StrokeNCT05877183
'Smart Reminder': a Randomized Controlled Trial on the Effect of a Wearable Device
A study testing Wearable device -'Smart Reminder' in people with Stroke and Wearable Device, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
Using wearable devices in the home setting allows continuous remote monitoring and feedback for intense self-directed training, an effective alternative to in-person rehabilitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Wearable Device
- What is being tested?
- Wearable device -'Smart Reminder'
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2023to 31 Mar 2024
- 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 ≥ 18 years
- unilateral hemispherical involvement
- diagnosis of stroke with onset ≥ three months
- hemiplegic upper limb with Functional test for hemiplegic upper extremity-Hong Kong version score (FTHUE-HK) (Fong et al., 2004) between 3 to 6 (with a maximum score of 7)
- no complaint of excessive pain and swelling over the hemiplegic arm
- Modified Ashworth scale ≤ 2
- Mini-mental State Examination (MMSE) ≥ 19 (Wei et al., 2019)
- able to follow verbal instructions and 2-step commands in using the wearable device and smartphone.
Who cannot join
- participation in another similar form of experimental study during the same period,
- having a history of botulinum toxin injection in the past three months
- other significant upper limb impairment, i.e. fixed contractures, frozen shoulder and severe arthritis
- diagnosis which will interfere in the use of the device, i.e. visual impairment, active cardiac issues and palliative treatment
- not fully vaccinated from COVID-19 .
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Kenneth FONG
Hong Kong, 000000
Kenneth FONG, 27666716, rsnkfong@polyu.edu.hk
About this study
Official title: 'Smart Reminder': a Randomized Controlled Trial on the Effect of a Wearable Device to Provide Telerehabilitation for Persons With Stroke
Using wearable devices in the home setting allows continuous remote monitoring and feedback for intense self-directed training, an effective alternative to in-person rehabilitation. Emerging literature demonstrated that wearable devices are promising tools to enhance and deliver home-based upper limb training in stroke survivors. Nevertheless, previous reviews (Wang et al., 2017; Rodgers et al., 2019) highlighted a paucity of high-quality evidence concerning the clinical application of wearable devices in home-based rehabilitation.
This study examines the effectiveness of the enhanced version of the wearable device as a home-based upper limb rehabilitation intervention to improve the hemiplegic upper limb motor function of persons with stroke. The study seeks to address the research question:
Read more
'Is wearable device intervention in the home more effective in promoting arm recovery in stroke survivors than conventional therapy with a sham device after treatment and follow-up?' We hypothesize that the multimodal feedback system and improved features from the wearable device will provide a more effective and sustainable treatment option than conventional therapy with a sham device to promote the motor recovery of the hemiplegic UL function in persons with stroke.
A parallel single-blinded randomized controlled trial will be conducted in Hong Kong hospital outpatient and/or community stroke service settings. There will be two study groups: (1) a wearable device group and (2) a sham group. Forty participants will be randomly allocated into any of the two study groups (1) the experimental (wearable device) group and (2) the sham group (use the pictorial handout and sham device) using a computer-generated random number sequence to conceal the allocation.
Participants in the experimental group will undergo a 4-week wearable device treatment and participants in the sham group will receive a sham device and complete a 4-week conventional training. Upper limb motor outcome measures will be evaluated at the following intervals: baseline, post-treatment at 4-week, and follow-up at 8-week by blinded assessors.
The results of this study will show the possible efficacy of the wristwatch device in promoting motor recovery of the hemiplegic upper limb in stroke survivors and pave the way for an alternative stroke therapy that uses novel wearable technology in the home setting.
- Conditions
- Stroke, Wearable Device
- Being tested
- Wearable device -'Smart Reminder', Sham device
- Keywords
- wearable device, telerehabilitation, upper limb, Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable device -'Smart Reminder'Device
The wearable device, a wristwatch, has a Bluetooth function to link to mobile devices for the participants to view the prescribed videos and engage in telerehabilitation. It has sensors to monitor arm movements and provides multiple feedbacks (auditory, visual and tactile). Participants were instructed to practice the prescribed exercises -tailored according to the severity of UL paresis for the recommended therapy dose. The device recorded the angles of arm movement and the number of repetitions completed and data collected is uploaded to an encrypted cloud server for remote monitoring. Weekly, the participants will receive a 45-minute consultation session to review their progress and modify prescribed exercises based on the wearable device data.
Sham deviceDevice
The sham device is also a wristwatch, which consists of an accelerometer, a gyroscope sensor, and a rechargeable battery that supports up to 72 hours of continuous use. The device will monitor the participant's arm activity, but it will not emit any reminders or be connected to a telerehabilitation system. The participants were instructed to perform the exercises from the pictorial handout for the recommended therapy dose and received a weekly therapy consultation as well.
| Study group | Role | What they receive |
|---|---|---|
| Wearable device group | Experimental | Participants will be instructed to wear the wristwatch for a minimum of 3 hours per day, 5 days per week and engage in telerehabilitation, 1 hour per day 5 times per week over 4 weeks. Weekly, there will be a 45-minute therapy consultation. Receives: Device: Wearable device -'Smart Reminder' |
| Sham group | Sham comparator | The participants will be instructed to wear the sham device for a minimum of 3 hours per day, 5 days per week. In addition, they will be instructed to engage in upper limb training with the prescribed exercises presented in the form of a pictorial handout rather than an in-app video, 1 hour per day 5 times per week over 4 weeks. Weekly, there will be a 45-minute therapy consultation. Receives: Device: Sham device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline: Fugl Meyer Upper Extremity assessment
The FMA-UE is a 3-point scale with a maximum score of 66 that measures the synergistic pattern and ability to make arm movements (Fugl, 1975). The total score is further subdivided into upper-extremity and hand subscores (Fugl, 1975).
Measured: Outcome measures will be evaluated at three intervals: baseline, post-treatment at 4 weeks, and follow-up at 8 weeks.
Change from baseline: Action Research Arm Test (ARAT)
The ARAT is a frequently used assessment tool for hemiplegic upper limb function. It consists of 19 items comprising four domains: grasp, grip, pinch, and gross motor, and it has a total score of 57 (Lyle, 1981).
Measured: Outcome measures will be evaluated at three intervals: baseline, post-treatment at 4 weeks, and follow-up at 8 weeks.
Change from baseline: Motor Activity Log (MAL)
The MAL is a self-reported questionnaire designed to assess how frequently and effectively patients utilize their affected arm daily (Uswatte, Taub, Morris, Light, \& Thompson, 2006). It included two subscales to measure patients' perceived amount of arm use (MAL-AOU) and quality of arm use (MAL-QOM) (Uswatte et al., 2006).
Measured: Outcome measures will be evaluated at three intervals: baseline, post-treatment at 4 weeks, and follow-up at 8 weeks.
Change from baseline: Muscle strength of the affected elbow and shoulder
The muscle strength of the affected elbow and shoulder will be measured using a force gauge.
Measured: Outcome measures will be evaluated at three intervals: baseline, post-treatment at 4 weeks, and follow-up at 8 weeks.
Change from baseline: Active Range of motion of the affected shoulder (flexion/extension), elbow (flexion/ extension), and forearm pronation/supination.
A digital goniometer will be used to evaluate the active ROM of the affected shoulder (flexion/extension), elbow (flexion/ extension), and forearm pronation/supination.
Measured: Outcome measures will be evaluated at three intervals: baseline, post-treatment at 4 weeks, and follow-up at 8 weeks.
Secondary outcomes (1)
Kinematic data of arm movement
The wristwatch's built-in accelerometer will record the kinematic data of arm movements. This kinematic data referred to the mean acceleration in the X, Y, and Z directions over the 3-hour wearing period daily (Wei et al., 2019). The amount of arm movements is calculated using the ratio of the total number of movements divided by the total wearing duration (Wei et al., 2019).
Measured: Outcome measure will be evaluated post-treatment at 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start1 Jun 2023
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- Randomized controlled trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
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
- NCT05877183
- Sponsor's protocol ID
- Smart reminder
- Status last verified
- May 2023
- First submitted
- 17 May 2023
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fong, K., Ng, B., Chan, D., Chan, E., Ma, D., Au, B., ... & Occupational Therapy Central Coordinating Committee. (2004). Development of the Hong Kong version of the functional test for the hemiplegic upper extremity (FTHUE-HK). Hong Kong Journal of Occupational Therapy, 14(1), 21-29.
Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.
PubMed 1135616Lyle RC. A performance test for assessment of upper limb function in physical rehabilitation treatment and research. Int J Rehabil Res. 1981;4(4):483-92. doi: 10.1097/00004356-198112000-00001. No abstract available.
PubMed 7333761Uswatte G, Taub E, Morris D, Light K, Thompson PA. The Motor Activity Log-28: assessing daily use of the hemiparetic arm after stroke. Neurology. 2006 Oct 10;67(7):1189-94. doi: 10.1212/01.wnl.0000238164.90657.c2.
PubMed 17030751Wei WXJ, Fong KNK, Chung RCK, Cheung HKY, Chow ESL. "Remind-to-Move" for Promoting Upper Extremity Recovery Using Wearable Devices in Subacute Stroke: A Multi-Center Randomized Controlled Study. IEEE Trans Neural Syst Rehabil Eng. 2019 Jan;27(1):51-59. doi: 10.1109/TNSRE.2018.2882235. Epub 2018 Nov 20.
PubMed 30475722Wang Q, Markopoulos P, Yu B, Chen W, Timmermans A. Interactive wearable systems for upper body rehabilitation: a systematic review. J Neuroeng Rehabil. 2017 Mar 11;14(1):20. doi: 10.1186/s12984-017-0229-y.
PubMed 28284228Rodgers MM, Alon G, Pai VM, Conroy RS. Wearable technologies for active living and rehabilitation: Current research challenges and future opportunities. J Rehabil Assist Technol Eng. 2019 Apr 26;6:2055668319839607. doi: 10.1177/2055668319839607. eCollection 2019 Jan-Dec.
PubMed 31245033Toh FM, Lam WWT, Cruz Gonzalez P, Fong KNK. Effects of a Wearable-Based Intervention on the Hemiparetic Upper Limb in Persons With Stroke: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2025 Jan;39(1):31-46. doi: 10.1177/15459683241283412. Epub 2024 Sep 27.
PubMed 39328083
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 'Smart Reminder': a Randomized Controlled Trial on the Effect of a Wearable Device to Provide Telerehabilitation for Persons With Stroke
- ClinicalTrials.gov ID
- NCT05877183
- Acronym / sponsor ID
- Smart reminder
- Conditions
- Stroke, Wearable Device
- Keywords
- wearable device, telerehabilitation, upper limb, Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 26 May 2023 (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.
Using wearable devices in the home setting allows continuous remote monitoring and feedback for intense self-directed training, an effective alternative to in-person rehabilitation. Emerging literature demonstrated that wearable devices are promising tools to enhance and deliver home-based upper limb training in stroke survivors. Nevertheless, previous reviews (Wang et al., 2017; Rodgers et al., 2019) highlighted a paucity of high-quality evidence concerning the clinical application of wearable devices in home-based rehabilitation.
This study examines the effectiveness of the enhanced version of the wearable device as a home-based upper limb rehabilitation intervention to improve the hemiplegic upper limb motor function of persons with stroke. The study seeks to address the research question:
'Is wearable device intervention in the home more effective in promoting arm recovery in stroke survivors than conventional therapy with a sham device after treatment and follow-up?' We hypothesize that the multimodal feedback system and improved features from the wearable device will provide a more effective and sustainable treatment option than conventional therapy with a sham device to promote the motor recovery of the hemiplegic UL function in persons with stroke.
A parallel single-blinded randomized controlled trial will be conducted in Hong Kong hospital outpatient and/or community stroke service settings. There will be two study groups: (1) a wearable device group and (2) a sham group. Forty participants will be randomly allocated into any of the two study groups (1) the experimental (wearable device) group and (2) the sham group (use the pictorial handout and sham device) using a computer-generated random number sequence to conceal the allocation.
Participants in the experimental group will undergo a 4-week wearable device treatment and participants in the sham group will receive a sham device and complete a 4-week conventional training. Upper limb motor outcome measures will be evaluated at the following intervals: baseline, post-treatment at 4-week, and follow-up at 8-week by blinded assessors.
The results of this study will show the possible efficacy of the wristwatch device in promoting motor recovery of the hemiplegic upper limb in stroke survivors and pave the way for an alternative stroke therapy that uses novel wearable technology in the home setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Wearable device group | Experimental | Device: Wearable device -'Smart Reminder'Participants will be instructed to wear the wristwatch for a minimum of 3 hours per day, 5 days per week and engage in telerehabilitation, 1 hour per day 5 times per week over 4 weeks. Weekly, there will be a 45-minute therapy consultation. |
| Sham group | Sham comparator | Device: Sham deviceThe participants will be instructed to wear the sham device for a minimum of 3 hours per day, 5 days per week. In addition, they will be instructed to engage in upper limb training with the prescribed exercises presented in the form of a pictorial handout rather than an in-app video, 1 hour per day 5 times per week over 4 weeks. Weekly, there will be a 45-minute therapy consultation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- age ≥ 18 years
- unilateral hemispherical involvement
- diagnosis of stroke with onset ≥ three months
- hemiplegic upper limb with Functional test for hemiplegic upper extremity-Hong Kong version score (FTHUE-HK) (Fong et al., 2004) between 3 to 6 (with a maximum score of 7)
- no complaint of excessive pain and swelling over the hemiplegic arm
Key exclusion criteria (5 listed)
- participation in another similar form of experimental study during the same period,
- having a history of botulinum toxin injection in the past three months
- other significant upper limb impairment, i.e. fixed contractures, frozen shoulder and severe arthritis
- diagnosis which will interfere in the use of the device, i.e. visual impairment, active cardiac issues and palliative treatment
- not fully vaccinated from COVID-19 .
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 |
|---|---|---|
| Wearable device -'Smart Reminder'The wearable device, a wristwatch, has a Bluetooth function to link to mobile devices for the participants to view the prescribed videos and engage in telerehabilitation. It has sensors to monitor arm movements and provides multiple feedbacks (auditory, visual and tactile). Participants were instructed to practice the prescribed exercises -tailored according to the severity of UL paresis for the recommended therapy dose. The device recorded the angles of arm movement and the number of repetitions completed and data collected is uploaded to an encrypted cloud server for remote monitoring. Weekly, the participants will receive a 45-minute consultation session to review their progress and modify prescribed exercises based on the wearable device data. | Device | Wearable device group |
| Sham deviceThe sham device is also a wristwatch, which consists of an accelerometer, a gyroscope sensor, and a rechargeable battery that supports up to 72 hours of continuous use. The device will monitor the participant's arm activity, but it will not emit any reminders or be connected to a telerehabilitation system. The participants were instructed to perform the exercises from the pictorial handout for the recommended therapy dose and received a weekly therapy consultation as well. | Device | Sham group |
Primary outcome
Change from baseline: Fugl Meyer Upper Extremity assessment
Time frame: Outcome measures will be evaluated at three intervals: baseline, post-treatment at 4 weeks, and follow-up at 8 weeks.
The FMA-UE is a 3-point scale with a maximum score of 66 that measures the synergistic pattern and ability to make arm movements (Fugl, 1975). The total score is further subdivided into upper-extremity and hand subscores (Fugl, 1975).
Change from baseline: Action Research Arm Test (ARAT)
Time frame: Outcome measures will be evaluated at three intervals: baseline, post-treatment at 4 weeks, and follow-up at 8 weeks.
The ARAT is a frequently used assessment tool for hemiplegic upper limb function. It consists of 19 items comprising four domains: grasp, grip, pinch, and gross motor, and it has a total score of 57 (Lyle, 1981).
Change from baseline: Motor Activity Log (MAL)
Time frame: Outcome measures will be evaluated at three intervals: baseline, post-treatment at 4 weeks, and follow-up at 8 weeks.
The MAL is a self-reported questionnaire designed to assess how frequently and effectively patients utilize their affected arm daily (Uswatte, Taub, Morris, Light, \& Thompson, 2006). It included two subscales to measure patients' perceived amount of arm use (MAL-AOU) and quality of arm use (MAL-QOM) (Uswatte et al., 2006).
Change from baseline: Muscle strength of the affected elbow and shoulder
Time frame: Outcome measures will be evaluated at three intervals: baseline, post-treatment at 4 weeks, and follow-up at 8 weeks.
The muscle strength of the affected elbow and shoulder will be measured using a force gauge.
Change from baseline: Active Range of motion of the affected shoulder (flexion/extension), elbow (flexion/ extension), and forearm pronation/supination.
Time frame: Outcome measures will be evaluated at three intervals: baseline, post-treatment at 4 weeks, and follow-up at 8 weeks.
A digital goniometer will be used to evaluate the active ROM of the affected shoulder (flexion/extension), elbow (flexion/ extension), and forearm pronation/supination.
1 secondary outcome
Kinematic data of arm movement
Time frame: Outcome measure will be evaluated post-treatment at 4 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- BackgroundFong, K., Ng, B., Chan, D., Chan, E., Ma, D., Au, B., ... & Occupational Therapy Central Coordinating Committee. (2004). Development of the Hong Kong version of the functional test for the hemiplegic upper extremity (FTHUE-HK). Hong Kong Journal of Occupational Therapy, 14(1), 21-29.
- Background: PubMed 1135616Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.
- Background: PubMed 7333761Lyle RC. A performance test for assessment of upper limb function in physical rehabilitation treatment and research. Int J Rehabil Res. 1981;4(4):483-92. doi: 10.1097/00004356-198112000-00001. No abstract available.
- Background: PubMed 17030751Uswatte G, Taub E, Morris D, Light K, Thompson PA. The Motor Activity Log-28: assessing daily use of the hemiparetic arm after stroke. Neurology. 2006 Oct 10;67(7):1189-94. doi: 10.1212/01.wnl.0000238164.90657.c2.
- Background: PubMed 30475722Wei WXJ, Fong KNK, Chung RCK, Cheung HKY, Chow ESL. "Remind-to-Move" for Promoting Upper Extremity Recovery Using Wearable Devices in Subacute Stroke: A Multi-Center Randomized Controlled Study. IEEE Trans Neural Syst Rehabil Eng. 2019 Jan;27(1):51-59. doi: 10.1109/TNSRE.2018.2882235. Epub 2018 Nov 20.
- Background: PubMed 28284228Wang Q, Markopoulos P, Yu B, Chen W, Timmermans A. Interactive wearable systems for upper body rehabilitation: a systematic review. J Neuroeng Rehabil. 2017 Mar 11;14(1):20. doi: 10.1186/s12984-017-0229-y.
- Background: PubMed 31245033Rodgers MM, Alon G, Pai VM, Conroy RS. Wearable technologies for active living and rehabilitation: Current research challenges and future opportunities. J Rehabil Assist Technol Eng. 2019 Apr 26;6:2055668319839607. doi: 10.1177/2055668319839607. eCollection 2019 Jan-Dec.
- Derived from this study: PubMed 39328083Toh FM, Lam WWT, Cruz Gonzalez P, Fong KNK. Effects of a Wearable-Based Intervention on the Hemiparetic Upper Limb in Persons With Stroke: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2025 Jan;39(1):31-46. doi: 10.1177/15459683241283412. Epub 2024 Sep 27.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable device -'Smart Reminder' in people with Stroke and Wearable Device, 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 8 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: status not confirmed, as of the sponsor's last update on 25 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline: Fugl Meyer Upper Extremity assessment (time frame: Outcome measures will be evaluated at three intervals: baseline, post-treatment at 4 weeks, and follow-up at 8 weeks.). The study lists 5 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 NCT05877183, which also lists 8 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 25 Sep 2023.