Effects of Intensive Training on Reocvery of Fingers Dexterity Following Stroke

Loewenstein Hospital

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Stroke

Treatments: Combination Product: Intensive Finger Individuation Therapy; Combination Product: Intensive non-directed finger movement therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04229329

LOE-19-19

Details and patient eligibility

About

The investigators aim to test whether intensive training of finger individuation during the sensitive window of the subacute phases can lead to a clinically-meaningful recovery of dexterous movement in stroke patients.

Enrollment: 70 estimated patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• First symptomatic ischemic or hemorrhagic stroke
• Clinically evident upper-limb motor deficit
• Understand the study aim, is able to cooperate with the task for the specified time
• Clinically stable

Exclusion criteria

• Other neurological or psychiatric illness which affects upper-limb motor function
• An orthopedic or rheumatologic disease that affects the ability to undergo a robotic hand therapy.
• Sensory problems that prevent the patient from reporting pain during the robotic hand therapy
• Skin breakdown or wounds located in places where the hand contacts the robot.
• Patients with C/I to TMS (history of seizures, the existence of cardiac pacer, VP shunt, spinal stimulator or any other hardware that may malfunction at the presence of strong magnetic fields) will no undergo TMS but may participate in the study
• Participation in another interventional study for upper limb rehabilitation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

70 participants in 2 patient groups

Intervention

Experimental group

Description:

The patient hand will be restrained to a robotic arm AMADEO(TM) which enables the measurement and manipulation of forces at each finger individually. After appropriate calibration, the force measurements obtained from the robot will be used to move a cursor on the screen. The patient will be rewarded visually and auditory when a higher degree of finger individuation will be measured. Specifically, when the applied force of the instructed fingers hit the predefined force target and at the same, the force in the non-instructed fingers stay as low as possible

Treatment:

Combination Product: Intensive Finger Individuation Therapy

Control

Sham Comparator group

Description:

The patient hand will be restrained to a robotic arm AMADEO(TM) which enables the measurement and manipulation of forces at each finger individually. After appropriate calibration, the force measurements obtained from the robot will be used to move a cursor on the screen. The patient will be rewarded in a way that is unrelated to the degree of individuation. In other words, a successful trial considered when the applied force of the instructed fingers hits the predefined force target regardless of the force exerted in the non-instructed fingers.

Treatment:

Combination Product: Intensive non-directed finger movement therapy