Upper Arm Training With Armeo Spring for Stroke

NCT01485354 | Terminated Results FDA Device

• 1 other identifier: 2008-P-001255
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the clinical outcomes of upper extremity training using the Armeo Spring system in a chronic post-stroke population with impaired upper extremity function.

Conditions

Stroke

Keywords

Stroke; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in Upper-extremity Fugl-Meyer Score (Measure of Motor Impairment) (i.e. Difference Between Fugl-Meyer Score at Baseline and at Completion of the 3-week Intervention)

  The upper-extremity Fugl-Meyer scale allow one to assess the severity of motor impairments in stroke survivors using a scale from 0 (severe impairment) to 66 (no impairment). It is based on visual observations gathered by asking subjects to perform upper-limb movements using the stroke-affected limb. Therapists rate the performance of the motor tasks using an ordinal scale ranging from 0 (cannot perform) to 2 (can perform fully) that captures the motor ability of the individual. The investigators computed the difference between the Fugl-Meyer score at completion of the 3-week intervention and the Fugl-Meyer score at baseline.

  Data collected at baseline and at completion of the 3-week intervention

Secondary Outcomes (4)

• Change in Wolf Motor Function Test Score (a Functional Test) (i.e. Difference Between Wolf Motor Function Test Score at Baseline and at Completion of the 3-week Intervention)

  Data collected at baseline and at completion of the 3-week intervention

• Change in Functional Ability Scale Score (Scale to Rate Quality of Movement) (i.e. Difference Between Functional Ability Scale Score at Baseline and at Completion of the 3-week Intervention)

  Data collected at baseline and at completion of the 3-week intervention

• Change in Box and Block Test Score (Manual Dexterity Test) (i.e. Difference Between Box and Block Test Score at Baseline and at Completion of the 3-week Intervention)

  Data collected at baseline and at completion of the 3-week intervention

• Change in Grip Strength (Strength Test) (i.e. Difference Between Grip Strength at Baseline and at Completion of the 3-week Intervention)

  Data collected at baseline and at completion of the 3-week intervention

Study Arms (1)

Armeo Spring training

EXPERIMENTAL

Subjects will participate in upper extremity rehabilitation using the Armeo Spring system for a period of 6 weeks. The intervention will consist of 18 training sessions (60 minute sessions, 3 times a week).

Device: Armeo Spring training

Interventions

Armeo Spring training DEVICE

Upper-limb training using the Armeo system for a period of 6 weeks

Also known as: Armeo Spring (Hocoma AG, Switzerland)

Armeo Spring training

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female, community dwelling, age 18-70
• First-time non-traumatic ischemic or hemorrhagic stroke at least 3 months prior to study enrollment
• Score of 15-55 out of 66 on arm motor Fugl-Meyer scale
• The ability to extend \>=10 degrees at metacarpophalangeal and interphalangeal joint of all digits

You may not qualify if:

• Cognitive impairment that may interfere with understanding instructions for motor tasks and assessment tools
• Inability to operate the Armeo system (subjects must have sufficient range of movement to enable calibration of the virtual workspace)
• Participation in other forms of therapy/intervention for upper extremity motor recovery

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead

Study Sites (1)

Spaulding Rehabilitation Hospital Boston

Boston, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Paolo Bonato
• Organization: Spaulding Rehabilitation Hospital

pbonato@partners.org

617-952-6319

Study Officials

• Paolo Bonato, PhD

  Spaulding Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Motion Analysis Laboratory

Study Record Dates

• First Submitted: June 28, 2011
• First Posted: December 5, 2011
• Study Start: December 1, 2008
• Primary Completion: October 1, 2015
• Study Completion: March 1, 2017
• Last Updated: July 12, 2017
• Results First Posted: July 12, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)