StrokeNCT02628418
Feasibility and Efficacy of a Robotic Device for Hand Rehabilitation
A study testing General Rehabilitation, Specific hand rehabilitation by Gloreha device and Specific hand rehabilitation performed by physiotherapist in people with Stroke and Upper Extremity Hemiplegia, run by Fondazione Salvatore Maugeri.
Trial summary
Hand recovery following cerebral stroke is complex and requires intensive training. The investigators aimed to evaluate the feasibility and efficacy of robot-assisted hand rehabilitation compared to physiotherapist-guided treatment in recovering dexterity and hand strength in hospitalized sub-acute hemiplegic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Upper Extremity Hemiplegia, Disorder of Hand
- What is being tested?
- General Rehabilitation, Specific hand rehabilitation by Gloreha device and Specific hand rehabilitation performed by physiotherapist
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- May 2013to Jun 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients affected by stroke from cerebral ischemia or hemorrhage that had occurred ≤ 30 days before, with Ashworth spasticity index < 3.
Who cannot join
- orthopedic limitation (amputations, irreducible articular limitations, advanced osteoarthritis, active rheumatoid arthritis);
- peripheral nerve injury;
- uncontrolled inflammation;
- severe cognitive and behavioral disorders;
- neurodegenerative and neuromuscular diseases;
- Ashworth spasticity index ≥ 3.
About this study
Official title: Feasibility and Efficacy of a Robotic Device for Hand Rehabilitation in Hemiplegic Stroke Patients: a Randomized Pilot Controlled Study
Hand recovery following cerebral stroke is complex and requires intensive training. The investigators aimed to evaluate the feasibility and efficacy of robot-assisted hand rehabilitation compared to physiotherapist-guided treatment in recovering dexterity and hand strength in hospitalized sub-acute hemiplegic patients. Design. 30 patients affected by stroke from cerebral ischemia or hemorrhage (Ashworth spasticity index <3) were randomized. Patients in the Treatment group received intensive hand training with Gloreha, a hand rehabilitation glove that provides computer-controlled, repetitive, passive mobilization of the fingers, with multisensory feedback. Patients in the Control group received conventional intensive hand rehabilitation under physiotherapist guidance. Hand motor function (Motricity Index, MI), fine manual dexterity (Nine Hole Peg Test, NHPT) and strength (Grip and Pinch test) were measured at baseline and after rehabilitation, and the differences between final and basal results were compared between groups.
Read the detailed description
Upper limb recovery, particularly that of the hand, is complex in patients with cerebral stroke and requires an intensive approach.
Regarding upper limb rehabilitation, several research groups have developed robotic devices to provide passive and/or active movements. Their use appears to reduce the motor deficit of the arm and affected hand and to improve hand function both at the wrist and fingers. Hence, the evidence supporting specific robot-assisted rehabilitation of the hand is very promising even if further study is required.In particular, evidence is limited about the benefit of passive exercises and mobilization of the hemiplegic upper limb following stroke, and further research is called for.
In this study the investigators used Gloreha, a new hand rehabilitation glove that provides computer-controlled, repetitive and passive mobilization of the fingers, with multi-sensory feedback. The purpose of the study was to evaluate in the rehabilitation of patients with ischemic or hemorrhagic stroke in the sub-acute phase: 1) the feasibility of this new neuromotor rehabilitation device 2) its efficacy in improving arm function abilities, and 3) the costs involved.
Post-stroke patients admitted for inpatient rehabilitation between May 2013 and January 2014 were screened for enrollment. Eligible patients were randomly assigned, following a simple randomization procedure (computerized random numbers) conducted independently of the study investigators, to Treatment group or Control group, on a 1:1 ratio.
- Conditions
- Stroke, Upper Extremity Hemiplegia, Disorder of Hand
- Being tested
- General Rehabilitation, Specific hand rehabilitation by Gloreha device, Specific hand rehabilitation performed by physiotherapist
- Keywords
- Rehabilitation, Robotics
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General RehabilitationOther
All patients underwent basic rehabilitation following the guidelines according to the Bobath concept. Mobilization performed by physiotherapist of the lower and upper limbs through passive and/or active manoeuvres, gait training, standing and functional exercises and speech rehabilitation.
Specific hand rehabilitation by Gloreha deviceDevice
Each training session consisted of six parts:
- A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min);
- 7 min of a number sequence (counting from one to five);
- A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min)
- A sequence of wave-like finger movements (7 min)
- A sequence of fist opening/closing (7 min)
- A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min).
Specific hand rehabilitation performed by physiotherapistOther
The activities were:
- Flexion-extension of the fingers (10 min);
- Thumb opposition with the other fingers keeping the forearm in supine position (10 min);
- Adduction and abduction of the fingers (10 min);
- Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min).
| Study group | Role | What they receive |
|---|---|---|
| Gloreha Group | Experimental | The patients in the "Gloreha Group" underwent to following interventions:
1. General Rehabilitation
2. Specific hand rehabilitation by Gloreha device Receives: Other: General Rehabilitation; Device: Specific hand rehabilitation by Gloreha device |
| Control Group | Other | The patients in the Control Group underwent to following interventions:
1. General Rehabilitation
2. Specific hand rehabilitation performed by physiotherapist Receives: Other: General Rehabilitation; Other: Specific hand rehabilitation performed by physiotherapist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Who Completed the Hand Rehabilitation Program
Measured: Through study completion. The specific hand interventionn consisted of a total of 30 sessions, lasting 40 min/day, for 5 days/week , from admission to discharge in the Rehabilitation Centre, over a period of about 6 weeks.
Side Effects Using Gloreha Device
The feasibility of the device was assessed in terms of side effects (the physiotherapist was required to report any adverse events occurring during the study in regard to the use of Gloreha);
Measured: Through study completion. The specific hand intervention consisted of a total of 30 sessions, lasting 40 min/day, for 5 days/week , from admission to discharge in the Rehabilitation Centre, over a period of about 6 weeks.
Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Motricity Index at End of Inpatient Rehabilitation
Motricity Index, a measure of the motor function of the paretic upper limb. Motricity Index used to measure the ability to activate a muscle group to move a body segment through a range of motion and resist external force. The upper extremity motricity index includes: 1. pinch grasp, 2. elbow flexion, and 3. shoulder abduction.
The total upper extremity score involved adding one to the sum of the three actions.
The score of each action ranges from 0 (no ability) to 33 (maximal ability) with a maximum possible score=100.
Measured: Baseline and end of the study after 30 sessions, an average of 6 weeks
Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Nine Hole Peg Test at End of Inpatient Rehabilitation.
Nine Hole Peg Test (NHPT), a measure of coordination and mono-manual dexterity. It consists in collecting 9 pegs and inserting them into holes in a wooden base within a 50-sec time limit. The score is the average number of pegs inserted/tests performed.
Measured: Baseline and end of the study after 30 sessions, an average of 6 weeks
Secondary outcomes (5)
The Feasibility of This New Neuromotor Rehabilitation Device (Gloreha)
The feasibility of the device was assessed in terms of the level of operator difficulty for the physiotherapist in managing the device, assessed by visual analogue scale (VAS) (0 extremely simple - 10 extremely difficult). This outcome was measured only in the Gloreha Group in which patients were treated with device.
Measured: Baseline and end of the study after 30 sessions, an average of 6 weeks
Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Grip Test at End of Inpatient Rehabilitation.
The Grip test is a measure of hand strength. Each patient, at baseline and at the end of the study, repeated the test 3 times and the mean value was normalized for body mass index (BMI).
Measured: Baseline and end of the study after 30 sessions, an average of 6 weeks
Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Pinch Test at End of Inpatient Rehabilitation.
The Pinch test is a measure of hand strength. Each patient, at baseline and at the end of the study, repeated the test 3 times and the mean value was normalized for body mass index (BMI).
Measured: Baseline and end of the study after 30 sessions, an average of 6 weeks
Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Quick-DASH Questionnaire at End of Inpatient Rehabilitation.
The Arm disability was assessed of the study with the Quick version of the Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) questionnaire.
The Quick-DASH is a 19-item ordinal scale with a 5-level rating of items from 1 (no difficulty) to 5 (unable to do).
Quick-Dash can be divided into an 11-item (abilities and symptoms) and an 8-item optional work module and sports/performing arts module. In the 11-item sub-scale, the subject defines the ability to perform some actions (8 items) and the intensity of some symptoms (3 items), referring to the previous week. The total score range is from 19 (no disability) to 95 (full disability).
Measured: Baseline and end of the study after 30 sessions, an average of 6 weeks
The Costs Involved in Using Gloreha in the Rehabilitation
Costs were calculated in terms of the time required by healthcare personnel, using the average cost per hour of a physiotherapist per total number of rehabilitation treatments per patient. The equivalent cost of the device for the period of patient treatment was calculated incorporating depreciation, considering the estimated residual value of the device with depreciation rate of 20%.. Indirect costs were not considered because these were common to both groups.
Measured: Through study completion, from admission to discharge in the Rehabilitation Centre, over a period of about 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startMay 2013
- Primary completionMar 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Salvatore Maugeri
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Palmira Bernocchi, Fondazione Salvatore Maugeri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02628418
- Sponsor's protocol ID
- 1
- Status last verified
- Aug 2016
- First submitted
- 3 Dec 2015
- Last updated
- 15 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Vanoglio F, Bernocchi P, Mule C, Garofali F, Mora C, Taveggia G, Scalvini S, Luisa A. Feasibility and efficacy of a robotic device for hand rehabilitation in hemiplegic stroke patients: a randomized pilot controlled study. Clin Rehabil. 2017 Mar;31(3):351-360. doi: 10.1177/0269215516642606. Epub 2016 Jul 10.
PubMed 27056250
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Efficacy of a Robotic Device for Hand Rehabilitation in Hemiplegic Stroke Patients: a Randomized Pilot Controlled Study
- ClinicalTrials.gov ID
- NCT02628418
- Acronym / sponsor ID
- 1
- Conditions
- Stroke, Upper Extremity Hemiplegia, Disorder of Hand
- Keywords
- Rehabilitation, Robotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fondazione Salvatore MaugeriUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 11 Dec 2015 (estimated)
- Results
- Posted 3 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hand recovery following cerebral stroke is complex and requires intensive training. The investigators aimed to evaluate the feasibility and efficacy of robot-assisted hand rehabilitation compared to physiotherapist-guided treatment in recovering dexterity and hand strength in hospitalized sub-acute hemiplegic patients. Design. 30 patients affected by stroke from cerebral ischemia or hemorrhage (Ashworth spasticity index <3) were randomized. Patients in the Treatment group received intensive hand training with Gloreha, a hand rehabilitation glove that provides computer-controlled, repetitive, passive mobilization of the fingers, with multisensory feedback. Patients in the Control group received conventional intensive hand rehabilitation under physiotherapist guidance. Hand motor function (Motricity Index, MI), fine manual dexterity (Nine Hole Peg Test, NHPT) and strength (Grip and Pinch test) were measured at baseline and after rehabilitation, and the differences between final and basal results were compared between groups.
Detailed description
Upper limb recovery, particularly that of the hand, is complex in patients with cerebral stroke and requires an intensive approach.
Regarding upper limb rehabilitation, several research groups have developed robotic devices to provide passive and/or active movements. Their use appears to reduce the motor deficit of the arm and affected hand and to improve hand function both at the wrist and fingers. Hence, the evidence supporting specific robot-assisted rehabilitation of the hand is very promising even if further study is required.In particular, evidence is limited about the benefit of passive exercises and mobilization of the hemiplegic upper limb following stroke, and further research is called for.
In this study the investigators used Gloreha, a new hand rehabilitation glove that provides computer-controlled, repetitive and passive mobilization of the fingers, with multi-sensory feedback. The purpose of the study was to evaluate in the rehabilitation of patients with ischemic or hemorrhagic stroke in the sub-acute phase: 1) the feasibility of this new neuromotor rehabilitation device 2) its efficacy in improving arm function abilities, and 3) the costs involved.
Post-stroke patients admitted for inpatient rehabilitation between May 2013 and January 2014 were screened for enrollment. Eligible patients were randomly assigned, following a simple randomization procedure (computerized random numbers) conducted independently of the study investigators, to Treatment group or Control group, on a 1:1 ratio.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gloreha Group | Experimental | Other: General Rehabilitation, Device: Specific hand rehabilitation by Gloreha deviceThe patients in the "Gloreha Group" underwent to following interventions: 1. General Rehabilitation 2. Specific hand rehabilitation by Gloreha device |
| Control Group | Other | Other: General Rehabilitation, Other: Specific hand rehabilitation performed by physiotherapistThe patients in the Control Group underwent to following interventions: 1. General Rehabilitation 2. Specific hand rehabilitation performed by physiotherapist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients affected by stroke from cerebral ischemia or hemorrhage that had occurred ≤ 30 days before, with Ashworth spasticity index < 3.
Key exclusion criteria (6 listed)
- orthopedic limitation (amputations, irreducible articular limitations, advanced osteoarthritis, active rheumatoid arthritis);
- peripheral nerve injury;
- uncontrolled inflammation;
- severe cognitive and behavioral disorders;
- neurodegenerative and neuromuscular diseases;
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 |
|---|---|---|
| General RehabilitationAll patients underwent basic rehabilitation following the guidelines according to the Bobath concept. Mobilization performed by physiotherapist of the lower and upper limbs through passive and/or active manoeuvres, gait training, standing and functional exercises and speech rehabilitation. | Other | Control Group, Gloreha Group |
| Specific hand rehabilitation by Gloreha deviceEach training session consisted of six parts: 1. A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2. 7 min of a number sequence (counting from one to five); 3. A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4. A sequence of wave-like finger movements (7 min) 5. A sequence of fist opening/closing (7 min) 6. A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min). | Device | Gloreha Group |
| Specific hand rehabilitation performed by physiotherapistThe activities were: 1. Flexion-extension of the fingers (10 min); 2. Thumb opposition with the other fingers keeping the forearm in supine position (10 min); 3. Adduction and abduction of the fingers (10 min); 4. Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min). | Other | Control Group |
Primary outcome
Number of Patients Who Completed the Hand Rehabilitation Program
Time frame: Through study completion. The specific hand interventionn consisted of a total of 30 sessions, lasting 40 min/day, for 5 days/week , from admission to discharge in the Rehabilitation Centre, over a period of about 6 weeks.
Side Effects Using Gloreha Device
Time frame: Through study completion. The specific hand intervention consisted of a total of 30 sessions, lasting 40 min/day, for 5 days/week , from admission to discharge in the Rehabilitation Centre, over a period of about 6 weeks.
The feasibility of the device was assessed in terms of side effects (the physiotherapist was required to report any adverse events occurring during the study in regard to the use of Gloreha);
Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Motricity Index at End of Inpatient Rehabilitation
Time frame: Baseline and end of the study after 30 sessions, an average of 6 weeks
Motricity Index, a measure of the motor function of the paretic upper limb. Motricity Index used to measure the ability to activate a muscle group to move a body segment through a range of motion and resist external force. The upper extremity motricity index includes: 1. pinch grasp, 2. elbow flexion, and 3. shoulder abduction. The total upper extremity score involved adding one to the sum of the three actions. The score of each action ranges from 0 (no ability) to 33 (maximal ability) with a maximum possible score=100.
Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Nine Hole Peg Test at End of Inpatient Rehabilitation.
Time frame: Baseline and end of the study after 30 sessions, an average of 6 weeks
Nine Hole Peg Test (NHPT), a measure of coordination and mono-manual dexterity. It consists in collecting 9 pegs and inserting them into holes in a wooden base within a 50-sec time limit. The score is the average number of pegs inserted/tests performed.
5 secondary outcomes
The Feasibility of This New Neuromotor Rehabilitation Device (Gloreha)
Time frame: Baseline and end of the study after 30 sessions, an average of 6 weeks
Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Grip Test at End of Inpatient Rehabilitation.
Time frame: Baseline and end of the study after 30 sessions, an average of 6 weeks
Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Pinch Test at End of Inpatient Rehabilitation.
Time frame: Baseline and end of the study after 30 sessions, an average of 6 weeks
Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Quick-DASH Questionnaire at End of Inpatient Rehabilitation.
Time frame: Baseline and end of the study after 30 sessions, an average of 6 weeks
The Costs Involved in Using Gloreha in the Rehabilitation
Time frame: Through study completion, from admission to discharge in the Rehabilitation Centre, over a period of about 6 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27056250Vanoglio F, Bernocchi P, Mule C, Garofali F, Mora C, Taveggia G, Scalvini S, Luisa A. Feasibility and efficacy of a robotic device for hand rehabilitation in hemiplegic stroke patients: a randomized pilot controlled study. Clin Rehabil. 2017 Mar;31(3):351-360. doi: 10.1177/0269215516642606. Epub 2016 Jul 10.
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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 General Rehabilitation, Specific hand rehabilitation by Gloreha device and Specific hand rehabilitation performed by physiotherapist in people with Stroke and Upper Extremity Hemiplegia, run by Fondazione Salvatore Maugeri.
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 1 inclusion and 6 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 15 Sep 2016. 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?
Yes. Results are posted in the registry (first posted 3 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients Who Completed the Hand Rehabilitation Program (time frame: Through study completion. The specific hand interventionn consisted of a total of 30 sessions, lasting 40 min/day, for 5 days/week , from admission to discharge in the Rehabilitation Centre, over a period of about 6 weeks.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02628418, which also lists 1 linked publication.
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 15 Sep 2016.