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

Not Applicable

Withdrawn

• Conditions: Traumatic Brain Injury; Vascular Accident, Brain
• Interventions: Device: Armeo Spring; Other: conventional physiotherapy

• Registration Number: NCT01398553
• Lead Sponsor: Krankenhaus Bozen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-29
• Study Start: 2011-03
• Study First Submitted QC: 2011-07-19
• Study First Posted: 2011-07-20
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-05
• Last Update Posted: 2016-09-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Armeo Spring	Armeo Spring	-
conventional physiotherapy	conventional physiotherapy	-

Primary Outcome Measures

Name	Time	Method
Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke	12 weeks

Secondary Outcome Measures

Name	Time	Method
Upper Extremity Motor Activity Log for measuring real use of the upper limb	12 weeks
Wolf Motor Function Test for measurement of timed joint-segment movements	12 weeks
Clinical Global Impression Score for the measurement of change over time of the illness' severity	12 weeks

Trial Locations

Locations (2)

Valduce Hospital; 🇮🇹 Costa Masnaga, Lombardia, Italy

Krankenhaus Bozen; 🇮🇹 Bozen, Südtirol, Italy