Automated Versus Standard Physiotherapy for Upper Limb Rehabilitation in Patients With Acquired Brain Lesions
NCT ID: NCT01398553
Last Updated: 2016-09-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2011-03-31
2015-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Armeo Spring
Armeo Spring
30min Armeo Spring + 15min task oriented therapy over 6 weeks Frequency: 3 x/week
conventional physiotherapy
conventional physiotherapy
30min occupational therapy(15min ADL-training, 15min repetitive training) + 15min task oriented therapy over 6 weeks Frequency: 3x/week
Interventions
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Armeo Spring
30min Armeo Spring + 15min task oriented therapy over 6 weeks Frequency: 3 x/week
conventional physiotherapy
30min occupational therapy(15min ADL-training, 15min repetitive training) + 15min task oriented therapy over 6 weeks Frequency: 3x/week
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
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Valduce Hospital
OTHER
Krankenhaus Bozen
OTHER
Responsible Party
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Principal Investigators
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Peter Zelger, MD
Role: PRINCIPAL_INVESTIGATOR
Krankenhaus Bozen
Franco Molteni, MD
Role: STUDY_DIRECTOR
Valduce Hospital
Elisabeth Hofer, MD
Role: STUDY_CHAIR
Krankenhaus Bozen
Mauro Rossini, MSc
Role: STUDY_CHAIR
Valduce Hospital
Locations
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Valduce Hospital
Costa Masnaga, Lombardy, Italy
Krankenhaus Bozen
Bolzano, Südtirol, Italy
Countries
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References
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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.
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.
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.
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.
Related Links
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Participating Centre
Other Identifiers
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Gesundheitsbezirk Bozen
Identifier Type: -
Identifier Source: org_study_id
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