StrokeNCT02711787
Efficacy of Robot-Assisted Rehabilitation of Hand Paralysis After Stroke
A study testing Experimental group and traditional rehabilitation in people with Stroke, run by Fondazione Don Carlo Gnocchi ETS.
Trial summary
Among robotic devices, Gloreha, with its compliant mechanical transmission, may represent an easily applied innovative solution to rehabilitation, because the hand can perform grasp and release activities wearing the device by mean of a flexible and light orthosis. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Experimental group and traditional rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Jun 2015
- 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 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- acute phase of stroke
- first stroke episode.
- no history of peripheral nerve injury or musculoskeletal disease
- no contracture of the affected wrist or fingers (Modified Ashworth<3)
- no history of any invasive procedure (Botulinum toxin type A) for the treatment of spasticity for at least 6 months prior to the start of this study.
- paralysis of the wrist and fingers
Who cannot join
- unstable medical disorders, active Complex Regional Pain Syndrome (CRPS) severe spatial neglect, aphasia, or cognitive problems.
- scored greater than 4 points on the Beck Depression Inventory (BDI)
- more than 30 points in the State Trait Anxiety Inventory (STAI)
About this study
Official title: Efficacy of Short-Term Robot-Assisted Rehabilitation in Patients With Hand Paralysis After Stroke: a Randomized Clinical Trial
Among robotic devices, Gloreha, with its compliant mechanical transmission, may represent an easily applied innovative solution to rehabilitation, because the hand can perform grasp and release activities wearing the device by mean of a flexible and light orthosis. Our objective on this research was to the robotic assisted motion and activity in additional to physiotherapy (PT) and occupational therapy (OT), on stroke patients with hand paralysis.
Read the detailed description
The investigators evaluated the effectiveness of a robotic-assisted motion and activity in additional to physiotherapy (PT) and occupational therapy (OT), on stroke patients with hand paralysis. A randomized controlled trial. The experimental group received a passive mobilization of the hand through the robotic device Gloreha and control group received a PT and OT for 3 consecutive weeks (3 days/week) in addition to traditional rehabilitation. Outcomes included the National Institutes of Health Stroke Scale (NIHSS), Modified Ashworth Scale (MAS), Barthel index (BI), Motricity index (MI), short version of the Disabilities of the Arm, Shoulder and Hand (quickDASH), and the Visual Analogue Scale (VAS) measurements. All measures were collected at baseline and end of the intervention (3 weeks).
- Conditions
- Stroke
- Being tested
- Experimental group, Control group, traditional rehabilitation
- Keywords
- Hand, Paralysis, Stroke
- Medical subject headings
- Stroke, Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental groupDevice
Robotic assisted passive mobilization (Gloreha, Idrogenet, Italy) and traditional rehabilitation.
Control groupDevice
Physiotherapy and occupational therapy.
traditional rehabilitationDevice
Assisted stretching, shoulder and arm exercises, and functional reaching tasks
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Robotic device Gloreha (Gloreha, Idrogenet, Italy) and traditional rehabilitation, 60-minute session for 3 consecutive weeks (3 days/week). Receives: Device: Experimental group; Device: traditional rehabilitation |
| Control group | Active comparator | Physiotherapy, occupational therapy and traditional rehabilitation, 60-minute session for 3 consecutive weeks (3 days/week). Receives: Device: Control group; Device: traditional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from National Institutes of Health Stroke Scale (NIHSS)
Measured: baseline, immediately post-intervention (3 weeks).
Secondary outcomes (4)
Change from Visual analogue scale (VAS)
Measured: baseline, immediately post-intervention (3 weeks).
Change from Barthel Index (BI)
Measured: baseline, immediately post-intervention (3 weeks).
Change from Modified Ashworth Scale (MAS)
Measured: baseline, immediately post-intervention
Change from Disabilities of the Arm, Shoulder and Hand (quickDASH)
Measured: baseline, immediately post-intervention (3 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startJul 2014
- Primary completionFeb 2015
- Study completionJun 2015
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge Hugo Villafañe, PhD, Fondazione Don Carlo Gnocchi ETS
- Investigators
- JORGE H VILLAFAÑE, PhD, Principal investigator, IRCCS Don Gnocchi Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711787
- Sponsor's protocol ID
- Project Code:RC-2015-Gloreha
- Status last verified
- Mar 2016
- First submitted
- 5 Mar 2016
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Short-Term Robot-Assisted Rehabilitation in Patients With Hand Paralysis After Stroke: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02711787
- Acronym / sponsor ID
- Project Code:RC-2015-Gloreha
- Conditions
- Stroke
- Keywords
- Hand, Paralysis, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 17 Mar 2016 (estimated)
- 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.
Among robotic devices, Gloreha, with its compliant mechanical transmission, may represent an easily applied innovative solution to rehabilitation, because the hand can perform grasp and release activities wearing the device by mean of a flexible and light orthosis. Our objective on this research was to the robotic assisted motion and activity in additional to physiotherapy (PT) and occupational therapy (OT), on stroke patients with hand paralysis.
Detailed description
The investigators evaluated the effectiveness of a robotic-assisted motion and activity in additional to physiotherapy (PT) and occupational therapy (OT), on stroke patients with hand paralysis. A randomized controlled trial. The experimental group received a passive mobilization of the hand through the robotic device Gloreha and control group received a PT and OT for 3 consecutive weeks (3 days/week) in addition to traditional rehabilitation. Outcomes included the National Institutes of Health Stroke Scale (NIHSS), Modified Ashworth Scale (MAS), Barthel index (BI), Motricity index (MI), short version of the Disabilities of the Arm, Shoulder and Hand (quickDASH), and the Visual Analogue Scale (VAS) measurements. All measures were collected at baseline and end of the intervention (3 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Experimental group, Device: traditional rehabilitationRobotic device Gloreha (Gloreha, Idrogenet, Italy) and traditional rehabilitation, 60-minute session for 3 consecutive weeks (3 days/week). |
| Control group | Active comparator | Device: Control group, Device: traditional rehabilitationPhysiotherapy, occupational therapy and traditional rehabilitation, 60-minute session for 3 consecutive weeks (3 days/week). |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- acute phase of stroke
- first stroke episode.
- no history of peripheral nerve injury or musculoskeletal disease
- no contracture of the affected wrist or fingers (Modified Ashworth<3)
- no history of any invasive procedure (Botulinum toxin type A) for the treatment of spasticity for at least 6 months prior to the start of this study.
Key exclusion criteria (3 listed)
- unstable medical disorders, active Complex Regional Pain Syndrome (CRPS) severe spatial neglect, aphasia, or cognitive problems.
- scored greater than 4 points on the Beck Depression Inventory (BDI)
- more than 30 points in the State Trait Anxiety Inventory (STAI)
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 groupRobotic assisted passive mobilization (Gloreha, Idrogenet, Italy) and traditional rehabilitation. | Device | Experimental group |
| Control groupPhysiotherapy and occupational therapy. | Device | Control group |
| traditional rehabilitationAssisted stretching, shoulder and arm exercises, and functional reaching tasks | Device | Control group, Experimental group |
Primary outcome
Change from National Institutes of Health Stroke Scale (NIHSS)
Time frame: baseline, immediately post-intervention (3 weeks).
4 secondary outcomes
Change from Visual analogue scale (VAS)
Time frame: baseline, immediately post-intervention (3 weeks).
Change from Barthel Index (BI)
Time frame: baseline, immediately post-intervention (3 weeks).
Change from Modified Ashworth Scale (MAS)
Time frame: baseline, immediately post-intervention
Change from Disabilities of the Arm, Shoulder and Hand (quickDASH)
Time frame: baseline, immediately post-intervention (3 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 17 Mar 2016.
- Individual participant dataSharing planned: No
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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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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.
JORGE H VILLAFAÑE, PhD principal investigator
IRCCS Don Gnocchi Foundation
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group and traditional rehabilitation in people with Stroke, 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 6 inclusion and 3 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 17 Mar 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?
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?
Change from National Institutes of Health Stroke Scale (NIHSS) (time frame: baseline, immediately post-intervention (3 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 17 Mar 2016.