Evaluation of Vibration-based Wearable Upper Limb Rehabilitation Device

Stroke Clinical Trial

Official title:

Development and Evaluation of Vibration-based Wearable Upper Limb Rehabilitation Device

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04698369
• Other study ID #: 9686
• Status: Terminated
• Phase: N/A
• Start date: August 30, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2024
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: December 31, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Vibration Massage Therapy
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.

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

References & Publications (3)

Celletti 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. — View Citation

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. — View Citation

Paoloni 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4 weeks
Primary	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	4 weeks
Primary	Changes in grip strength	the affected side grip strength measured by a dynamometer	Change from Baseline Grip Strength at 4 weeks
Primary	Changes in arm and hand function as assessed by CAHAI-7	Chedoke Arm and Hand Activity Inventory - 7	Change from Baseline CAHAI-7 at 4 weeks
Primary	Changes in sensorimotor impairment as assessed by FMA-UE	Fugl-Meyer Assessment of the Upper Extremity	Change from Baseline FMA-UE at 4 weeks
Primary	Changes in upper extremity performance as assessed by ARAT	Action Research Arm Test	Change from Baseline ARAT at 4 weeks
Primary	Changes in self-reported functional upper extremity performance as assessed by MAL	Motor Activity Log	Change from Baseline MAL at 4 weeks