StrokeNCT04556903
Effects of m CIMT and Bilateral Arm Training on Upper Extremity Chronic Stroke Patients
A study testing Bilateral Arm Training and modified constrained induce movement therapy in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
To compare and evaluate the effects of Modified Constraint Induced Movement Therapy (mCIMT) \& Bilateral Arm Training on upper extremity in chronic stroke patients this study will be conducted Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Stroke
- What is being tested?
- Bilateral Arm Training and modified constrained induce movement therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jun 2019to 30 Dec 2019
- 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
- Ability to follow instruction \& 2 steps command(Mini mental state score > 22)
- At least 6 month after stroke
Who cannot join
- Spasticity, defined as a score of 3 or more on Modified As worth scale (MAS)
- Uncontrolled hypertension (190/110 mm Hg)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Modified Constraint Induced Movement Therapy and Bilateral Arm Training on Upper Extremity in Chronic Stroke Patients
To compare and evaluate the effects of Modified Constraint Induced Movement Therapy (mCIMT) \& Bilateral Arm Training on upper extremity in chronic stroke patients this study will be conducted
Read the detailed description
Stroke is the abrupt loss of neurological function, due to disturbance of the blood flow in the brain. There is variety of crucial sign and symptoms that can occur during stroke include changes in the level of consciousness and impairments of sensation and motor or cognitive function loss. It also includes changes in perceptual and language functions. Worldwide, 55 million people died of stroke in 2002, and approximately 20 percent of these deaths occurred in South Asia. Predicting amounts of deaths from stroke will increase to 63 million in 2015 and 78 million by 2030 with the mass occurring in the poor countries of the world. Rehabilitation plays a major role in minimizing activity limitation and participation restriction or to decrease extent of impairments. Stroke can cause variety of impairments which have greater impact on the patient quality of life. Hemiparesis is the common impairment, in which involvement of upper limb is commonly seen.
mCIMT and BAT techniques both play an important role in the treatment of stroke. In this research, both techniques will be use to evaluate which treatment technique is better for upper extremity chronic stroke patients. Written informed consent will be taken. Each participant will be requested to draw either number one or number two from a box. Number one will be allocated to Group A and number two will be allocated to group B. The A group will receive mCIMT after applying conservative management and Group B will receive BAT for 5 days a week for 8 weeks.
- Conditions
- Stroke
- Being tested
- Bilateral Arm Training, modified constrained induce movement therapy
- Keywords
- Bilateral Arm Training (BAT), Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral Arm TrainingCombination product
First component of mCIMT will comprise one hour activity and a rest period of five minute given between each ten minutes of task practice. These activities will base on activities of daily living (ADL'S) and I
modified constrained induce movement therapyCombination product
BAT involves in four sessions, each session involve repetitive practice of bilateral tasks for one hour and a rest period of 5 minutes. The tasks are:
- Block placement- 10minutes
- Peg targeting- 10 minutes
- Peg inversion-10miutes
- Transferring objects- 10minutes
| Study group | Role | What they receive |
|---|---|---|
| Bilateral Arm Training | Experimental | Bilateral Arm Training Receives: Combination Product: Bilateral Arm Training |
| modified constrained induce movement therapy | Active comparator | modified constrained induce movement therapy Receives: Combination Product: modified constrained induce movement therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Action Research arm test
The Action Research Arm Test (ARAT) is a 19 item observational measure used by physical therapists and other health care professionals to assess upper extremity performance (coordination, dexterity and functioning) in stroke recovery,
Measured: 1 hour
Fugl-Meyer assessment test (Upper Extremity Section)
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based ... of three evidence based strategies to increase upper extremity function
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start15 Jun 2019
- Primary completion15 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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
- Model description
- Each participant will be requested to draw either number one or number two from a box. Number one will be allocated to Group A and number two will be allocated to group B. The A group will receive mCIMT after applying conservative treatment and Group B will receive BAT for 5 days a week for 8 weeks.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zeest Hashmi, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04556903
- Sponsor's protocol ID
- REC/00297 Zobia khan
- Status last verified
- Sep 2020
- First submitted
- 16 Sep 2020
- Last updated
- 21 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bonita R, Beaglehole R. Stroke prevention in poor countries: time for action. Stroke. 2007 Nov;38(11):2871-2. doi: 10.1161/STROKEAHA.107.504589. Epub 2007 Oct 22. No abstract available.
PubMed 17954904Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006 Nov;3(11):e442. doi: 10.1371/journal.pmed.0030442.
PubMed 17132052Andrews K, Stewart J. Stroke recovery: he can but does he? Rheumatol Rehabil. 1979 Feb;18(1):43-8. doi: 10.1093/rheumatology/18.1.43. No abstract available.
PubMed 424667Sterr A, Elbert T, Berthold I, Kolbel S, Rockstroh B, Taub E. Longer versus shorter daily constraint-induced movement therapy of chronic hemiparesis: an exploratory study. Arch Phys Med Rehabil. 2002 Oct;83(10):1374-7. doi: 10.1053/apmr.2002.35108.
PubMed 12370871Stewart KC, Cauraugh JH, Summers JJ. Bilateral movement training and stroke rehabilitation: a systematic review and meta-analysis. J Neurol Sci. 2006 May 15;244(1-2):89-95. doi: 10.1016/j.jns.2006.01.005. Epub 2006 Feb 14.
PubMed 16476449Dobkin BH. Clinical practice. Rehabilitation after stroke. N Engl J Med. 2005 Apr 21;352(16):1677-84. doi: 10.1056/NEJMcp043511.
PubMed 15843670Taub E, Miller NE, Novack TA, Cook EW 3rd, Fleming WC, Nepomuceno CS, Connell JS, Crago JE. Technique to improve chronic motor deficit after stroke. Arch Phys Med Rehabil. 1993 Apr;74(4):347-54.
PubMed 8466415
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Modified Constraint Induced Movement Therapy and Bilateral Arm Training on Upper Extremity in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT04556903
- Acronym / sponsor ID
- REC/00297 Zobia khan
- Conditions
- Stroke
- Keywords
- Bilateral Arm Training (BAT), Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jun 2019 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 21 Sep 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.
To compare and evaluate the effects of Modified Constraint Induced Movement Therapy (mCIMT) \& Bilateral Arm Training on upper extremity in chronic stroke patients this study will be conducted
Detailed description
Stroke is the abrupt loss of neurological function, due to disturbance of the blood flow in the brain. There is variety of crucial sign and symptoms that can occur during stroke include changes in the level of consciousness and impairments of sensation and motor or cognitive function loss. It also includes changes in perceptual and language functions. Worldwide, 55 million people died of stroke in 2002, and approximately 20 percent of these deaths occurred in South Asia. Predicting amounts of deaths from stroke will increase to 63 million in 2015 and 78 million by 2030 with the mass occurring in the poor countries of the world. Rehabilitation plays a major role in minimizing activity limitation and participation restriction or to decrease extent of impairments. Stroke can cause variety of impairments which have greater impact on the patient quality of life. Hemiparesis is the common impairment, in which involvement of upper limb is commonly seen.
mCIMT and BAT techniques both play an important role in the treatment of stroke. In this research, both techniques will be use to evaluate which treatment technique is better for upper extremity chronic stroke patients. Written informed consent will be taken. Each participant will be requested to draw either number one or number two from a box. Number one will be allocated to Group A and number two will be allocated to group B. The A group will receive mCIMT after applying conservative management and Group B will receive BAT for 5 days a week for 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Each participant will be requested to draw either number one or number two from a box. Number one will be allocated to Group A and number two will be allocated to group B. The A group will receive mCIMT after applying conservative treatment and Group B will receive BAT for 5 days a week for 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| Bilateral Arm Training | Experimental | Combination Product: Bilateral Arm TrainingBilateral Arm Training |
| modified constrained induce movement therapy | Active comparator | Combination Product: modified constrained induce movement therapymodified constrained induce movement therapy |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Ability to follow instruction \& 2 steps command(Mini mental state score > 22)
- At least 6 month after stroke
Key exclusion criteria (2 listed)
- Spasticity, defined as a score of 3 or more on Modified As worth scale (MAS)
- Uncontrolled hypertension (190/110 mm Hg)
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 |
|---|---|---|
| Bilateral Arm TrainingFirst component of mCIMT will comprise one hour activity and a rest period of five minute given between each ten minutes of task practice. These activities will base on activities of daily living (ADL'S) and I | Combination product | Bilateral Arm Training |
| modified constrained induce movement therapyBAT involves in four sessions, each session involve repetitive practice of bilateral tasks for one hour and a rest period of 5 minutes. The tasks are: * Block placement- 10minutes * Peg targeting- 10 minutes * Peg inversion-10miutes * Transferring objects- 10minutes | Combination product | modified constrained induce movement therapy |
Primary outcome
Action Research arm test
Time frame: 1 hour
The Action Research Arm Test (ARAT) is a 19 item observational measure used by physical therapists and other health care professionals to assess upper extremity performance (coordination, dexterity and functioning) in stroke recovery,
Fugl-Meyer assessment test (Upper Extremity Section)
Time frame: 1 hour
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based ... of three evidence based strategies to increase upper extremity function
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 21 Sep 2020.
- Background: PubMed 17954904Bonita R, Beaglehole R. Stroke prevention in poor countries: time for action. Stroke. 2007 Nov;38(11):2871-2. doi: 10.1161/STROKEAHA.107.504589. Epub 2007 Oct 22. No abstract available.
- Background: PubMed 17132052Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006 Nov;3(11):e442. doi: 10.1371/journal.pmed.0030442.
- Background: PubMed 424667Andrews K, Stewart J. Stroke recovery: he can but does he? Rheumatol Rehabil. 1979 Feb;18(1):43-8. doi: 10.1093/rheumatology/18.1.43. No abstract available.
- Background: PubMed 12370871Sterr A, Elbert T, Berthold I, Kolbel S, Rockstroh B, Taub E. Longer versus shorter daily constraint-induced movement therapy of chronic hemiparesis: an exploratory study. Arch Phys Med Rehabil. 2002 Oct;83(10):1374-7. doi: 10.1053/apmr.2002.35108.
- Background: PubMed 16476449Stewart KC, Cauraugh JH, Summers JJ. Bilateral movement training and stroke rehabilitation: a systematic review and meta-analysis. J Neurol Sci. 2006 May 15;244(1-2):89-95. doi: 10.1016/j.jns.2006.01.005. Epub 2006 Feb 14.
- Background: PubMed 15843670Dobkin BH. Clinical practice. Rehabilitation after stroke. N Engl J Med. 2005 Apr 21;352(16):1677-84. doi: 10.1056/NEJMcp043511.
- Background: PubMed 8466415Taub E, Miller NE, Novack TA, Cook EW 3rd, Fleming WC, Nepomuceno CS, Connell JS, Crago JE. Technique to improve chronic motor deficit after stroke. Arch Phys Med Rehabil. 1993 Apr;74(4):347-54.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Zeest Hashmi, MS 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 Bilateral Arm Training and modified constrained induce movement 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 2 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: finished, as of the sponsor's last update on 21 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?
Action Research arm test (time frame: 1 hour). The study lists 2 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 NCT04556903, which also lists 7 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 21 Sep 2020.