StrokeNCT06199375
Effect of Modified Mirror Therapy in Patients With Upper Limb Hemiparesis After Stroke
A study testing Routine treatment, Rehabilitation training and Modified mirror therapy in people with Stroke, run by Zeng Changhao at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- Routine treatment, Rehabilitation training and Modified mirror therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Clinical Effect of Modified Mirror Therapy in Patients With Upper Limb Hemiparesis After Stroke: A Randomized Controlled Study
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Routine treatment, Rehabilitation training, Modified mirror therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine treatmentBehavioural
Also called Comprehensive 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.)
Rehabilitation trainingBehavioural
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 therapyBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| modified mirror therapy+Modified mirror 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. Receives: Behavioral: Routine treatment; Behavioral: Rehabilitation training; 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. Receives: Behavioral: Routine treatment; Behavioral: Rehabilitation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 1 and day 30
Secondary outcomes (5)
the coordinated contraction rate-Surface electromyography-The biceps brachii
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).
Measured: day 1 and day 30
the coordinated contraction rate-Surface electromyography-The triceps brachii
The surface electromyography (sEMG) was used to assess the coordinated contraction rates of the triceps brachii on the affected upper limb. The surface electromyography device was used for detection, with the most prominent part of muscle belly of triceps 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 triceps 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).
Measured: day 1 and day 30
Visual Analog Scale
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.
Measured: day 1 and day 30
Anxiety
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.
Measured: day 1 and day 30
Depression
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.
Measured: day 1 and day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start1 Aug 2022
- Primary completion12 Jul 2023
- Study completion31 Aug 2023
Why it stopped: Ethical issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeng Changhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zeng Changhao, People's Hospital of Zhengzhou University
- Investigators
- Nieto Luis, Doctor, Principal investigator, Site Coordinator of United Medical Group located in Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199375
- Sponsor's protocol ID
- 2022-KY-0523-012
- Status last verified
- Mar 2024
- First submitted
- 24 Dec 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Effect of Modified Mirror Therapy in Patients With Upper Limb Hemiparesis After Stroke: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06199375
- Acronym / sponsor ID
- 2022-KY-0523-012
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Ethical issues
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Zeng ChanghaoUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 12 Jul 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| modified mirror therapy+Modified mirror therapy | Experimental | Behavioral: Routine treatment, Behavioral: Rehabilitation training, Behavioral: Modified mirror therapyThe 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 | Active comparator | Behavioral: Routine treatment, Behavioral: Rehabilitation trainingThe 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. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine treatmentAlso: Comprehensive routine treatmentThe routine treatment included intervention for risk factors (such as blood pressure, blood lipids, and blood glucose control, restriction of smoking and alcohol, exercise, etc.) | Behavioural | modified mirror therapy+Modified mirror therapy, routine rehabilitation therapy |
| Rehabilitation trainingThe 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. | Behavioural | modified mirror therapy+Modified mirror therapy, routine rehabilitation therapy |
| Modified mirror therapyThe 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). | Behavioural | modified mirror therapy+Modified mirror therapy |
Primary outcome
Fugl-Meyer Assessment-Upper Extremity
Time frame: 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.
5 secondary outcomes
the coordinated contraction rate-Surface electromyography-The biceps brachii
Time frame: day 1 and day 30
the coordinated contraction rate-Surface electromyography-The triceps brachii
Time frame: day 1 and day 30
Visual Analog Scale
Time frame: day 1 and day 30
Anxiety
Time frame: day 1 and day 30
Depression
Time frame: day 1 and day 30
Results and safety
The study was stopped early (reason given: Ethical issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nieto Luis, Doctor principal investigator
Site Coordinator of United Medical Group located in Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine treatment, Rehabilitation training and Modified mirror therapy in people with Stroke, run by Zeng Changhao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Ethical issues). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment-Upper Extremity (time frame: day 1 and day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.