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

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01398553

Enrollment

Registered

2011-07-20

Start date

2011-03-31

Completion date

2015-12-31

Last updated

2016-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury, Vascular Accident, Brain

Keywords

stroke, tbi, rehabilitation, upper limb

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.

Interventions

DEVICEArmeo Spring

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

OTHERconventional physiotherapy

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame
Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke	Enrollment

Secondary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026