Viewing Study NCT04441437



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Last Modification Date: 2024-10-26 @ 1:38 PM
Study NCT ID: NCT04441437
Status: COMPLETED
Last Update Posted: 2020-06-23
First Post: 2020-06-16

Brief Title: The Efficacy of Dynamic Hand Splint Treatment in Spastic Hemiparetic Patients
Sponsor: Chang Gung Memorial Hospital
Organization: Chang Gung Memorial Hospital

Study Overview

Official Title: The Efficacy of Dynamic Hand Splint Treatment in Spastic Hemiparetic Patients A Randomized Controlled Trial
Status: COMPLETED
Status Verified Date: 2020-06
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: The purpose of this randomized controlled trial was designed to study the efficacy of dynamic hand splinting on spastic hemiparetic patients due to stroke or traumatic brain injury
Detailed Description: Subjects were recruited from both inpatients and outpatients who received rehabilitation programs in the Department of Physical Medicine and Rehabilitation at a regional teaching hospital in Taiwan The participants were randomly divided into two groups the splint group and the control group The subjects in the splint group received 1-hour task-oriented training with wearing a customized dynamic hand splint totally 15 times in a duration of one month plus conventional rehabilitation programs The subjects in the control group received the same treatments but without splint used Evaluations including Modified Ashworth Scale MAS active range of motion AROM grip strength Fugl-Meyer Assessment FMA Motor Activity Log 30MAL and FM ratio were performed at baseline post-training and 2 months later after the intervention finished and the evaluators were blinded to the grouping of the subjects

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