StrokeRoHa-SNCT05983822
Robotic Hand Rehabilitation
A study testing Technological Group and Conventional Treatment in people with Stroke and Spasticity as Sequela of Stroke, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The performance of activities of daily living (ADL) depends to a large extent on the functionality of the upper limb and hand. Stroke is the leading cause of disability worldwide, with a significant individual, family and economic impact. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Stroke, Spasticity as Sequela of Stroke, Upper Limb
- What is being tested?
- Technological Group and Conventional Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 2 Oct 2023to 28 Oct 2024
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with ischaemic or haemorrhagic stroke documented by neuroimaging techniques (magnetic resonance imaging or computed tomography)
- Latency since acute event between 1 and 6 months;
- Cognitive ability to execute simple orders and understand the physiotherapist's instructions, assessed by Token Test (score ≥ 26.5);
- Ability to understand and sign informed consent.
Who cannot join
- Presence of a pincer grip "possible against resistance but weaker than the contralateral" as assessed by the Upper Limb Motricity Index ≥ 26;
- Behavioural, cognitive disorders and/or reduced compliance that could interfere with rehabilitation treatment;
- Presence of ankylosis as assessed by the modified Ashworth Scale ≥ 4;
- Inability to discriminate distinctly between images displayed on a monitor placed at eye level of each subject at a distance of approximately 50 cm, even with corrective glasses;
- Inability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, RM, 00168
About this study
Official title: Robotic Hand Rehabilitation in Stroke Patients
The performance of activities of daily living (ADL) depends to a large extent on the functionality of the upper limb and hand. Stroke is the leading cause of disability worldwide, with a significant individual, family and economic impact. After a stroke event, however, a large percentage of affected patients have a deficit of the hand and, six months after the acute event, 65% of patients with a deficit of the hand are unable to use and integrate the affected hand in activities of daily living, significantly reducing its quality. The impairment of strength, grip and general hand function makes it difficult to perform ADLs and affects the independence of functional activities, making the recovery of hand function an extremely challenging field in stroke rehabilitation.
Read the detailed description
Rehabilitation of the hand in stroke patients has changed substantially over the last decades, with an increasing interest in the use of robotic devices for the treatment of the upper limb. Indeed, the use of such systems makes it possible to increase the amount and intensity of therapy, to standardise treatment, to provide complex but controlled multisensory stimulation, and to support the patient while performing various tasks, preventing inappropriate movements. Moreover, through robotic systems it is possible to acquire kinematic and kinetic data that are processed to obtain quantitative indices in order to objectively evaluate the patient's motor performance before and after the rehabilitation treatment.
Amadeo® (Tyromotion, Austria) is an end-effector type robotic device, specifically designed for hand treatment, effective in reducing hand disability in stroke patients.
The aim of the study is to evaluate the effects of robotic rehabilitation with an Amadeo® hand end-effector robot (Tyromotion, Austria):
(i) in terms of improved hand function (assessed by clinical and instrumental scales); (ii) on fatigue and quality of life. 24 patients will be recruited at the UOS Post-Acute Rehabilitation, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome. Patients will be divided into two groups by randomization: one group (experimental group, GA) will perform specific rehabilitation for balance disorders using the end-effector robot Amadeo® (Tyromotion, Austria) 3 times a week, for 4 weeks (12 total sessions), for 45 minutes of treatment, in addition to the conventional treatment, and one group will perform only the conventional treatment (conventional group, GC), as a daily routine, as described below.
- Conditions
- Stroke, Spasticity as Sequela of Stroke, Upper Limb
- Being tested
- Technological Group, Conventional Treatment
- Keywords
- Stroke, Robotic rehabilitation, Upper limb
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technological GroupDevice
Also called Amadeo® (Tyromotion, Austria)
Specific rehabilitation for the recovery of hand function using the end-effector robot
Conventional TreatmentOther
Conventional rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group (GA) | Experimental | The experimental group (GA) will perform specific rehabilitation for the recovery of hand function using the end-effector robot Amadeo® (Tyromotion, Austria) 3 times a week, for 4 weeks (12 total sessions), for 45 minutes of treatment in addition to conventional treatment. In particular, the technological rehabilitation performed using the robot will mostly aim at improving finger mobility and strength, and flexion-extension exercises will be proposed in passive, active assisted and active mode, exercises for improving strength and muscle tone. Receives: Device: Technological Group |
| Conventional Group (GC) | Active comparator | GC patients will undergo conventional rehabilitation treatment only, using the main rehabilitation methods (e.g. neurocognitive theory, progressive neuromuscular facilitation, etc.). Receives: Device: Technological Group; Other: Conventional Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment - Upper Extremity (FMA-UE)
The Fugl-Meyer Assessment - Upper Extremity (FMA-UE) is a stroke-specific, performance-based impairment index. Upper Extremity section is designed to assess motor functioning, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment.
For each item, a score can be assigned on direct observation of performance. The scale items are scored according to the ability to complete the item using a 3-point ordinal scale where 0=not able to perform, 1=performs partially and 2=performs completely.
The motor function macro-area has a maximum total score of 66; the sensitivity macro-area has a maximum total score of 60.
Measured: Change from Baseline FMA-UE at 4 weeks
Secondary outcomes (11)
Modified Fatigue Impact Scale (MFIS)
The MFIS is an instrument that provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. The full-length MFIS consists of 21 items while the abbreviated version has 5 items. The MFIS is a structured, self-report questionnaire that the patient can generally complete with little or no intervention from an interviewer. However, patients with visual or upper extremity impairments may need to have the MFIS administered as an interview. Interviewers should be trained in basic interviewing skills and in the use of this instrument.
The total score for the MFIS is the sum of the scores for the 21 items. Individual subscale scores for physical, cognitive, and psychosocial functioning can also be generated by calculating the sum of specific sets of items.
Measured: Change from Baseline MFIS at 4 weeks
Fatigue Scale for Motor and Cognitive Function (FSMC)
The FSMC is an assessment of MS-related cognitive and motor fatigue. A Likert-type 5-point scale (ranging from 'does not apply at all' to 'applies completely') produces a score between 1 and 5 for each scored question. Thus minimum value is 20 (no fatigue at all) and maximum value is 100 (severest grade of fatigue). Two subscales (mental and physical fatigue) can be made. Items included in the subscale mental are 1-4-7-8-11-13-15-17-18-20 and items included in the subscale physical are 2-3-5-6-9-10-12-14-16-19.
Measured: Change from Baseline FSMC at 4 weeks
The Medical Research Council (MRC) Scale
The MRC Scale is a 6-value scale for measuring strength through the observation of movement and muscle behaviour for grades 0 to 3 and the administration of Manual Muscle Tests for grades 4 and 5.
The MRC Scale provides a score ranging from 0 to 5:
0 Absence of contraction
- Hint of muscle contraction
- Active movement that eliminates the force of gravity
- Active movement against the force of gravity
- Active movement against the force of gravity and a resistance
- Normal force
Measured: Change from Baseline MRC at 4 weeks
Motricity Index - Upper Limb (MI-UL)
MI-UL can be used to assess the upper limb motor impairment in a patient who has had a stroke.
Test for each upper limb:
pincer grip elbow flexion shoulder abduction For the pincer grip: 0 points, no movement 19 points, grip possible but not against gravity 33 points, normal grip For all other items: 0 points, no movement 14 points, Visible movement but not for the entire joint range or against gravity 19 points, movement possible for the entire joint range against gravity but not against resistance 33 points movement performed with normal force Each segment has a total score obtained by adding the value "1" to the score of each individual item. The total score then ranges from 1 (no movement) to 100 (normal movement).
Measured: Change from Baseline MI-UL at 4 weeks
Stroke Upper Limb Capacity Scale (SULCS)
The SULCS is a scale that assesses various arm and hand skills in the hemiplegic patient; in particular, it assesses highly functional movements related to activities of daily living.
It consists of 10 items, assessable with a score of 0 or 1 (not performed/executed correctly), of which 3 items for limb skills without hand activity 4 items for limb skills and simple hand skills 3 items for complex hand skills The SULCS is a hierarchical scale: if the patient has poor upper limb skills and is unable to perform 3 consecutive items, all subsequent items will automatically receive a score of 0 without having to be performed.
The maximum scale score is 10.
Measured: Change from Baseline SULCS at 4 weeks
9-Hole Peg test (9HPT)
The 9HPT is used to measure finger dexterity. The patient is asked to take the pegs from a container, one by one, and insert them into the holes in the board, as quickly as possible, using only his hand to assess. He/she must then remove them, one at a time, and reinsert them into the container.
The final score is given by the time it takes the patient to complete the test.
Measured: Change from Baseline 9HPT at 4 weeks
Box&Block test (BBT)
The BBT) measures unilateral gross manual dexterity. It is a quick, simple and inexpensive test.
The BBT consists of a wooden box divided into two compartments by a divider and 150 blocks. The administration of the BBT consists of asking the patient to move, one at a time, the maximum number of blocks from one compartment of the box to another of equal size, within 60 seconds. The test must begin with the upper limb unaffected.
The score is given according to the number of blocks moved from one compartment to another in 60 seconds. The score is assigned to each hand separately. Higher scores indicate better manual dexterity.
Measured: Change from Baseline BBT at 4 weeks
Modified Ashworth Scale (MAS)
It is performed by first extending the patient's limb from a position of maximum possible flexion to maximum possible extension.
The score ranges from 0 to 4:
0 No increase in tone
1 Slight increase in tone, giving a signal when there is a slight increase in muscle tone, manifested when the limb is moved into flexion or extension.
1+ slight increase in muscle tone, manifested by a jerk followed by minimal resistance throughout the movement (ROM) 2 more marked increase in tone, but more marked increase in muscle tone through most of the limb easily flexed 3 marked increase in tone, difficult passive movement 4 stiff limb in flexion or extension
Measured: Change from Baseline MAS at 4 weeks
HandGrip Test (HGT)
HGT is a test performed with a dynamometer, which goes to assess muscle strength (in kilograms). Starting with the elbow flexed to 90°, the patient must squeeze the dynamometer as hard as they can at one time. Three repeated measurements are taken on each side 20 seconds apart.
The average of the three assessments is used as the final value.
Measured: Change from Baseline HGT at 4 weeks
modified Barthel Index (mBI)
mBI for activities of daily living is meant to be used in the assessment of patient performance (or degree of assistance required) with respect to self-care, sphincter management, transfers and locomotion. The index consist of 10 items (each scored with a number of points) that relate to activities of daily living (ADLs) where the final score is calculated by summing the points awarded to each item. A five-point rating scales for each item to improve sensitivity to detecting change.
The 10 items assessed relate to:
Help needed with feeding; Help needed with bathing; Help needed with grooming; Help needed with dressing; Presence or absence of fecal incontinence; Presence or absence of urinary incontinence; Help needed with transfers; Help needed with walking; Help needed with climbing stairs.
Interpretation:
91-100 Slight dependency 61-90 Moderate dependency 21-60 Severe dependency 0-20 Total dependency
Measured: Change from Baseline mBI at 4 weeks
EuroQol- 5 Dimension (EQ-5D)
EQ-5D is an instrument which evaluates the generic quality of life. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The answers given to ED-5D permit to find 243 unique health states or can be converted into EQ- 5D index an utility scores anchored at 0 for death and 1 for perfect health.
Measured: Change from Baseline EQ-5D at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start2 Oct 2023
- Primary completion30 Apr 2024
- Study completion28 Oct 2024
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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GIOVANNINI SILVIA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Silvia Giovannini, MD, phD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05983822
- Sponsor's protocol ID
- 0000052/23
- Acronym
- RoHa-S
- Status last verified
- Dec 2024
- First submitted
- 2 Aug 2023
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Hand Rehabilitation in Stroke Patients
- ClinicalTrials.gov ID
- NCT05983822
- Acronym / sponsor ID
- RoHa-S / 0000052/23
- Conditions
- Stroke, Spasticity as Sequela of Stroke, Upper Limb
- Keywords
- Stroke, Robotic rehabilitation, Upper limb
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 28 Oct 2024 (actual)
- First posted
- 9 Aug 2023 (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 performance of activities of daily living (ADL) depends to a large extent on the functionality of the upper limb and hand. Stroke is the leading cause of disability worldwide, with a significant individual, family and economic impact. After a stroke event, however, a large percentage of affected patients have a deficit of the hand and, six months after the acute event, 65% of patients with a deficit of the hand are unable to use and integrate the affected hand in activities of daily living, significantly reducing its quality. The impairment of strength, grip and general hand function makes it difficult to perform ADLs and affects the independence of functional activities, making the recovery of hand function an extremely challenging field in stroke rehabilitation.
Detailed description
Rehabilitation of the hand in stroke patients has changed substantially over the last decades, with an increasing interest in the use of robotic devices for the treatment of the upper limb. Indeed, the use of such systems makes it possible to increase the amount and intensity of therapy, to standardise treatment, to provide complex but controlled multisensory stimulation, and to support the patient while performing various tasks, preventing inappropriate movements. Moreover, through robotic systems it is possible to acquire kinematic and kinetic data that are processed to obtain quantitative indices in order to objectively evaluate the patient's motor performance before and after the rehabilitation treatment.
Amadeo® (Tyromotion, Austria) is an end-effector type robotic device, specifically designed for hand treatment, effective in reducing hand disability in stroke patients.
The aim of the study is to evaluate the effects of robotic rehabilitation with an Amadeo® hand end-effector robot (Tyromotion, Austria):
(i) in terms of improved hand function (assessed by clinical and instrumental scales); (ii) on fatigue and quality of life. 24 patients will be recruited at the UOS Post-Acute Rehabilitation, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome. Patients will be divided into two groups by randomization: one group (experimental group, GA) will perform specific rehabilitation for balance disorders using the end-effector robot Amadeo® (Tyromotion, Austria) 3 times a week, for 4 weeks (12 total sessions), for 45 minutes of treatment, in addition to the conventional treatment, and one group will perform only the conventional treatment (conventional group, GC), as a daily routine, as described below.
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 (GA) | Experimental | Device: Technological GroupThe experimental group (GA) will perform specific rehabilitation for the recovery of hand function using the end-effector robot Amadeo® (Tyromotion, Austria) 3 times a week, for 4 weeks (12 total sessions), for 45 minutes of treatment in addition to conventional treatment. In particular, the technological rehabilitation performed using the robot will mostly aim at improving finger mobility and strength, and flexion-extension exercises will be proposed in passive, active assisted and active mode, exercises for improving strength and muscle tone. |
| Conventional Group (GC) | Active comparator | Device: Technological Group, Other: Conventional TreatmentGC patients will undergo conventional rehabilitation treatment only, using the main rehabilitation methods (e.g. neurocognitive theory, progressive neuromuscular facilitation, etc.). |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with ischaemic or haemorrhagic stroke documented by neuroimaging techniques (magnetic resonance imaging or computed tomography)
- Latency since acute event between 1 and 6 months;
- Cognitive ability to execute simple orders and understand the physiotherapist's instructions, assessed by Token Test (score ≥ 26.5);
- Ability to understand and sign informed consent.
Key exclusion criteria (5 listed)
- Presence of a pincer grip "possible against resistance but weaker than the contralateral" as assessed by the Upper Limb Motricity Index ≥ 26;
- Behavioural, cognitive disorders and/or reduced compliance that could interfere with rehabilitation treatment;
- Presence of ankylosis as assessed by the modified Ashworth Scale ≥ 4;
- Inability to discriminate distinctly between images displayed on a monitor placed at eye level of each subject at a distance of approximately 50 cm, even with corrective glasses;
- Inability to provide 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 |
|---|---|---|
| Technological GroupAlso: Amadeo® (Tyromotion, Austria)Specific rehabilitation for the recovery of hand function using the end-effector robot | Device | Conventional Group (GC), Experimental Group (GA) |
| Conventional TreatmentConventional rehabilitation | Other | Conventional Group (GC) |
Primary outcome
Fugl-Meyer Assessment - Upper Extremity (FMA-UE)
Time frame: Change from Baseline FMA-UE at 4 weeks
The Fugl-Meyer Assessment - Upper Extremity (FMA-UE) is a stroke-specific, performance-based impairment index. Upper Extremity section is designed to assess motor functioning, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. For each item, a score can be assigned on direct observation of performance. The scale items are scored according to the ability to complete the item using a 3-point ordinal scale where 0=not able to perform, 1=performs partially and 2=performs completely. The motor function macro-area has a maximum total score of 66; the sensitivity macro-area has a maximum total score of 60.
11 secondary outcomes
Modified Fatigue Impact Scale (MFIS)
Time frame: Change from Baseline MFIS at 4 weeks
Fatigue Scale for Motor and Cognitive Function (FSMC)
Time frame: Change from Baseline FSMC at 4 weeks
The Medical Research Council (MRC) Scale
Time frame: Change from Baseline MRC at 4 weeks
Motricity Index - Upper Limb (MI-UL)
Time frame: Change from Baseline MI-UL at 4 weeks
Stroke Upper Limb Capacity Scale (SULCS)
Time frame: Change from Baseline SULCS at 4 weeks
9-Hole Peg test (9HPT)
Time frame: Change from Baseline 9HPT at 4 weeks
Box&Block test (BBT)
Time frame: Change from Baseline BBT at 4 weeks
Modified Ashworth Scale (MAS)
Time frame: Change from Baseline MAS at 4 weeks
HandGrip Test (HGT)
Time frame: Change from Baseline HGT at 4 weeks
modified Barthel Index (mBI)
Time frame: Change from Baseline mBI at 4 weeks
EuroQol- 5 Dimension (EQ-5D)
Time frame: Change from Baseline EQ-5D at 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
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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.
Silvia Giovannini, MD, phD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technological Group and Conventional Treatment in people with Stroke and Spasticity as Sequela of Stroke, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Fugl-Meyer Assessment - Upper Extremity (FMA-UE) (time frame: Change from Baseline FMA-UE at 4 weeks). 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 13 Dec 2024.