Effect of Modified Mirror Therapy in Patients With Upper Limb Hemiparesis After Stroke

NCT06199375 | Terminated DMC

• 1 other identifier: 2022-KY-0523-012
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

This was a randomized controlled study in China conducted during Aug. 2022 to Aug. 2023. Totally, patients with upper limb hemiplegia after stroke, who were admitted in the Department of Rehabilitation Medicine of two hospitals, were enrolled. The study lasted 30 days for each participant. The patients enrolled were randomly divided into the experimental group and the control group, all under routine rehabilitation therapy. Additionally, the patients in the experimental group were given modified mirror therapy.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment-Upper Extremity

  The Fugl-Meyer Assessment-Upper Extremity was used to evaluate the patient's upper limb function and motor control. It included the assessment of movements in the shoulder, elbow joint, wrist, and fingers. During the assessment, the assessor observed and recorded the patient's abilities and limitations in specific actions. Based on the patient's performance in each sub-item, the assessor assigned a score using a 0-2 scale, a score of 0 indicating inability to perform, 1 indicating partial ability, and 2 indicating full ability. Finally, the scores for each sub-item were summed up to obtain an overall upper limb function score of 0-66, with scores positively correlated with the upper limb function.

  day 1 and day 30

Secondary Outcomes (5)

• the coordinated contraction rate-Surface electromyography-The biceps brachii

  day 1 and day 30

• the coordinated contraction rate-Surface electromyography-The triceps brachii

  day 1 and day 30

• Visual Analog Scale

  day 1 and day 30

• Anxiety

  day 1 and day 30

• Depression

  day 1 and day 30

Study Arms (2)

modified mirror therapy+Modified mirror therapy

EXPERIMENTAL

The study lasted 30 days for each participant. The patients enrolled were randomly divided into the experimental group and the control group, all under routine rehabilitation therapy. Additionally, the patients in the experimental group were given modified mirror therapy.

Behavioral: Routine treatment; Behavioral: Rehabilitation training; Behavioral: Modified mirror therapy

routine rehabilitation therapy

ACTIVE COMPARATOR

The study lasted 30 days for each participant. The patients enrolled were randomly divided into the experimental group and the control group, all under routine rehabilitation therapy.

Behavioral: Routine treatment; Behavioral: Rehabilitation training

Interventions

Routine treatment BEHAVIORAL

The routine treatment included intervention for risk factors (such as blood pressure, blood lipids, and blood glucose control, restriction of smoking and alcohol, exercise, etc.)

Also known as: Comprehensive routine treatment

modified mirror therapy+Modified mirror therapy; routine rehabilitation therapy

Rehabilitation training BEHAVIORAL

The Participants with stable vital signs were scheduled for specialized rehabilitation training upon enrollment, and targeted rehabilitation programs were selected based on the patient's specific limb function impairment, conducted by experienced rehabilitation therapists.

modified mirror therapy+Modified mirror therapy; routine rehabilitation therapy

Modified mirror therapy BEHAVIORAL

The patients were instructed to watch the recorded video and imitate the movements of their affected limbs. After the video ended, only the instructions and synchronized music were played. The patient was required to sit in front of a mirror table, with the mirror placed between both arms and facing the healthy side. The patient was required to recall the video based on the verbal instructions while using the healthy side to perform movement training. They were also asked to observe the reflected motion of the healthy limb in the mirror, simultaneously imagining the affected limb moving in sync (the patient focused on the front of the mirror, avoiding direct eye contact with the healthy hand, to create the sensation that it was the affected hand performing the movements).

modified mirror therapy+Modified mirror therapy

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meeting the diagnostic criteria of stroke, by CT or MRI.
• The first-onset stroke.
• Presenting with unilateral upper limb dysfunction, within Brunnstrom stage Ⅱ to Ⅳ on the affected side, and Ash-worth score ≤2.
• No obvious cognitive impairment, with Mini-Mental State Examination (MMSE) score \>21 points.
• National Institutes of Health Stroke Scale (NIHSS) score \>4 points.
• Stable vital signs, no severe diseases such as cancer, liver or kidney disorders.
• Aged 35-70 years.
• Courses of diseases 2-6 weeks.

You may not qualify if:

• Presence of aphasia, apraxia, or hemispatial neglect.
• Presence of hearing, vision, or comprehension impairments that hinder diagnosis and treatment.
• Complicate with traumas, fractures, or other progressive neuro-muscular system diseases.
• Severe spasticity in the upper limbs.
• Severe bone, joint, or muscle deformities or lesions.
• History of mental illness.

Sponsors & Collaborators

• Zeng Changhao: lead

Study Sites (1)

Zheng da yi fu yuan hospital

Zhengzhou, Henan, 450000, China

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Nieto Luis, Doctor

  Site Coordinator of United Medical Group located in Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: December 24, 2023
• First Posted: January 10, 2024
• Study Start: August 1, 2022
• Primary Completion: July 12, 2023
• Study Completion: August 31, 2023
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)