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

September 5, 2016 updated by: Krankenhaus Bozen

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Lombardia
      • Costa Masnaga, Lombardia, Italy, 23845
        • Valduce Hospital
    • Südtirol
      • Bozen, Südtirol, Italy, 39100
        • Krankenhaus Bozen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Krankenhaus Bozen

Collaborators

Valduce Hospital

Investigators

  • Principal Investigator: Peter Zelger, MD, Krankenhaus Bozen
  • Study Director: Franco Molteni, MD, Valduce Hospital
  • Study Chair: Elisabeth Hofer, MD, Krankenhaus Bozen
  • Study Chair: Mauro Rossini, MSc, Valduce Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

November 29, 2010

First Submitted That Met QC Criteria

July 19, 2011

First Posted (Estimate)

July 20, 2011

Study Record Updates

Last Update Posted (Estimate)

September 7, 2016

Last Update Submitted That Met QC Criteria

September 5, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gesundheitsbezirk Bozen

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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