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

NCT ID: NCT06199375

Last Updated: 2024-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2023-08-31

Brief Summary

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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.

Detailed Description

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Upper limb hemiparesis is a motor and sensory disorder that occurs after stroke, with an incidence rate of up to 55% to 75%. Effective upper limb rehabilitation methods help reduce the occurrence of disuse syndrome and complex regional pain syndrome. Therefore, finding active and effective limb rehabilitation methods has important practical significance.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. The assessment was conducted respectively on day 1 and day 30.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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modified mirror therapy+Modified mirror therapy

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.

Group Type EXPERIMENTAL

Routine treatment

Intervention Type 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.)

Rehabilitation training

Intervention Type 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

Intervention Type 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).

routine rehabilitation therapy

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.

Group Type ACTIVE_COMPARATOR

Routine treatment

Intervention Type 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.)

Rehabilitation training

Intervention Type 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.

Interventions

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Routine treatment

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.)

Intervention Type BEHAVIORAL

Rehabilitation training

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.

Intervention Type BEHAVIORAL

Modified mirror therapy

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).

Intervention Type BEHAVIORAL

Other Intervention Names

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Comprehensive routine treatment

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zeng Changhao

OTHER

Sponsor Role lead

Responsible Party

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Zeng Changhao

PI

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Nieto Luis, Doctor

Role: PRINCIPAL_INVESTIGATOR

Site Coordinator of United Medical Group located in Miami

Locations

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Zheng da yi fu yuan hospital

Zhengzhou, Henan, China

Site Status

Countries

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China

Other Identifiers

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2022-KY-0523-012

Identifier Type: -

Identifier Source: org_study_id

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