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NCT Number: NCT06950749

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Mirror Therapy Nervous System Diseases Neurorehabilitation Robotics Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foundation University College of Physical Therapy

Islamabad, 46000, Pakistan

Location status: Recruiting

Location contact

FURQAN Ahmed Siddiqi, PhD in Rehabilitation Sciences

CONTACT

[email protected]

+923004414981

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Robotic Gloves assisted Task-oriented mirror therapy

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.

Task-Oriented Mirror Therapy

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

ABDUL REHMAN, DPT

CONTACT

[email protected]

003037105609

Sponsors and collaborators

Lead sponsor

Foundation University Islamabad

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 30, 2025
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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