Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-25 @ 3:09 PM
Study NCT ID:
NCT06649968
Status:
RECRUITING
Last Update Posted:
2024-10-31
First Post:
2024-10-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Validation of an Instrumented Glove for Sensorimotor Rehabilitation
Sponsor:
Christian Cipriani
Organization:
Study Overview
Official Title:
Clinical Validation of an Instrumented Glove for Sensorimotor Rehabilitation After Stroke (DESC-Glove)
Status:
RECRUITING
Status Verified Date:
2024-10
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 goal of this clinical trial is to evaluate the DESC-Glove, an instrumented glove developed for sensorimotor rehabilitation in individuals recovering from a stroke, utilizing non-invasive vibrational feedback. The primary objective is to assess the technical functionality, safety, and reliability of the device during post-stroke rehabilitation, providing insights for future technical and functional improvements.
The secondary objectives are:
1. To evaluate the usability and acceptability of the device in clinical rehabilitation from the perspectives of both patients and healthcare professionals;
2. To assess the short-term effects of the DESC-Glove on sensorimotor performance and manual dexterity in post-stroke individuals.
To meet the second objective, researchers will compare three groups:
an experimental treatment group (using the DESC-Glove during hand rehabilitation), a sham control group (using the DESC-Glove without vibration), and a conventional control group (receiving hand rehabilitation without the device).
The secondary objectives are:
1. To evaluate the usability and acceptability of the device in clinical rehabilitation from the perspectives of both patients and healthcare professionals;
2. To assess the short-term effects of the DESC-Glove on sensorimotor performance and manual dexterity in post-stroke individuals.
To meet the second objective, researchers will compare three groups:
an experimental treatment group (using the DESC-Glove during hand rehabilitation), a sham control group (using the DESC-Glove without vibration), and a conventional control group (receiving hand rehabilitation without the device).
Detailed Description:
The study is divided into two phases:
Phase 1: Preliminary Investigation of Device Functionality. This phase involves testing the DESC-Glove on 5 patients to assess its initial functionality. Each patient will complete four treatment sessions using the device, focusing on both fine motor exercises for the hand and gross motor exercises for the upper limb. This phase will also help evaluate patient compliance with the rehabilitation treatment on a smaller scale, allowing for a better understanding of the recovery process's duration. During the treatment, patients will wear the DESC-Glove on the affected hand, receiving vibratory stimuli synchronized with the exercises, following the device's operational guidelines.
Phase 2: Multicenter Randomized Controlled Trial (RCT).
In this phase, 42 participants will be recruited and randomly assigned to one of three parallel groups (1:1:1):
The experimental treatment group (using the DESC-Glove), The sham control group (using the DESC-Glove without vibration), and The conventional control group (not using the DESC-Glove). The sample size of 42 (14 participants per group) was chosen following Julious et al. \[doi: 10.1002/pst.185\], which recommends a minimum of 12 subjects per group for pilot studies. This number was increased to 42 to account for potential dropouts, ensuring robust data collection and analysis.
Phase 1: Preliminary Investigation of Device Functionality. This phase involves testing the DESC-Glove on 5 patients to assess its initial functionality. Each patient will complete four treatment sessions using the device, focusing on both fine motor exercises for the hand and gross motor exercises for the upper limb. This phase will also help evaluate patient compliance with the rehabilitation treatment on a smaller scale, allowing for a better understanding of the recovery process's duration. During the treatment, patients will wear the DESC-Glove on the affected hand, receiving vibratory stimuli synchronized with the exercises, following the device's operational guidelines.
Phase 2: Multicenter Randomized Controlled Trial (RCT).
In this phase, 42 participants will be recruited and randomly assigned to one of three parallel groups (1:1:1):
The experimental treatment group (using the DESC-Glove), The sham control group (using the DESC-Glove without vibration), and The conventional control group (not using the DESC-Glove). The sample size of 42 (14 participants per group) was chosen following Julious et al. \[doi: 10.1002/pst.185\], which recommends a minimum of 12 subjects per group for pilot studies. This number was increased to 42 to account for potential dropouts, ensuring robust data collection and analysis.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| PNC0000007 | OTHER_GRANT | Italian Ministry of Research | View |