Clinical trial NCT02017093: Error Enhancement of the Velocity Component
Official title: Error Enhancement of the Velocity Component in the Course of Stroke Patients' Reaching Movements - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Hemiparesis
Keywords: CVA, rehabilitation
Lead sponsor: University of Haifa
Sponsor class: OTHER
Collaborators: name: Ben-Gurion University of the Negev
name: Tel Aviv University
First posted: 2013-12-20
Enrollment: 7
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this pilot study was to explore the impact of enhancement of the velocity component error in the course of reaching movements of the impaired/hemiparetic limb in an acute stroke subject. We hypothesized that the method would shift velocity profiles toward the optimal, resulting in a reduction in error. A prototype robot. This robotic device system has a two-dimensional motor, basic measurement capacities, and a robotic arm which is engaged to the subject's upper-limb in a sitting position.

The enhancement of the velocity component error would shift velocity profiles toward the optimal, resulting in a reduction in error.

Detailed description: The wrist of the subject is connected to the robotic arm by a strip which supports the arm but allows free movements of the wrist. This configuration allows subjects with impaired grasping ability to use the system. A bio-feedback system enables the subject to perform various functional motor tasks that are presented on the screen in front of him. The system's sensors detect motor errors or deviations from an optimal/proper movement trajectory or velocity profile. Any deviation in direction, velocity, acceleration or necessary force from the optimal trajectory results in applied robotic forces that enhance such errors/deviations. The sensors and the applied forces all work and compute in real time, so that the force measurements and the applied force are updated to the executed movement.

Eligibility criteria: Inclusion Criteria:

* Single stroke
* Two to three weeks post Stroke
* Able to understand simple commands
* Able to perform some reaching movements with the affected arm.
* No other neurological, neuromuscular, orthopedic disorders and visual deficit

Exclusion Criteria:

* Perceptual, apraxic, or major cognitive deficits,
* Shoulder joint subluxation or pain in the upper-limb, and
* Spasticity \> 1 (single muscle Modified Ashworth Scale).

Primary outcomes:
measure: Improvement in Average Movement Trajectory Error From T1 to T2
timeFrame: The outcome was assessed at the begining of the rehabilitation (T1) and about 5 weeks later at the end of rehabilitation (T2).
measure: Fugl-Meyer Assessment Score
timeFrame: The measured assessed at the begining of the rehabilitation (T1) and about 5 weeks later at the end of the rehabilitation (T2).
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Reuth Medical Center
Study officials:
affiliation: University of Haifa
name: Eli Carmeli, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Givon-Mayo R, Simons E, Ohry A, Karpin H, Israely S, Carmeli E. A preliminary investigation of error enhancement of the velocity component in stroke patients' reaching movements. International Journal of Therapy and Rehabilitation. 2014;21(4):160-168.