Vascular Accident, BrainNCT01398553
Automated Versus Standard Physiotherapy for Upper Limb Rehabilitation in Patients With Acquired Brain Lesions
A study testing Armeo Spring and conventional physiotherapy in people with Vascular Accident, Brain and Traumatic Brain Injury, run by Krankenhaus Bozen at 2 sites in Italy.
Trial summary
The Armeo Spring has proven its effectiveness in the rehabilitation of acute stroke patients. It neutralizes limb weight, enabling patients to use residual control in both arm and hand and to follow exercises guided by simulations of real-life challenges. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Vascular Accident, Brain, Traumatic Brain Injury
- What is being tested?
- Armeo Spring and conventional physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesItaly
- Study dates
- Mar 2011to Dec 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 6 month after the onset of disease
- acquired brain lesions in adults with upper limb hemiparesis
- modified Ashworth <= 3
- muscular strength MRC =>1 mano; MRC =>2 elbow e shoulder
- Fugl Meyer => 18
Who cannot join
- NYHA >III
- MMSE (mini mental status examination test) < 24
- muscular strength (MRC) < 1
- Dystonia, spasticity (Ashworth => 3)
- articular contractions in the upper limb
- previous upper limb lesions
- cognitive/language impairment likely to influence assessments
- any diagnosis likely to interfere with rehabilitation
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Krankenhaus Bozen
Bolzano, Südtirol, 39100
Valduce Hospital
Costa Masnaga, Lombardy, 23845
About this study
Official title: Armeo® Versus Standard Physiotherapy for Upper Limb Rehabilitation in Patients With Acquired Brain Lesions
The Armeo Spring has proven its effectiveness in the rehabilitation of acute stroke patients. It neutralizes limb weight, enabling patients to use residual control in both arm and hand and to follow exercises guided by simulations of real-life challenges. The Armeo Spring incorporates wrist pronation and supination, allowing patients to enhance functional reaching patterns.
Aim of the study is to compare the Armeo device with standard physiotherapy in chronic patients with acquired brain lesions.
The result of the trial should show which treatment is more effective in the clinical practice. A significant better outcome of one arm should suggest to follow one treatment strategy more than the other.
- Conditions
- Vascular Accident, Brain, Traumatic Brain Injury
- Being tested
- Armeo Spring, conventional physiotherapy
- Keywords
- stroke, tbi, rehabilitation, upper limb
- Medical subject headings
- Stroke, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Armeo SpringDevice
Also called group A
30min Armeo Spring + 15min task oriented therapy over 6 weeks Frequency: 3 x/week
conventional physiotherapyOther
Also called group B
30min occupational therapy(15min ADL-training, 15min repetitive training) + 15min task oriented therapy over 6 weeks Frequency: 3x/week
| Study group | Role | What they receive |
|---|---|---|
| Armeo Spring | Experimental | Not described Receives: Device: Armeo Spring |
| conventional physiotherapy | Active comparator | Not described Receives: Other: conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke
Measured: Enrollment
Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke
Measured: Baseline
Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke
Measured: 6 weeks
Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke
Measured: 8 weeks
Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke
Measured: 12 weeks
Secondary outcomes (15)
Upper Extremity Motor Activity Log for measuring real use of the upper limb
Measured: Enrolment
Upper Extremity Motor Activity Log for measuring real use of the upper limb
Measured: Baseline
Upper Extremity Motor Activity Log for measuring real use of the upper limb
Measured: 6 weeks
Upper Extremity Motor Activity Log for measuring real use of the upper limb
Measured: 8 weeks
Upper Extremity Motor Activity Log for measuring real use of the upper limb
Measured: 12 weeks
Wolf Motor Function Test for measurement of timed joint-segment movements
Measured: Enrolment
Wolf Motor Function Test for measurement of timed joint-segment movements
Measured: Baseline
Wolf Motor Function Test for measurement of timed joint-segment movements
Measured: 6 weeks
Wolf Motor Function Test for measurement of timed joint-segment movements
Measured: 8 weeks
Wolf Motor Function Test for measurement of timed joint-segment movements
Measured: 12 weeks
Clinical Global Impression Score for the measurement of change over time of the illness' severity
Measured: Enrolment
Clinical Global Impression Score for the measurement of change over time of the illness' severity
Measured: Baseline
Clinical Global Impression Score for the measurement of change over time of the illness' severity
Measured: 6 weeks
Clinical Global Impression Score for the measurement of change over time of the illness' severity
Measured: 8 weeks
Clinical Global Impression Score for the measurement of change over time of the illness' severity
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Why it stopped: the human resources in the organisation are to limited to do the trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Vascular Accident, BrainStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Krankenhaus Bozen
- Sponsor type
- University, hospital or other
- Collaborators
- Valduce Hospital
- Responsible party
- Sponsor
- Investigators
- Peter Zelger, MD, Principal investigator, Krankenhaus BozenFranco Molteni, MD, Study director, Valduce HospitalElisabeth Hofer, MD, Study chair, Krankenhaus BozenMauro Rossini, MSc, Study chair, Valduce Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01398553
- Sponsor's protocol ID
- Gesundheitsbezirk Bozen
- Status last verified
- Sep 2016
- First submitted
- 29 Nov 2010
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Kwakkel G, Kollen BJ, Krebs HI. Effects of robot-assisted therapy on upper limb recovery after stroke: a systematic review. Neurorehabil Neural Repair. 2008 Mar-Apr;22(2):111-21. doi: 10.1177/1545968307305457. Epub 2007 Sep 17.
PubMed 17876068Prange GB, Jannink MJ, Groothuis-Oudshoorn CG, Hermens HJ, Ijzerman MJ. Systematic review of the effect of robot-aided therapy on recovery of the hemiparetic arm after stroke. J Rehabil Res Dev. 2006 Mar-Apr;43(2):171-84. doi: 10.1682/jrrd.2005.04.0076.
PubMed 16847784Lam P, Hebert D, Boger J, Lacheray H, Gardner D, Apkarian J, Mihailidis A. A haptic-robotic platform for upper-limb reaching stroke therapy: preliminary design and evaluation results. J Neuroeng Rehabil. 2008 May 22;5:15. doi: 10.1186/1743-0003-5-15.
PubMed 18498641Masiero S, Celia A, Rosati G, Armani M. Robotic-assisted rehabilitation of the upper limb after acute stroke. Arch Phys Med Rehabil. 2007 Feb;88(2):142-9. doi: 10.1016/j.apmr.2006.10.032.
PubMed 17270510
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Armeo® Versus Standard Physiotherapy for Upper Limb Rehabilitation in Patients With Acquired Brain Lesions
- ClinicalTrials.gov ID
- NCT01398553
- Acronym / sponsor ID
- Gesundheitsbezirk Bozen
- Conditions
- Vascular Accident, Brain, Traumatic Brain Injury
- Keywords
- stroke, tbi, rehabilitation, upper limb
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: the human resources in the organisation are to limited to do the trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Krankenhaus BozenUniversity, hospital or other
- Collaborators
- Valduce Hospital
- Study start
- Mar 2011
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 20 Jul 2011 (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.
The Armeo Spring has proven its effectiveness in the rehabilitation of acute stroke patients. It neutralizes limb weight, enabling patients to use residual control in both arm and hand and to follow exercises guided by simulations of real-life challenges. The Armeo Spring incorporates wrist pronation and supination, allowing patients to enhance functional reaching patterns.
Aim of the study is to compare the Armeo device with standard physiotherapy in chronic patients with acquired brain lesions.
The result of the trial should show which treatment is more effective in the clinical practice. A significant better outcome of one arm should suggest to follow one treatment strategy more than the other.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Armeo Spring | Experimental | Device: Armeo Spring |
| conventional physiotherapy | Active comparator | Other: conventional physiotherapy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 6 month after the onset of disease
- acquired brain lesions in adults with upper limb hemiparesis
- modified Ashworth <= 3
- muscular strength MRC =>1 mano; MRC =>2 elbow e shoulder
- Fugl Meyer => 18
Key exclusion criteria (8 listed)
- NYHA >III
- MMSE (mini mental status examination test) < 24
- muscular strength (MRC) < 1
- Dystonia, spasticity (Ashworth => 3)
- articular contractions in the upper limb
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 SpringAlso: group A30min Armeo Spring + 15min task oriented therapy over 6 weeks Frequency: 3 x/week | Device | Armeo Spring |
| conventional physiotherapyAlso: group B30min occupational therapy(15min ADL-training, 15min repetitive training) + 15min task oriented therapy over 6 weeks Frequency: 3x/week | Other | conventional physiotherapy |
Primary outcome
Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke
Time frame: Enrollment
Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke
Time frame: Baseline
Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke
Time frame: 6 weeks
Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke
Time frame: 8 weeks
Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke
Time frame: 12 weeks
15 secondary outcomes
Upper Extremity Motor Activity Log for measuring real use of the upper limb
Time frame: Enrolment
Upper Extremity Motor Activity Log for measuring real use of the upper limb
Time frame: Baseline
Upper Extremity Motor Activity Log for measuring real use of the upper limb
Time frame: 6 weeks
Upper Extremity Motor Activity Log for measuring real use of the upper limb
Time frame: 8 weeks
Upper Extremity Motor Activity Log for measuring real use of the upper limb
Time frame: 12 weeks
Wolf Motor Function Test for measurement of timed joint-segment movements
Time frame: Enrolment
Wolf Motor Function Test for measurement of timed joint-segment movements
Time frame: Baseline
Wolf Motor Function Test for measurement of timed joint-segment movements
Time frame: 6 weeks
Wolf Motor Function Test for measurement of timed joint-segment movements
Time frame: 8 weeks
Wolf Motor Function Test for measurement of timed joint-segment movements
Time frame: 12 weeks
Clinical Global Impression Score for the measurement of change over time of the illness' severity
Time frame: Enrolment
Clinical Global Impression Score for the measurement of change over time of the illness' severity
Time frame: Baseline
Clinical Global Impression Score for the measurement of change over time of the illness' severity
Time frame: 6 weeks
Clinical Global Impression Score for the measurement of change over time of the illness' severity
Time frame: 8 weeks
Clinical Global Impression Score for the measurement of change over time of the illness' severity
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
- Background: PubMed 17876068Kwakkel G, Kollen BJ, Krebs HI. Effects of robot-assisted therapy on upper limb recovery after stroke: a systematic review. Neurorehabil Neural Repair. 2008 Mar-Apr;22(2):111-21. doi: 10.1177/1545968307305457. Epub 2007 Sep 17.
- Background: PubMed 16847784Prange GB, Jannink MJ, Groothuis-Oudshoorn CG, Hermens HJ, Ijzerman MJ. Systematic review of the effect of robot-aided therapy on recovery of the hemiparetic arm after stroke. J Rehabil Res Dev. 2006 Mar-Apr;43(2):171-84. doi: 10.1682/jrrd.2005.04.0076.
- Background: PubMed 18498641Lam P, Hebert D, Boger J, Lacheray H, Gardner D, Apkarian J, Mihailidis A. A haptic-robotic platform for upper-limb reaching stroke therapy: preliminary design and evaluation results. J Neuroeng Rehabil. 2008 May 22;5:15. doi: 10.1186/1743-0003-5-15.
- Background: PubMed 17270510Masiero S, Celia A, Rosati G, Armani M. Robotic-assisted rehabilitation of the upper limb after acute stroke. Arch Phys Med Rehabil. 2007 Feb;88(2):142-9. doi: 10.1016/j.apmr.2006.10.032.
- Participating CentreLink provided by the sponsor.
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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.
Peter Zelger, MD principal investigator
Krankenhaus Bozen
Franco Molteni, MD study director
Valduce Hospital
Elisabeth Hofer, MD study chair
Krankenhaus Bozen
2 sites 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 physiotherapy in people with Vascular Accident, Brain and Traumatic Brain Injury, run by Krankenhaus Bozen at 2 sites 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 5 inclusion and 8 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: withdrawn, as of the sponsor's last update on 7 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was withdrawn before enrolling participants, so there are no results.
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 Score for sensorymotor recovery of the upper limb after stroke (time frame: Enrollment). The study lists 5 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 NCT01398553, which also lists 4 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 7 Sep 2016.