The General Use of Robots in Stroke Recovery

Not Applicable

Withdrawn

• Conditions: Stroke
• Interventions: Device: IMT Robotic Arm therapy

• Registration Number: NCT01726660
• Lead Sponsor: Northwell Health

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-10-26
• Study First Submitted QC: 2012-11-09
• Study First Posted: 2012-11-15
• Primary Completion: 2015-11
• Study Completion: 2015-12
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-02
• Last Update Posted: 2018-02-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IMT Robotic Arm Therapy: Functional training	IMT Robotic Arm therapy	Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for whole arm, functional training, 3x/week for 12 weeks.
IMT Robotic Arm Therapy: Aim training	IMT Robotic Arm therapy	Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for aim training, 3x/week for 12 weeks.
IMT Robotic Arm Therapy: Smoothness Training	IMT Robotic Arm therapy	Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for smoothness training, 3x/week for 12 weeks.
IMT Robotic Arm Therapy: Impairment training	IMT Robotic Arm therapy	Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for whole-arm, impairment training, 3x/week for 12 weeks.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change from baseline in Kinematic Data	12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)	Kinematic Data recorded during therapy with IMT robots
Change from baseline in Fugl Meyer Sensation Scale	12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)
Change from baseline in Fugl Meyer Proprioception Scale	12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)

Trial Locations

Locations (1)

Feinstein Institute for Medical Research; 🇺🇸 Manhasset, New York, United States