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

Study Description

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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

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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

Arms and Interventions

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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

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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

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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

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

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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

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Additional Information:

Study Sponsor 

Participating Centre 

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
First Posted:	July 20, 2011
Last Update Posted:	September 7, 2016
Last Verified:	September 2016

Keywords provided by Krankenhaus Bozen:

stroke; tbi; rehabilitation; upper limb

Additional relevant 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