Stroke PatientNCT04468945
Mirror Therapy Versus Repetitive Facilitation Exercise on Upper Limb Function
A study testing mirror box therapy and Repetitive Facilitation Exercise in people with Stroke Patient, run by Riphah International University at 1 site in Pakistan.
Trial summary
The objective of the study is to determine the effects of Mirror therapy on upper limb function in a post-stroke patient, To determine the effects of Repetitive Facilitation Exercise on upper limb function in a post-stroke patient and To compare the effects of Mirror therapy versus Repetitive Facilitation Exercise on… Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke Patient
- What is being tested?
- mirror box therapy and Repetitive Facilitation Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jul 2019to 15 Jan 2020
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Hemiparetic patient
- Sub-acute and chronic stroke patients
- First-ever stroke patient
- Age: 40-60
- Gender: both male and female
- MMSE >24
Show all 9Show fewer
- Modified Ashworth scale <3
- Stable patient (Good sitting balance )
- No visual-spatial hemineglect.
Who cannot join
- Unstable patient
- Uncooperative patient
- Orthopaedic deformity
- Aphasia
- Visual infection
- Joint pain (shoulder, elbow, wrist, hip, knee, ankle)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Mirror Therapy Versus Repetitive Facilitation Exercise on Upper Limb Function in Post-stroke Patient
The objective of the study is to determine the effects of Mirror therapy on upper limb function in a post-stroke patient, To determine the effects of Repetitive Facilitation Exercise on upper limb function in a post-stroke patient and To compare the effects of Mirror therapy versus Repetitive Facilitation Exercise on upper limb function in the post-stroke patient. Study Design is Randomized control trial with a sample size of 50 participants. Sampling Technique used is Non-probability purposive assessor-blinded sampling technique and randomization through sealed envelope method Duration of study was 6 months.Study Setting of Railway general hospital. Inclusion criteria had Hemiparetic patient, Sub-acute and chronic stroke patients, First-ever stroke patient, Age: 40-60, Gender: both male and female, MMSE >24, Modified Ashworth scale <3, Stable patient (Good sitting balance ) and No visual-spatial hemineglect. Exclusion criteria of Unstable patient, Uncooperative patient, Orthopedic deformity, Aphasia, Visual infection and joint pain (shoulder, elbow, wrist, hip, knee, ankle)
Read the detailed description
Stroke is classically characterized as a neurological deficit attributed to an acute focal injury of the central nervous system by a vascular cause, including cerebral infarction, intracerebral haemorrhage, and subarachnoid haemorrhage, and is a major cause of disability and death worldwide. Stroke is the second leading cause of death and the third leading cause of disability. Stroke, the sudden death of some brain cells due to lack of oxygen when the blood flow to the brain is lost by blockage or rupture of an artery to the brain, is also a leading cause of dementia and depression. Stroke kills about 140,000 Americans each year that's 1 out of every 20 deaths. In Pakistan, the stroke incidence of 95 per 100,000 persons per year for the following Years 2000 to 2016, with the highest incidence being 584,000 of 650,000, noted among individuals aged 75 to 85. The paretic upper limb is a common and undesirable consequence of stroke that increases activity limitation. A number of interventions have been published evaluating the effect of various rehabilitation methods improving upper extremity control and functioning. Mirror therapy is a relatively new therapeutic intervention which is simple, inexpensive and most importantly patient-directed treatment that focuses on moving the unimpaired limb. It was first introduced by Ramachandran and Roger Ramachandran to treat phantom limb pain after amputation.The principle of mirror therapy (MT) is use of a mirror to create reflective illusion of an affected limb in order to trick the brain into thinking movement has occurred without pain. It involves placing the affected limb behind a mirror, which is sited to the reflection of the opposing limb appears in placing of the hidden limb. During performing the tasks with the unaffected hand, the participants were instructed to move their affected arm synchronically in the same way while viewing the mirror during the practices with the unaffected arm, the participants were instructed to move their affected arm synchronically while viewing the mirror. Repetitive facilitative exercise (RFE), a combination of high repetition rate and neuro facilitation, is a recently developed approach to the rehabilitation of stroke-related limb impairment. The RFE sessions used a novel facilitation technique to elicit movements of the shoulder, elbow and each finger isolated from synergy and give sufficient physical stimulation, such as by the stretch reflex or skin-muscle reflex that is elicited immediately before or at the same time as when the patient makes an effort to move his hemiplegic hand or finger. Functional recovery of the hemiplegic upper limb and hand might depend on the repetition of voluntary movements elicited by the RFEs, especially when they are influenced by a synergistic pattern. Principles for selection and treatment included the following: (1) an emphasis on the proximal musculature, given its role in stabilizing distal movements, gradual increases in movement difficulty with a goal of maintaining movement purity and avoiding synergy; and consideration of the importance/nature of the movement (eg, the first and second fingers were trained separately and the third and fourth together to facilitate the acquisition of pinch. This aim of the study is to improve the function of the upper limb in post-stroke hemiparesis patient. Repetitive Facilitation exercise has proved beneficial effects for improving upper limb function on stroke patients. There is also different opinion about the effectiveness of Mirror therapy on upper limb function. So the purpose of my study is to investigate whether Mirror Therapy or Repetitive Facilitation exercise is more effective in improving upper limb function in Stroke patients.
- Conditions
- Stroke Patient
- Being tested
- mirror box therapy, Repetitive Facilitation Exercise
- Keywords
- Mirror therapy, Repetitive Facilitation Exercise, stroke, Upper limb
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mirror box therapyOther
- Patients in Task-specific mirror box therapy group will receive therapy for 30 min/day, 3 times/week for 6 weeks.
- The patient is seated close to a table a mirror (33*35 cm) was placed vertically. The involved hand was placed behind the mirror and uninvolved in front of the mirror.
- The subject is asked to transfer small cubes from the middle position to the lateral side, placing pegs in holes and taking them out, turning over paper cards, placing steel needles in holes, stacking blocks, and putting glass on a shelf.
- During the sessions, subjects will be asked to try and do the activity on the unaffected side and asked to do some movement with the paretic hand simultaneously.
Repetitive Facilitation ExerciseOther
- The patients in the control group will receive Repetitive Facilitation Exercise for 30 min/day, 3 times/week for 6 weeks.
- Repetitive facilitative techniques were used to elicit movement of the shoulder, elbow, wrist, and fingers in a manner designed to minimize synergistic movements.
- Participants were directed to concentrate on generating movement on the joint being treated while avoiding contraction of non-targeted muscles.
- Therapists provided verbal directions with commands such as "bend/straighten" or "one, two, three.
- Participant efforts were supplemented as necessary to achieve a full range of motion (ROM)
| Study group | Role | What they receive |
|---|---|---|
| mirror box therapy | Experimental | The objects use for task-specific mirror therapy are duster, glass, the wooden block of different sizes and shapes, beads, coin, paper cards and spongy ball. In all these activities shoulder horizontal flexion-extension, adduction-abduction, elbow flexion-extension, forearm supination-pronation, wrist flexion-extension, finger flexion-extension, abduction, adduction, opposition, are performed automatically. Receives: Other: mirror box therapy |
| Repetitive Facilitation Exercise | Experimental | Treatment involved rapid passive stretching of the muscles of the targeted joints in conjunction with tapping and rubbing the skin to assist in the generation of a contraction.Shoulder horizontal flexion-extension , adduction-abduction ,elbow flexion-extension, forearm supination-pronation, wrist flexion-extension, finger flexion-extension, abduction, adduction, opposition, are performed Receives: Other: Repetitive Facilitation Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugal Meyer scale
Fugl Meyer assessment tool is used for the evaluation of recovery extent in post stroke patients. It consists of 226 total points and is divided in 5 major domains including sensory function, motor function, joint range of motion, balance and pain each domain contain multiple sub items. Scoring is being recorded on a (3-points ordinal scale) . upper limb total score is 66. Fugyl Meyer is also a reliable and highly valid tool with ICC=0.96 and internal consistency is 94.7%.
Measured: From baseline to 6th week
Wolf motor scale
The Wolf motor scale is considered as numerical catalogue for the assessment of upper extremity motor function. Motor skills of patients are assessed through time and well designed, practical and functional tasks. Total 15 task has been performed. the minimum value for each task is 1 and maximum value is 3. increased value shows improvement.This is also a reliable tool for upper limb motor function with fair inter rater reliability as the value of ICC=0.97-0.99 and internal consistency is 92.4%.
Measured: From baseline to 6th week
Upper extremity functional index
Upper extremity functional index is use for outcome measure in stroke patient. It consist of 20-item questionnaire and each item has 5 point ordinal scale The total sum of all item the final score is 80 point. The reliability of upper extremity functional index is (ICC=0.94)
Measured: From baseline to 6th week
Brunnstrom scale
Brunnstrom recovery scale is use for motor recovery in stroke patient .It consist of 7-stages, 1=Flaccid Paralysis,2=Spasticity,3=Spasticity is marked ,4=Spasticity decreased,5= Spasticity wanes,6= Coordination and pattern of movement can be near normal ,7=Normal The inter-rater reliability if burnnstrom recovery scale is (ICC 0.89-0.98) for arm and (ICC 0.69-0.92)for hand.
Measured: From baseline to 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start15 Jul 2019
- Primary completion15 Dec 2019
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Stroke PatientStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aruba Saeed, PHD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04468945
- Sponsor's protocol ID
- REC/00556 Saba Karamat
- Status last verified
- Sep 2020
- First submitted
- 8 Jul 2020
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sacco RL, Kasner SE, Broderick JP, Caplan LR, Connors JJ, Culebras A, Elkind MS, George MG, Hamdan AD, Higashida RT, Hoh BL, Janis LS, Kase CS, Kleindorfer DO, Lee JM, Moseley ME, Peterson ED, Turan TN, Valderrama AL, Vinters HV; American Heart Association Stroke Council, Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular and Stroke Nursing; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Council on Nutrition, Physical Activity and Metabolism. An updated definition of stroke for the 21st century: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Jul;44(7):2064-89. doi: 10.1161/STR.0b013e318296aeca. Epub 2013 May 7.
PubMed 23652265Owolabi MO, Akarolo-Anthony S, Akinyemi R, Arnett D, Gebregziabher M, Jenkins C, Tiwari H, Arulogun O, Akpalu A, Sarfo FS, Obiako R, Owolabi L, Sagoe K, Melikam S, Adeoye AM, Lackland D, Ovbiagele B; Members of the H3Africa Consortium. The burden of stroke in Africa: a glance at the present and a glimpse into the future. Cardiovasc J Afr. 2015 Mar-Apr;26(2 Suppl 1):S27-38. doi: 10.5830/CVJA-2015-038.
PubMed 25962945Yang Q, Tong X, Schieb L, Vaughan A, Gillespie C, Wiltz JL, King SC, Odom E, Merritt R, Hong Y, George MG. Vital Signs: Recent Trends in Stroke Death Rates - United States, 2000-2015. MMWR Morb Mortal Wkly Rep. 2017 Sep 8;66(35):933-939. doi: 10.15585/mmwr.mm6635e1.
PubMed 28880858Scheid A, Choppin PW. Two disulfide-linked polypeptide chains constitute the active F protein of paramyxoviruses. Virology. 1977 Jul 1;80(1):54-66. doi: 10.1016/0042-6822(77)90380-4. No abstract available.
PubMed 195398Shimodozono M, Noma T, Nomoto Y, Hisamatsu N, Kamada K, Miyata R, Matsumoto S, Ogata A, Etoh S, Basford JR, Kawahira K. Benefits of a repetitive facilitative exercise program for the upper paretic extremity after subacute stroke: a randomized controlled trial. Neurorehabil Neural Repair. 2013 May;27(4):296-305. doi: 10.1177/1545968312465896. Epub 2012 Dec 3.
PubMed 23213077Riggs BL, Jowsey J, Kelly PJ, Arnaud CD. Role of hormonal factors in the pathogenesis of postmenopausal osteoporosis. Isr J Med Sci. 1976 Jul;12(7):615-9.
PubMed 972016
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mirror Therapy Versus Repetitive Facilitation Exercise on Upper Limb Function in Post-stroke Patient
- ClinicalTrials.gov ID
- NCT04468945
- Acronym / sponsor ID
- REC/00556 Saba Karamat
- Conditions
- Stroke Patient
- Keywords
- Mirror therapy, Repetitive Facilitation Exercise, stroke, Upper limb
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 13 Jul 2020 (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.
The objective of the study is to determine the effects of Mirror therapy on upper limb function in a post-stroke patient, To determine the effects of Repetitive Facilitation Exercise on upper limb function in a post-stroke patient and To compare the effects of Mirror therapy versus Repetitive Facilitation Exercise on upper limb function in the post-stroke patient. Study Design is Randomized control trial with a sample size of 50 participants. Sampling Technique used is Non-probability purposive assessor-blinded sampling technique and randomization through sealed envelope method Duration of study was 6 months.Study Setting of Railway general hospital. Inclusion criteria had Hemiparetic patient, Sub-acute and chronic stroke patients, First-ever stroke patient, Age: 40-60, Gender: both male and female, MMSE >24, Modified Ashworth scale <3, Stable patient (Good sitting balance ) and No visual-spatial hemineglect. Exclusion criteria of Unstable patient, Uncooperative patient, Orthopedic deformity, Aphasia, Visual infection and joint pain (shoulder, elbow, wrist, hip, knee, ankle)
Detailed description
Stroke is classically characterized as a neurological deficit attributed to an acute focal injury of the central nervous system by a vascular cause, including cerebral infarction, intracerebral haemorrhage, and subarachnoid haemorrhage, and is a major cause of disability and death worldwide. Stroke is the second leading cause of death and the third leading cause of disability. Stroke, the sudden death of some brain cells due to lack of oxygen when the blood flow to the brain is lost by blockage or rupture of an artery to the brain, is also a leading cause of dementia and depression. Stroke kills about 140,000 Americans each year that's 1 out of every 20 deaths. In Pakistan, the stroke incidence of 95 per 100,000 persons per year for the following Years 2000 to 2016, with the highest incidence being 584,000 of 650,000, noted among individuals aged 75 to 85. The paretic upper limb is a common and undesirable consequence of stroke that increases activity limitation. A number of interventions have been published evaluating the effect of various rehabilitation methods improving upper extremity control and functioning. Mirror therapy is a relatively new therapeutic intervention which is simple, inexpensive and most importantly patient-directed treatment that focuses on moving the unimpaired limb. It was first introduced by Ramachandran and Roger Ramachandran to treat phantom limb pain after amputation.The principle of mirror therapy (MT) is use of a mirror to create reflective illusion of an affected limb in order to trick the brain into thinking movement has occurred without pain. It involves placing the affected limb behind a mirror, which is sited to the reflection of the opposing limb appears in placing of the hidden limb. During performing the tasks with the unaffected hand, the participants were instructed to move their affected arm synchronically in the same way while viewing the mirror during the practices with the unaffected arm, the participants were instructed to move their affected arm synchronically while viewing the mirror. Repetitive facilitative exercise (RFE), a combination of high repetition rate and neuro facilitation, is a recently developed approach to the rehabilitation of stroke-related limb impairment. The RFE sessions used a novel facilitation technique to elicit movements of the shoulder, elbow and each finger isolated from synergy and give sufficient physical stimulation, such as by the stretch reflex or skin-muscle reflex that is elicited immediately before or at the same time as when the patient makes an effort to move his hemiplegic hand or finger. Functional recovery of the hemiplegic upper limb and hand might depend on the repetition of voluntary movements elicited by the RFEs, especially when they are influenced by a synergistic pattern. Principles for selection and treatment included the following: (1) an emphasis on the proximal musculature, given its role in stabilizing distal movements, gradual increases in movement difficulty with a goal of maintaining movement purity and avoiding synergy; and consideration of the importance/nature of the movement (eg, the first and second fingers were trained separately and the third and fourth together to facilitate the acquisition of pinch. This aim of the study is to improve the function of the upper limb in post-stroke hemiparesis patient. Repetitive Facilitation exercise has proved beneficial effects for improving upper limb function on stroke patients. There is also different opinion about the effectiveness of Mirror therapy on upper limb function. So the purpose of my study is to investigate whether Mirror Therapy or Repetitive Facilitation exercise is more effective in improving upper limb function in Stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mirror box therapy | Experimental | Other: mirror box therapyThe objects use for task-specific mirror therapy are duster, glass, the wooden block of different sizes and shapes, beads, coin, paper cards and spongy ball. In all these activities shoulder horizontal flexion-extension, adduction-abduction, elbow flexion-extension, forearm supination-pronation, wrist flexion-extension, finger flexion-extension, abduction, adduction, opposition, are performed automatically. |
| Repetitive Facilitation Exercise | Experimental | Other: Repetitive Facilitation ExerciseTreatment involved rapid passive stretching of the muscles of the targeted joints in conjunction with tapping and rubbing the skin to assist in the generation of a contraction.Shoulder horizontal flexion-extension , adduction-abduction ,elbow flexion-extension, forearm supination-pronation, wrist flexion-extension, finger flexion-extension, abduction, adduction, opposition, are performed |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Hemiparetic patient
- Sub-acute and chronic stroke patients
- First-ever stroke patient
- Age: 40-60
- Gender: both male and female
Key exclusion criteria (6 listed)
- Unstable patient
- Uncooperative patient
- Orthopaedic deformity
- Aphasia
- Visual infection
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 box therapy* Patients in Task-specific mirror box therapy group will receive therapy for 30 min/day, 3 times/week for 6 weeks. * The patient is seated close to a table a mirror (33*35 cm) was placed vertically. The involved hand was placed behind the mirror and uninvolved in front of the mirror. * The subject is asked to transfer small cubes from the middle position to the lateral side, placing pegs in holes and taking them out, turning over paper cards, placing steel needles in holes, stacking blocks, and putting glass on a shelf. * During the sessions, subjects will be asked to try and do the activity on the unaffected side and asked to do some movement with the paretic hand simultaneously. | Other | mirror box therapy |
| Repetitive Facilitation Exercise* The patients in the control group will receive Repetitive Facilitation Exercise for 30 min/day, 3 times/week for 6 weeks. * Repetitive facilitative techniques were used to elicit movement of the shoulder, elbow, wrist, and fingers in a manner designed to minimize synergistic movements. * Participants were directed to concentrate on generating movement on the joint being treated while avoiding contraction of non-targeted muscles. * Therapists provided verbal directions with commands such as "bend/straighten" or "one, two, three. * Participant efforts were supplemented as necessary to achieve a full range of motion (ROM) | Other | Repetitive Facilitation Exercise |
Primary outcome
Fugal Meyer scale
Time frame: From baseline to 6th week
Fugl Meyer assessment tool is used for the evaluation of recovery extent in post stroke patients. It consists of 226 total points and is divided in 5 major domains including sensory function, motor function, joint range of motion, balance and pain each domain contain multiple sub items. Scoring is being recorded on a (3-points ordinal scale) . upper limb total score is 66. Fugyl Meyer is also a reliable and highly valid tool with ICC=0.96 and internal consistency is 94.7%.
Wolf motor scale
Time frame: From baseline to 6th week
The Wolf motor scale is considered as numerical catalogue for the assessment of upper extremity motor function. Motor skills of patients are assessed through time and well designed, practical and functional tasks. Total 15 task has been performed. the minimum value for each task is 1 and maximum value is 3. increased value shows improvement.This is also a reliable tool for upper limb motor function with fair inter rater reliability as the value of ICC=0.97-0.99 and internal consistency is 92.4%.
Upper extremity functional index
Time frame: From baseline to 6th week
Upper extremity functional index is use for outcome measure in stroke patient. It consist of 20-item questionnaire and each item has 5 point ordinal scale The total sum of all item the final score is 80 point. The reliability of upper extremity functional index is (ICC=0.94)
Brunnstrom scale
Time frame: From baseline to 6th week
Brunnstrom recovery scale is use for motor recovery in stroke patient .It consist of 7-stages, 1=Flaccid Paralysis,2=Spasticity,3=Spasticity is marked ,4=Spasticity decreased,5= Spasticity wanes,6= Coordination and pattern of movement can be near normal ,7=Normal The inter-rater reliability if burnnstrom recovery scale is (ICC 0.89-0.98) for arm and (ICC 0.69-0.92)for hand.
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 9 Sep 2020.
- Background: PubMed 23652265Sacco RL, Kasner SE, Broderick JP, Caplan LR, Connors JJ, Culebras A, Elkind MS, George MG, Hamdan AD, Higashida RT, Hoh BL, Janis LS, Kase CS, Kleindorfer DO, Lee JM, Moseley ME, Peterson ED, Turan TN, Valderrama AL, Vinters HV; American Heart Association Stroke Council, Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular and Stroke Nursing; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Council on Nutrition, Physical Activity and Metabolism. An updated definition of stroke for the 21st century: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Jul;44(7):2064-89. doi: 10.1161/STR.0b013e318296aeca. Epub 2013 May 7.
- Background: PubMed 25962945Owolabi MO, Akarolo-Anthony S, Akinyemi R, Arnett D, Gebregziabher M, Jenkins C, Tiwari H, Arulogun O, Akpalu A, Sarfo FS, Obiako R, Owolabi L, Sagoe K, Melikam S, Adeoye AM, Lackland D, Ovbiagele B; Members of the H3Africa Consortium. The burden of stroke in Africa: a glance at the present and a glimpse into the future. Cardiovasc J Afr. 2015 Mar-Apr;26(2 Suppl 1):S27-38. doi: 10.5830/CVJA-2015-038.
- Background: PubMed 28880858Yang Q, Tong X, Schieb L, Vaughan A, Gillespie C, Wiltz JL, King SC, Odom E, Merritt R, Hong Y, George MG. Vital Signs: Recent Trends in Stroke Death Rates - United States, 2000-2015. MMWR Morb Mortal Wkly Rep. 2017 Sep 8;66(35):933-939. doi: 10.15585/mmwr.mm6635e1.
- Background: PubMed 195398Scheid A, Choppin PW. Two disulfide-linked polypeptide chains constitute the active F protein of paramyxoviruses. Virology. 1977 Jul 1;80(1):54-66. doi: 10.1016/0042-6822(77)90380-4. No abstract available.
- Background: PubMed 23213077Shimodozono M, Noma T, Nomoto Y, Hisamatsu N, Kamada K, Miyata R, Matsumoto S, Ogata A, Etoh S, Basford JR, Kawahira K. Benefits of a repetitive facilitative exercise program for the upper paretic extremity after subacute stroke: a randomized controlled trial. Neurorehabil Neural Repair. 2013 May;27(4):296-305. doi: 10.1177/1545968312465896. Epub 2012 Dec 3.
- Background: PubMed 972016Riggs BL, Jowsey J, Kelly PJ, Arnaud CD. Role of hormonal factors in the pathogenesis of postmenopausal osteoporosis. Isr J Med Sci. 1976 Jul;12(7):615-9.
- 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.
Aruba Saeed, 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 mirror box therapy and Repetitive Facilitation Exercise in people with Stroke Patient, 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 9 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 9 Sep 2020. 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?
Fugal Meyer scale (time frame: From baseline to 6th week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04468945, which also lists 6 linked publications.
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 9 Sep 2020.