Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06649968
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
Clinical Validation of an Instrumented Glove for Sensorimotor Rehabilitation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Validation of an Instrumented Glove for Sensorimotor Rehabilitation After Stroke DESC-Glove
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 processs duration During the treatment patients will wear the DESC-Glove on the affected hand receiving vibratory stimuli synchronized with the exercises following the devices 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 111
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 101002pst185 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 processs duration During the treatment patients will wear the DESC-Glove on the affected hand receiving vibratory stimuli synchronized with the exercises following the devices 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 111
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 101002pst185 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None