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Search / Trial NCT05877183

'Smart Reminder': a Randomized Controlled Trial on the Effect of a Wearable Device

Launched by THE HONG KONG POLYTECHNIC UNIVERSITY · May 17, 2023

Trial Information

Current as of May 27, 2025

Unknown status

Keywords

Wearable Device Telerehabilitation Upper Limb Stroke

ClinConnect Summary

This clinical trial, called 'Smart Reminder', is investigating whether a special wearable device can help stroke survivors improve the movement in their affected arm better than traditional therapy. The study aims to find out if using this device at home can provide more effective support for rehabilitation than a standard treatment with a non-functioning device. Participants will be divided into two groups: one will use the wearable device for four weeks, while the other will use a sham (non-working) device along with conventional therapy.

To participate in this study, individuals must be at least 18 years old, have had a stroke at least three months ago, and have some difficulty moving one arm. They should also be able to follow instructions on how to use the device. During the trial, participants will have their arm movement assessed at the beginning, after four weeks of treatment, and again after eight weeks. This research could lead to new and improved ways for stroke survivors to recover at home using innovative technology.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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.
  • Exclusion Criteria:
  • 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 .

About The Hong Kong Polytechnic University

The Hong Kong Polytechnic University (PolyU) is a leading institution in applied research and education, dedicated to advancing knowledge and innovation in various fields, including health sciences. As a clinical trial sponsor, PolyU focuses on conducting rigorous and ethically sound research to enhance understanding of medical interventions and improve patient outcomes. The university leverages its multidisciplinary expertise, state-of-the-art facilities, and collaboration with industry partners to facilitate groundbreaking studies that address pressing health challenges. Committed to fostering an environment of academic excellence, PolyU aims to translate research findings into practical solutions that benefit society and contribute to the global advancement of healthcare.

Locations

Hong Kong, , Hong Kong

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported