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

Krankenhaus Bozen

Status: Withdrawn

Conditions: Traumatic Brain Injury; Vascular Accident, Brain

Treatments: Device: Armeo Spring; Other: conventional physiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01398553

Gesundheitsbezirk Bozen

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Armeo Spring

Experimental group

Treatment:

Device: Armeo Spring

conventional physiotherapy

Active Comparator group

Treatment:

Other: conventional physiotherapy