Clinical trial NCT06301659: Impact of Adapted Mirror Therapy on Individuals With Hemiparesis of the Upper Limb Following a Stroke
Official title: Impact of Adapted Mirror Therapy on Individuals With Hemiparesis of the Upper Limb Following a Stroke: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiparesis
Lead sponsor: Ahmadu Bello University Teaching Hospital
Sponsor class: OTHER
First posted: 2024-03-08
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: SUPPORTIVE_CARE

Brief summary: Patients with upper limb hemiplegia after stroke, who were admitted in the Department of Rehabilitation Medicine, 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. On day 1 and day 30, patients' Upper Limb function were compared.

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%. This was a Randomized controlled trial. Patients with upper limb hemiplegia after stroke, who were admitted in the Department of Rehabilitation Medicine, 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. On day 1 and day 30, patients' Upper Limb function were compared.

Eligibility criteria: Inclusion Criteria:

* Meeting the diagnostic criteria of stroke.
* 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: coordinated contraction rate-Surface electromyography
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: Huabei
country: China
facility: Affiated Hos.
Study officials:
affiliation: Site Coordinator of United Medical Group
name: Nieto Luis, Master
role: STUDY_DIRECTOR
References: