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

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01398553
• Other study ID #: Gesundheitsbezirk Bozen
• Status: Withdrawn
• Phase: N/A
• First received: November 29, 2010
• Last updated: September 5, 2016
• Start date: March 2011
• Est. completion date: December 2015

Study information

• Verified date: September 2016
• Source: Krankenhaus Bozen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Stroke
• Traumatic Brain Injury
• Vascular Accident, Brain

Intervention

Device:
• Armeo Spring
30min Armeo Spring + 15min task oriented therapy over 6 weeks Frequency: 3 x/week

Other:
• conventional physiotherapy
30min occupational therapy(15min ADL-training, 15min repetitive training) + 15min task oriented therapy over 6 weeks Frequency: 3x/week

Locations

Country	Name	City	State
Italy	Krankenhaus Bozen	Bozen	Südtirol
Italy	Valduce Hospital	Costa Masnaga	Lombardia

Sponsors (2)

Lead Sponsor	Collaborator
Krankenhaus Bozen	Valduce Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke		Enrollment	Yes
Primary	Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke		Baseline	Yes
Primary	Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke		6 weeks	Yes
Primary	Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke		8 weeks	Yes
Primary	Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke		12 weeks	Yes
Secondary	Upper Extremity Motor Activity Log for measuring real use of the upper limb		Enrolment	Yes
Secondary	Upper Extremity Motor Activity Log for measuring real use of the upper limb		Baseline	Yes
Secondary	Upper Extremity Motor Activity Log for measuring real use of the upper limb		6 weeks	Yes
Secondary	Upper Extremity Motor Activity Log for measuring real use of the upper limb		8 weeks	Yes
Secondary	Upper Extremity Motor Activity Log for measuring real use of the upper limb		12 weeks	Yes
Secondary	Wolf Motor Function Test for measurement of timed joint-segment movements		Enrolment	Yes
Secondary	Wolf Motor Function Test for measurement of timed joint-segment movements		Baseline	Yes
Secondary	Wolf Motor Function Test for measurement of timed joint-segment movements		6 weeks	Yes
Secondary	Wolf Motor Function Test for measurement of timed joint-segment movements		8 weeks	Yes
Secondary	Wolf Motor Function Test for measurement of timed joint-segment movements		12 weeks	Yes
Secondary	Clinical Global Impression Score for the measurement of change over time of the illness' severity		Enrolment	Yes
Secondary	Clinical Global Impression Score for the measurement of change over time of the illness' severity		Baseline	Yes
Secondary	Clinical Global Impression Score for the measurement of change over time of the illness' severity		6 weeks	Yes
Secondary	Clinical Global Impression Score for the measurement of change over time of the illness' severity		8 weeks	Yes
Secondary	Clinical Global Impression Score for the measurement of change over time of the illness' severity		12 weeks	Yes

External Links

•   Participating Centre
•   Study Sponsor