Automated Versus Standard Physiotherapy for Upper Limb Rehabilitation in Patients With Acquired Brain Lesions
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ClinicalTrials.gov Identifier: NCT01398553 |
Recruitment Status :
Withdrawn
(the human resources in the organisation are to limited to do the trial)
First Posted : July 20, 2011
Last Update Posted : September 7, 2016
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Vascular Accident, Brain Traumatic Brain Injury | Device: Armeo Spring Other: conventional physiotherapy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Armeo® Versus Standard Physiotherapy for Upper Limb Rehabilitation in Patients With Acquired Brain Lesions |
Study Start Date : | March 2011 |
Estimated Primary Completion Date : | December 2015 |
Estimated Study Completion Date : | December 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: Armeo Spring |
Device: Armeo Spring
30min Armeo Spring + 15min task oriented therapy over 6 weeks Frequency: 3 x/week
Other Name: group A |
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 Name: group B |
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01398553
Italy | |
Valduce Hospital | |
Costa Masnaga, Lombardia, Italy, 23845 | |
Krankenhaus Bozen | |
Bozen, Südtirol, Italy, 39100 |
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 |
Publications:
Responsible Party: | Krankenhaus Bozen |
ClinicalTrials.gov Identifier: | NCT01398553 |
Other Study ID Numbers: |
Gesundheitsbezirk Bozen |
First Posted: | July 20, 2011 Key Record Dates |
Last Update Posted: | September 7, 2016 |
Last Verified: | September 2016 |
stroke tbi rehabilitation upper limb |
Brain Injuries Brain Injuries, Traumatic Stroke Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries Cerebrovascular Disorders Vascular Diseases Cardiovascular Diseases |