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

Primary Purpose

Vascular Accident, Brain, Traumatic Brain Injury

Status
Withdrawn
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Armeo Spring
conventional physiotherapy
Sponsored by
Krankenhaus Bozen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vascular Accident, Brain focused on measuring stroke, tbi, rehabilitation, upper limb

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Valduce Hospital
  • Krankenhaus Bozen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Armeo Spring

conventional physiotherapy

Arm Description

Outcomes

Primary Outcome Measures

Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke
Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke
Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke
Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke
Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke

Secondary Outcome Measures

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

Full Information

First Posted
November 29, 2010
Last Updated
September 5, 2016
Sponsor
Krankenhaus Bozen
Collaborators
Valduce Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01398553
Brief Title
Automated Versus Standard Physiotherapy for Upper Limb Rehabilitation in Patients With Acquired Brain Lesions
Official Title
Armeo® Versus Standard Physiotherapy for Upper Limb Rehabilitation in Patients With Acquired Brain Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Withdrawn
Why Stopped
the human resources in the organisation are to limited to do the trial
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Krankenhaus Bozen
Collaborators
Valduce Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Accident, Brain, Traumatic Brain Injury
Keywords
stroke, tbi, rehabilitation, upper limb

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Armeo Spring
Arm Type
Experimental
Arm Title
conventional physiotherapy
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Armeo Spring
Other Intervention Name(s)
group A
Intervention Description
30min Armeo Spring + 15min task oriented therapy over 6 weeks Frequency: 3 x/week
Intervention Type
Other
Intervention Name(s)
conventional physiotherapy
Other Intervention Name(s)
group B
Intervention Description
30min occupational therapy(15min ADL-training, 15min repetitive training) + 15min task oriented therapy over 6 weeks Frequency: 3x/week
Primary Outcome Measure Information:
Title
Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke
Time Frame
Enrollment
Title
Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke
Time Frame
Baseline
Title
Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke
Time Frame
6 weeks
Title
Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke
Time Frame
8 weeks
Title
Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Upper Extremity Motor Activity Log for measuring real use of the upper limb
Time Frame
Enrolment
Title
Upper Extremity Motor Activity Log for measuring real use of the upper limb
Time Frame
Baseline
Title
Upper Extremity Motor Activity Log for measuring real use of the upper limb
Time Frame
6 weeks
Title
Upper Extremity Motor Activity Log for measuring real use of the upper limb
Time Frame
8 weeks
Title
Upper Extremity Motor Activity Log for measuring real use of the upper limb
Time Frame
12 weeks
Title
Wolf Motor Function Test for measurement of timed joint-segment movements
Time Frame
Enrolment
Title
Wolf Motor Function Test for measurement of timed joint-segment movements
Time Frame
Baseline
Title
Wolf Motor Function Test for measurement of timed joint-segment movements
Time Frame
6 weeks
Title
Wolf Motor Function Test for measurement of timed joint-segment movements
Time Frame
8 weeks
Title
Wolf Motor Function Test for measurement of timed joint-segment movements
Time Frame
12 weeks
Title
Clinical Global Impression Score for the measurement of change over time of the illness' severity
Time Frame
Enrolment
Title
Clinical Global Impression Score for the measurement of change over time of the illness' severity
Time Frame
Baseline
Title
Clinical Global Impression Score for the measurement of change over time of the illness' severity
Time Frame
6 weeks
Title
Clinical Global Impression Score for the measurement of change over time of the illness' severity
Time Frame
8 weeks
Title
Clinical Global Impression Score for the measurement of change over time of the illness' severity
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Zelger, MD
Organizational Affiliation
Krankenhaus Bozen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Franco Molteni, MD
Organizational Affiliation
Valduce Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Elisabeth Hofer, MD
Organizational Affiliation
Krankenhaus Bozen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mauro Rossini, MSc
Organizational Affiliation
Valduce Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Valduce Hospital
City
Costa Masnaga
State/Province
Lombardia
ZIP/Postal Code
23845
Country
Italy
Facility Name
Krankenhaus Bozen
City
Bozen
State/Province
Südtirol
ZIP/Postal Code
39100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
17876068
Citation
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.
Results Reference
background
PubMed Identifier
16847784
Citation
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.
Results Reference
background
PubMed Identifier
18498641
Citation
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.
Results Reference
background
PubMed Identifier
17270510
Citation
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.
Results Reference
background
Links:
URL
http://www.valduce.it
Description
Participating Centre

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

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