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

NCT01398553 | Withdrawn

• 1 other identifier: Gesundheitsbezirk Bozen
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Vascular Accident, Brain; Traumatic Brain Injury

Keywords

stroke; tbi; rehabilitation; upper limb

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (15)

• 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

Study Arms (2)

Armeo Spring

EXPERIMENTAL

Device: Armeo Spring

conventional physiotherapy

ACTIVE COMPARATOR

Other: conventional physiotherapy

Interventions

Armeo Spring DEVICE

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

Also known as: group A

Armeo Spring

conventional physiotherapy OTHER

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

Also known as: group B

conventional physiotherapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Krankenhaus Bozen: lead
• Valduce Hospital: collaborator

Study Sites (2)

Valduce Hospital

Costa Masnaga, Lombardy, 23845, Italy

Location

Krankenhaus Bozen

Bolzano, Südtirol, 39100, Italy

Location

Related Publications (4)

• 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.

  PMID: 17876068 BACKGROUND

• 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.

  PMID: 16847784 BACKGROUND

• 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.

  PMID: 18498641 BACKGROUND

• 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.

  PMID: 17270510 BACKGROUND

Related Links

• Participating Centre

MeSH Terms

Conditions

Stroke; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Peter Zelger, MD

  Krankenhaus Bozen

  PRINCIPAL INVESTIGATOR

• Franco Molteni, MD

  Valduce Hospital

  STUDY DIRECTOR

• Elisabeth Hofer, MD

  Krankenhaus Bozen

  STUDY CHAIR

• Mauro Rossini, MSc

  Valduce Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2010
• First Posted: July 20, 2011
• Study Start: March 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 7, 2016

Record last verified: 2016-09

Locations

IT (2)