Automated Versus Standard Physiotherapy for Upper Limb Rehabilitation in Patients With Acquired Brain Lesions - Full Text View

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:

MedlinePlus related topics: Rehabilitation

U.S. FDA Resources

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:

Study Sponsor This link exits the ClinicalTrials.gov site

Participating Centre This link exits the ClinicalTrials.gov site

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.

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.

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.


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