Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06643273
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-10
Brief Title:
Evaluation of a Haptic Glove for Assessing Tactile Perception in Post-Stroke Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Randomized Controlled Trial on the Effects of Upper Limb Robotic Rehabilitation on Sensory and Cognitive Impairments in Subjects With Stroke The SCORES Sensory and Cognitive Outcomes of Robotic Exercises in Stroke Study Evaluation of a Haptic 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:
SCORES-glove
Brief Summary:
The aim of the SCORES Haptic Glove Study is to assess the technical features safety and reliability of a sensor-equipped glove designed to evaluate tactile perception This will help guide further technical and functional improvements to finalize the device The secondary goal is to validate a new tactile sensitivity index based on data collected using the glove This will be done in a randomized controlled multicenter study ClinicalTrialsgov ID NCT06109324 aimed to compare the effectiveness of robotic upper limb rehabilitation to conventional treatment in improving cognitive and sensory deficits as well as evaluating the impact of these deficits on motor recovery
Detailed Description:
Sensory and proprioceptive deficits in the upper limbs affect about 50-85 of stroke survivors These deficits can impact single sensations such as primary tactile senses like light touch pressure and localization and the ability to discriminate between different materials or temperatures as well as proprioception and multiple somatosensory modalities Furthermore somatosensory deficits have been strongly correlated with variations in treatment responses among patients However in clinical practice the use of appropriate quantitative tools to measure these deficits is not widespread and evidence for active sensory training remains limited
In recent years robotic therapy has been proposed as an effective approach for upper limb rehabilitation Nevertheless recent studies with large samples have failed to demonstrate the superiority of robotic treatment over traditional methods regarding the recovery of upper limb motor functions These studies primarily focus on motor aspects of stroke recovery often neglecting sensory and cognitive aspects of rehabilitation whether robotic or conventional
Actually there is limited evidence supporting the superiority of robotic approaches over conventional rehabilitation in recovering cognitive deficits and sensitivity Additionally it remains unclear whether cognitive andor sensory deficits impact motor outcomes differently when using robotic versus conventional approaches
To address this the SCORES Sensory and Cognitive Outcomes of Robotic Exercises in Stroke study is a multicenter randomized controlled study investigating the effects of robotic rehabilitation on cognitive and sensory deficits in stroke survivors It aims to compare robotic and conventional rehabilitation approaches regarding cognitive recovery and tactile sensitivity in subacute stroke patients While some quantitative methods exist to assess absolute perception levels of tactile stimuli standardized repeatable and objectively quantitative methods for assessing localization ability are lacking Therefore this study will evaluate how the tactile perceptual abilities of recruited patients evolve during and after a rehabilitation course-whether robotic or conventional-using a specifically developed haptic device that includes a glove with integrated vibrotactile elements This system aims to objectively define patients tactile sensitivity through psychophysical evaluations involving the identification and localization of randomized vibrations delivered to the surface of the hand affected by sensorimotor alterations Specifically this study will investigate the test-retest reliability discriminant ability responsiveness and clinical validity of the metrics obtained from the haptic glove
During each experimental session randomized vibrotactile stimuli will be administered to the recruited patient at different sites on the hand The patient will be asked to identify and verbally communicate the site of each perceived vibration as well as the intensity of the vibration itself between the two possible levels
In recent years robotic therapy has been proposed as an effective approach for upper limb rehabilitation Nevertheless recent studies with large samples have failed to demonstrate the superiority of robotic treatment over traditional methods regarding the recovery of upper limb motor functions These studies primarily focus on motor aspects of stroke recovery often neglecting sensory and cognitive aspects of rehabilitation whether robotic or conventional
Actually there is limited evidence supporting the superiority of robotic approaches over conventional rehabilitation in recovering cognitive deficits and sensitivity Additionally it remains unclear whether cognitive andor sensory deficits impact motor outcomes differently when using robotic versus conventional approaches
To address this the SCORES Sensory and Cognitive Outcomes of Robotic Exercises in Stroke study is a multicenter randomized controlled study investigating the effects of robotic rehabilitation on cognitive and sensory deficits in stroke survivors It aims to compare robotic and conventional rehabilitation approaches regarding cognitive recovery and tactile sensitivity in subacute stroke patients While some quantitative methods exist to assess absolute perception levels of tactile stimuli standardized repeatable and objectively quantitative methods for assessing localization ability are lacking Therefore this study will evaluate how the tactile perceptual abilities of recruited patients evolve during and after a rehabilitation course-whether robotic or conventional-using a specifically developed haptic device that includes a glove with integrated vibrotactile elements This system aims to objectively define patients tactile sensitivity through psychophysical evaluations involving the identification and localization of randomized vibrations delivered to the surface of the hand affected by sensorimotor alterations Specifically this study will investigate the test-retest reliability discriminant ability responsiveness and clinical validity of the metrics obtained from the haptic glove
During each experimental session randomized vibrotactile stimuli will be administered to the recruited patient at different sites on the hand The patient will be asked to identify and verbally communicate the site of each perceived vibration as well as the intensity of the vibration itself between the two possible levels
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