Pilot Study of the Effects of Protocol-Specific Robotic Arm Therapy in Stroke Recovery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Northwell Health
- Locations
- 1
- Primary Endpoint
- Change from baseline in Upper Extremity Fugl Meyer Motor Assessment
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
IMT Robotic Arm Therapy: Aim training
Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for aim training, 3x/week for 12 weeks.
Intervention: IMT Robotic Arm therapy (Device)
IMT Robotic Arm Therapy: Smoothness Training
Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for smoothness training, 3x/week for 12 weeks.
Intervention: IMT Robotic Arm therapy (Device)
IMT Robotic Arm Therapy: Impairment training
Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for whole-arm, impairment training, 3x/week for 12 weeks.
Intervention: IMT Robotic Arm therapy (Device)
IMT Robotic Arm Therapy: Functional training
Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for whole arm, functional training, 3x/week for 12 weeks.
Intervention: IMT Robotic Arm therapy (Device)
Outcomes
Primary Outcomes
Change from baseline in Upper Extremity Fugl Meyer Motor Assessment
Time Frame: 12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)
Secondary Outcomes
- Change from baseline in Kinematic Data(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))
Investigators
Bruce Volpe
Principal Investigator
Northwell Health