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

NCT ID: NCT06950749

Last Updated: 2025-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-12

Study Completion Date

2025-04-30

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Stroke Mirror Therapy Robotics Neurorehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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INTERVENTION GROUP (A)

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

Group Type EXPERIMENTAL

Robotic Gloves assisted Task-oriented mirror therapy

Intervention Type PROCEDURE

Robotic gloves assissted task-oriented Mirror therapy along with conventional therapy.

Conventional therapy consists of stretching exercises,active assisted and active ROMS of shoulder along with weight bearing and reaching activities.

Robotic gloves assisted task-oriented Mirror therapy will be delivered by syrebo robotic hand rehabilitation device.

it has different training modes including Mirror mode and task-oriented training.

5 sessions per week will be provided for 8 weeks exercises: 30 minutes (3 sets of 10 reps)

* In mirror training mode: Synchronized flexion and extension training with both hands.

INTERVENTIONAL GROUP (B)

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.

Group Type EXPERIMENTAL

Task-Oriented Mirror Therapy

Intervention Type PROCEDURE

Interventional group (B) will receive Task-Oriented Mirror Therapy along with conventional therapy.

To perform Task-Oriented Mirror Therapy both the extremities of the subject will be placed on the table and the mirror (40×60 cm) 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 can be seen. The subjects will be instructed to perform the movement bilaterally. The movement on the impaired limb will be performed. Affected arm is involved in exercise therapy either through patients trying to move themselves or with a therapist in assisting movement.

5 sessions per week will be provided for 8 weeks.

* Task-Oriented Mirror therapy exercises: 30 minutes. (3 sets of 10 reps)
* Hand flexion and extension through the tennis ball.
* Grasping and releasing (cylindrical grasp, spherical grasp, hook grasp, pincer grasp)
* Task oriented activities: positioning the cup upright, carrying a woode

Interventions

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Robotic Gloves assisted Task-oriented mirror therapy

Robotic gloves assissted task-oriented Mirror therapy along with conventional therapy.

Conventional therapy consists of stretching exercises,active assisted and active ROMS of shoulder along with weight bearing and reaching activities.

Robotic gloves assisted task-oriented Mirror therapy will be delivered by syrebo robotic hand rehabilitation device.

it has different training modes including Mirror mode and task-oriented training.

5 sessions per week will be provided for 8 weeks exercises: 30 minutes (3 sets of 10 reps)

* In mirror training mode: Synchronized flexion and extension training with both hands.

Intervention Type PROCEDURE

Task-Oriented Mirror Therapy

Interventional group (B) will receive Task-Oriented Mirror Therapy along with conventional therapy.

To perform Task-Oriented Mirror Therapy both the extremities of the subject will be placed on the table and the mirror (40×60 cm) 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 can be seen. The subjects will be instructed to perform the movement bilaterally. The movement on the impaired limb will be performed. Affected arm is involved in exercise therapy either through patients trying to move themselves or with a therapist in assisting movement.

5 sessions per week will be provided for 8 weeks.

* Task-Oriented Mirror therapy exercises: 30 minutes. (3 sets of 10 reps)
* Hand flexion and extension through the tennis ball.
* Grasping and releasing (cylindrical grasp, spherical grasp, hook grasp, pincer grasp)
* Task oriented activities: positioning the cup upright, carrying a woode

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Foundation University Islamabad

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Foundation University College of Physical Therapy

Islamabad, , Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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ABDUL REHMAN, DPT

Role: CONTACT

003037105609

Facility Contacts

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FURQAN Ahmed Siddiqi, PhD in Rehabilitation Sciences

Role: primary

+923004414981

Other Identifiers

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FUI/CTR/2024/50

Identifier Type: -

Identifier Source: org_study_id

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