StrokeNCT06649968
Clinical Validation of an Instrumented Glove for Sensorimotor Rehabilitation
A study testing DESC-Glove (active) and Traditional rehabilitation in people with Stroke, run by Christian Cipriani at 6 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- DESC-Glove (active) and Traditional rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 6 sitesItaly
- Study dates
- 21 Oct 2024to Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of ischemic or hemorrhagic stroke confirmed by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI);
- Time from the acute event between 1 and 6 months;
- Mild to moderate impairment of the upper limb, assessed using the Motricity Index (item score for "pinch grip" ≥ 19 and scores for "elbow flexion" and "shoulder abduction" ≥ 14).
Who cannot join
- Severe behavioral and cognitive disorders (Montreal Cognitive Assessment (MoCA) ≤ 15 ) and/or decreased compliance;
- Spasticity or hypertonia (Modified Ashworth Scale (MAS) > 3) in the affected limb;
- Concurrent participation in a rehabilitation trial that includes treatment training for the upper limb following a stroke;
- Refusal to sign informed consent.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Italy6 sites, 6 recruiting
- Not yet recruiting
Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo
Acerenza
Rocco Santarsiero
- Not yet recruiting
Fondazione Don Carlo Gnocchi, IRCCS Santa Maria Nascente
Milan
Claudia Salatino
- Recruiting
Fondazione Don Carlo Gnocchi, Centro Santa Maria della Provvidenza
Roma
Irene G Aprile, PhD, +390633086500, iaprile@dongnocchi.it
- Not yet recruiting
Fondazione Don Carlo Gnocchi, Centro Santa Maria al Mare
Salerno
Maria R Leone
- Not yet recruiting
Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo
Sant'Angelo dei Lombardi
Tommaso Cibellis
- Not yet recruiting
Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo
Tricarico
Massimo Tolve
About this study
Official title: Clinical Validation of an Instrumented Glove for Sensorimotor Rehabilitation After Stroke (DESC-Glove)
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:
Read more
- To evaluate the usability and acceptability of the device in clinical rehabilitation from the perspectives of both patients and healthcare professionals;
- 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).
Read the 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.
- Conditions
- Stroke
- Being tested
- DESC-Glove (active), DESC-Glove (sham), Traditional rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DESC-Glove (active)Device
Rehabilitation treatment for the upper limb using the DESC-Glove device. The protocol includes 8 exercises, each lasting 2 to 3 minutes. The treatment is conducted daily under the supervision of a therapist and consists of two 20-minute sessions per day, with a 10-minute break in between for neuro-muscular and attentional recovery. The treatment is performed three times a week, totaling 24 sessions over a 4-week period. During each session, patients will wear the DESC-Glove on the affected hand, receiving vibratory stimuli that are synchronized with the exercises being performed.
DESC-Glove (sham)Device
Rehabilitation treatment for the upper limb using the DESC-Glove device. The protocol includes 8 exercises, each lasting 2 to 3 minutes. The treatment is conducted daily under the supervision of a therapist and consists of two 20-minute sessions per day, with a 10-minute break in between for neuro-muscular and attentional recovery. The treatment is performed three times a week, totaling 24 sessions over a 4-week period. During each session, patients will wear the DESC-Glove on the affected hand, but will not receive any vibratory stimuli.
Traditional rehabilitationOther
Traditional rehabilitation treatment for the upper limb. The protocol includes 8 exercises, each lasting 2 to 3 minutes. The treatment is conducted daily under the supervision of a therapist and consists of two 20- minute sessions per day, with a 10-minute break in between for neuro-muscular and attentional recovery. The treatment is performed three times a week, totaling 24 sessions over a 4-week period. The DESC- Glove will not be used during this treatment.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Hand rehabilitation using the device Receives: Device: DESC-Glove (active) |
| Sham Group | Sham comparator | Hand rehabilitation while wearing the device, without providing vibrations to the patients. Receives: Device: DESC-Glove (sham) |
| Control Group | Active comparator | Hand rehabilitation without using the device Receives: Other: Traditional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device malfunctioning: number and types of device malfunctions
This outcome measure is designed to systematically document and analyze any malfunctions of the DESC-Glove device throughout the study. All malfunctions will be recorded in detail, including the frequency and type of malfunction. Each issue will be categorized based on the nature of the malfunction, such as hardware failures (e.g., sensor or vibration issues), software, or connectivity problems. This data will be used to assess the overall reliability and functionality of the device, guiding future improvements and treatment efficacy.
Measured: For both the first and second phase of the study: within one day after each rehabilitation session.
Device malfunctioning: number of dropouts device-related
This outcome measure aims to document the number of participants who withdraw from the study specifically due to issues related to the device.
Measured: For both the first and second phase of the study: within one day after each rehabilitation session.
Secondary outcomes (9)
Clinical outcome: Box and Blocks test
The Box and Blocks Test is a clinical assessment used to measure manual dexterity and upper limb function. During the test, participants transfer as many small blocks as possible from one compartment of a box to another within 60 seconds. The score is based on the number of blocks successfully moved, reflecting hand coordination and fine motor skills. The test is conducted under three conditions: (a) with the DESC-Glove providing vibratory feedback, (b) with the DESC-Glove not providing vibrations, and (c) without the DESC-Glove altogether
Measured: For both the first and second phase of the study: baseline assessment (within 3 days before the first rehabilitation session) and final assessment (within 3 days after the last rehabilitation session).
Clinical outcome: Frenchay Arm Test
The Frenchay Arm Test (FAT) is an assessment tool designed to measure upper extremity proximal motor control and dexterity during activities of daily living (ADL) in patients with neurological impairments. It focuses on evaluating activity limitations specific to the upper extremities. Each of the test's five items is scored as either a pass (1) or fail (0), with total scores ranging from 0 to 5.
Measured: For both the first and second phase of the study: baseline assessment (within 3 days before the first rehabilitation session) and final assessment (within 3 days after the last rehabilitation session).
Clinical outcome: Thumb Localizing Test
The Thumb Localizing Test is an assessment used to evaluate proprioception and sensory awareness in the hand. During the test, the examiner places the participant's thumb in various positions, either passively or with minimal resistance, while the participant's eyes are closed. The participant is then asked to replicate the position of their thumb with their opposite hand or to indicate the position of their thumb using verbal or tactile cues. It ranges from 0 (normal) to 3 (severely impaired).
Measured: For both the first and second phase of the study: baseline assessment (within 3 days before the first rehabilitation session) and final assessment (within 3 days after the last rehabilitation session).
Clinical outcome: 5-level EQ-5D
The 5-level EQ-5D is a standardized instrument used to measure health-related quality of life. It consists of a descriptive system and a visual analogue scale (VAS). The descriptive system evaluates five dimensions of health - mobility, self-care, usual activities, pain/discomfort and anxiety/depression - each with five levels of severity. The result is calculated by assigning a numerical value to each response level and summing these values across the five items.
Measured: For both the first and second phase of the study: baseline assessment (within 3 days before the first rehabilitation session) and final assessment (within 3 days after the last rehabilitation session).
Instrumental Outcome: Pick and Lift test
The Pick and Lift Test (PLT) assesses the ability of participants to lift a sensorized object using a bi-digit grip with their thumb and index finger. During the test, participants repeatedly lift the object while the levels of force applied during the manipulation tasks are recorded. The PLT is conducted under three conditions: (a) with the DESC-Glove providing vibratory feedback, (b) with the DESC-Glove not providing vibrations, and (c) without the DESC-Glove altogether. This design allows for an evaluation of the impact of vibratory feedback on force application and manipulation skills.
Such a system is not intended as a clinical validation tool but rather as a means of data acquisition to extract metrics considered standard in the scientific literature regarding motor coordination in manipulation.
Measured: For both the first and second phase of the study: Baseline (within 3 days before the first rehabilitation session); Weekly assessment (within 3 days after the last rehab session of each week).
Instrumental Outcome: Pick and Place test
The Pick and Place Test (PPT) with a fragile object involves performing a series of movements to transfer a fragile item from one side of a barrier to the other. This object walls collapse when the gripping force applied to these walls exceeds a certain threshold. It measures the participant's ability to regulate grip strength and dexterity.
Such a system is not intended as a clinical validation tool but rather as a means of data acquisition to extract metrics considered standard in the scientific literature regarding motor coordination in manipulation.
Measured: For both the first and second phase of the study: baseline assessment (within 3 days before the first rehabilitation session) and final assessment (within 3 days after the last rehabilitation session).
Questionnaire: System Usability Scale
The system usability scale (SUS) is a simple, ten-item attitude Likert scale giving a global view of subjective assessments of usability. A SUS score can range from 0 to 100, with higher scores indicating better usability. This questionnaire will be evaluated exclusively within the experimental group.
Measured: For both the first and second phase of the study: final assessment (within 3 days after the last rehabilitation session).
Questionnaire: Gradibility of the Device
The Gradibility Questionnaire has been specifically designed to provide a thorough assessment of user experiences. It consists of 13 items that evaluate the usability, acceptability, and satisfaction of users testing the device. This questionnaire will be evaluated exclusively within the experimental group.
Measured: For both the first and second phase of the study: final assessment (within 3 days after the last rehabilitation session).
Questionnaire: Technology Acceptance Model
The Technology Acceptance Model is designed to identify the determinants influencing the acceptance of Robotic and Allied Technology. It comprises four sections: perceived usefulness, ease of use, compatibility, and intention to use. Each question utilizes a 7-point Likert scale, ranging from 1 (worst) to 7 (best). The scoring for each section is calculated as the average of the responses, with scores ranging from 1 (worst) to 7 (best). This questionnaire will be evaluated exclusively within the experimental group.
Measured: For both the first and second phase of the study: final assessment (within 3 days after the last rehabilitation session).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start21 Oct 2024
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christian Cipriani
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christian Cipriani, Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06649968
- Sponsor's protocol ID
- DESC-Glove Validation
- Other IDs
- PNC0000007
- Status last verified
- Oct 2024
- First submitted
- 15 Oct 2024
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of an Instrumented Glove for Sensorimotor Rehabilitation After Stroke (DESC-Glove)
- ClinicalTrials.gov ID
- NCT06649968
- Acronym / sponsor ID
- DESC-Glove Validation
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Christian CiprianiUniversity, hospital or other
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 21 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To evaluate the usability and acceptability of the device in clinical rehabilitation from the perspectives of both patients and healthcare professionals;
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: DESC-Glove (active)Hand rehabilitation using the device |
| Sham Group | Sham comparator | Device: DESC-Glove (sham)Hand rehabilitation while wearing the device, without providing vibrations to the patients. |
| Control Group | Active comparator | Other: Traditional rehabilitationHand rehabilitation without using the device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of ischemic or hemorrhagic stroke confirmed by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI);
- Time from the acute event between 1 and 6 months;
- Mild to moderate impairment of the upper limb, assessed using the Motricity Index (item score for "pinch grip" ≥ 19 and scores for "elbow flexion" and "shoulder abduction" ≥ 14).
Key exclusion criteria (4 listed)
- Severe behavioral and cognitive disorders (Montreal Cognitive Assessment (MoCA) ≤ 15 ) and/or decreased compliance;
- Spasticity or hypertonia (Modified Ashworth Scale (MAS) > 3) in the affected limb;
- Concurrent participation in a rehabilitation trial that includes treatment training for the upper limb following a stroke;
- Refusal to sign informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DESC-Glove (active)Rehabilitation treatment for the upper limb using the DESC-Glove device. The protocol includes 8 exercises, each lasting 2 to 3 minutes. The treatment is conducted daily under the supervision of a therapist and consists of two 20-minute sessions per day, with a 10-minute break in between for neuro-muscular and attentional recovery. The treatment is performed three times a week, totaling 24 sessions over a 4-week period. During each session, patients will wear the DESC-Glove on the affected hand, receiving vibratory stimuli that are synchronized with the exercises being performed. | Device | Experimental Group |
| DESC-Glove (sham)Rehabilitation treatment for the upper limb using the DESC-Glove device. The protocol includes 8 exercises, each lasting 2 to 3 minutes. The treatment is conducted daily under the supervision of a therapist and consists of two 20-minute sessions per day, with a 10-minute break in between for neuro-muscular and attentional recovery. The treatment is performed three times a week, totaling 24 sessions over a 4-week period. During each session, patients will wear the DESC-Glove on the affected hand, but will not receive any vibratory stimuli. | Device | Sham Group |
| Traditional rehabilitationTraditional rehabilitation treatment for the upper limb. The protocol includes 8 exercises, each lasting 2 to 3 minutes. The treatment is conducted daily under the supervision of a therapist and consists of two 20- minute sessions per day, with a 10-minute break in between for neuro-muscular and attentional recovery. The treatment is performed three times a week, totaling 24 sessions over a 4-week period. The DESC- Glove will not be used during this treatment. | Other | Control Group |
Primary outcome
Device malfunctioning: number and types of device malfunctions
Time frame: For both the first and second phase of the study: within one day after each rehabilitation session.
This outcome measure is designed to systematically document and analyze any malfunctions of the DESC-Glove device throughout the study. All malfunctions will be recorded in detail, including the frequency and type of malfunction. Each issue will be categorized based on the nature of the malfunction, such as hardware failures (e.g., sensor or vibration issues), software, or connectivity problems. This data will be used to assess the overall reliability and functionality of the device, guiding future improvements and treatment efficacy.
Device malfunctioning: number of dropouts device-related
Time frame: For both the first and second phase of the study: within one day after each rehabilitation session.
This outcome measure aims to document the number of participants who withdraw from the study specifically due to issues related to the device.
9 secondary outcomes
Clinical outcome: Box and Blocks test
Time frame: For both the first and second phase of the study: baseline assessment (within 3 days before the first rehabilitation session) and final assessment (within 3 days after the last rehabilitation session).
Clinical outcome: Frenchay Arm Test
Time frame: For both the first and second phase of the study: baseline assessment (within 3 days before the first rehabilitation session) and final assessment (within 3 days after the last rehabilitation session).
Clinical outcome: Thumb Localizing Test
Time frame: For both the first and second phase of the study: baseline assessment (within 3 days before the first rehabilitation session) and final assessment (within 3 days after the last rehabilitation session).
Clinical outcome: 5-level EQ-5D
Time frame: For both the first and second phase of the study: baseline assessment (within 3 days before the first rehabilitation session) and final assessment (within 3 days after the last rehabilitation session).
Instrumental Outcome: Pick and Lift test
Time frame: For both the first and second phase of the study: Baseline (within 3 days before the first rehabilitation session); Weekly assessment (within 3 days after the last rehab session of each week).
Instrumental Outcome: Pick and Place test
Time frame: For both the first and second phase of the study: baseline assessment (within 3 days before the first rehabilitation session) and final assessment (within 3 days after the last rehabilitation session).
Questionnaire: System Usability Scale
Time frame: For both the first and second phase of the study: final assessment (within 3 days after the last rehabilitation session).
Questionnaire: Gradibility of the Device
Time frame: For both the first and second phase of the study: final assessment (within 3 days after the last rehabilitation session).
Questionnaire: Technology Acceptance Model
Time frame: For both the first and second phase of the study: final assessment (within 3 days after the last rehabilitation session).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DESC-Glove (active) and Traditional rehabilitation in people with Stroke, run by Christian Cipriani at 6 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Cipriani, PhD (+39 050 883133, christian.cipriani@santannapisa.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device malfunctioning: number and types of device malfunctions (time frame: For both the first and second phase of the study: within one day after each rehabilitation session.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.