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

April 27, 2025 updated by: Foundation University Islamabad
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
      • Islamabad, Pakistan, 46000
        • Recruiting
        • Foundation University College of Physical Therapy
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Procedure: 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.
Experimental: 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hand motor functions
Time Frame: 08 Weeks
Fugl Meyer Assessment (FMA-UE), wii be used to assess motor functions of hands FMA:used to measure motor recovery in stroke patients. it has a maximum score of 66 points FMA hand section will be used to assess motor functions of hands from baseline to end of interventions.
08 Weeks
Dexterity
Time Frame: 8 weeks
An action research arm test will be used. Scores were rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performed normally) for a maximum score of 57.
8 weeks
unilateral gross manual dexterity
Time Frame: 8 weeks
Box and block test is used to assess the unilateral gross manual dexterity of the hand. Subjects will be asked to move a wooden block from one compartment to the other.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Foundation University Islamabad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2024

Primary Completion (Actual)

March 15, 2025

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

November 14, 2024

First Submitted That Met QC Criteria

April 27, 2025

First Posted (Actual)

April 30, 2025

Study Record Updates

Last Update Posted (Actual)

April 30, 2025

Last Update Submitted That Met QC Criteria

April 27, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUI/CTR/2024/50

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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