NCT07435688

Brief Summary

The goal of this clinical trial is to compare the effectiveness of conventional mirror therapy and robotic mirror mode training in promoting upper extremity motor recovery in adult patients with ischemic stroke during the early subacute phase. The main questions it aims to answer are: Does mirror mode of a robotic hand device result in greater motor function recovery compared to conventional mirror therapy? Are there differences between the groups in somatosensory improvement and gross motor skill outcomes? Do both intervention modalities result in clinically significant improvements in motor and functional outcomes? Researchers will compare a conventional mirror therapy group and a robotic-assisted mirror mode group to determine which provides more significant gains in motor function, somatosensory input, and functional use of the paretic arm. Participants will: Receive standard physiotherapy sessions for 6 weeks Be randomly assigned to either mirror therapy or robotic mirror mode intervention Be evaluated using Fugl-Meyer Assessment, ARAT, Box and Block Test, Wolf Motor Function Test and Tactile/proprioceptive sensory test using Fugl-Meyer Assessment Sensory subsection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2025

Completed
8 months until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
Last Updated

April 15, 2026

Status Verified

February 1, 2026

Enrollment Period

11 months

First QC Date

June 18, 2025

Last Update Submit

April 12, 2026

Conditions

Stroke, IschemicStrokeCVA (Cerebrovascular Accident)

Keywords

robotic rehabilitationmirror therapystroke rehabilitationneurorehabilitation

Outcome Measures

Primary Outcomes (1)

  • Fugl Meyer Assesment

    The Fugl-Meyer Assessment-Upper Extremity is a stroke-specific, performance-based impairment scale and gold-standard measure of post-stroke motor recovery that quantifies upper limb motor function using a standardized ordinal scoring system assessing reflex activity, movement control, coordination, and joint function.

    30 minutes

Secondary Outcomes (3)

  • Action Research Arm Test

    15 minutes

  • Wolf Motor Function Test

    30 minutes

  • Box and Block Test

    5 minutes

Study Arms (2)

Mirror Therapy Group

ACTIVE COMPARATOR

The group who receives conventional mirror therapy

Device: Therapy Mirror

Hand Robot Group

ACTIVE COMPARATOR

The group who receives mirror mode of a soft robotic glove

Device: Hand Robot Mirror Mode

Interventions

Hand Robot Mirror ModeDEVICE

Mirror mode of the hand robot group will mimic the movement of the unaffected arm. The robot will provide proprioceptive and visual feedback and make patient believe that the affected arm is moving.

Also known as: Syrebo C12 / SY-HRC12
Hand Robot Group
Therapy MirrorDEVICE

Patients in the mirror therapy group will glance at the reflection of their non-affected arm and fall into the illusion that their non-affected limb is moving. This is supposed to assist patients regain motor deficits by reducing non-use paralysis.

Mirror Therapy Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having a ischemic/hemorrhagic stroke diagnosis through MRI and/or CT
  • Volunteering to enter the study
  • First ever stroke or no sequeale (mRS 0)
  • Being in subacute/chronic phase of stroke (between 1st week to 1 year)
  • Having a adequate sitting balance or able to maintain upright sitting position for 30 minutes
  • Having a motor deficit in the hand (Brunnstrom hand motor recovery stages 1-4 )
  • Having a full range of motion in hand

You may not qualify if:

  • Severe Pain (VAS ≥ 8)
  • Having a neurological or orthopedic problem in hand
  • Severe spatial hemineglect (NIHSS 11th subscale\> 1)
  • Spasticity (mAS ≥ 2)
  • Apraxia
  • Visual/auditory loss that affects treatment
  • Unstable Vital Signs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Istanbul University- Cerrahpasa

Istanbul, Büyükcekmece, 34500, Turkey (Türkiye)

Location

Alkent 2000, 34500 Büyükçekmece/İstanbul

Istanbul, Istanbul, 34500, Turkey (Türkiye)

Location

Related Publications (11)

  • Arya KN, Verma R, Garg RK. Estimating the minimal clinically important difference of an upper extremity recovery measure in subacute stroke patients. Top Stroke Rehabil. 2011 Oct;18 Suppl 1:599-610. doi: 10.1310/tsr18s01-599.

    PMID: 22120029BACKGROUND

  • Baniqued PDE, Stanyer EC, Awais M, Alazmani A, Jackson AE, Mon-Williams MA, Mushtaq F, Holt RJ. Brain-computer interface robotics for hand rehabilitation after stroke: a systematic review. J Neuroeng Rehabil. 2021 Jan 23;18(1):15. doi: 10.1186/s12984-021-00820-8.

    PMID: 33485365BACKGROUND

  • Chien WT, Chong YY, Tse MK, Chien CW, Cheng HY. Robot-assisted therapy for upper-limb rehabilitation in subacute stroke patients: A systematic review and meta-analysis. Brain Behav. 2020 Aug;10(8):e01742. doi: 10.1002/brb3.1742. Epub 2020 Jun 26.

    PMID: 32592282BACKGROUND

  • Faria-Fortini I, Michaelsen SM, Cassiano JG, Teixeira-Salmela LF. Upper extremity function in stroke subjects: relationships between the international classification of functioning, disability, and health domains. J Hand Ther. 2011 Jul-Sep;24(3):257-64; quiz 265. doi: 10.1016/j.jht.2011.01.002. Epub 2011 Mar 21.

    PMID: 21420279BACKGROUND

  • Ho NS, Tong KY, Hu XL, Fung KL, Wei XJ, Rong W, Susanto EA. An EMG-driven exoskeleton hand robotic training device on chronic stroke subjects: task training system for stroke rehabilitation. IEEE Int Conf Rehabil Robot. 2011;2011:5975340. doi: 10.1109/ICORR.2011.5975340.

    PMID: 22275545BACKGROUND

  • Jorgensen HS, Nakayama H, Raaschou HO, Olsen TS. Recovery of walking function in stroke patients: the Copenhagen Stroke Study. Arch Phys Med Rehabil. 1995 Jan;76(1):27-32. doi: 10.1016/s0003-9993(95)80038-7.

    PMID: 7811170BACKGROUND

  • Kwakkel G, Kollen BJ, van der Grond J, Prevo AJ. Probability of regaining dexterity in the flaccid upper limb: impact of severity of paresis and time since onset in acute stroke. Stroke. 2003 Sep;34(9):2181-6. doi: 10.1161/01.STR.0000087172.16305.CD. Epub 2003 Aug 7.

    PMID: 12907818BACKGROUND

  • Mehrholz J, Pohl M, Platz T, Kugler J, Elsner B. Electromechanical and robot-assisted arm training for improving activities of daily living, arm function, and arm muscle strength after stroke. Cochrane Database Syst Rev. 2018 Sep 3;9(9):CD006876. doi: 10.1002/14651858.CD006876.pub5.

    PMID: 30175845BACKGROUND

  • Nakayama H, Jorgensen HS, Raaschou HO, Olsen TS. Recovery of upper extremity function in stroke patients: the Copenhagen Stroke Study. Arch Phys Med Rehabil. 1994 Apr;75(4):394-8. doi: 10.1016/0003-9993(94)90161-9.

    PMID: 8172497BACKGROUND

  • Raine, S., Meadows, L., & Lynch-Ellerington, M. (2009). Bobath Concept: Theory and Clinical Practice in Neurological Rehabilitation. In Bobath Concept: Theory and Clinical Practice in Neurological Rehabilitation. https://doi.org/10.1002/9781444314601

    BACKGROUND

  • Thieme H, Morkisch N, Mehrholz J, Pohl M, Behrens J, Borgetto B, Dohle C. Mirror therapy for improving motor function after stroke. Cochrane Database Syst Rev. 2018 Jul 11;7(7):CD008449. doi: 10.1002/14651858.CD008449.pub3.

    PMID: 29993119BACKGROUND

Related Links

MeSH Terms

Conditions

Ischemic StrokeStroke

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesRehabilitationTherapeutics

Study Officials

  • Ela Tarakcı, 1

    Istanbul University- Cerrahapaşa

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
Due to the nature of the intervention, participant and therapist blinding was not feasible, and outcome assessments were performed without masking.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

June 18, 2025

First Posted

February 27, 2026

Study Start

January 10, 2024

Primary Completion

November 25, 2024

Study Completion

December 10, 2024

Last Updated

April 15, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(2)