Automated Versus Standard Physiotherapy for Upper Limb Rehabilitation in Patients With Acquired Brain Lesions
Study Details
Study Description
Brief 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. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Armeo Spring
|
Device: Armeo Spring
30min Armeo Spring + 15min task oriented therapy over 6 weeks Frequency: 3 x/week
Other Names:
|
| Active Comparator: conventional physiotherapy
|
Other: conventional physiotherapy
30min occupational therapy(15min ADL-training, 15min repetitive training) + 15min task oriented therapy over 6 weeks Frequency: 3x/week
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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]
Secondary Outcome Measures
- 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]
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
Exclusion Criteria:
-
NYHA >III
-
MMSE (mini mental status examination test) < 24
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muscular strength (MRC) < 1
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Dystonia, spasticity (Ashworth => 3)
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articular contractions in the upper limb
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previous upper limb lesions
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cognitive/language impairment likely to influence assessments
-
any diagnosis likely to interfere with rehabilitation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Valduce Hospital | Costa Masnaga | Lombardia | Italy | 23845 |
| 2 | Krankenhaus Bozen | Bozen | Südtirol | Italy | 39100 |
Sponsors and Collaborators
- Krankenhaus Bozen
- Valduce Hospital
Investigators
- Principal Investigator: Peter Zelger, MD, Krankenhaus Bozen
- Study Director: Franco Molteni, MD, Valduce Hospital
- Study Chair: Elisabeth Hofer, MD, Krankenhaus Bozen
- Study Chair: Mauro Rossini, MSc, Valduce Hospital
Study Documents (Full-Text)
None provided.More Information
Additional Information:
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. Epub 2007 Sep 17. Review.
- 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.
- 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. Review.
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