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the human resources in the organisation are to limited to do the trial
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| Name | Class |
|---|---|
| Valduce Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Armeo Spring | Experimental |
| |
| conventional physiotherapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Armeo Spring | Device | 30min Armeo Spring + 15min task oriented therapy over 6 weeks Frequency: 3 x/week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke | Enrollment | |
| Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke | Baseline | |
| Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke | 6 weeks | |
| Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke | 8 weeks | |
| Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Upper Extremity Motor Activity Log for measuring real use of the upper limb | Enrolment | |
| Upper Extremity Motor Activity Log for measuring real use of the upper limb | Baseline | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Zelger, MD | Krankenhaus Bozen | Principal Investigator |
| Franco Molteni, MD | Valduce Hospital | Study Director |
| Elisabeth Hofer, MD | Krankenhaus Bozen | Study Chair |
| Mauro Rossini, MSc | Valduce Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valduce Hospital | Costa Masnaga | Lombardy | 23845 | Italy | ||
| Krankenhaus Bozen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17876068 | Background | 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. | |
| 16847784 | Background | Prange 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. |
| Label | URL |
|---|---|
| Participating Centre | View source |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| conventional physiotherapy | Other | 30min occupational therapy(15min ADL-training, 15min repetitive training) + 15min task oriented therapy over 6 weeks Frequency: 3x/week |
|
|
| Upper Extremity Motor Activity Log for measuring real use of the upper limb |
| 6 weeks |
| Upper Extremity Motor Activity Log for measuring real use of the upper limb | 8 weeks |
| Upper Extremity Motor Activity Log for measuring real use of the upper limb | 12 weeks |
| Wolf Motor Function Test for measurement of timed joint-segment movements | Enrolment |
| Wolf Motor Function Test for measurement of timed joint-segment movements | Baseline |
| Wolf Motor Function Test for measurement of timed joint-segment movements | 6 weeks |
| Wolf Motor Function Test for measurement of timed joint-segment movements | 8 weeks |
| Wolf Motor Function Test for measurement of timed joint-segment movements | 12 weeks |
| Clinical Global Impression Score for the measurement of change over time of the illness' severity | Enrolment |
| Clinical Global Impression Score for the measurement of change over time of the illness' severity | Baseline |
| Clinical Global Impression Score for the measurement of change over time of the illness' severity | 6 weeks |
| Clinical Global Impression Score for the measurement of change over time of the illness' severity | 8 weeks |
| Clinical Global Impression Score for the measurement of change over time of the illness' severity | 12 weeks |
| Bolzano |
| Südtirol |
| 39100 |
| Italy |
| 18498641 | Background | Lam 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. |
| 17270510 | Background | Masiero 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001930 | Brain Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |