StrokeNCT04527783
The Use of an Engineered Glove for the Assessment and Rehabilitation of Manual Dexterity in People With Stroke.
A study testing experimental group in people with Stroke and Hand Grasp, run by Fondazione Don Carlo Gnocchi ETS.
Trial summary
Stroke often results in impairments of upper extremity, including coordination deficits, reducing of force, weakness and changes in the kinetic and kinematic workspace of fingers with 75% of stroke survivors facing difficulties performing activities of daily living. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke, Hand Grasp
- What is being tested?
- experimental group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 31 Mar 2021
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a single stroke,
- some movement of the fingers,
- any technical and difficulties with wearing the glove on the paretic hand
Who cannot join
- visual or cognitive deficits that would prevent them for performing the task
About this study
Official title: The Use of an Engineered Glove for the Assessment and Rehabilitation of Manual Dexterity in People With Stroke: a Pilot Randomized Control Trial.
Stroke often results in impairments of upper extremity, including coordination deficits, reducing of force, weakness and changes in the kinetic and kinematic workspace of fingers with 75% of stroke survivors facing difficulties performing activities of daily living.
The ability to oppose the fingertip of the thumb to each fingertip of the same hand is the basis of grasping objects of various sizes and operating tools and assessing and improving distal upper extremity function is of primary goal in the rehabilitation of stroke survivors. Moreover, repetitive movement practice seems to be crucial for maximizing therapeutic benefits.
Read more
Recent studies, proposed an engineered glove to assess motor performance during finger-to-thumb opposition movements and to provide objective and reproducible measures.
The same tool can be integrated with Virtual Reality and serious games to provide repetitive practice of activities improving motivation and adherence with therapy.
the investigators developed a new integrated glove and virtual reality to facilitate the recovery of hand functionality.
The aim of this study is to investigate the feasibility of the engineered glove in the assessment and treatment of hand dysfunction in people with Stroke.
- Conditions
- Stroke, Hand Grasp
- Being tested
- experimental group, control group
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimental groupOther
Each subject will undergo 10 rehabilitation sessions 2-3 times a week, lasting around 30'.
control groupOther
Each subject will undergo 10 rehabilitation sessions 2-3 times a week, lasting around 30'.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Each subject will perform a variety of VR exercises to reduce impairments in their finger range of motion, speed and strength.
It includes a glove-shaped sensor device and a software application. Receives: Other: experimental group |
| control group | Active comparator | Each subject will perform usual care rehabilitation aimed at improving manual dexterity Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Box and Blocks Test
Block and Box Test assesses grasp and transport and upper limb functional disorders and measures unilateral gross manual dexterity.
Measured: baseline- immediately after the intervention
Secondary outcomes (3)
Change in 9-Hole Peg Test
It measures finger dexterity. Patient takes the pegs from a container and place them into the holes as quickly as possible.
Measured: baseline- immediately after the intervention
Change in Manual Ability Measurement
It is a self reported questionnaire to rate perceived manual ability on a scale ranging from 0 (impossible to complete any of activity cited) to 100 (every activity cited is accomplished without any difficulty).
Measured: baseline- immediately after the intervention
Change in the instrumented indexes
Subjects perform a repetitive finger-to-thumb opposition sequence (index, medium, ring and little finger) with their affected hand at maximal velocity and with the two hands simultaneously at a frequency of 2 Hz paced by a metronome. The testing session includes one 60sec trial per condition.
They wear a sensor-engineered glove on both hands to quantitatively assess finger motor performance
Measured: baseline- immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start1 Sep 2020 (estimated)
- Primary completion28 Feb 2021 (estimated)
- Study completion31 Mar 2021 (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.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Davide Cattaneo, Fondazione Don Carlo Gnocchi ETS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04527783
- Sponsor's protocol ID
- GREVAP
- Status last verified
- Aug 2020
- First submitted
- 19 Aug 2020
- Last updated
- 27 Aug 2020
- Results posted
- 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 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of an Engineered Glove for the Assessment and Rehabilitation of Manual Dexterity in People With Stroke: a Pilot Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT04527783
- Acronym / sponsor ID
- GREVAP
- Conditions
- Stroke, Hand Grasp
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 28 Feb 2021 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 27 Aug 2020 (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.
Stroke often results in impairments of upper extremity, including coordination deficits, reducing of force, weakness and changes in the kinetic and kinematic workspace of fingers with 75% of stroke survivors facing difficulties performing activities of daily living.
The ability to oppose the fingertip of the thumb to each fingertip of the same hand is the basis of grasping objects of various sizes and operating tools and assessing and improving distal upper extremity function is of primary goal in the rehabilitation of stroke survivors. Moreover, repetitive movement practice seems to be crucial for maximizing therapeutic benefits.
Recent studies, proposed an engineered glove to assess motor performance during finger-to-thumb opposition movements and to provide objective and reproducible measures.
The same tool can be integrated with Virtual Reality and serious games to provide repetitive practice of activities improving motivation and adherence with therapy.
the investigators developed a new integrated glove and virtual reality to facilitate the recovery of hand functionality.
The aim of this study is to investigate the feasibility of the engineered glove in the assessment and treatment of hand dysfunction in people with Stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: experimental groupEach subject will perform a variety of VR exercises to reduce impairments in their finger range of motion, speed and strength. It includes a glove-shaped sensor device and a software application. |
| control group | Active comparator | Other: control groupEach subject will perform usual care rehabilitation aimed at improving manual dexterity |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- a single stroke,
- some movement of the fingers,
- any technical and difficulties with wearing the glove on the paretic hand
Key exclusion criteria (1 listed)
- visual or cognitive deficits that would prevent them for performing the task
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 |
|---|---|---|
| experimental groupEach subject will undergo 10 rehabilitation sessions 2-3 times a week, lasting around 30'. | Other | experimental group |
| control groupEach subject will undergo 10 rehabilitation sessions 2-3 times a week, lasting around 30'. | Other | control group |
Primary outcome
Change in Box and Blocks Test
Time frame: baseline- immediately after the intervention
Block and Box Test assesses grasp and transport and upper limb functional disorders and measures unilateral gross manual dexterity.
3 secondary outcomes
Change in 9-Hole Peg Test
Time frame: baseline- immediately after the intervention
Change in Manual Ability Measurement
Time frame: baseline- immediately after the intervention
Change in the instrumented indexes
Time frame: baseline- immediately after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2020.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing experimental group in people with Stroke and Hand Grasp, run by Fondazione Don Carlo Gnocchi ETS.
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 1 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 27 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Box and Blocks Test (time frame: baseline- immediately after the intervention). 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 27 Aug 2020.