Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Automated Versus Standard Physiotherapy for Upper Limb Rehabilitation in Patients With Acquired Brain Lesions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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Recruitment Status : Withdrawn (the human resources in the organisation are to limited to do the trial)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
Sponsor:
Collaborator:
Valduce Hospital
Information provided by (Responsible Party):
Krankenhaus Bozen

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Vascular Accident, Brain Traumatic Brain Injury Device: Armeo Spring Other: conventional physiotherapy Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke [ Time Frame: Enrollment ]
  2. Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke [ Time Frame: Baseline ]
  3. Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke [ Time Frame: 6 weeks ]
  4. Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke [ Time Frame: 8 weeks ]
  5. Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Upper Extremity Motor Activity Log for measuring real use of the upper limb [ Time Frame: Enrolment ]
  2. Upper Extremity Motor Activity Log for measuring real use of the upper limb [ Time Frame: Baseline ]
  3. Upper Extremity Motor Activity Log for measuring real use of the upper limb [ Time Frame: 6 weeks ]
  4. Upper Extremity Motor Activity Log for measuring real use of the upper limb [ Time Frame: 8 weeks ]
  5. Upper Extremity Motor Activity Log for measuring real use of the upper limb [ Time Frame: 12 weeks ]
  6. Wolf Motor Function Test for measurement of timed joint-segment movements [ Time Frame: Enrolment ]
  7. Wolf Motor Function Test for measurement of timed joint-segment movements [ Time Frame: Baseline ]
  8. Wolf Motor Function Test for measurement of timed joint-segment movements [ Time Frame: 6 weeks ]
  9. Wolf Motor Function Test for measurement of timed joint-segment movements [ Time Frame: 8 weeks ]
  10. Wolf Motor Function Test for measurement of timed joint-segment movements [ Time Frame: 12 weeks ]
  11. Clinical Global Impression Score for the measurement of change over time of the illness' severity [ Time Frame: Enrolment ]
  12. Clinical Global Impression Score for the measurement of change over time of the illness' severity [ Time Frame: Baseline ]
  13. Clinical Global Impression Score for the measurement of change over time of the illness' severity [ Time Frame: 6 weeks ]
  14. Clinical Global Impression Score for the measurement of change over time of the illness' severity [ Time Frame: 8 weeks ]
  15. Clinical Global Impression Score for the measurement of change over time of the illness' severity [ Time Frame: 12 weeks ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Layout table for location information
Italy
Valduce Hospital
Costa Masnaga, Lombardia, Italy, 23845
Krankenhaus Bozen
Bozen, Südtirol, Italy, 39100
Sponsors and Collaborators
Krankenhaus Bozen
Valduce Hospital
Investigators
Layout table for investigator information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications:

Layout table for additonal information
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
Keywords provided by Krankenhaus Bozen:
stroke
tbi
rehabilitation
upper limb
Additional relevant MeSH terms:
Layout table for MeSH terms
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