Impact of Adapted Mirror Therapy on Individuals With Hemiparesis of the Upper Limb Following a Stroke

Not Applicable

Completed

• Conditions: Hemiparesis
• Interventions: Behavioral: routine rehabilitation therapy; Behavioral: Modified mirror therapy

• Registration Number: NCT06301659
• Lead Sponsor: Ahmadu Bello University Teaching Hospital

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.

Study Timeline

• Study Start: 2022-08-01
• Primary Completion: 2023-07-12
• Study Completion: 2023-08-31
• Study First Submitted: 2024-03-04
• Study First Submitted QC: 2024-03-04
• Study First Posted: 2024-03-08
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-07
• Last Update Posted: 2024-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
modified mirror therapy+routine rehabilitation 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.
modified mirror therapy+routine rehabilitation therapy	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. Additionally, the patients in the experimental group were given modified mirror therapy.
routine rehabilitation therapy	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.

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Assessment-Upper Extremity	day 1 and day 30	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.

Secondary Outcome Measures

Name	Time	Method
Depression	day 1 and day 30	The depression was assessed using the Patient Health Questionnaire-9 (PHQ-9), with aspects including mood swings, optimism, sleep quality, appetite, etc. The total score of PHQ-9 ranged from 0 to 27, which was positively correlated with potential depression. In the previous study, the PHQ-9 scale demonstrated a Cronbach's α-coefficient of 0.913.The scores range from 0 to 27.The higher scores mean a worse outcome.
Anxiety	day 1 and day 30	The anxiety was assessed using the Generalized Anxiety Disorder-7 (GAD-7), including items related to fear, worry, attention, etc. The total score ranged from 0 to 21, which was positively correlated with potential anxiety. In the previous study, the GAD-7 scale demonstrated a Cronbach's α-coefficient of 0.879. The scores range from 0 to 21. The higher scores mean a worse outcome.
Visual Analog Scale	day 1 and day 30	the pain level of the affected shoulder was measured using the Visual Analog Scale (VAS), with 0 indicating no pain and 10 indicating unbearable severe pain. The lower score indicated the lighter pain.
coordinated contraction rate-Surface electromyography	day 1 and day 30	The surface electromyography (sEMG) was used to assess the coordinated contraction rates of the biceps brachii on the affected upper limb. The surface electromyography device was used for detection, with the most prominent part of muscle belly of the biceps brachii serving as the monitoring points. During the maximum isometric voluntary contraction (MIVC) state of elbow flexion or extension, two channels were used to separately record the integrated electromyographic values (iEMG) of the biceps brachii, and the antagonists. Measurements were taken three times to obtain the maximum value, and the coordinated contraction rate (CR) during elbow flexion or extension under MIVC conditions was calculated using the formula: CR (%) = Antagonist muscle iEMG / (Agonist muscle iEMG + Antagonist muscle iEMG).

Trial Locations

Locations (1)

Affiated Hos.; 🇨🇳 Huabei, China