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

This study has been withdrawn prior to enrollment.
(the human resources in the organisation are to limited to do the trial)
Sponsor:
Collaborator:
Valduce Hospital
Information provided by (Responsible Party):
Krankenhaus Bozen
ClinicalTrials.gov Identifier:
NCT01398553
First received: November 29, 2010
Last updated: September 5, 2016
Last verified: September 2016
  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 ]

Enrollment: 0
Study Start Date: March 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (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   (Adult, Senior)
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01398553

Locations
Italy
Valduce Hospital
Costa Masnaga, Lombardia, Italy, 23845
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
  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: September 5, 2016
Health Authority: Italy: National Institute of Health

Keywords provided by Krankenhaus Bozen:
stroke
tbi
rehabilitation
upper limb

Additional relevant MeSH terms:
Brain Injuries
Stroke
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 27, 2016