StrokeNCT06308211
Comparative Effects of Motor Imagery and Mirror Therapy Versus Motor Relearning Program in Subacute Stroke Patients
A study testing MOTOR IMAGERY+MIRROR THERAPY+ROUTINE PHYSICAL THERAPY and MOTOR RELEARNING PROGRAM+ROUTINE PHYSICAL THERAPY in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
Use of motor imagery, mirror therapy and motor relearning program in rehabilitation of people with stroke is on rise and these are unique and emerging techniques. Motor imagery is a mental rehearsal through visualization while mirror therapy creates a reflection of non-effected limb by using a mirror. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- MOTOR IMAGERY+MIRROR THERAPY+ROUTINE PHYSICAL THERAPY and MOTOR RELEARNING PROGRAM+ROUTINE PHYSICAL THERAPY
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Feb 2024to 30 Sep 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stroke patient of both gender.
- Stroke patient of age 40-65 year .
- Patient diagnosis of cerebral ischemic stroke .
- Patients who had suffered a stroke with hemiplegia, were subacute at least 3 months to 5 months since the onset.
- Ability to walk with minimal assistance (functional ambulation category 1 to 3.
- Patient with score > 25 on mini-mental status examination.
Who cannot join
- Patients who presented with hemiplegic neglect or apraxia
- Patients with history of global or receptive aphasia
- Patients with history of psychological or emotional problems
- Patients with history of decompensated cardiovascular/ respiratory/ digestive/ renal disorders, biologic inflammatory syndrome, neoplastic disorders, neurogenic bladder or skin disorders (bedsores).
- Patients with history of artificial joints
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Motor Imagery and Mirror Therapy Versus Motor Relearning Program on Balance, Motor Function and Activities of Daily Living in Subacute Stroke Patients
Use of motor imagery, mirror therapy and motor relearning program in rehabilitation of people with stroke is on rise and these are unique and emerging techniques. Motor imagery is a mental rehearsal through visualization while mirror therapy creates a reflection of non-effected limb by using a mirror. Moreover, motor relearning is task-oriented approach, benefacial for balance and motor funCtion in patients with stroke that emphasizes on relearning.The aim of the study is to determine the comparative effects of motor imagery and mirror therapy versus motor relearning program in addition to routine physical therapy on balance, motor function and activities of daily living in subacute stroke patients.
Read the detailed description
This randomized clinical trial will be conducted at medical centre Fifty stroke patients will be included using convenience sampling technique. The participants in the study will be randomly allocated in to two groups . Twenty five participants will be included in both Groups A d B. Group A (motor imagery and mirror therapy) will receive 60 minutes treatment session that consists of 20 minutes motor imagery, 20 minutes mirror therapy along with 20 minutes routine physical therapy and Group B (motor relearning program) will receive treatment session of 60 minutes including motor relearning program of 40 minutes duration along with routine physical therapy of 20 minutes. Both groups will undergo 60 minutes session for 5 days per week for 12 weeks. Berg balance scale will be used to assess balance, Fugl-meyer assessment to assess motor function and Functional independence measure for activities of daily living. Assessment will be carried out at baseline, 4th week, 8th week and at 12th week after the discontinuation of treatment.
- Conditions
- Stroke
- Being tested
- MOTOR IMAGERY+MIRROR THERAPY+ROUTINE PHYSICAL THERAPY, MOTOR RELEARNING PROGRAM+ROUTINE PHYSICAL THERAPY
- Keywords
- Mirror therapy, Motor relearning Programme, stroke, Motor Imagery
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOTOR IMAGERY+MIRROR THERAPY+ROUTINE PHYSICAL THERAPYOther
Also called Rehabilitation
Subjects will be instructed to watch the video provided and recorded by investigator.In next step participants will be asked to close the eyes to focus and then to imagine how they are doing task they had previously observed 10 times.Participants will be than instructed to carry out the task in verbal commands given whenever necessary.The unaffected limb will be placed in front of the mirror so that the reflected illusion of the limb would be hallucinated to represent the affected limb and routine physical therapy includes passive and active assisted range of motion for the upper and lower extremity including the shoulder, forearm, wrist, hip, knee and ankle will be given (10 - 15 repititions).
MOTOR RELEARNING PROGRAM+ROUTINE PHYSICAL THERAPYOther
Also called Rehabilitation
Motor relearning consists of five components including analysis of task, practice of missing components, practice of task and transference of training. Patient will be asked to practice task in both sitting and standing
- supine to side-lying to sitting
- looking up at ceiling (ensure that centre of body mass does not move back when head is tilted back)
- without moving one's feet, turning to gaze over each other's shoulders and scanning the surroundings for specific items, reaching motions in multiple directions while moving the head and trunk, scooting in bed, altering the base of support (standing with your feet together, in tandem, with one foot on a step, or on one leg)
- squatting to pick up an object and cross over stepping and routine physical therapy includes Passive and active assisted range of motion for the upper and lower extremity including the shoulder, forearm, wrist, hip, knee and ankle will be given (10 - 15 repititions).
| Study group | Role | What they receive |
|---|---|---|
| GROUP A (MOTOR IMAGERY+MIRROR THERAPY+ROUTINE PHYSICAL THERAPY) | Experimental | Group A will receive treatment session of 60 minutes including motor imagery for 20 minutes and mirror therapy for 20 minutes along with routine physical therapy of 20 minutes for 5 days per week for 12 weeks.In motor imagery subjects will watch the video and will be asked to close the eyes to focus and imagine how they are doing task they had previously observed 10 times and instructed to carry out the task in verbal commands given whenever necessary.
In mirror therapy,The unaffected limb will be placed in front of the mirror and patient will try to make the identical motions with the paretic limb while moving the non-paretic limb during the session and routine physical therapy includes passive and active assisted range of motion for the upper and lower extremity including the shoulder, forearm, wrist, hip, knee and ankle will be given (10 - 15 repititions). Receives: Other: MOTOR IMAGERY+MIRROR THERAPY+ROUTINE PHYSICAL THERAPY |
| GROUP B (MOTOR RELEARNING PROGRAM+ROUTINE PHYSICAL THERAPY) | Experimental | GROUP B will receive treatment session of 60 minutes including motor relearning program of 40 minutes duration along with routine physical therapy of 20 minutes as explained in group A protocol. Treatment session will be given 5 days per week for 12 weeks.
Motor relearning consists of five components including analysis of task, practice of missing components, practice of task and transference of training. Receives: Other: MOTOR RELEARNING PROGRAM+ROUTINE PHYSICAL THERAPY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg balance scale (BBS)
The BBS is postural balance scale containing 14 items including standing and sitting unsupported, reaching forward, and placing the alternating foot on a stool. Administering the BBS takes approximately 15 min. Each of the 14 items are scored on a 5-level ordinal scale from 0 ("unable to perform or requiring help") to 4 ("normal performance"), thus providing a potential maximum score of 56 points
Measured: 12th week
FUGL-MEYER ASSESMENT (FMA)
The Fugl-Meyer Assessment is a welldesigned, feasible and efficient clinical examination method that has been tested widely in the stroke population. A three-level ordinal scale (0, can perform no part of the test; 1, performs test partially; 2, performs test normally) is applied to each item. A total possible score for the lower extremity is 34. The higher the score, the better the performance.
Measured: 12th week
FUNCTIONAL INDEPENDENCE MEASURE (FIM)
The Functional Independence Measure (FIM) is one of the most frequently used outcome measures in stroke rehabilitation trials. The five FIM items dealing with transfers and locomotion, including transfers to bed/chair/wheelchair, toileting, bathing, walking or wheelchair management and stairs, were used in this pilot study to evaluate the activities of daily living in the patients with stroke. Each item is rated on a seven-level scale, with 1 = total assistance and 7 (complete independence). By adding the points for each item in the transfers and locomotion, the possible total score ranges from 5 (lowest) to 35 (highest) level of independence; the higher the score, the better the independence. This scale has good reliability for the assessment of recovery of function in stroke patients.
Measured: 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start25 Feb 2024
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
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 Riphah International UniversityThe 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Kashif, PhD, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06308211
- Sponsor's protocol ID
- REC/RCR&AHS/23/0289
- Status last verified
- Oct 2024
- First submitted
- 4 Mar 2024
- Last updated
- 15 Oct 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 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Motor Imagery and Mirror Therapy Versus Motor Relearning Program on Balance, Motor Function and Activities of Daily Living in Subacute Stroke Patients
- ClinicalTrials.gov ID
- NCT06308211
- Acronym / sponsor ID
- REC/RCR&AHS/23/0289
- Conditions
- Stroke
- Keywords
- Mirror therapy, Motor relearning Programme, stroke, Motor Imagery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 25 Feb 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 13 Mar 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.
Use of motor imagery, mirror therapy and motor relearning program in rehabilitation of people with stroke is on rise and these are unique and emerging techniques. Motor imagery is a mental rehearsal through visualization while mirror therapy creates a reflection of non-effected limb by using a mirror. Moreover, motor relearning is task-oriented approach, benefacial for balance and motor funCtion in patients with stroke that emphasizes on relearning.The aim of the study is to determine the comparative effects of motor imagery and mirror therapy versus motor relearning program in addition to routine physical therapy on balance, motor function and activities of daily living in subacute stroke patients.
Detailed description
This randomized clinical trial will be conducted at medical centre Fifty stroke patients will be included using convenience sampling technique. The participants in the study will be randomly allocated in to two groups . Twenty five participants will be included in both Groups A d B. Group A (motor imagery and mirror therapy) will receive 60 minutes treatment session that consists of 20 minutes motor imagery, 20 minutes mirror therapy along with 20 minutes routine physical therapy and Group B (motor relearning program) will receive treatment session of 60 minutes including motor relearning program of 40 minutes duration along with routine physical therapy of 20 minutes. Both groups will undergo 60 minutes session for 5 days per week for 12 weeks. Berg balance scale will be used to assess balance, Fugl-meyer assessment to assess motor function and Functional independence measure for activities of daily living. Assessment will be carried out at baseline, 4th week, 8th week and at 12th week after the discontinuation of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP A (MOTOR IMAGERY+MIRROR THERAPY+ROUTINE PHYSICAL THERAPY) | Experimental | Other: MOTOR IMAGERY+MIRROR THERAPY+ROUTINE PHYSICAL THERAPYGroup A will receive treatment session of 60 minutes including motor imagery for 20 minutes and mirror therapy for 20 minutes along with routine physical therapy of 20 minutes for 5 days per week for 12 weeks.In motor imagery subjects will watch the video and will be asked to close the eyes to focus and imagine how they are doing task they had previously observed 10 times and instructed to carry out the task in verbal commands given whenever necessary. In mirror therapy,The unaffected limb will be placed in front of the mirror and patient will try to make the identical motions with the paretic limb while moving the non-paretic limb during the session and routine physical therapy includes passive and active assisted range of motion for the upper and lower extremity including the shoulder, forearm, wrist, hip, knee and ankle will be given (10 - 15 repititions). |
| GROUP B (MOTOR RELEARNING PROGRAM+ROUTINE PHYSICAL THERAPY) | Experimental | Other: MOTOR RELEARNING PROGRAM+ROUTINE PHYSICAL THERAPYGROUP B will receive treatment session of 60 minutes including motor relearning program of 40 minutes duration along with routine physical therapy of 20 minutes as explained in group A protocol. Treatment session will be given 5 days per week for 12 weeks. Motor relearning consists of five components including analysis of task, practice of missing components, practice of task and transference of training. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Stroke patient of both gender.
- Stroke patient of age 40-65 year .
- Patient diagnosis of cerebral ischemic stroke .
- Patients who had suffered a stroke with hemiplegia, were subacute at least 3 months to 5 months since the onset.
- Ability to walk with minimal assistance (functional ambulation category 1 to 3.
Key exclusion criteria (5 listed)
- Patients who presented with hemiplegic neglect or apraxia
- Patients with history of global or receptive aphasia
- Patients with history of psychological or emotional problems
- Patients with history of decompensated cardiovascular/ respiratory/ digestive/ renal disorders, biologic inflammatory syndrome, neoplastic disorders, neurogenic bladder or skin disorders (bedsores).
- Patients with history of artificial joints
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 |
|---|---|---|
| MOTOR IMAGERY+MIRROR THERAPY+ROUTINE PHYSICAL THERAPYAlso: RehabilitationSubjects will be instructed to watch the video provided and recorded by investigator.In next step participants will be asked to close the eyes to focus and then to imagine how they are doing task they had previously observed 10 times.Participants will be than instructed to carry out the task in verbal commands given whenever necessary.The unaffected limb will be placed in front of the mirror so that the reflected illusion of the limb would be hallucinated to represent the affected limb and routine physical therapy includes passive and active assisted range of motion for the upper and lower extremity including the shoulder, forearm, wrist, hip, knee and ankle will be given (10 - 15 repititions). | Other | GROUP A (MOTOR IMAGERY+MIRROR THERAPY+ROUTINE PHYSICAL THERAPY) |
| MOTOR RELEARNING PROGRAM+ROUTINE PHYSICAL THERAPYAlso: RehabilitationMotor relearning consists of five components including analysis of task, practice of missing components, practice of task and transference of training. Patient will be asked to practice task in both sitting and standing * supine to side-lying to sitting * looking up at ceiling (ensure that centre of body mass does not move back when head is tilted back) * without moving one's feet, turning to gaze over each other's shoulders and scanning the surroundings for specific items, reaching motions in multiple directions while moving the head and trunk, scooting in bed, altering the base of support (standing with your feet together, in tandem, with one foot on a step, or on one leg) * squatting to pick up an object and cross over stepping and routine physical therapy includes Passive and active assisted range of motion for the upper and lower extremity including the shoulder, forearm, wrist, hip, knee and ankle will be given (10 - 15 repititions). | Other | GROUP B (MOTOR RELEARNING PROGRAM+ROUTINE PHYSICAL THERAPY) |
Primary outcome
Berg balance scale (BBS)
Time frame: 12th week
The BBS is postural balance scale containing 14 items including standing and sitting unsupported, reaching forward, and placing the alternating foot on a stool. Administering the BBS takes approximately 15 min. Each of the 14 items are scored on a 5-level ordinal scale from 0 ("unable to perform or requiring help") to 4 ("normal performance"), thus providing a potential maximum score of 56 points
FUGL-MEYER ASSESMENT (FMA)
Time frame: 12th week
The Fugl-Meyer Assessment is a welldesigned, feasible and efficient clinical examination method that has been tested widely in the stroke population. A three-level ordinal scale (0, can perform no part of the test; 1, performs test partially; 2, performs test normally) is applied to each item. A total possible score for the lower extremity is 34. The higher the score, the better the performance.
FUNCTIONAL INDEPENDENCE MEASURE (FIM)
Time frame: 12th week
The Functional Independence Measure (FIM) is one of the most frequently used outcome measures in stroke rehabilitation trials. The five FIM items dealing with transfers and locomotion, including transfers to bed/chair/wheelchair, toileting, bathing, walking or wheelchair management and stairs, were used in this pilot study to evaluate the activities of daily living in the patients with stroke. Each item is rated on a seven-level scale, with 1 = total assistance and 7 (complete independence). By adding the points for each item in the transfers and locomotion, the possible total score ranges from 5 (lowest) to 35 (highest) level of independence; the higher the score, the better the independence. This scale has good reliability for the assessment of recovery of function in stroke patients.
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 15 Oct 2024.
- Individual participant dataSharing planned: No
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
Muhammad Kashif, PhD study chair
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 MOTOR IMAGERY+MIRROR THERAPY+ROUTINE PHYSICAL THERAPY and MOTOR RELEARNING PROGRAM+ROUTINE PHYSICAL 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 6 inclusion and 5 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 15 Oct 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 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?
Berg balance scale (BBS) (time frame: 12th week). 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 15 Oct 2024.