StrokeNCT02721212
Impact of a New Technology to Functional Recovery Upper Limb in Post Stroke Patients.
A study testing Armeo Spring and Conventional Rehabilitation in people with Stroke, run by Habilita S.p.A. at 1 site in Italy.
Trial summary
54 inpatients participants were randomly divided into two groups (experimental and conventional). Individual of experimental group were treated according to an established protocol for ARMEO Spring (30 minutes/session with "Armeo Spring" and 30 minutes/session with conventional treatment 5 days/week for 6 weeks). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Armeo Spring and Conventional Rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2016to May 2016
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The clinical diagnosis of stroke
- post stroke hemiparesis
- maximum six months from stroke
- stability of the clinical picture at the time of roll-in
- minimum level of upper arm motility (>2) movement against gravity
- trunk control and ability to maintain sitting position for at least 120 minutes
Who cannot join
- Hemiplegia of other aetiology ( neurodegenerative, neoplastic)
- Presence of articular ankyloses, spasms and/or severe muscle spasticity with complete loss of movement in any of the three major joints
- Instability of upper limb bone (not consolidated fractures)
- Presence of cognitive impairment (MMSE<=21) and/or psychiatric disease
- Concomitant disease that could prevent the rehabilitation program (respiratory failure, heart failure, osteomyelitis, thrombophlebitis and other clinical condition that are against rehabilitation treatment)
- Ulcer sores that can contraindicate the use to ARMEO Spring
- Ashworth > 3 (for each of the three upper limb joints)
Trial locations and contacts
1 site in 1 country.
Italy1 site
Habilita, Sarnico's Hospital
Sarnico, Bergamo, 24067
Giovanni Taveggia, MD, +39035918 ext. 293, giovannitaveggia@habilitasarnico.it
Chiara Mulè, MD
About this study
Official title: Impact of a New Technology to Functional Recovery Upper Limb in Post Stroke Patients: a Randomized Controlled Study
54 inpatients participants were randomly divided into two groups (experimental and conventional). Individual of experimental group were treated according to an established protocol for ARMEO Spring (30 minutes/session with "Armeo Spring" and 30 minutes/session with conventional treatment 5 days/week for 6 weeks). The conventional treatment consists of passive and active assisted mobilization of the upper limbs, traditional training based on the Bobath concept. Inpatients of control group were treated with conventional treatment with training session of 60 minutes 5 days/week for 6 weeks. All patients were evaluated by a blinded observer using the outcomes tests at enrollment (T0), after the treatment (T1) and at follow up 6 weeks later (T2). We assessed the impact on functional recovery (Functional Independence Measure - FIM scale), strength (ARM Motricity Index-MI), spasticity (Modified Ashworth Scale-MAS) and pain (Numeric Rating Pain Scale -NRPS).
Read the detailed description
Authors conducted a double blind randomized controlled trial. Informed consent was obtained from all participants and procedures were conducted according to the Declaration of Helsinki. The protocol (N° U0074917/11110) was approved by the Local Ethical Committee of Bergamo, Italy. A number of clinical trials have shown significant advances in upper limb recovery with the use of different sensory - motor techniques, including intensive repetitive movement, constraint-induced movement therapy, functional electrical stimulation treatment, the use of robot-assisted therapy in association with virtual reality. Robot-assisted virtual reality intervention has been shown more effective than conventional interventions and achieved more improvement in upper limb function, however the effect size reported by recent reviews was small and this datum is always reported as a cost-benefit ratio to challenge the use of virtual reality technology in rehabilitation. Robot aided rehabilitation is increasingly used in stroke rehabilitation, with a broad spectrum of applied technology from motor to non-motor aided systems, posing the problem to match the clinical need of the patient with the proper device. In the immediate post stroke period the motor recovery usually do not allow the use of non-motored robot device while the use of motored robot aid after months can be too delayed to obtain some valuable clinical results. The wide range of available devices are certainly a richness in the clinical possibility but also a critical factor in selecting a suitable technology tailored for the clinical feature of the patient at the actual state of the art. This can affect the comparison and interpretation of the literature so far published. Virtual reality therapy recreates favorable conditions to motor learning. Functional recovery is achieved through use-dependent cortical reorganization. The time/intensity of its application is therefore a pivotal point in this learning process. Its duration is not standardized and can varies from 3-4 to 20 hours of total treatment making results accordingly variable, adding further bias in data interpretation. A prerequisite to gain the best results is patients selection and early application when is possible.All these factors, have been ascribed as possible causes of small effect size reported in recent literature in comparing robot-aided virtual reality rehabilitation versus traditional rehabilitation alone.In a group of patients with hemiparesis following stroke, we compared the efficacy of a neurorehabilitation program consist of combination of non-motor robot-assisted therapy with virtual reality (Armeo®Spring) to conventional therapy with the primary aim to verify if the punctual application of what suggested by the single papers is able to improve differences of the efficacy between treatments and, therefore, creating a better effect size. And, as a secondary arm, if it is possible to improve the clinical picture also in post-acute stroke patients and as a secondary aim, if motor selection and intensive treatments can improve the small effect size reported by the literature.
- Conditions
- Stroke
- Being tested
- Armeo Spring, Conventional Rehabilitation
- Keywords
- Robotic, Stroke, Upper Limb Rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Armeo SpringDevice
All patients of experimental group were treated according to an established protocol for ARMEO Spring. In the first session the device was adjusted for patients arms. The physiotherapist controlled functional space of upper limb movement and correct position of working station.
Each training session consisted of two parts with 30 minutes per session with "Armeo Spring" and 30 minutes per session with conventional treatment 5 days per week, for 6 weeks.
Conventional RehabilitationOther
The conventional treatment, under control of physiotherapist, consists of passive and active assisted mobilization of the upper limbs traditional training based on the Bobath concept (neuromuscular facilitation, postural control and proprioception exercises, verticalization and gait training).
Each training session consisted of 60 minutes with conventional treatment 5 days per week, for 6 weeks in a control group.
The conventional session in the experimental group lasted 30 minutes with the same techniques and methods.
| Study group | Role | What they receive |
|---|---|---|
| Armeo Spring | Experimental | All patients of experimental group were treated according to an established protocol for ARMEO Spring. In the first session the device was adjusted for patients arms. The physiotherapist controlled functional space of upper limb movement and correct position of working station.
Each training session consisted of two parts with 30 minutes per session with "Armeo Spring" and 30 minutes per session with conventional treatment 5 days per week, for 6 weeks. Receives: Device: Armeo Spring |
| Control Group | Active comparator | The conventional treatment, under control of physiotherapist, consists of passive and active assisted mobilization of the upper limbs traditional training based on the Bobath concept (neuromuscular facilitation, postural control and proprioception exercises, verticalization and gait training).
Each training session consisted of 60 minutes with conventional treatment 5 days per week, for 6 weeks in a control group.
The conventional session in the experimental group lasted 30 minutes with the same techniques and methods. Receives: Other: Conventional Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Functional Independence Measure - FIM
All patients were evaluated by a blinded observer using the outcomes tests at enrollment (T0), after the treatment (T1) and at follow up 6 weeks later (T2). Investigators assessed the impact on functional recovery (Functional Independence Measure - FIM scale).
Measured: From baseline (T0) to 6 weeks (T1) and 12 weeks (T2)
Change in strength (ARM Motricity Index-MI)
All patients were evaluated by a blinded observer using the outcomes tests at enrollment (T0), after the treatment (T1) and at follow up 6 weeks later (T2). Investigators assessed the impact on strength (ARM Motricity Index-MI)
Measured: From baseline (T0) to 6 weeks (T1) and 12 weeks (T2)
Secondary outcomes (2)
Change in spasticity (Modified Ashworth Scale-MAS)
All patients were evaluated by a blinded observer using the outcomes tests at enrollment (T0), after the treatment (T1) and at follow up 6 weeks later (T2). Investigators assessed the impact on spasticity (Modified Ashworth Scale-MAS)
Measured: From baseline (T0) to 6 weeks (T1) and 12 weeks (T2)
Change in pain (Numeric Rating Pain Scale -NRPS)
All patients were evaluated by a blinded observer using the outcomes tests at enrollment (T0), after the treatment (T1) and at follow up 6 weeks later (T2). Investigators assessed the impact on pain (Numeric Rating Pain Scale -NRPS)
Measured: From baseline (T0) to 6 weeks (T1) and 12 weeks (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionMay 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Habilita S.p.A.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Taveggia, Habilita S.p.A.
- Investigators
- Giovanni Taveggia, MD, Principal investigator, Habilita S.p.A.Roberto Casale, MD, Study director, Habilita S.p.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02721212
- Sponsor's protocol ID
- Habilita-Armeo-01
- Other IDs
- U0074917/11110
- Status last verified
- Mar 2016
- First submitted
- 1 Mar 2016
- Last updated
- 29 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Kernan WN, Ovbiagele B, Kittner SJ; Secondary Prevention Guideline Writing Group. Response to letter regarding article, "Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association". Stroke. 2015 Apr;46(4):e87-9. doi: 10.1161/STROKEAHA.115.008661. Epub 2015 Mar 5. No abstract available.
PubMed 25744519Kernan WN, Ovbiagele B, Black HR, Bravata DM, Chimowitz MI, Ezekowitz MD, Fang MC, Fisher M, Furie KL, Heck DV, Johnston SC, Kasner SE, Kittner SJ, Mitchell PH, Rich MW, Richardson D, Schwamm LH, Wilson JA; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Peripheral Vascular Disease. Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Jul;45(7):2160-236. doi: 10.1161/STR.0000000000000024. Epub 2014 May 1.
PubMed 24788967Colomer C, Baldovi A, Torrome S, Navarro MD, Moliner B, Ferri J, Noe E. Efficacy of Armeo(R) Spring during the chronic phase of stroke. Study in mild to moderate cases of hemiparesis. Neurologia. 2013 Jun;28(5):261-7. doi: 10.1016/j.nrl.2012.04.017. Epub 2012 Jun 23. English, Spanish.
PubMed 22727271Boian R, Sharma A, Han C, Merians A, Burdea G, Adamovich S, Recce M, Tremaine M, Poizner H. Virtual reality-based post-stroke hand rehabilitation. Stud Health Technol Inform. 2002;85:64-70.
PubMed 15458061Brokaw EB, Murray T, Nef T, Lum PS. Retraining of interjoint arm coordination after stroke using robot-assisted time-independent functional training. J Rehabil Res Dev. 2011;48(4):299-316. doi: 10.1682/jrrd.2010.04.0064.
PubMed 21674385Butefisch C, Hummelsheim H, Denzler P, Mauritz KH. Repetitive training of isolated movements improves the outcome of motor rehabilitation of the centrally paretic hand. J Neurol Sci. 1995 May;130(1):59-68. doi: 10.1016/0022-510x(95)00003-k.
PubMed 7650532Wolf SL, Winstein CJ, Miller JP, Taub E, Uswatte G, Morris D, Giuliani C, Light KE, Nichols-Larsen D; EXCITE Investigators. Effect of constraint-induced movement therapy on upper extremity function 3 to 9 months after stroke: the EXCITE randomized clinical trial. JAMA. 2006 Nov 1;296(17):2095-104. doi: 10.1001/jama.296.17.2095.
PubMed 17077374Knutson JS, Hisel TZ, Harley MY, Chae J. A novel functional electrical stimulation treatment for recovery of hand function in hemiplegia: 12-week pilot study. Neurorehabil Neural Repair. 2009 Jan;23(1):17-25. doi: 10.1177/1545968308317577. Epub 2008 Sep 23.
PubMed 18812432Basteris A, Nijenhuis SM, Stienen AH, Buurke JH, Prange GB, Amirabdollahian F. Training modalities in robot-mediated upper limb rehabilitation in stroke: a framework for classification based on a systematic review. J Neuroeng Rehabil. 2014 Jul 10;11:111. doi: 10.1186/1743-0003-11-111.
PubMed 25012864Laver KE, George S, Thomas S, Deutsch JE, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2015 Feb 12;2015(2):CD008349. doi: 10.1002/14651858.CD008349.pub3.
PubMed 25927099Tesio L, Granger CV, Perucca L, Franchignoni FP, Battaglia MA, Russell CF. The FIM instrument in the United States and Italy: a comparative study. Am J Phys Med Rehabil. 2002 Mar;81(3):168-76. doi: 10.1097/00002060-200203000-00003.
PubMed 11989512Fasoli SE, Krebs HI, Stein J, Frontera WR, Hughes R, Hogan N. Robotic therapy for chronic motor impairments after stroke: Follow-up results. Arch Phys Med Rehabil. 2004 Jul;85(7):1106-11. doi: 10.1016/j.apmr.2003.11.028.
PubMed 15241758Kim YJ, Ku J, Cho S, Kim HJ, Cho YK, Lim T, Kang YJ. Facilitation of corticospinal excitability by virtual reality exercise following anodal transcranial direct current stimulation in healthy volunteers and subacute stroke subjects. J Neuroeng Rehabil. 2014 Aug 18;11:124. doi: 10.1186/1743-0003-11-124.
PubMed 25135003Teasell RW, Murie Fernandez M, McIntyre A, Mehta S. Rethinking the continuum of stroke rehabilitation. Arch Phys Med Rehabil. 2014 Apr;95(4):595-6. doi: 10.1016/j.apmr.2013.11.014. Epub 2014 Feb 14.
PubMed 24529594Lum PS, Burgar CG, Shor PC, Majmundar M, Van der Loos M. Robot-assisted movement training compared with conventional therapy techniques for the rehabilitation of upper-limb motor function after stroke. Arch Phys Med Rehabil. 2002 Jul;83(7):952-9. doi: 10.1053/apmr.2001.33101.
PubMed 12098155
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a New Technology to Functional Recovery Upper Limb in Post Stroke Patients: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02721212
- Acronym / sponsor ID
- Habilita-Armeo-01
- Conditions
- Stroke
- Keywords
- Robotic, Stroke, Upper Limb Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Habilita S.p.A.University, hospital or other
- Study start
- Mar 2016
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 29 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.
54 inpatients participants were randomly divided into two groups (experimental and conventional). Individual of experimental group were treated according to an established protocol for ARMEO Spring (30 minutes/session with "Armeo Spring" and 30 minutes/session with conventional treatment 5 days/week for 6 weeks). The conventional treatment consists of passive and active assisted mobilization of the upper limbs, traditional training based on the Bobath concept. Inpatients of control group were treated with conventional treatment with training session of 60 minutes 5 days/week for 6 weeks. All patients were evaluated by a blinded observer using the outcomes tests at enrollment (T0), after the treatment (T1) and at follow up 6 weeks later (T2). We assessed the impact on functional recovery (Functional Independence Measure - FIM scale), strength (ARM Motricity Index-MI), spasticity (Modified Ashworth Scale-MAS) and pain (Numeric Rating Pain Scale -NRPS).
Detailed description
Authors conducted a double blind randomized controlled trial. Informed consent was obtained from all participants and procedures were conducted according to the Declaration of Helsinki. The protocol (N° U0074917/11110) was approved by the Local Ethical Committee of Bergamo, Italy. A number of clinical trials have shown significant advances in upper limb recovery with the use of different sensory - motor techniques, including intensive repetitive movement, constraint-induced movement therapy, functional electrical stimulation treatment, the use of robot-assisted therapy in association with virtual reality. Robot-assisted virtual reality intervention has been shown more effective than conventional interventions and achieved more improvement in upper limb function, however the effect size reported by recent reviews was small and this datum is always reported as a cost-benefit ratio to challenge the use of virtual reality technology in rehabilitation. Robot aided rehabilitation is increasingly used in stroke rehabilitation, with a broad spectrum of applied technology from motor to non-motor aided systems, posing the problem to match the clinical need of the patient with the proper device. In the immediate post stroke period the motor recovery usually do not allow the use of non-motored robot device while the use of motored robot aid after months can be too delayed to obtain some valuable clinical results. The wide range of available devices are certainly a richness in the clinical possibility but also a critical factor in selecting a suitable technology tailored for the clinical feature of the patient at the actual state of the art. This can affect the comparison and interpretation of the literature so far published. Virtual reality therapy recreates favorable conditions to motor learning. Functional recovery is achieved through use-dependent cortical reorganization. The time/intensity of its application is therefore a pivotal point in this learning process. Its duration is not standardized and can varies from 3-4 to 20 hours of total treatment making results accordingly variable, adding further bias in data interpretation. A prerequisite to gain the best results is patients selection and early application when is possible.All these factors, have been ascribed as possible causes of small effect size reported in recent literature in comparing robot-aided virtual reality rehabilitation versus traditional rehabilitation alone.In a group of patients with hemiparesis following stroke, we compared the efficacy of a neurorehabilitation program consist of combination of non-motor robot-assisted therapy with virtual reality (Armeo®Spring) to conventional therapy with the primary aim to verify if the punctual application of what suggested by the single papers is able to improve differences of the efficacy between treatments and, therefore, creating a better effect size. And, as a secondary arm, if it is possible to improve the clinical picture also in post-acute stroke patients and as a secondary aim, if motor selection and intensive treatments can improve the small effect size reported by the literature.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Armeo Spring | Experimental | Device: Armeo SpringAll patients of experimental group were treated according to an established protocol for ARMEO Spring. In the first session the device was adjusted for patients arms. The physiotherapist controlled functional space of upper limb movement and correct position of working station. Each training session consisted of two parts with 30 minutes per session with "Armeo Spring" and 30 minutes per session with conventional treatment 5 days per week, for 6 weeks. |
| Control Group | Active comparator | Other: Conventional RehabilitationThe conventional treatment, under control of physiotherapist, consists of passive and active assisted mobilization of the upper limbs traditional training based on the Bobath concept (neuromuscular facilitation, postural control and proprioception exercises, verticalization and gait training). Each training session consisted of 60 minutes with conventional treatment 5 days per week, for 6 weeks in a control group. The conventional session in the experimental group lasted 30 minutes with the same techniques and methods. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The clinical diagnosis of stroke
- post stroke hemiparesis
- maximum six months from stroke
- stability of the clinical picture at the time of roll-in
- minimum level of upper arm motility (>2) movement against gravity
Key exclusion criteria (7 listed)
- Hemiplegia of other aetiology ( neurodegenerative, neoplastic)
- Presence of articular ankyloses, spasms and/or severe muscle spasticity with complete loss of movement in any of the three major joints
- Instability of upper limb bone (not consolidated fractures)
- Presence of cognitive impairment (MMSE<=21) and/or psychiatric disease
- Concomitant disease that could prevent the rehabilitation program (respiratory failure, heart failure, osteomyelitis, thrombophlebitis and other clinical condition that are against rehabilitation treatment)
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 |
|---|---|---|
| Armeo SpringAll patients of experimental group were treated according to an established protocol for ARMEO Spring. In the first session the device was adjusted for patients arms. The physiotherapist controlled functional space of upper limb movement and correct position of working station. Each training session consisted of two parts with 30 minutes per session with "Armeo Spring" and 30 minutes per session with conventional treatment 5 days per week, for 6 weeks. | Device | Armeo Spring |
| Conventional RehabilitationThe conventional treatment, under control of physiotherapist, consists of passive and active assisted mobilization of the upper limbs traditional training based on the Bobath concept (neuromuscular facilitation, postural control and proprioception exercises, verticalization and gait training). Each training session consisted of 60 minutes with conventional treatment 5 days per week, for 6 weeks in a control group. The conventional session in the experimental group lasted 30 minutes with the same techniques and methods. | Other | Control Group |
Primary outcome
Change in Functional Independence Measure - FIM
Time frame: From baseline (T0) to 6 weeks (T1) and 12 weeks (T2)
All patients were evaluated by a blinded observer using the outcomes tests at enrollment (T0), after the treatment (T1) and at follow up 6 weeks later (T2). Investigators assessed the impact on functional recovery (Functional Independence Measure - FIM scale).
Change in strength (ARM Motricity Index-MI)
Time frame: From baseline (T0) to 6 weeks (T1) and 12 weeks (T2)
All patients were evaluated by a blinded observer using the outcomes tests at enrollment (T0), after the treatment (T1) and at follow up 6 weeks later (T2). Investigators assessed the impact on strength (ARM Motricity Index-MI)
2 secondary outcomes
Change in spasticity (Modified Ashworth Scale-MAS)
Time frame: From baseline (T0) to 6 weeks (T1) and 12 weeks (T2)
Change in pain (Numeric Rating Pain Scale -NRPS)
Time frame: From baseline (T0) to 6 weeks (T1) and 12 weeks (T2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2016.
- Results publication: PubMed 25744519Kernan WN, Ovbiagele B, Kittner SJ; Secondary Prevention Guideline Writing Group. Response to letter regarding article, "Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association". Stroke. 2015 Apr;46(4):e87-9. doi: 10.1161/STROKEAHA.115.008661. Epub 2015 Mar 5. No abstract available.
- Results publication: PubMed 24788967Kernan WN, Ovbiagele B, Black HR, Bravata DM, Chimowitz MI, Ezekowitz MD, Fang MC, Fisher M, Furie KL, Heck DV, Johnston SC, Kasner SE, Kittner SJ, Mitchell PH, Rich MW, Richardson D, Schwamm LH, Wilson JA; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Peripheral Vascular Disease. Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Jul;45(7):2160-236. doi: 10.1161/STR.0000000000000024. Epub 2014 May 1.
- Results publication: PubMed 22727271Colomer C, Baldovi A, Torrome S, Navarro MD, Moliner B, Ferri J, Noe E. Efficacy of Armeo(R) Spring during the chronic phase of stroke. Study in mild to moderate cases of hemiparesis. Neurologia. 2013 Jun;28(5):261-7. doi: 10.1016/j.nrl.2012.04.017. Epub 2012 Jun 23. English, Spanish.
- Results publication: PubMed 15458061Boian R, Sharma A, Han C, Merians A, Burdea G, Adamovich S, Recce M, Tremaine M, Poizner H. Virtual reality-based post-stroke hand rehabilitation. Stud Health Technol Inform. 2002;85:64-70.
- Results publication: PubMed 21674385Brokaw EB, Murray T, Nef T, Lum PS. Retraining of interjoint arm coordination after stroke using robot-assisted time-independent functional training. J Rehabil Res Dev. 2011;48(4):299-316. doi: 10.1682/jrrd.2010.04.0064.
- Results publication: PubMed 7650532Butefisch C, Hummelsheim H, Denzler P, Mauritz KH. Repetitive training of isolated movements improves the outcome of motor rehabilitation of the centrally paretic hand. J Neurol Sci. 1995 May;130(1):59-68. doi: 10.1016/0022-510x(95)00003-k.
- Results publication: PubMed 17077374Wolf SL, Winstein CJ, Miller JP, Taub E, Uswatte G, Morris D, Giuliani C, Light KE, Nichols-Larsen D; EXCITE Investigators. Effect of constraint-induced movement therapy on upper extremity function 3 to 9 months after stroke: the EXCITE randomized clinical trial. JAMA. 2006 Nov 1;296(17):2095-104. doi: 10.1001/jama.296.17.2095.
- Results publication: PubMed 18812432Knutson JS, Hisel TZ, Harley MY, Chae J. A novel functional electrical stimulation treatment for recovery of hand function in hemiplegia: 12-week pilot study. Neurorehabil Neural Repair. 2009 Jan;23(1):17-25. doi: 10.1177/1545968308317577. Epub 2008 Sep 23.
- Results publication: PubMed 25012864Basteris A, Nijenhuis SM, Stienen AH, Buurke JH, Prange GB, Amirabdollahian F. Training modalities in robot-mediated upper limb rehabilitation in stroke: a framework for classification based on a systematic review. J Neuroeng Rehabil. 2014 Jul 10;11:111. doi: 10.1186/1743-0003-11-111.
- Results publication: PubMed 25927099Laver KE, George S, Thomas S, Deutsch JE, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2015 Feb 12;2015(2):CD008349. doi: 10.1002/14651858.CD008349.pub3.
- Results publication: PubMed 11989512Tesio L, Granger CV, Perucca L, Franchignoni FP, Battaglia MA, Russell CF. The FIM instrument in the United States and Italy: a comparative study. Am J Phys Med Rehabil. 2002 Mar;81(3):168-76. doi: 10.1097/00002060-200203000-00003.
- Results publication: PubMed 15241758Fasoli SE, Krebs HI, Stein J, Frontera WR, Hughes R, Hogan N. Robotic therapy for chronic motor impairments after stroke: Follow-up results. Arch Phys Med Rehabil. 2004 Jul;85(7):1106-11. doi: 10.1016/j.apmr.2003.11.028.
- Individual participant dataSharing planned: Yes
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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.
Giovanni Taveggia, MD principal investigator
Habilita S.p.A.
Roberto Casale, MD study director
Habilita S.p.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Armeo Spring and Conventional Rehabilitation in people with Stroke, run by Habilita S.p.A. 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 6 inclusion and 7 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 29 Mar 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lorena Salvi, Vice Coord. (+39035918 ext. 293, salvi.lorena@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Functional Independence Measure - FIM (time frame: From baseline (T0) to 6 weeks (T1) and 12 weeks (T2)). 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?
On the ClinicalTrials.gov record for NCT02721212, which also lists 33 linked publications.
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 29 Mar 2016.