The General Use of Robots in Stroke Recovery

Study Overview
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Brief Summary
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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.

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

Conditions
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Stroke

Intervention / Treatment
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* Device: IMT Robotic Arm therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMT Robotic Arm Therapy: Aim training<br>Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for aim training, 3x/week for 12 weeks. | Device: IMT Robotic Arm therapy<br>* Interactive Motion Technologies (IMT) planar and wrist robots for robotic arm therapy<br>|
| Experimental: IMT Robotic Arm Therapy: Smoothness Training<br>Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for smoothness training, 3x/week for 12 weeks. | Device: IMT Robotic Arm therapy<br>* Interactive Motion Technologies (IMT) planar and wrist robots for robotic arm therapy<br>|
| Experimental: IMT Robotic Arm Therapy: Impairment training<br>Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for whole-arm, impairment training, 3x/week for 12 weeks. | Device: IMT Robotic Arm therapy<br>* Interactive Motion Technologies (IMT) planar and wrist robots for robotic arm therapy<br>|
| Experimental: IMT Robotic Arm Therapy: Functional training<br>Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for whole arm, functional training, 3x/week for 12 weeks. | Device: IMT Robotic Arm therapy<br>* Interactive Motion Technologies (IMT) planar and wrist robots for robotic arm therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Cerebrovascular Accident, Cerebral stroke, CVA, robotic therapy, upper extremity recovery, kinematic training