Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05877183
Status:
RECRUITING
Last Update Posted:
2023-09-25
First Post:
2023-05-17
Brief Title:
Smart Reminder a Randomized Controlled Trial on the Effect of a Wearable Device
Sponsor:
The Hong Kong Polytechnic University
Organization:
The Hong Kong Polytechnic University
Study Overview
Official Title:
Smart Reminder a Randomized Controlled Trial on the Effect of a Wearable Device to Provide Telerehabilitation for Persons With Stroke
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 andor 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
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 andor 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None