional training. | Other | Mirror therapy (MT) |
| Control interventionAfter injecting Botulinum toxin type A on the spasticity upper extremity, the CI group will receive 75-minute rehabilitation program, focusing on upper extremity training and including neurodevelopmental techniques, trunk-arm control, weight bearing by the affected arm, fine motor tasks practice, functional task practice, and practice on compensatory strategies for daily activities. | Other | Control Intervention (CI) |
Primary outcome
Motor function assessed on Fugl-Meyer Assessment (FMA)
Time frame: Change from baseline at 5 months
The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.
13 secondary outcomes
Muscle power assessed on Medical Research Council Scale (MRC)
Time frame: Change from baseline at 5 months
Muscle tone assessed on Modified Ashworth Scale (MAS)
Time frame: Change from baseline at 5 months
The functional state assessed on Myometer Assessment
Time frame: Change from baseline at 5 months
The amount of movement assessed on Actigraph Assessment
Time frame: Change from baseline at 2 months
The quality of sleep assessed on Pittsburgh Sleep Quality Index (PSQI)
Time frame: Change from baseline at 5 months
Walking speed assessed on Ten Meter Walk Test (10MWT)
Time frame: Change from baseline at 2 months
The upper extremity motor ability assessed on Wolf Motor Function Test (WMFT)
Time frame: Change from baseline at 5 months
The quality of movement and amount of use assessed on Motor Activity Log (MAL)
Time frame: Change from baseline at 5 months
The instrumental activities of daily living assessed on Nottingham Extended Activities of Daily Living Scale (NEADL)
Time frame: Change from baseline at 5 months
The participant's perception of the performance assessed on Canadian Occupational Performance Measure (COPM)
Time frame: Change from baseline at 2 months
The participants' individual goals assessed on Goal attainment scale (GAS)
Time frame: Change from baseline at 5 months
Revised Notttingham Sensory Assessment (RNSA)
Time frame: Change from baseline at 2 months
Stroke Impact Scale (SIS)
Time frame: Change from baseline at 5 months
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 18 Jul 2018.
- Results publication: PubMed 16777777Ada L, O'Dwyer N, O'Neill E. Relation between spasticity, weakness and contracture of the elbow flexors and upper limb activity after stroke: an observational study. Disabil Rehabil. 2006 Jul 15-30;28(13-14):891-7. doi: 10.1080/09638280500535165.
- Results publication: PubMed 25592185Amano S, Takebayashi T, Hanada K, Umeji A, Marumoto K, Furukawa K, Domen K. Constraint-Induced Movement Therapy After Injection of Botulinum Toxin Type A for a Patient With Chronic Stroke: One-Year Follow-up Case Report. Phys Ther. 2015 Jul;95(7):1039-45. doi: 10.2522/ptj.20140329. Epub 2015 Jan 15.
- Results publication: PubMed 10896696Bhakta BB, Cozens JA, Chamberlain MA, Bamford JM. Impact of botulinum toxin type A on disability and carer burden due to arm spasticity after stroke: a randomised double blind placebo controlled trial. J Neurol Neurosurg Psychiatry. 2000 Aug;69(2):217-21. doi: 10.1136/jnnp.69.2.217.
- Results publication: PubMed 3809245Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.
- 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.
Jen-Wen Hung principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Botulinum Toxin Type A, Robot-assisted therapy and Mirror therapy in people with Stroke, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 4 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 18 Jul 2018. 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 Taiwan. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Motor function assessed on Fugl-Meyer Assessment (FMA) (time frame: Change from baseline at 5 months). 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 NCT02749591, which also lists 4 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 18 Jul 2018.