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

NCT ID: NCT01398553

Last Updated: 2016-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2015-12-31

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.

Detailed Description

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Conditions

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Vascular Accident, Brain Traumatic Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Armeo Spring

Group Type EXPERIMENTAL

Armeo Spring

Intervention Type DEVICE

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

conventional physiotherapy

Group Type ACTIVE_COMPARATOR

conventional physiotherapy

Intervention Type OTHER

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

Interventions

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Armeo Spring

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

Intervention Type DEVICE

conventional physiotherapy

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

Intervention Type OTHER

Other Intervention Names

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group A group B

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Valduce Hospital

OTHER

Sponsor Role collaborator

Krankenhaus Bozen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Zelger, MD

Role: PRINCIPAL_INVESTIGATOR

Krankenhaus Bozen

Franco Molteni, MD

Role: STUDY_DIRECTOR

Valduce Hospital

Elisabeth Hofer, MD

Role: STUDY_CHAIR

Krankenhaus Bozen

Mauro Rossini, MSc

Role: STUDY_CHAIR

Valduce Hospital

Locations

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Valduce Hospital

Costa Masnaga, Lombardy, Italy

Site Status

Krankenhaus Bozen

Bolzano, Südtirol, Italy

Site Status

Countries

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Italy

References

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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. doi: 10.1177/1545968307305457. Epub 2007 Sep 17.

Reference Type BACKGROUND
PMID: 17876068 (View on PubMed)

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. doi: 10.1682/jrrd.2005.04.0076.

Reference Type BACKGROUND
PMID: 16847784 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18498641 (View on PubMed)

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. doi: 10.1016/j.apmr.2006.10.032.

Reference Type BACKGROUND
PMID: 17270510 (View on PubMed)

Related Links

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http://www.valduce.it

Participating Centre

Other Identifiers

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Gesundheitsbezirk Bozen

Identifier Type: -

Identifier Source: org_study_id

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