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

NCT06301659 | Completed

• 1 other identifier: Jingxiang-Jiu
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemiparesis

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 (4)

• coordinated contraction rate-Surface electromyography

  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+routine rehabilitation 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 rehabilitation therapy; 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 rehabilitation therapy

Interventions

routine rehabilitation therapy 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+routine rehabilitation 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+routine rehabilitation 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.
• 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

• Ahmadu Bello University Teaching Hospital: lead

Study Sites (1)

Affiated Hos.

Huabei, China

Location

MeSH Terms

Conditions

Paresis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nieto Luis, Master

  Site Coordinator of United Medical Group

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 8, 2024
• Study Start: August 1, 2022
• Primary Completion: July 12, 2023
• Study Completion: August 31, 2023
• Last Updated: June 10, 2024

Record last verified: 2024-06

Locations

CN (1)