Acute StrokeNCT06074081
Comparison of 4-weeks of Motor Relearning Program and Mirror Therapy in Improving Upper Limb Motor Function in Stroke Patients.
A study testing motor relearning program and mirror therapy in people with Acute Stroke, run by Yusra Medical and Dental College at 1 site in Pakistan.
Trial summary
Cerebrovascular accident(CVA) or stroke is one of common condition affecting people in developed and underdeveloped countries. MRP is a therapy to regain particular motor function and neglecting accessory movements by engaging cognitive behavior. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Acute Stroke
- What is being tested?
- motor relearning program and mirror therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 4 Sep 2023to 27 Feb 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute(hemiplegic attack within 1-2 weeks) and sub-acute stroke(hemiplegic attack within 3- 11 weeks).
- 20 to 80 years.
- No physical deformity prior to stroke
- No history of serious underlying pathology and structural deformities.
Who cannot join
- Patient with chronic hemiplegic stroke.
- Patient with congenital deformity.
Trial locations and contacts
1 site in 1 country.
About this study
Cerebrovascular accident(CVA) or stroke is one of common condition affecting people in developed and underdeveloped countries.
MRP is a therapy to regain particular motor function and neglecting accessory movements by engaging cognitive behavior.
Mirror therapy enhance functional activities in patient with hemiplegic stroke. For betterment of result high quality methodological studies and larger sample size is required.
Read the detailed description
Cerebrovascular accident(CVA) or stroke is one of common condition affecting people in developed and underdeveloped countries. Mostly patient with stroke face many disabilities and the most important one is upper limb motor impairment. For the optimization of upper extremity and prevention of patient from permanent disability it is essential to promotes Neuro-rehabilitation interventions. Physiotherapy techniques need to be monotonous, thorough and task oriented for neuroplasticity to generate better recovery. There is notable enhancement in ADLS when the rehabilitation program starts within 16 hours to 6 months after stroke In improving upper extremity motor functions there are tremendous types of techniques used i.e. Proprioceptive neuromuscular facilitation(PNF),Brunnstorm, Bobath therapy, Motor relearning program(MRP),Constraint induced movement therapy(CIMT) and Mirror therapy(MT).Out of which we are using two basic techniques i.e. motor relearning program(MRP) and mirror therapy(MT).Mirror therapy enhance functional activities in patient with hemiplegic stroke. For betterment of result high quality methodological studies and larger sample size is required. Mirror therapy enhance functional activities in patient with hemiplegic stroke. MRP is a therapy to regain particular motor function and neglecting accessory movements by engaging cognitive behavior .MRP is a therapy to regain particular motor function and neglecting accessory movements by engaging cognitive behavior.
- Conditions
- Acute Stroke
- Being tested
- motor relearning program, mirror therapy
- Keywords
- Motor Relearning Program, 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.
motor relearning programOther
MRP is a therapy to regain particular motor function and neglecting accessory movements by engaging cognitive behavior .
mirror therapyOther
Mirror therapy enhance functional activities in patient with hemiplegic stroke. For betterment of result high quality methodological studies and larger sample size is required.
| Study group | Role | What they receive |
|---|---|---|
| motor relearning program | Experimental | Patients in this group will receive treatment through Motor-relearning programme. Patients will be instructed to perform multiple task like holding object, elbow extension/flexion and multiple movements of shoulder joint. This group will receive MRP for about time duration of 4 weeks,3 days per week,2 hours session per day. Receives: Other: motor relearning program |
| mirror therapy | Other | Patient in this group will receive treatment through mirror therapy. Patient will sit in such a way that the mirror will be placed in perpendicular direction on a table. Sound limb will place in front of mirror and affected limb will place behind the mirror. Patient will receive visual feedback from sound limb. This group will receive MT for about 4 weeks, 3 days per week, 2 hours session per day. Receives: Other: mirror therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
fugl meyer assessment scale (FMA)
This test is recommended for checking functional return of patient having impairments with stroke.Test consists on the base of assessing patient with moving limb in low tone movements or synergistic pattern and then move actively back to normal function. Total scoring for upper limb is 18.
Measured: upto 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start4 Sep 2023
- Primary completion26 Dec 2023 (estimated)
- Study completion27 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Acute 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
- Model description
- Participants are divided into 2 groups Patients in experimental group will receive treatment through Motor-relearning program. Patient in controlled group will receive treatment through mirror therapy .
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yusra Medical and Dental College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maham Nasir, Yusra Medical and Dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06074081
- Sponsor's protocol ID
- Motor Relearning Program
- Status last verified
- Oct 2023
- First submitted
- 18 Sep 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jan S, Arsh A, Darain H, Gul S. A randomized control trial comparing the effects of motor relearning programme and mirror therapy for improving upper limb motor functions in stroke patients. J Pak Med Assoc. 2019 Sep;69(9):1242-1245.
PubMed 31511706Ng JC, Churojana A, Pongpech S, Vu LD, Sadikin C, Mahadevan J, Subramaniam J, Jocson VE, Lee W. Current state of acute stroke care in Southeast Asian countries. Interv Neuroradiol. 2019 Jun;25(3):291-296. doi: 10.1177/1591019918811804. Epub 2018 Nov 21.
PubMed 30463501Zhang Y, Xing Y, Li C, Hua Y, Hu J, Wang Y, Ya R, Meng Q, Bai Y. Mirror therapy for unilateral neglect after stroke: A systematic review. Eur J Neurol. 2022 Jan;29(1):358-371. doi: 10.1111/ene.15122. Epub 2021 Oct 5.
PubMed 34558762Ullah I, Arsh A, Zahir A, Jan S. Motor relearning program along with electrical stimulation for improving upper limb function in stroke patients: A quasi experimental study. Pak J Med Sci. 2020 Nov-Dec;36(7):1613-1617. doi: 10.12669/pjms.36.7.2351.
PubMed 33235584Gandhi DB, Sterba A, Khatter H, Pandian JD. Mirror Therapy in Stroke Rehabilitation: Current Perspectives. Ther Clin Risk Manag. 2020 Feb 7;16:75-85. doi: 10.2147/TCRM.S206883. eCollection 2020.
PubMed 32103968improved upper limb motor recovery and level of independence after stroke: a randomized controlled trial. CadernosBrasileiros de TerapiaOcupacional. 2022 Sep 2;30.
Zeng W, Guo Y, Wu G, Liu X, Fang Q. Mirror therapy for motor function of the upper extremity in patients with stroke: A meta-analysis. J Rehabil Med. 2018 Jan 10;50(1):8-15. doi: 10.2340/16501977-2287.
PubMed 29077129Hsieh YW, Lin YH, Zhu JD, Wu CY, Lin YP, Chen CC. Treatment Effects of Upper Limb Action Observation Therapy and Mirror Therapy on Rehabilitation Outcomes after Subacute Stroke: A Pilot Study. Behav Neurol. 2020 Jan 2;2020:6250524. doi: 10.1155/2020/6250524. eCollection 2020.
PubMed 32377266Maratis J, Wahidin A, Ivanali K. COMPARE THE EFFECTIVENESS OF CONSTRAINT INDUCED MOVEMENT THERAPY AND MOTOR RELEARNING PROGRAMME IN POST STROKE PATIENTS. In Academic Physiotherapy Conference Proceeding 2021 (pp. 179-190).
Rehme AK, Eickhoff SB, Rottschy C, Fink GR, Grefkes C. Activation likelihood estimation meta-analysis of motor-related neural activity after stroke. Neuroimage. 2012 Feb 1;59(3):2771-82. doi: 10.1016/j.neuroimage.2011.10.023. Epub 2011 Oct 17.
PubMed 22023742Hassani Z, Mokhtarinia HR, Kahlaee AH, Gabel CP. Translation, Validity, and Reliability of the Upper Extremity Fugl-Meyer Assessment (FMA-UE) in Persian Speaking Stroke Patients. Iranian Rehabilitation Journal. 2022 Mar 10;20:37-46.
Malouin F, Pichard L, Bonneau C, Durand A, Corriveau D. Evaluating motor recovery early after stroke: comparison of the Fugl-Meyer Assessment and the Motor Assessment Scale. Arch Phys Med Rehabil. 1994 Nov;75(11):1206-12. doi: 10.1016/0003-9993(94)90006-x.
PubMed 7979930Platz T, Pinkowski C, van Wijck F, Kim IH, di Bella P, Johnson G. Reliability and validity of arm function assessment with standardized guidelines for the Fugl-Meyer Test, Action Research Arm Test and Box and Block Test: a multicentre study. Clin Rehabil. 2005 Jun;19(4):404-11. doi: 10.1191/0269215505cr832oa.
PubMed 15929509Arfianti L, Rochman F, Hidayati HB, Subadi I. The addition of mirror therapy
Murphy SJ, Werring DJ. Stroke: causes and clinical features. Medicine (Abingdon). 2020 Sep;48(9):561-566. doi: 10.1016/j.mpmed.2020.06.002. Epub 2020 Aug 6.
PubMed 32837228
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 4-weeks of Motor Relearning Program and Mirror Therapy in Improving Upper Limb Motor Function in Stroke Patients.
- ClinicalTrials.gov ID
- NCT06074081
- Acronym / sponsor ID
- Motor Relearning Program
- Conditions
- Acute Stroke
- Keywords
- Motor Relearning Program, Mirror therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Yusra Medical and Dental CollegeUniversity, hospital or other
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- 26 Dec 2023 (estimated)
- Study completion
- 27 Feb 2024 (estimated)
- First posted
- 10 Oct 2023 (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.
Cerebrovascular accident(CVA) or stroke is one of common condition affecting people in developed and underdeveloped countries.
MRP is a therapy to regain particular motor function and neglecting accessory movements by engaging cognitive behavior.
Mirror therapy enhance functional activities in patient with hemiplegic stroke. For betterment of result high quality methodological studies and larger sample size is required.
Detailed description
Cerebrovascular accident(CVA) or stroke is one of common condition affecting people in developed and underdeveloped countries. Mostly patient with stroke face many disabilities and the most important one is upper limb motor impairment. For the optimization of upper extremity and prevention of patient from permanent disability it is essential to promotes Neuro-rehabilitation interventions. Physiotherapy techniques need to be monotonous, thorough and task oriented for neuroplasticity to generate better recovery. There is notable enhancement in ADLS when the rehabilitation program starts within 16 hours to 6 months after stroke In improving upper extremity motor functions there are tremendous types of techniques used i.e. Proprioceptive neuromuscular facilitation(PNF),Brunnstorm, Bobath therapy, Motor relearning program(MRP),Constraint induced movement therapy(CIMT) and Mirror therapy(MT).Out of which we are using two basic techniques i.e. motor relearning program(MRP) and mirror therapy(MT).Mirror therapy enhance functional activities in patient with hemiplegic stroke. For betterment of result high quality methodological studies and larger sample size is required. Mirror therapy enhance functional activities in patient with hemiplegic stroke. MRP is a therapy to regain particular motor function and neglecting accessory movements by engaging cognitive behavior .MRP is a therapy to regain particular motor function and neglecting accessory movements by engaging cognitive behavior.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants are divided into 2 groups Patients in experimental group will receive treatment through Motor-relearning program. Patient in controlled group will receive treatment through mirror therapy .
| Arm | Type | Receives |
|---|---|---|
| motor relearning program | Experimental | Other: motor relearning programPatients in this group will receive treatment through Motor-relearning programme. Patients will be instructed to perform multiple task like holding object, elbow extension/flexion and multiple movements of shoulder joint. This group will receive MRP for about time duration of 4 weeks,3 days per week,2 hours session per day. |
| mirror therapy | Other | Other: mirror therapyPatient in this group will receive treatment through mirror therapy. Patient will sit in such a way that the mirror will be placed in perpendicular direction on a table. Sound limb will place in front of mirror and affected limb will place behind the mirror. Patient will receive visual feedback from sound limb. This group will receive MT for about 4 weeks, 3 days per week, 2 hours session per day. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Acute(hemiplegic attack within 1-2 weeks) and sub-acute stroke(hemiplegic attack within 3- 11 weeks).
- 20 to 80 years.
- No physical deformity prior to stroke
- No history of serious underlying pathology and structural deformities.
Key exclusion criteria (2 listed)
- Patient with chronic hemiplegic stroke.
- Patient with congenital deformity.
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 relearning programMRP is a therapy to regain particular motor function and neglecting accessory movements by engaging cognitive behavior . | Other | motor relearning program |
| mirror therapyMirror therapy enhance functional activities in patient with hemiplegic stroke. For betterment of result high quality methodological studies and larger sample size is required. | Other | mirror therapy |
Primary outcome
fugl meyer assessment scale (FMA)
Time frame: upto 4 weeks
This test is recommended for checking functional return of patient having impairments with stroke.Test consists on the base of assessing patient with moving limb in low tone movements or synergistic pattern and then move actively back to normal function. Total scoring for upper limb is 18.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Background: PubMed 31511706Jan S, Arsh A, Darain H, Gul S. A randomized control trial comparing the effects of motor relearning programme and mirror therapy for improving upper limb motor functions in stroke patients. J Pak Med Assoc. 2019 Sep;69(9):1242-1245.
- Background: PubMed 30463501Ng JC, Churojana A, Pongpech S, Vu LD, Sadikin C, Mahadevan J, Subramaniam J, Jocson VE, Lee W. Current state of acute stroke care in Southeast Asian countries. Interv Neuroradiol. 2019 Jun;25(3):291-296. doi: 10.1177/1591019918811804. Epub 2018 Nov 21.
- Background: PubMed 34558762Zhang Y, Xing Y, Li C, Hua Y, Hu J, Wang Y, Ya R, Meng Q, Bai Y. Mirror therapy for unilateral neglect after stroke: A systematic review. Eur J Neurol. 2022 Jan;29(1):358-371. doi: 10.1111/ene.15122. Epub 2021 Oct 5.
- Background: PubMed 33235584Ullah I, Arsh A, Zahir A, Jan S. Motor relearning program along with electrical stimulation for improving upper limb function in stroke patients: A quasi experimental study. Pak J Med Sci. 2020 Nov-Dec;36(7):1613-1617. doi: 10.12669/pjms.36.7.2351.
- Background: PubMed 32103968Gandhi DB, Sterba A, Khatter H, Pandian JD. Mirror Therapy in Stroke Rehabilitation: Current Perspectives. Ther Clin Risk Manag. 2020 Feb 7;16:75-85. doi: 10.2147/TCRM.S206883. eCollection 2020.
- Backgroundimproved upper limb motor recovery and level of independence after stroke: a randomized controlled trial. CadernosBrasileiros de TerapiaOcupacional. 2022 Sep 2;30.
- Background: PubMed 29077129Zeng W, Guo Y, Wu G, Liu X, Fang Q. Mirror therapy for motor function of the upper extremity in patients with stroke: A meta-analysis. J Rehabil Med. 2018 Jan 10;50(1):8-15. doi: 10.2340/16501977-2287.
- Background: PubMed 32377266Hsieh YW, Lin YH, Zhu JD, Wu CY, Lin YP, Chen CC. Treatment Effects of Upper Limb Action Observation Therapy and Mirror Therapy on Rehabilitation Outcomes after Subacute Stroke: A Pilot Study. Behav Neurol. 2020 Jan 2;2020:6250524. doi: 10.1155/2020/6250524. eCollection 2020.
- BackgroundMaratis J, Wahidin A, Ivanali K. COMPARE THE EFFECTIVENESS OF CONSTRAINT INDUCED MOVEMENT THERAPY AND MOTOR RELEARNING PROGRAMME IN POST STROKE PATIENTS. In Academic Physiotherapy Conference Proceeding 2021 (pp. 179-190).
- Background: PubMed 22023742Rehme AK, Eickhoff SB, Rottschy C, Fink GR, Grefkes C. Activation likelihood estimation meta-analysis of motor-related neural activity after stroke. Neuroimage. 2012 Feb 1;59(3):2771-82. doi: 10.1016/j.neuroimage.2011.10.023. Epub 2011 Oct 17.
- BackgroundHassani Z, Mokhtarinia HR, Kahlaee AH, Gabel CP. Translation, Validity, and Reliability of the Upper Extremity Fugl-Meyer Assessment (FMA-UE) in Persian Speaking Stroke Patients. Iranian Rehabilitation Journal. 2022 Mar 10;20:37-46.
- Background: PubMed 7979930Malouin F, Pichard L, Bonneau C, Durand A, Corriveau D. Evaluating motor recovery early after stroke: comparison of the Fugl-Meyer Assessment and the Motor Assessment Scale. Arch Phys Med Rehabil. 1994 Nov;75(11):1206-12. doi: 10.1016/0003-9993(94)90006-x.
- 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.
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 motor relearning program and mirror therapy in people with Acute Stroke, run by Yusra Medical and Dental College 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 4 inclusion and 2 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 10 Oct 2023. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fugl meyer assessment scale (FMA) (time frame: upto 4 weeks). 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 NCT06074081, which also lists 16 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 10 Oct 2023.