StrokeNCT07078812
Mirror Therapy and Action Observation Therapy on Upper Limb Sensory Motor Recovery and Quality of Life in Subacute Stroke Patients
A study testing Mirror Therapy and Action Observation Therapy in people with Stroke, run by University of Lahore at 1 site in Pakistan.
Trial summary
This clinical study is being conducted to compare the effects of two different rehabilitation techniques-Mirror Therapy and Action Observation Therapy (AOT)-on improving upper limb movement and quality of life in individuals who have recently experienced a stroke. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Mirror Therapy and Action Observation Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Nov 2024to 8 Jul 2025
- 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 45 and 65 years (Tsai et al., 2012).
- Gender as either male or female (Tsai et al., 2012).
- Only subacute stroke patients will be included (Uyttenboogaart et al., 2005).
- A baseline Fugl-Meyer Assessment (FMA) score between 20 and 60 for upper limb motor function (Fugl-Meyer et al., 1975).
- The ability to follow study instructions, assessed using the Taiwan version of the Montreal Cognitive Assessment (MoCA) (Tsai et al., 2012), with scores below 26 indicating cognitive impairment, as patients scoring around 60 are considered to have near-normal cognitive function.
- The capability to participate in therapy and assessment sessions (Wang et al., 2011).
- Patient who have 1st onset of stroke ( 1st time stroke) (Hsieh et al., 2009).
Who cannot join
- Participants having hamonomus hemianopia (Tsai et al., 2012).
- Other neurological conditions for example, parkinsons, alzehmiers, ADHD, autism, etc (Tsai et al., 2012).
- Participants having recurrent stroke history (Wang et al., 2011).
- Global or receptive aphasia (Banks and Marotta, 2007).
- Severe neglect (Duncan et al., 2003).
- Major medical problems or comorbidities that influenced UE usage or cause severe pain (Hsieh et al., 2009).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Mirror Therapy and Action Observation Therapy on Upper Limb Sensory Motor Recovery and Quality of Life in Subacute Stroke Patients
This clinical study is being conducted to compare the effects of two different rehabilitation techniques-Mirror Therapy and Action Observation Therapy (AOT)-on improving upper limb movement and quality of life in individuals who have recently experienced a stroke. Stroke survivors often face weakness and coordination problems in their arms and hands. Helping them regain motor function is crucial for performing everyday tasks like dressing, eating, and writing.
Mirror Therapy works by having patients perform movements while watching the reflection of their unaffected limb in a mirror, tricking the brain into believing both limbs are working. This may help activate brain regions responsible for motor control.
Read more
Action Observation Therapy, on the other hand, involves patients watching videos of someone else performing arm and hand movements. After observing, patients try to mimic the actions themselves. This method is based on the theory that watching and imitating movements can enhance brain recovery.
In this study, patients will be randomly assigned to either the Mirror Therapy group or the Action Observation Therapy group. Both groups will receive therapy over several weeks, along with routine stroke rehabilitation care. Researchers will assess each patient's progress using standard tools to measure arm strength, hand coordination, and overall quality of life.
This study aims to find out which therapy leads to better recovery and could become a recommended part of post-stroke rehabilitation programs.
Read the detailed description
Background Stroke is a major cause of adult disability worldwide. One of the most disabling consequences is upper limb impairment, which reduces independence and daily functioning. Although traditional rehabilitation helps, recovery is often incomplete. Therefore, innovative, neuroplasticity-driven therapies like Mirror Therapy (MT) and Action Observation Therapy (AOT) are gaining interest.
MT relies on visual feedback from a mirror to create an illusion of movement in the affected limb, activating motor cortical areas. AOT involves observing purposeful movement followed by imitation, leveraging the brain's mirror neuron system to promote recovery.
While both therapies have shown individual effectiveness, few studies have directly compared them in subacute stroke-a critical recovery window. This study aims to address that gap, offering evidence to inform clinical practice.
Objectives
Primary Objective:
To compare the effects of MT and AOT on upper limb sensorimotor recovery in individuals with subacute stroke.
Secondary Objective:
To assess the impact of these therapies on stroke survivors' quality of life.
Hypotheses
Null Hypothesis (H₀):
There is no significant difference between MT and AOT in improving motor function or quality of life.
Alternative Hypothesis (H₁):
There is a significant difference between the two interventions in enhancing motor recovery and life quality.
Study Design Type: Randomized Controlled Trial (RCT)
Setting: Outpatient Neurological Rehabilitation Center
Duration: 6-week intervention
Sample Size: 40 participants (20 per group)
Randomization: Block randomization with concealed allocation
Blinding: Assessor-blinded
Assessment Points: Baseline, Week 3, Week 6
Eligibility Criteria
Inclusion Criteria:
Aged 40-70 years
First-ever ischemic or hemorrhagic stroke (diagnosed via imaging)
Stroke onset within 6 months (subacute phase)
Hemiparesis involving upper limb
MMSE score ≥ 24
Medically stable
Exclusion Criteria:
MAS score > 2 (severe spasticity)
Cardiac instability or other severe comorbidities
Visual impairments affecting mirror or screen-based tasks
History of upper limb orthopedic surgeries
Enrolled in other rehabilitation trials
Intervention Groups Group A: Mirror Therapy (MT) Participants will perform upper limb tasks while viewing the mirrored reflection of their unaffected limb for 30 minutes/session, 5 days/week for 6 weeks.
Group B: Action Observation Therapy (AOT) Participants will observe upper limb task videos (15 min) followed by 15 minutes of physical practice of the same tasks, 5 days/week for 6 weeks.
All participants will continue to receive standard rehabilitation care, including physiotherapy and occupational therapy.
Outcome Measures
Primary Outcome:
Fugl-Meyer Assessment - Upper Extremity (FMA-UE):
Evaluates upper limb motor control and coordination.
Secondary Outcomes:
Stroke Impact Scale (SIS):
Assesses quality of life across physical and emotional domains.
Modified Ashworth Scale (MAS):
Quantifies muscle spasticity.
Box and Block Test:
Measures gross manual dexterity.
Motor Activity Log (MAL):
Evaluates the functional use of the affected arm in daily tasks.
Assessments will be conducted at three time points: baseline, week 3, and week 6.
- Conditions
- Stroke
- Being tested
- Mirror Therapy, Action Observation Therapy
- Keywords
- Action observation therapy, Mirror therapy, Quality of life, Stroke rehabilitation, Upper limb recovery
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirror TherapyBehavioural
Mirror Therapy involves placing a mirror in the patient's midsagittal plane to reflect movements of the unaffected upper limb, creating a visual illusion of movement in the paretic limb. Patients perform bilateral symmetrical movements while focusing on the mirror reflection, helping to stimulate motor cortex activation and promote neuroplasticity. Sessions last 30 minutes, 5 days per week, for 6 weeks. This intervention is delivered in addition to standard stroke rehabilitation.
Action Observation TherapyBehavioural
Action Observation Therapy consists of observing video demonstrations of functional upper limb movements, followed by the patient imitating the observed actions. Each session includes 15 minutes of watching goal-directed tasks and 15 minutes of active execution. This therapy aims to activate the mirror neuron system and enhance motor recovery. The protocol is administered 5 days per week for 6 weeks and is combined with routine stroke rehabilitation practices.
| Study group | Role | What they receive |
|---|---|---|
| Mirror Therapy for Upper Limb Rehabilitation | Experimental | Participants in this arm will undergo Mirror Therapy sessions targeting the affected upper limb. A mirror will be positioned along the patient's midline, reflecting movements of the non-paretic limb, creating the illusion of movement in the affected limb. Patients will perform bilateral symmetrical movements while observing the mirrored reflection for 30 minutes per session, 5 days per week, over a 6-week period. Standard stroke rehabilitation exercises will also be provided. Receives: Behavioral: Mirror Therapy |
| Action Observation Therapy for Upper Limb Rehabilitation | Experimental | Participants in this arm will receive Action Observation Therapy involving the observation of video clips demonstrating functional upper limb tasks, followed by physical practice of the same movements. Each session will consist of 15 minutes of video observation and 15 minutes of task execution, conducted 5 days per week for 6 weeks. This intervention will be supplemented by routine post-stroke rehabilitation exercises. Receives: Behavioral: Action Observation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Upper Limb Motor Function as Measured by the Fugl-Meyer Assessment
The Fugl-Meyer Assessment for Upper Extremity is a standardized, stroke-specific performance-based measure that evaluates motor functioning, balance, and joint coordination. The upper limb subscale (score range: 0-66) assesses voluntary movement, reflex activity, and coordination of the shoulder, elbow, forearm, wrist, and hand. A higher score indicates better motor function and recovery. This tool has strong psychometric properties and is widely used in stroke rehabilitation research to detect motor improvements over time.
Measured: Baseline, Week 3 (Mid-intervention), and Week 6 (Post-intervention)
Secondary outcomes (2)
Change in Stroke-Related Disability (Modified Rankin Scale)
The Modified Rankin Scale measures the degree of disability or dependence in daily activities following a stroke. It ranges from 0 (no symptoms) to 6 (death). Lower scores indicate better functional independence.
Measured: Baseline, Week 3, and Week 6
Change in Health-Related Quality of Life (Stroke Impact Scale - Version 3.0)
The Stroke Impact Scale is a stroke-specific, self-reported questionnaire that assesses physical, emotional, and social aspects of recovery. It includes domains such as strength, mobility, memory, communication, and participation. Higher scores indicate better quality of life.
Measured: Baseline, Week 3, and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start15 Nov 2024
- Primary completion19 May 2025
- Study completion8 Jul 2025
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.
- More trials run by University of LahoreThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Komal Mushtaq, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07078812
- Sponsor's protocol ID
- UOL/IREB/25/09/0005
- Status last verified
- Jul 2025
- First submitted
- 12 Jul 2025
- Last updated
- 25 Jul 2025
- 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 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Mirror Therapy and Action Observation Therapy on Upper Limb Sensory Motor Recovery and Quality of Life in Subacute Stroke Patients
- ClinicalTrials.gov ID
- NCT07078812
- Acronym / sponsor ID
- UOL/IREB/25/09/0005
- Conditions
- Stroke
- Keywords
- Action observation therapy, Mirror therapy, Quality of life, Stroke rehabilitation, Upper limb recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 19 May 2025 (actual)
- Study completion
- 8 Jul 2025 (actual)
- First posted
- 22 Jul 2025 (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 clinical study is being conducted to compare the effects of two different rehabilitation techniques-Mirror Therapy and Action Observation Therapy (AOT)-on improving upper limb movement and quality of life in individuals who have recently experienced a stroke. Stroke survivors often face weakness and coordination problems in their arms and hands. Helping them regain motor function is crucial for performing everyday tasks like dressing, eating, and writing.
Mirror Therapy works by having patients perform movements while watching the reflection of their unaffected limb in a mirror, tricking the brain into believing both limbs are working. This may help activate brain regions responsible for motor control.
Action Observation Therapy, on the other hand, involves patients watching videos of someone else performing arm and hand movements. After observing, patients try to mimic the actions themselves. This method is based on the theory that watching and imitating movements can enhance brain recovery.
In this study, patients will be randomly assigned to either the Mirror Therapy group or the Action Observation Therapy group. Both groups will receive therapy over several weeks, along with routine stroke rehabilitation care. Researchers will assess each patient's progress using standard tools to measure arm strength, hand coordination, and overall quality of life.
This study aims to find out which therapy leads to better recovery and could become a recommended part of post-stroke rehabilitation programs.
Detailed description
Background Stroke is a major cause of adult disability worldwide. One of the most disabling consequences is upper limb impairment, which reduces independence and daily functioning. Although traditional rehabilitation helps, recovery is often incomplete. Therefore, innovative, neuroplasticity-driven therapies like Mirror Therapy (MT) and Action Observation Therapy (AOT) are gaining interest.
MT relies on visual feedback from a mirror to create an illusion of movement in the affected limb, activating motor cortical areas. AOT involves observing purposeful movement followed by imitation, leveraging the brain's mirror neuron system to promote recovery.
While both therapies have shown individual effectiveness, few studies have directly compared them in subacute stroke-a critical recovery window. This study aims to address that gap, offering evidence to inform clinical practice.
Objectives
Primary Objective:
To compare the effects of MT and AOT on upper limb sensorimotor recovery in individuals with subacute stroke.
Secondary Objective:
To assess the impact of these therapies on stroke survivors' quality of life.
Hypotheses
Null Hypothesis (H₀):
There is no significant difference between MT and AOT in improving motor function or quality of life.
Alternative Hypothesis (H₁):
There is a significant difference between the two interventions in enhancing motor recovery and life quality.
Study Design Type: Randomized Controlled Trial (RCT)
Setting: Outpatient Neurological Rehabilitation Center
Duration: 6-week intervention
Sample Size: 40 participants (20 per group)
Randomization: Block randomization with concealed allocation
Blinding: Assessor-blinded
Assessment Points: Baseline, Week 3, Week 6
Eligibility Criteria
Inclusion Criteria:
Aged 40-70 years
First-ever ischemic or hemorrhagic stroke (diagnosed via imaging)
Stroke onset within 6 months (subacute phase)
Hemiparesis involving upper limb
MMSE score ≥ 24
Medically stable
Exclusion Criteria:
MAS score > 2 (severe spasticity)
Cardiac instability or other severe comorbidities
Visual impairments affecting mirror or screen-based tasks
History of upper limb orthopedic surgeries
Enrolled in other rehabilitation trials
Intervention Groups Group A: Mirror Therapy (MT) Participants will perform upper limb tasks while viewing the mirrored reflection of their unaffected limb for 30 minutes/session, 5 days/week for 6 weeks.
Group B: Action Observation Therapy (AOT) Participants will observe upper limb task videos (15 min) followed by 15 minutes of physical practice of the same tasks, 5 days/week for 6 weeks.
All participants will continue to receive standard rehabilitation care, including physiotherapy and occupational therapy.
Outcome Measures
Primary Outcome:
Fugl-Meyer Assessment - Upper Extremity (FMA-UE):
Evaluates upper limb motor control and coordination.
Secondary Outcomes:
Stroke Impact Scale (SIS):
Assesses quality of life across physical and emotional domains.
Modified Ashworth Scale (MAS):
Quantifies muscle spasticity.
Box and Block Test:
Measures gross manual dexterity.
Motor Activity Log (MAL):
Evaluates the functional use of the affected arm in daily tasks.
Assessments will be conducted at three time points: baseline, week 3, and week 6.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mirror Therapy for Upper Limb Rehabilitation | Experimental | Behavioral: Mirror TherapyParticipants in this arm will undergo Mirror Therapy sessions targeting the affected upper limb. A mirror will be positioned along the patient's midline, reflecting movements of the non-paretic limb, creating the illusion of movement in the affected limb. Patients will perform bilateral symmetrical movements while observing the mirrored reflection for 30 minutes per session, 5 days per week, over a 6-week period. Standard stroke rehabilitation exercises will also be provided. |
| Action Observation Therapy for Upper Limb Rehabilitation | Experimental | Behavioral: Action Observation TherapyParticipants in this arm will receive Action Observation Therapy involving the observation of video clips demonstrating functional upper limb tasks, followed by physical practice of the same movements. Each session will consist of 15 minutes of video observation and 15 minutes of task execution, conducted 5 days per week for 6 weeks. This intervention will be supplemented by routine post-stroke rehabilitation exercises. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 45 and 65 years (Tsai et al., 2012).
- Gender as either male or female (Tsai et al., 2012).
- Only subacute stroke patients will be included (Uyttenboogaart et al., 2005).
- A baseline Fugl-Meyer Assessment (FMA) score between 20 and 60 for upper limb motor function (Fugl-Meyer et al., 1975).
- The ability to follow study instructions, assessed using the Taiwan version of the Montreal Cognitive Assessment (MoCA) (Tsai et al., 2012), with scores below 26 indicating cognitive impairment, as patients scoring around 60 are considered to have near-normal cognitive function.
Key exclusion criteria (6 listed)
- Participants having hamonomus hemianopia (Tsai et al., 2012).
- Other neurological conditions for example, parkinsons, alzehmiers, ADHD, autism, etc (Tsai et al., 2012).
- Participants having recurrent stroke history (Wang et al., 2011).
- Global or receptive aphasia (Banks and Marotta, 2007).
- Severe neglect (Duncan et al., 2003).
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 |
|---|---|---|
| Mirror TherapyMirror Therapy involves placing a mirror in the patient's midsagittal plane to reflect movements of the unaffected upper limb, creating a visual illusion of movement in the paretic limb. Patients perform bilateral symmetrical movements while focusing on the mirror reflection, helping to stimulate motor cortex activation and promote neuroplasticity. Sessions last 30 minutes, 5 days per week, for 6 weeks. This intervention is delivered in addition to standard stroke rehabilitation. | Behavioural | Mirror Therapy for Upper Limb Rehabilitation |
| Action Observation TherapyAction Observation Therapy consists of observing video demonstrations of functional upper limb movements, followed by the patient imitating the observed actions. Each session includes 15 minutes of watching goal-directed tasks and 15 minutes of active execution. This therapy aims to activate the mirror neuron system and enhance motor recovery. The protocol is administered 5 days per week for 6 weeks and is combined with routine stroke rehabilitation practices. | Behavioural | Action Observation Therapy for Upper Limb Rehabilitation |
Primary outcome
Change in Upper Limb Motor Function as Measured by the Fugl-Meyer Assessment
Time frame: Baseline, Week 3 (Mid-intervention), and Week 6 (Post-intervention)
The Fugl-Meyer Assessment for Upper Extremity is a standardized, stroke-specific performance-based measure that evaluates motor functioning, balance, and joint coordination. The upper limb subscale (score range: 0-66) assesses voluntary movement, reflex activity, and coordination of the shoulder, elbow, forearm, wrist, and hand. A higher score indicates better motor function and recovery. This tool has strong psychometric properties and is widely used in stroke rehabilitation research to detect motor improvements over time.
2 secondary outcomes
Change in Stroke-Related Disability (Modified Rankin Scale)
Time frame: Baseline, Week 3, and Week 6
Change in Health-Related Quality of Life (Stroke Impact Scale - Version 3.0)
Time frame: Baseline, Week 3, and Week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Stroke
Active, not recruitingObservational study
Symptomatic Carotid Outcomes Registry
Carotid Stenosis, Ischemic Stroke
RecruitingPhase 3
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
Atrial Fibrillation (AF)
Not yet recruiting
The Effects of an Augmented Reality-Based Mirror Therapy System in Patients With Stroke
Stroke
Recruiting
A Pivotal Study Evaluating Safety and Effectiveness of Adaptative Tip Catheter in Patients With Acute Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
Role of EEG in Differentiation Between Ischemic and Hemorrhagic Stroke
Acute Ischemic Stroke, Acute Haemorrhagic Stroke
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mirror Therapy and Action Observation Therapy in people with Stroke, run by University of Lahore at 1 site in Pakistan.
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 7 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: finished, as of the sponsor's last update on 25 Jul 2025. 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 Pakistan. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Upper Limb Motor Function as Measured by the Fugl-Meyer Assessment (time frame: Baseline, Week 3 (Mid-intervention), and Week 6 (Post-intervention)). 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 25 Jul 2025.