NCT06950749

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 12, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 14, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

5 months

First QC Date

November 14, 2024

Last Update Submit

April 27, 2025

Conditions

Keywords

strokemirror therapyroboticsneurorehabilitation

Outcome Measures

Primary Outcomes (3)

  • hand motor functions

    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

    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

    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

Study Arms (2)

INTERVENTION GROUP (A)

EXPERIMENTAL

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

INTERVENTIONAL GROUP (B)

EXPERIMENTAL

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

Interventions

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 GROUP (A)

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

INTERVENTIONAL GROUP (B)

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Islamabad, 46000, Pakistan

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2024

First Posted

April 30, 2025

Study Start

October 12, 2024

Primary Completion

March 15, 2025

Study Completion

April 30, 2025

Last Updated

April 30, 2025

Record last verified: 2025-04

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