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

Study Overview
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Brief Summary
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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.

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

Conditions
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Vascular Accident, Brain, Traumatic Brain Injury

Intervention / Treatment
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* Device: Armeo Spring
* Other: conventional physiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Armeo Spring<br> | Device: Armeo Spring<br>* 30min Armeo Spring + 15min task oriented therapy over 6 weeks Frequency: 3 x/week<br>* Other names: group A;|
| Active Comparator: conventional physiotherapy<br> | Other: conventional physiotherapy<br>* 30min occupational therapy(15min ADL-training, 15min repetitive training) + 15min task oriented therapy over 6 weeks Frequency: 3x/week<br>* Other names: group B;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke |  | Enrollment | 
| Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke |  | Baseline | 
| Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke |  | 6 weeks | 
| Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke |  | 8 weeks | 
| Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper Extremity Motor Activity Log for measuring real use of the upper limb |  | Enrolment | 
| Upper Extremity Motor Activity Log for measuring real use of the upper limb |  | Baseline | 
| Upper Extremity Motor Activity Log for measuring real use of the upper limb |  | 6 weeks | 
| Upper Extremity Motor Activity Log for measuring real use of the upper limb |  | 8 weeks | 
| 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 |  | Enrolment | 
| Wolf Motor Function Test for measurement of timed joint-segment movements |  | Baseline | 
| Wolf Motor Function Test for measurement of timed joint-segment movements |  | 6 weeks | 
| Wolf Motor Function Test for measurement of timed joint-segment movements |  | 8 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 |  | Enrolment | 
| Clinical Global Impression Score for the measurement of change over time of the illness' severity |  | Baseline | 
| Clinical Global Impression Score for the measurement of change over time of the illness' severity |  | 6 weeks | 
| Clinical Global Impression Score for the measurement of change over time of the illness' severity |  | 8 weeks | 
| Clinical Global Impression Score for the measurement of change over time of the illness' severity |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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upper limb, stroke, tbi, rehabilitation