Effects of Robotic Gloves Along With Task-oriented Mirror Therapy on Motor Functions of Hands in Sub-acute Stroke Patients

Foundation University Islamabad

Status: Enrolling

Conditions: Robotics; Stroke; Neurorehabilitation; Mirror Therapy

Treatments: Procedure: Task-Oriented Mirror Therapy; Procedure: Robotic Gloves assisted Task-oriented mirror therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06950749

FUI/CTR/2024/50

Details and patient eligibility

About

This study is randomized control trial and purpose of this study is to find effects of robotic gloves assisted task-oriented mirror therapy in comparison with task-oriented mirror therapy on motor functions of hand in sub-acute stroke patients.

Full description

Motor functions of the hand involve different movements and activities that the hand can perform due to the coordination of different muscles group in everyday activities which involves dexterity, manipulative skills and task performance skills which includes grasp, release and different types of grips of hand.

RATIONALE:

While the mirror therapy has been studied extensively and literature provide good quality of evidence for effects of mirror therapy on motor functions of hands the integration of pneumatic Robotic Mirror Therapy is relatively less explored .

and there is no comparison between Task oriented MT and pneumatic Robotic Mirror Therapy

SIGNIFICANCE This study will increase the understanding and therapeutic potential of robotic gloves assisted task-oriented MT mirror therapy and will demonstrate its efficacy as beneficial interventions.

Modern devices like robotic gloves can potentially increase patient compliance by providing positive outcomes, setting goals and improving functional performance.

They can make therapy more engaging, interactive and help the patients track their progress, which can motivate them to adhere to their rehabilitation program.

HYPOTHESIS ALTERNATE HYPOTHESIS There will be a statistically significant difference in the effects of Task oriented Mirror Therapy in comparison with Robotic gloves Assisted task-oriented Mirror Therapy on motor functions of hand in patients with sub-acute Stroke (p<0.05).

NULL HYPOTHESIS There will be no statistically significant difference in the effects of Task oriented Mirror Therapy in comparison with Robotic gloves Assisted task-oriented Mirror Therapy on motor functions of hand in patients with sub-acute Stroke (p>0.05).

Enrollment: 30 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 40 years and above.
• Ischemic (MCA) stroke.
• Male and females both.
• Montreal Cognitive Assessment (MoCA score >24 points).
• Motor power of proximal upper Extremity at least 3 with ability to reach out.
• FMA score for upper Extremity below 47
• Modified Ashworth spasticity score <2 in hands and finger joints.
• Ability to sit for at least 60 minutes

Exclusion criteria

• Musculoskeletal problems such as severe pain in any joints of the paretic upper extremity.
• Contractures in shoulder, elbow, hand or finger joints.
• Severe Visual impairments.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

INTERVENTION GROUP (A)

Experimental group

Description:

INTERVENTION GROUP (A) will receive Robotic Gloves Assisted Task-Oriented Mirror Therapy along with conventional therapy. subjects will sit on a chair and placed their both hands on the table. Patients will wear the soft robotic glove on affected hand and the data glove the unaffected hand. Subjects will be instructed to visually observe the hand being moved by soft robotic glove * In mirror training mode: Synchronized flexion and extension training with both hands. * Task oriented activities: With help of robot patient will practice grasping, releasing the tennis ball, positioning the cup upright, carrying a wooded block, putting a ball

Treatment:

Procedure: Robotic Gloves assisted Task-oriented mirror therapy

INTERVENTIONAL GROUP (B)

Experimental group

Description:

INTERVENTIONAL GROUP (B) will receive Task-Oriented Mirror Therapy along with conventional therapy. Both the extremities of the subject will be placed on the table and mirror will be placed in the patients' mid sagittal plane. Mirror will be placed in such a way that the reflection of the non-affected arm to be seen. * Grasping and releasing (cylindrical grasp, spherical grasp, hook grasp, pincer grasp) * Task oriented activities: positioning the cup upright, carrying a wooded block and putting a ball.

Treatment:

Procedure: Task-Oriented Mirror Therapy