The General Use of Robots in Stroke Recovery

Stroke Clinical Trial

Official title:

Pilot Study of the Effects of Protocol-Specific Robotic Arm Therapy in Stroke Recovery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01726660
• Other study ID #: 11-121B
• Status: Withdrawn
• Phase: N/A
• First received: October 26, 2012
• Last updated: February 2, 2018
• Start date: February 2012
• Est. completion date: December 2015

Study information

• Verified date: February 2018
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if tailoring multiple sessions of upper extremity robotic therapy to focus on a particular aspect of movement (e.g smoothness vs. aiming; active range of motion vs. functional practice)can optimize therapeutic results and lead to greater functional returns in arm mobility after stroke.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• First single focal unilateral lesion with diagnosis verified by brain imaging, which occurred at least 6 months prior

• Cognitive function sufficient enough to understand experiments and follow instructions

• Fugl Meyer assessment at admission of 7 to 38 out of 66 (neither hemiplegic nor fully recovered motor function in the muscles of the shoulder, elbow, and wrist)

Exclusion Criteria:

• Prior experience with robotic arm therapy

• Fixed contraction of the affected limb

• Complete flaccid paralysis of the affected limb

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• IMT Robotic Arm therapy
Interactive Motion Technologies (IMT) planar and wrist robots for robotic arm therapy

Locations

Country	Name	City	State
United States	Feinstein Institute for Medical Research	Manhasset	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

References & Publications (1)

Stein J, Krebs HI, Frontera WR, Fasoli SE, Hughes R, Hogan N. Comparison of two techniques of robot-aided upper limb exercise training after stroke. Am J Phys Med Rehabil. 2004 Sep;83(9):720-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Upper Extremity Fugl Meyer Motor Assessment		12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)
Secondary	Change from baseline in Kinematic Data	Kinematic Data recorded during therapy with IMT robots	12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)
Secondary	Change from baseline in Fugl Meyer Sensation Scale		12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)
Secondary	Change from baseline in Fugl Meyer Proprioception Scale		12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)