StrokeNCT04698369
Evaluation of Vibration-based Wearable Upper Limb Rehabilitation Device
A study testing Vibration Massage Therapy in people with Stroke, run by University of Oklahoma at 1 site in United States.
Trial summary
The investigators will perform a pilot 4-week at home study with 48 individuals with stroke and 10 therapists working with stroke patients to examine the feasibility and effect of a wearable focal muscle vibration device on upper limb strength and function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Vibration Massage Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2021to 31 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischemic or hemorrhagic stroke with Chedoke McMaster's Stroke Assessment (CMSA) level four or above;
- over 18 years of age;
- have been using a smartphone more than one year;
- live within 40 miles from the University of Oklahoma Health Sciences Center (OUHSC)
Who cannot join
- a history of fractures or dislocations in the shoulder, elbow, or wrist from which the participant has not fully recovered,
- severe impairment of verbal communication ability (for example, severe aphasia),
- inability to consent (for example, dementia),
- simultaneous participation in another treatment study targeting stroke recovery
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: Development and Evaluation of Vibration-based Wearable Upper Limb Rehabilitation Device
The investigators will perform a pilot 4-week at home study with 48 individuals with stroke and 10 therapists working with stroke patients to examine the feasibility and effect of a wearable focal muscle vibration device on upper limb strength and function.
Read the detailed description
Stroke often leads to significant impairment of upper limb function and is associated with decreased quality of life. Patients have difficulty moving out of the upper extremity flexion synergies that often dominate attempts to function after stroke. Change in muscle activation is the key underlying factor. Despite study results from several interventions for muscle activation and motor coordination, wide-scale adoption remains largely elusive due to the lack of sustainability of those interventions. The main reasons for the unsustainability are under-doses of the interventions and low patient compliance and participation. Recent studies among individuals without disabilities as well as those with strokes have shown that with focal vibration, there is greater potential to increase and coordinate muscle recruitment and build muscle strength and endurance. This form of treatment could widely benefit stroke patients and therapists who are in need of sustainable intervention that is effective and efficient to building muscle work capacity for function. Thus, the aims of this study are to evaluate the usability and feasibility of a novel vibration-based wearable device for upper limb rehabilitation in stroke patients. Forty-eight stroke patients and 10 therapists working with those stroke patients will be recruited to evaluate the usability of the device. All stroke patients will participate in a 4-week in-home vibration treatment to evaluate the feasibility of the device. Patients will be randomized into four groups receiving vibrations with different frequency (60 Hz or 120 Hz) and amplitude (0.2mm or 2mm). All groups will follow a prescribed dose of vibration based on the therapists' recommendations. Strength and functional outcomes will be measured before and after the 4-week in-home intervention. The investigators hypothesize that all groups will show an increase in grip strength and upper limb function at the end of study compared to baseline and that the increases in outcomes will be different in different groups. The investigators also expect all participants will tolerate the wearable device without adverse side effects and report high levels of satisfaction with the device. This pilot study may help to develop a novel sustainable wearable system providing vibration-based muscle activation for upper limb function rehabilitation. It may provide patients opportunity to apply the prescribed vibratory stimuli in-home and/or at community settings. It may also allow therapists to monitor treatment usage and patient performance and to adjust the treatment doses based on progression.
- Conditions
- Stroke
- Being tested
- Vibration Massage Therapy
- Keywords
- focal muscle vibration, wearable, mHealth, in-home rehabilitation, stroke, upper extremity
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibration Massage TherapyDevice
Also called WearUL
WearUL is a patent pending wearable rehabilitation technology that targets localized vibration massage therapy directly onto the body. The frequency and amplitude combinations to be delivered by WearUL are safe and effective in clinical and research settings based on previous studies on focal vibration.
| Study group | Role | What they receive |
|---|---|---|
| low frequency low amplitude | Experimental | The vibration frequency is 60 Hz and amplitude is 0.2 mm Receives: Device: Vibration Massage Therapy |
| low frequency high amplitude | Experimental | The vibration frequency is 60 Hz and amplitude is 2 mm Receives: Device: Vibration Massage Therapy |
| high frequency low amplitude | Experimental | The vibration frequency is 120 Hz and amplitude is 0.2 mm Receives: Device: Vibration Massage Therapy |
| high frequency high amplitude | Experimental | The vibration frequency is 120 Hz and amplitude is 2 mm Receives: Device: Vibration Massage Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability of the WearUL as assessed by the System Usability Scale (SUS)
SUS is a reliable tool for measuring the usability of a device or system
Measured: 4 weeks
Usability of the WearUL app as assessed by the mHealth App Usability Questionnaire (MAUQ)
MAUQ is a reliable and valid questionnaire to assess mHealth app usability
Measured: 4 weeks
Changes in grip strength
the affected side grip strength measured by a dynamometer
Measured: Change from Baseline Grip Strength at 4 weeks
Changes in arm and hand function as assessed by CAHAI-7
Chedoke Arm and Hand Activity Inventory - 7
Measured: Change from Baseline CAHAI-7 at 4 weeks
Changes in sensorimotor impairment as assessed by FMA-UE
Fugl-Meyer Assessment of the Upper Extremity
Measured: Change from Baseline FMA-UE at 4 weeks
Changes in upper extremity performance as assessed by ARAT
Action Research Arm Test
Measured: Change from Baseline ARAT at 4 weeks
Changes in self-reported functional upper extremity performance as assessed by MAL
Motor Activity Log
Measured: Change from Baseline MAL 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 posted6 Jan 2021
- Study start30 Aug 2021
- Primary completion30 Nov 2021
- Study completion31 Dec 2021
Why it stopped: The original PI left the institution and the remaining study team did not have the resources to continue. The data were not analyzed; there are no results to report.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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
- Model description
- Subjects will be randomized using a computer-generated random table in four blocks of four (four different vibration intensities) to equalize the group numbers across the study period. The four vibration intensities are: 60 Hz 0.2 mm, 60 Hz 2 mm, 120 Hz 0.2 mm, and 120 Hz 2mm.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hongwu Wang, PhD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04698369
- Sponsor's protocol ID
- 9686P
- Status last verified
- Mar 2026
- First submitted
- 2 Nov 2020
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The de-identified data might be shared with permission from the funder and PI per request.
Publications
Murillo N, Valls-Sole J, Vidal J, Opisso E, Medina J, Kumru H. Focal vibration in neurorehabilitation. Eur J Phys Rehabil Med. 2014 Apr;50(2):231-42.
PubMed 24842220Paoloni M, Tavernese E, Fini M, Sale P, Franceschini M, Santilli V, Mangone M. Segmental muscle vibration modifies muscle activation during reaching in chronic stroke: A pilot study. NeuroRehabilitation. 2014;35(3):405-14. doi: 10.3233/NRE-141131.
PubMed 25227540Celletti C, Sinibaldi E, Pierelli F, Monari G, Camerota F. Focal Muscle Vibration and Progressive Modular Rebalancing with neurokinetic facilitations in post- stroke recovery of upper limb. Clin Ter. 2017 Jan-Feb;168(1):e33-e36. doi: 10.7417/CT.2017.1979.
PubMed 28240760
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of Vibration-based Wearable Upper Limb Rehabilitation Device
- ClinicalTrials.gov ID
- NCT04698369
- Acronym / sponsor ID
- 9686P
- Conditions
- Stroke
- Keywords
- focal muscle vibration, wearable, mHealth, in-home rehabilitation, stroke, upper extremity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The original PI left the institution and the remaining study team did not have the resources to continue. The data were not analyzed; there are no results to report.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 6 Jan 2021 (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 investigators will perform a pilot 4-week at home study with 48 individuals with stroke and 10 therapists working with stroke patients to examine the feasibility and effect of a wearable focal muscle vibration device on upper limb strength and function.
Detailed description
Stroke often leads to significant impairment of upper limb function and is associated with decreased quality of life. Patients have difficulty moving out of the upper extremity flexion synergies that often dominate attempts to function after stroke. Change in muscle activation is the key underlying factor. Despite study results from several interventions for muscle activation and motor coordination, wide-scale adoption remains largely elusive due to the lack of sustainability of those interventions. The main reasons for the unsustainability are under-doses of the interventions and low patient compliance and participation. Recent studies among individuals without disabilities as well as those with strokes have shown that with focal vibration, there is greater potential to increase and coordinate muscle recruitment and build muscle strength and endurance. This form of treatment could widely benefit stroke patients and therapists who are in need of sustainable intervention that is effective and efficient to building muscle work capacity for function. Thus, the aims of this study are to evaluate the usability and feasibility of a novel vibration-based wearable device for upper limb rehabilitation in stroke patients. Forty-eight stroke patients and 10 therapists working with those stroke patients will be recruited to evaluate the usability of the device. All stroke patients will participate in a 4-week in-home vibration treatment to evaluate the feasibility of the device. Patients will be randomized into four groups receiving vibrations with different frequency (60 Hz or 120 Hz) and amplitude (0.2mm or 2mm). All groups will follow a prescribed dose of vibration based on the therapists' recommendations. Strength and functional outcomes will be measured before and after the 4-week in-home intervention. The investigators hypothesize that all groups will show an increase in grip strength and upper limb function at the end of study compared to baseline and that the increases in outcomes will be different in different groups. The investigators also expect all participants will tolerate the wearable device without adverse side effects and report high levels of satisfaction with the device. This pilot study may help to develop a novel sustainable wearable system providing vibration-based muscle activation for upper limb function rehabilitation. It may provide patients opportunity to apply the prescribed vibratory stimuli in-home and/or at community settings. It may also allow therapists to monitor treatment usage and patient performance and to adjust the treatment doses based on progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
- Model description
- Subjects will be randomized using a computer-generated random table in four blocks of four (four different vibration intensities) to equalize the group numbers across the study period. The four vibration intensities are: 60 Hz 0.2 mm, 60 Hz 2 mm, 120 Hz 0.2 mm, and 120 Hz 2mm.
| Arm | Type | Receives |
|---|---|---|
| low frequency low amplitude | Experimental | Device: Vibration Massage TherapyThe vibration frequency is 60 Hz and amplitude is 0.2 mm |
| low frequency high amplitude | Experimental | Device: Vibration Massage TherapyThe vibration frequency is 60 Hz and amplitude is 2 mm |
| high frequency low amplitude | Experimental | Device: Vibration Massage TherapyThe vibration frequency is 120 Hz and amplitude is 0.2 mm |
| high frequency high amplitude | Experimental | Device: Vibration Massage TherapyThe vibration frequency is 120 Hz and amplitude is 2 mm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ischemic or hemorrhagic stroke with Chedoke McMaster's Stroke Assessment (CMSA) level four or above;
- over 18 years of age;
- have been using a smartphone more than one year;
- live within 40 miles from the University of Oklahoma Health Sciences Center (OUHSC)
Key exclusion criteria (4 listed)
- a history of fractures or dislocations in the shoulder, elbow, or wrist from which the participant has not fully recovered,
- severe impairment of verbal communication ability (for example, severe aphasia),
- inability to consent (for example, dementia),
- simultaneous participation in another treatment study targeting stroke recovery
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 |
|---|---|---|
| Vibration Massage TherapyAlso: WearULWearUL is a patent pending wearable rehabilitation technology that targets localized vibration massage therapy directly onto the body. The frequency and amplitude combinations to be delivered by WearUL are safe and effective in clinical and research settings based on previous studies on focal vibration. | Device | high frequency high amplitude, high frequency low amplitude, low frequency high amplitude, low frequency low amplitude |
Primary outcome
Usability of the WearUL as assessed by the System Usability Scale (SUS)
Time frame: 4 weeks
SUS is a reliable tool for measuring the usability of a device or system
Usability of the WearUL app as assessed by the mHealth App Usability Questionnaire (MAUQ)
Time frame: 4 weeks
MAUQ is a reliable and valid questionnaire to assess mHealth app usability
Changes in grip strength
Time frame: Change from Baseline Grip Strength at 4 weeks
the affected side grip strength measured by a dynamometer
Changes in arm and hand function as assessed by CAHAI-7
Time frame: Change from Baseline CAHAI-7 at 4 weeks
Chedoke Arm and Hand Activity Inventory - 7
Changes in sensorimotor impairment as assessed by FMA-UE
Time frame: Change from Baseline FMA-UE at 4 weeks
Fugl-Meyer Assessment of the Upper Extremity
Changes in upper extremity performance as assessed by ARAT
Time frame: Change from Baseline ARAT at 4 weeks
Action Research Arm Test
Changes in self-reported functional upper extremity performance as assessed by MAL
Time frame: Change from Baseline MAL at 4 weeks
Motor Activity Log
Results and safety
The study was stopped early (reason given: The original PI left the institution and the remaining study team did not have the resources to continue. The data were not analyzed; there are no results to report.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Background: PubMed 24842220Murillo N, Valls-Sole J, Vidal J, Opisso E, Medina J, Kumru H. Focal vibration in neurorehabilitation. Eur J Phys Rehabil Med. 2014 Apr;50(2):231-42.
- Background: PubMed 25227540Paoloni M, Tavernese E, Fini M, Sale P, Franceschini M, Santilli V, Mangone M. Segmental muscle vibration modifies muscle activation during reaching in chronic stroke: A pilot study. NeuroRehabilitation. 2014;35(3):405-14. doi: 10.3233/NRE-141131.
- Background: PubMed 28240760Celletti C, Sinibaldi E, Pierelli F, Monari G, Camerota F. Focal Muscle Vibration and Progressive Modular Rebalancing with neurokinetic facilitations in post- stroke recovery of upper limb. Clin Ter. 2017 Jan-Feb;168(1):e33-e36. doi: 10.7417/CT.2017.1979.
- Individual participant dataSharing planned: Yes. The de-identified data might be shared with permission from the funder and PI per request.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Hongwu Wang, PhD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibration Massage Therapy in people with Stroke, run by University of Oklahoma at 1 site in United States.
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 4 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: stopped early, as of the sponsor's last update on 6 Apr 2026. 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 United States. 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?
The study was stopped early (reason given: The original PI left the institution and the remaining study team did not have the resources to continue. The data were not analyzed; there are no results to report.). Results are not available in the source record.
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?
Usability of the WearUL as assessed by the System Usability Scale (SUS) (time frame: 4 weeks). The study lists 7 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 NCT04698369, which also lists 3 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 6 Apr 2026.