StrokeNCT05544747
Action Observation Therapy Versus Mirror Therapy on Upper Limb in Stroke
A study testing Action Observation Therapy and Mirror Therapy in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
Stroke is a medical condition which causes the cessation of blood flow to the brain cells and results in cell death and ultimately can lead to motor disorders, perception disorders, language disorders, sensory disturbances.It is well known that stroke is the leading cause of death and one of the greatest causes of… Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Stroke
- What is being tested?
- Action Observation Therapy and Mirror Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2022to 1 Mar 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both male and female
- Middle cerebral artery stroke
- 1 to 6 months of stroke onset
- Baseline score of the Fugyl Myer Assessment is between 20 and 60 for the upper limb.
- Modified Ashworth scale with a score of 2 Ability to follow the study instructions-Mini mental state examination (MMSE) score >25
Who cannot join
- Participants failing to fall in this category would be excluded from the study.
- Patients who cannot perform the active movement of the upper limb in pre-stroke condition due to musculoskeletal problems
- cardiopulmonary diseases which could hinder their ability to participate in the rehabilitation program in this study
- Patient with impaired cognition
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Helping hand institute of rehabilitation sciences
Mansehra
Sania Syed, MS NMPT*
Sania Syed, MS-(NMPT)*
About this study
Official title: Comparison of Action Observation Therapy Versus Mirror Therapy on Upper Limb Physical Performance and Quality of Life in Stroke
Stroke is a medical condition which causes the cessation of blood flow to the brain cells and results in cell death and ultimately can lead to motor disorders, perception disorders, language disorders, sensory disturbances.It is well known that stroke is the leading cause of death and one of the greatest causes of long-term motor disability in adults.The incidence of stroke is increasing day by day in low-income countries as compared to high-income countries because of the effects of not using evidence-based practice in health-related conditions in low-income countries. In the last few years, several approaches have been used for the recovery of hand dexterity after stroke. Among them, the Mirror therapy, task-oriented therapy, robot-assisted rehabilitation and action observation has gained greatest attention.Action observation training is one of the new developing rehabilitation technique that targets motor learning by the activation of mirror neurons and is the most important approach that targets the motor and functional recovery in stroke patients. In action observation training, the movements are produced because of the external stimuli in which actually the visual attention recruit the cerebellar-thalamic-cortical circuit of the brain. Action observation is based on activities of the motor neuron system and they discharge mostly in association with complex tasks as compared to simple tasks.
- Conditions
- Stroke
- Being tested
- Action Observation Therapy, 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.
Action Observation TherapyOther
following phases will be included in action observation therapy group:
- upper limb active range of motion (AROM) exercises.
- reaching movement or object manipulation.
- upper limb functional tasks.
Mirror TherapyOther
following phases will be included in mirror therapy group:
- AROM exercises),
- reaching movement or object manipulation, and
- functional task practice
| Study group | Role | What they receive |
|---|---|---|
| Action Observation Therapy | Experimental | The patients in the action observation therapy group will be required to observe the upper limb movements or functional actions in video clips. (i.e., the observation phase) and to execute what they had observed to the best of their ability (i.e., the execution phase). Three common categories of movements and tasks will be elected in the action observation therapy protocol based on the related literature Receives: Other: Action Observation Therapy |
| Mirror Therapy | Active comparator | During the mirror therapy, the patients will be seated in front of a mirror box placed at their mid-sagittal plane. The affected arm of the participants will be placed inside the mirror box and the unaffected arm in front of the mirror. The patient will be instructed to watch the mirror reflection of the movement performed by his/her unaffected hand carefully and to imagine that the movement was performed by the affected hand. Receives: Other: Mirror Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugel Meyer assessment scale for upper limb
An assessment scale for post stroke hemiplegic patients and is performance-based impairment index. This scale is having 5 domains namely Motor functioning, Sensory Functioning, Balance, Joint Range of Motion and Joint pain. I divided the motor functioning for upper extremity into 0 to 66 points and evaluates mobility, speed and coordination
Measured: week 6
Box and Block Test (BBT)
This test is used to evaluate the manual dexterity of post stroke patients. BBT is composed of wooden box with two equal compartments having 150 boxes in one compartment and patient is asked to move the boxes from one compartment to another within 60 seconds. Before starting the test an extra 15 seconds time is given to the patient for familiarization with the test. First the patient performed the activity with the healthy arm and then with the affected arm. Scoring is done on the basis of the number of boxes transferred from one compartment to another within 60 seconds
Measured: week 6
Functional Independence Measure (FIM)
The FIM is a commonly used scale for assessing the performance in basic daily activities. It contains 18 items (i.e., 13 motor and 5 cognition items), and the total score ranges from 0 to 126
Measured: week 6
Secondary outcomes (1)
Stroke Impact Scale (SIS) version 3.0
The SIS 3.0 is a stroke-specific, patient-reported questionnaire for evaluating the function, participation, and health-related quality of life of stroke survivors. The SIS 3.0 has sound psychometric properties. It consists of 59 items, and higher scores indicate better function and greater participation.
Measured: week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start1 Oct 2022
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 2023 (estimated)
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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ayesha Afridi, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05544747
- Sponsor's protocol ID
- REC-01332 Sania
- Status last verified
- Dec 2022
- First submitted
- 14 Sep 2022
- Last updated
- 12 Dec 2022
- 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 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Action Observation Therapy Versus Mirror Therapy on Upper Limb Physical Performance and Quality of Life in Stroke
- ClinicalTrials.gov ID
- NCT05544747
- Acronym / sponsor ID
- REC-01332 Sania
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 16 Sep 2022 (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.
Stroke is a medical condition which causes the cessation of blood flow to the brain cells and results in cell death and ultimately can lead to motor disorders, perception disorders, language disorders, sensory disturbances.It is well known that stroke is the leading cause of death and one of the greatest causes of long-term motor disability in adults.The incidence of stroke is increasing day by day in low-income countries as compared to high-income countries because of the effects of not using evidence-based practice in health-related conditions in low-income countries. In the last few years, several approaches have been used for the recovery of hand dexterity after stroke. Among them, the Mirror therapy, task-oriented therapy, robot-assisted rehabilitation and action observation has gained greatest attention.Action observation training is one of the new developing rehabilitation technique that targets motor learning by the activation of mirror neurons and is the most important approach that targets the motor and functional recovery in stroke patients. In action observation training, the movements are produced because of the external stimuli in which actually the visual attention recruit the cerebellar-thalamic-cortical circuit of the brain. Action observation is based on activities of the motor neuron system and they discharge mostly in association with complex tasks as compared to simple tasks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Action Observation Therapy | Experimental | Other: Action Observation TherapyThe patients in the action observation therapy group will be required to observe the upper limb movements or functional actions in video clips. (i.e., the observation phase) and to execute what they had observed to the best of their ability (i.e., the execution phase). Three common categories of movements and tasks will be elected in the action observation therapy protocol based on the related literature |
| Mirror Therapy | Active comparator | Other: Mirror TherapyDuring the mirror therapy, the patients will be seated in front of a mirror box placed at their mid-sagittal plane. The affected arm of the participants will be placed inside the mirror box and the unaffected arm in front of the mirror. The patient will be instructed to watch the mirror reflection of the movement performed by his/her unaffected hand carefully and to imagine that the movement was performed by the affected hand. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Both male and female
- Middle cerebral artery stroke
- 1 to 6 months of stroke onset
- Baseline score of the Fugyl Myer Assessment is between 20 and 60 for the upper limb.
- Modified Ashworth scale with a score of 2 Ability to follow the study instructions-Mini mental state examination (MMSE) score >25
Key exclusion criteria (4 listed)
- Participants failing to fall in this category would be excluded from the study.
- Patients who cannot perform the active movement of the upper limb in pre-stroke condition due to musculoskeletal problems
- cardiopulmonary diseases which could hinder their ability to participate in the rehabilitation program in this study
- Patient with impaired cognition
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 |
|---|---|---|
| Action Observation Therapyfollowing phases will be included in action observation therapy group: 1. upper limb active range of motion (AROM) exercises. 2. reaching movement or object manipulation. 3. upper limb functional tasks. | Other | Action Observation Therapy |
| Mirror Therapyfollowing phases will be included in mirror therapy group: 1. AROM exercises), 2. reaching movement or object manipulation, and 3. functional task practice | Other | Mirror Therapy |
Primary outcome
Fugel Meyer assessment scale for upper limb
Time frame: week 6
An assessment scale for post stroke hemiplegic patients and is performance-based impairment index. This scale is having 5 domains namely Motor functioning, Sensory Functioning, Balance, Joint Range of Motion and Joint pain. I divided the motor functioning for upper extremity into 0 to 66 points and evaluates mobility, speed and coordination
Box and Block Test (BBT)
Time frame: week 6
This test is used to evaluate the manual dexterity of post stroke patients. BBT is composed of wooden box with two equal compartments having 150 boxes in one compartment and patient is asked to move the boxes from one compartment to another within 60 seconds. Before starting the test an extra 15 seconds time is given to the patient for familiarization with the test. First the patient performed the activity with the healthy arm and then with the affected arm. Scoring is done on the basis of the number of boxes transferred from one compartment to another within 60 seconds
Functional Independence Measure (FIM)
Time frame: week 6
The FIM is a commonly used scale for assessing the performance in basic daily activities. It contains 18 items (i.e., 13 motor and 5 cognition items), and the total score ranges from 0 to 126
1 secondary outcome
Stroke Impact Scale (SIS) version 3.0
Time frame: week 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- 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.
Ayesha Afridi, PhD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Action Observation Therapy and Mirror Therapy in people with Stroke, run by Riphah International University 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 12 Dec 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sania Syed, MS NMPT* (+92 321 1930855, saniasyed48@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugel Meyer assessment scale for upper limb (time frame: week 6). The study lists 3 primary outcomes in all. 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 12 Dec 2022.