Clinical trial NCT06199375: Effect of Modified Mirror Therapy in Patients With Upper Limb Hemiparesis After Stroke
Official title: The Clinical Effect of Modified Mirror Therapy in Patients With Upper Limb Hemiparesis After Stroke: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Lead sponsor: People's Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 116
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fugl-Meyer Assessment-Upper Extremity
timeFrame: day 1 and day 30
Secondary outcomes:
measure: the coordinated contraction rate-Surface electromyography-The biceps brachii
timeFrame: day 1 and day 30
measure: the coordinated contraction rate-Surface electromyography-The triceps brachii
timeFrame: day 1 and day 30
measure: Visual Analog Scale
timeFrame: day 1 and day 30
measure: Anxiety
timeFrame: day 1 and day 30
measure: Depression
timeFrame: day 1 and day 30
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Zheng da yi fu yuan hospital
state: Henan
Study officials:
affiliation: Site Coordinator of United Medical Group located in Miami
name: Nieto Luis, Doctor
role: PRINCIPAL_INVESTIGATOR
References: