Mirror Therapy Combined With TENS for Motor Recovery in Paretic Upper Limbs of Chronic Stroke Patients

NCT06770712 | Completed

• 1 other identifier: 2023/273
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine whether mirror therapy, applied in addition to bilateral upper extremity transcutaneous electrical nerve stimulation in patients with chronic stroke, has an additive effect on upper extremity motor recovery

Conditions

Hemiplegia

Keywords

Upper extremity motor function; TENS therapy; Mirror therapy; Fugl-Meyer Assessment; Functional improvement

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment for Upper Extremity

  The Fugl-Meyer Motor Assessment Scale evaluates reflex activity, synergy, and non-synergistic patterns, as well as motor skills and coordination, reflecting the stages of motor development. This assessment consists of a total of 33 items, with each item scored on a 2-point scale. When scoring for the upper extremity, a participant can receive a maximum of 66 points. In the upper extremity assessment, a score of 53-66 points is classified as full capacity, 48-52 points as sufficient capacity, 32-47 points as limited capacity, and 31 points or below as weak capacity.

  Change from baseline in the Fugl-Meyer Motor Assessment Scale immediately post-treatment (1 month) and 2 months after treatment completion.

Study Arms (2)

Bilateral TENS+ Mirror therapy

EXPERIMENTAL

In addition to conventional treatment, the mirror therapy group received TENS therapy on the finger extensor muscles of both the intact and paretic sides, five times a week for four weeks, with a total of 20 sessions, each lasting 30 minutes. Following TENS therapy, 30 minutes of mirror therapy were administered in each session.

Other: Mirror therapy; Device: Transcutaneous Electrical Nerve Stimulation

Bilateral TENS

ACTIVE COMPARATOR

In addition to conventional treatment, the control group received TENS therapy on the finger extensor muscles of both the intact and paretic sides, five times a week for four weeks, with a total of 20 sessions, each lasting 30 minutes.

Device: Transcutaneous Electrical Nerve Stimulation

Interventions

Mirror therapy OTHER

The patients were asked to sit in front of a table at an appropriate height and rest their arms on the table. A mirror was placed between both arms. The mirror was positioned so that the reflection of the healthy extremity overlapped with the paralytic extremity. In this way, the movements of the healthy upper extremity were viewed through the mirror, creating a visual movement illusion for the hemiplegic upper extremity. During the mirror therapy, exercises including forearm supination-pronation, wrist flexion-extension, finger flexion-extension, finger counting, grasping and releasing a cup, grasping and releasing a ball, and writing with a pen were performed. First, 30 minutes of bilateral TENS therapy were applied, followed by 30 minutes of mirror therapy

Bilateral TENS+ Mirror therapy

Transcutaneous Electrical Nerve Stimulation DEVICE

Received stimulation on the extensor muscles of the hand fingers of both the intact and paretic sides, with a frequency of 100 Hz, pulse width of 200 microseconds, and a biphasic symmetric pulse for 30 minutes. The intensity of the current was adjusted to a level that produced a visible, comfortable muscle contraction. Self-adhesive electrodes, measuring 5x5 cm, were placed on the extensor surface of the forearm, 5 cm distal to the olecranon, parallel to the long axis of the muscle. Electrical stimulation was applied using the Cefar Rehab X2 device (DJO France SAS).

Bilateral TENS; Bilateral TENS+ Mirror therapy

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with a history of unilateral stroke
• Cases with a stroke duration of \>6 months
• Brunnstrom stage for the upper extremity ≥3
• Brunnstrom stage for the hand ≥4
• Mini-mental test score \>21
• Normal vision and hearing functions

You may not qualify if:

• Individuals with aphasia
• Individuals with neglect
• Those with a history of traumatic brain injury
• Individuals with uncontrolled cardiovascular disease
• Active inflammatory rheumatological or infectious diseases
• Individuals with significant upper extremity peripheral neuropathy
• Those with severe sensory deficits
• Individuals with severe shoulder, elbow, wrist, or finger severe spasticity(Modified Ashworth Scale score of 4)
• Individuals with a cardiac pacemaker
• Those with lesions on the skin of the upper extremity
• Individuals with skin allergies

Sponsors & Collaborators

• Istanbul Physical Medicine Rehabilitation Training and Research Hospital: lead

Study Sites (1)

T.C Sağlik Bilimleri Üniversitesi İstanbul Fizik Tedavi Rehabilitasyon Eğitim Ve Araştirma Hastanesi

Istanbul, BAHÇELİEVLER, 34212, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hemiplegia

Interventions

Mirror Movement Therapy; Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Rehabilitation; Therapeutics; Electric Stimulation Therapy; Analgesia; Anesthesia and Analgesia

Study Officials

• İlhan KARACAN, Professor Doctor

  T.C SAĞLIK BİLİMLERİ ÜNİVERSİTESİ İSTANBUL FİZİK TEDAVİ REHABİLİTASYON EĞİTİM VE ARAŞTIRMA HASTANESİ

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Doctor

Model Details: This study consists of two groups: the Mirror Group and the Control Group.

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 13, 2025
• Study Start: October 30, 2023
• Primary Completion: September 2, 2024
• Study Completion: December 27, 2024
• Last Updated: May 21, 2025

Record last verified: 2025-01

Locations

TU (1)