Clinical trial NCT01398553: Automated Versus Standard Physiotherapy for Upper Limb Rehabilitation in Patients With Acquired Brain Lesions
Official title: Armeo® Versus Standard Physiotherapy for Upper Limb Rehabilitation in Patients With Acquired Brain Lesions
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Vascular Accident, Brain
Traumatic Brain Injury
Keywords: stroke
tbi
rehabilitation
upper limb
Lead sponsor: Krankenhaus Bozen
Sponsor class: OTHER
Collaborators: name: Valduce Hospital
First posted: 2011-07-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke
timeFrame: Enrollment
measure: Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke
timeFrame: Baseline
measure: Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke
timeFrame: 6 weeks
measure: Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke
timeFrame: 8 weeks
measure: Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke
timeFrame: 12 weeks
Secondary outcomes:
measure: Upper Extremity Motor Activity Log for measuring real use of the upper limb
timeFrame: Enrolment
measure: Upper Extremity Motor Activity Log for measuring real use of the upper limb
timeFrame: Baseline
measure: Upper Extremity Motor Activity Log for measuring real use of the upper limb
timeFrame: 6 weeks
measure: Upper Extremity Motor Activity Log for measuring real use of the upper limb
timeFrame: 8 weeks
measure: Upper Extremity Motor Activity Log for measuring real use of the upper limb
timeFrame: 12 weeks
measure: Wolf Motor Function Test for measurement of timed joint-segment movements
timeFrame: Enrolment
measure: Wolf Motor Function Test for measurement of timed joint-segment movements
timeFrame: Baseline
measure: Wolf Motor Function Test for measurement of timed joint-segment movements
timeFrame: 6 weeks
measure: Wolf Motor Function Test for measurement of timed joint-segment movements
timeFrame: 8 weeks
measure: Wolf Motor Function Test for measurement of timed joint-segment movements
timeFrame: 12 weeks
measure: Clinical Global Impression Score for the measurement of change over time of the illness' severity
timeFrame: Enrolment
measure: Clinical Global Impression Score for the measurement of change over time of the illness' severity
timeFrame: Baseline
measure: Clinical Global Impression Score for the measurement of change over time of the illness' severity
timeFrame: 6 weeks
measure: Clinical Global Impression Score for the measurement of change over time of the illness' severity
timeFrame: 8 weeks
measure: Clinical Global Impression Score for the measurement of change over time of the illness' severity
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Costa Masnaga
country: Italy
facility: Valduce Hospital
state: Lombardia
city: Bozen
country: Italy
facility: Krankenhaus Bozen
state: Südtirol
Study officials:
affiliation: Krankenhaus Bozen
name: Peter Zelger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Valduce Hospital
name: Franco Molteni, MD
role: STUDY_DIRECTOR
affiliation: Krankenhaus Bozen
name: Elisabeth Hofer, MD
role: STUDY_CHAIR
affiliation: Valduce Hospital
name: Mauro Rossini, MSc
role: STUDY_CHAIR
References:
citation: 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. doi: 10.1177/1545968307305457. Epub 2007 Sep 17.
citation: 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. doi: 10.1682/jrrd.2005.04.0076.
citation: 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.
citation: 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. doi: 10.1016/j.apmr.2006.10.032.