Automated Versus Standard Physiotherapy for Upper Limb Rehabilitation in Patients With Acquired Brain Lesions
This study is currently recruiting participants.
Verified July 2011 by Krankenhaus Bozen
Sponsor:
Krankenhaus Bozen
Collaborator:
Valduce Hospital
Information provided by (Responsible Party):
Krankenhaus Bozen
ClinicalTrials.gov Identifier:
NCT01398553
First received: November 29, 2010
Last updated: August 23, 2011
Last verified: July 2011
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Purpose
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 | Intervention |
|---|---|
|
Vascular Accident, Brain Traumatic Brain Injury |
Device: Armeo Spring Other: conventional physiotherapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Armeo® Versus Standard Physiotherapy for Upper Limb Rehabilitation in Patients With Acquired Brain Lesions |
Resource links provided by NLM:
Further study details as provided by Krankenhaus Bozen:
Primary Outcome Measures:
- Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke [ Time Frame: Enrollment ] [ Designated as safety issue: Yes ]
- Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
- Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
- Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Upper Extremity Motor Activity Log for measuring real use of the upper limb [ Time Frame: Enrolment ] [ Designated as safety issue: Yes ]
- Upper Extremity Motor Activity Log for measuring real use of the upper limb [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
- Upper Extremity Motor Activity Log for measuring real use of the upper limb [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
- Upper Extremity Motor Activity Log for measuring real use of the upper limb [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- Upper Extremity Motor Activity Log for measuring real use of the upper limb [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- Wolf Motor Function Test for measurement of timed joint-segment movements [ Time Frame: Enrolment ] [ Designated as safety issue: Yes ]
- Wolf Motor Function Test for measurement of timed joint-segment movements [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
- Wolf Motor Function Test for measurement of timed joint-segment movements [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
- Wolf Motor Function Test for measurement of timed joint-segment movements [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- Wolf Motor Function Test for measurement of timed joint-segment movements [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- Clinical Global Impression Score for the measurement of change over time of the illness' severity [ Time Frame: Enrolment ] [ Designated as safety issue: Yes ]
- Clinical Global Impression Score for the measurement of change over time of the illness' severity [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
- Clinical Global Impression Score for the measurement of change over time of the illness' severity [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
- Clinical Global Impression Score for the measurement of change over time of the illness' severity [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- Clinical Global Impression Score for the measurement of change over time of the illness' severity [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01398553
Contacts
| Contact: Peter Zelger, MD | +39 0471 907428 | peter.zelger@asbz.it |
| Contact: Elisabeth Hofer, MD | +39 0471 907428 | elisabeth.hofer@asb.it |
Locations
| Italy | |
| Valduce Hospital | Not yet recruiting |
| Costa Masnaga, Lombardia, Italy, 23845 | |
| Contact: Franco Molteni, MD +39 031 8544216 fmolteni@valduce.it | |
| Contact: Mauro Rossini, MSc +39 031 8544211 mrarss@tin.it | |
| Principal Investigator: Franco Molteni, MD | |
| Sub-Investigator: Mauro Rossini, MSc | |
| Krankenhaus Bozen | Recruiting |
| Bozen, Südtirol, Italy, 39100 | |
| Contact: Peter Zelger, MD +39 0471 907428 peter.zelger@asbz.it | |
| Contact: Elisabeth Hofer, MD +39 0471 907428 elisabeth.hofer@asbz.it | |
| Principal Investigator: Peter Zelger, MD | |
| Sub-Investigator: Elisabeth Hofer, MD | |
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 |
More Information
Additional Information:
Publications:
| Responsible Party: | Krankenhaus Bozen |
| ClinicalTrials.gov Identifier: | NCT01398553 History of Changes |
| Other Study ID Numbers: | Gesundheitsbezirk Bozen |
| Study First Received: | November 29, 2010 |
| Last Updated: | August 23, 2011 |
| Health Authority: | Italy: National Institute of Health |
Keywords provided by Krankenhaus Bozen:
|
stroke tbi rehabilitation upper limb |
Additional relevant MeSH terms:
|
Cerebral Infarction Stroke Brain Injuries Brain Infarction Brain Ischemia Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 16, 2013