StrokeNCT04757467
Comparison of Frequency & Duration of Task Practice During Constraint Induced Movement Therapy
A study testing Standard physiotherapy neuro-rehabilitation, Repetition-CIMT and Hour-CIMT in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
Stroke is a very serious medical condition, classically categorized as a neurological disorder that occurs due to obstructed blood flow to specific parts of the brain, and resultant death of that area.This obstructed blood supply results in compromised function of that part of the brain, resulting in paralysis or… Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Stroke
- What is being tested?
- Standard physiotherapy neuro-rehabilitation, Repetition-CIMT and Hour-CIMT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2020to 28 Feb 2021
- 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 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Stroke population (ACA)
- Lower limb impairment
- Ability to follow verbal and visual instructions
- No significant cognitive impairment (MMSE score ≥ 24)
- Moderate risk of fall (Tinetti gait and balance score 19-23).
- FMA-LE score of 21 or below out of 34
Who cannot join
- Other neurological conditions
- Lower limb impairment due to any other reason (fracture, diabetic neuropathy etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Frequency & Duration of Task Practice During Constraint-Induced Movement Therapy on Lower Limb in Stroke Patients
Stroke is a very serious medical condition, classically categorized as a neurological disorder that occurs due to obstructed blood flow to specific parts of the brain, and resultant death of that area.This obstructed blood supply results in compromised function of that part of the brain, resulting in paralysis or interference with the normal function of the body controlled by that specific region of the brain. Stroke is usually of two types i.e. Ischemic and hemorrhagic. Ischemic stroke results in reduced or complete obstruction in blood flow in the vessels resulting in ischemia, while a hemorrhagic stroke occurs due to rupture of blood carrying vessels and results in clotting. CIMT has proven effective in rehabilitation of motor functions of lower limbs in many pieces of evidence but still, the evidence is less as compared to the upper extremity. Evidence about improvement in balance and gait using CIMT is very little. In some studies, hours of daily practice for the task has used as a total therapeutic dose measurement. While, in other studies, repetitions of the task have used to calculate the total amount of therapeutic intervention. This study will evaluate the effects of frequency and duration of the task in CIMT on motor functions, gait \& balance of lower limb stroke patients by intervention using these two protocols of CIMT.
Read the detailed description
Stroke is a very serious medical condition, classically categorized as a neurological disorder that occurs due to obstructed blood flow to specific parts of the brain, and resultant death of that area. This obstructed blood supply results in compromised function of that part of the brain, resulting in paralysis or interference with the normal function of the body controlled by that specific region of the brain. Stroke is usually of two types i.e. Ischemic and hemorrhagic. Ischemic stroke results in reduced or complete obstruction in blood flow in the vessels resulting in ischemia, while a hemorrhagic stroke occurs due to rupture of blood carrying vessels and results in clotting. Both types reduce the supply of oxygen to the parts of the brain and result in cognitive and physical disabilities. Most common physical disabilities e.g. moving certain parts, swallowing, speaking, bowel bladder, coordination \& balance. Other commonly occurring underlying disabilities range from cognitive, emotional to behavioural issues. Constrained Induced Moment Therapy (CIMT) is a therapeutic intervention involving the family of techniques, used most commonly to treat physical disabilities in patients of stroke. These techniques involve restraint of the intact or normal limb over an extended period, in combination with several movement repetitions of task-specific training by the affected limb and lead to improved functional status. Frequency and duration of tasks performed by affected limbs can affect outcomes effectively. Physiologically brain has characteristics of plasticity, which is the basis for CIMT as a treatment. The neurophysiological mechanism that is believed to be underline treatment benefits of CIMT includes overcoming learned outcomes and plastic reorganization of the brain. The brain changes itself when effected extremity is used intensively and repetitively. The physiological effects of CIMT are explained as cortical reorganization, dendritic branching, redundancy learned and synaptic strength Evidence on CIMT interventions for lower limb was quite rare. But many pieces of research supported that CIMT can be used as an equally effective intervention for a lower limb as it is being used for the upper limb. Constraining the lower extremity was difficult and complex as compared to the upper extremity. Improved functional status of the lower limb by treating with CIMT was accompanied by less balance, coordination and short stepped gate. Some researchers focused on repetitions while others focused on forced movements. All the evidence showed improved functional level in the post-stroke lower limb.
Stroke can be managed by a variety of different techniques, one of which is constraint-induced movement therapy (CIMT). This form of rehabilitation focuses on the intensive use of the affected limb while restricting the use of the unaffected limb. The types of restraints used include a splint, a sling, a glove, a mitt and a combination of a sling and a resting hand splint. CIMT has been more commonly practised in the upper limb but after positive results were obtained from the upper extremity protocol, a protocol was developed for the lower extremity as well. A vast number of studies have shown the success of CIMT in treating the reduction of upper limb use in the practical world after traumatic brain injury, cerebral palsy, multiple sclerosis and stroke. A specially adapted form of CIMT for the lower limb has also been successful in treating deficits in the lower limb after spinal cord injury and stroke
- Conditions
- Stroke
- Being tested
- Standard physiotherapy neuro-rehabilitation, Repetition-CIMT, Hour-CIMT
- Keywords
- stroke, constraint induced movement therapy, rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard physiotherapy neuro-rehabilitationOther
Treatment interventions which will be used for this group Passive range of movement exercises. Therapeutic positioning of the lower limb. Strengthening exercise for the lower limb. Over-ground gait training 5 times a week for 4 weeks. First week= 30 min exercise Second week= 1hour exercise Third week= 1hour and 30 min exercise Fourth week= 2 hours exercise All the treatment protocols will be applied to the patient for 5 times a week for consecutive 4 weeks. Interventions will be performed in the clinic and through home-based exercises using patient education
Repetition-CIMTOther
In this group of patients, the CIMT technique will be used for treatment. Following tasks will be performed by the patient, the unaffected limb will be constrained using a tight knee brace for about3 hr.
- Sit-to-Stand
- Forward and Backward stepping
- Stair Climbing and Descending (only the first stair will be used)
- Side-to-Side stepping with the affected limb
Each task will be performed 10 times per session in the first week and 2 sessions a day. In the second week, each task will be performed 20 times per session for 2 sessions a day. In the third week, each task will be performed 30 times per session for 2 sessions a day.In the fourth week, each task will be performed 40 times per session for 2 sessions a day. The session will be held 5 days in a week for the period of consecutive 4 weeks. Total of 1000 repetitions of the above mentions tasks will be performed in 4 weeks' study time by every participant
Hour-CIMTOther
A task that performed by the participants in this group will be the same as performed by the rep-CIMT group. The unaffected limb will be in constrained for 3 hours. (15) Sessions will be held 5 days in the week for a period of consecutive 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Standard physiotherapy neuro-rehabilitation | Active comparator | Control Group: Patients included in the control group will receive standard physiotherapy neurorehabilitation protocols. Receives: Other: Standard physiotherapy neuro-rehabilitation |
| Repetition-CIMT | Experimental | In this group of patients, the CIMT technique will be used for treatment. Following tasks will be performed by the patient, the unaffected limb will be constrained using a tight knee brace for about3 hr Receives: Other: Repetition-CIMT |
| Hour-CIMT | Experimental | The task that performed by the participants in this group will be the same as performed by the rep-CIMT group. The unaffected limb will be in constrained for 3 hours. Receives: Other: Hour-CIMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer assessment scale- lower extremity (FMA-LE)
Fugl-Meyer Assessment (FMA) scale is an index to assess the sensorimotor impairment in individuals who have had a stroke. FMA scale has shown high validity and moderate to high reliability. Researches have shown stable responsiveness for this scale, lower extremity (maximum score of 34 points) are recommended as core measures to be used in every stroke recovery and rehabilitation trial.
Measured: week 4
Tinetti gait and balance test
Tinetti Balance and Gate Test is a reliable and valid tool to measure gait ability in stroke patients. The Tinetti-gait and balance scale is a reliable and valid tool to measure gait ability in patients with chronic stroke. The inter-rater reliability of the Tinetti-gait scale is high.
Scoring of the Tinetti Assessment Tool is done on a three point ordinal scale with a range of 0 to 2.
A score of 0 represents the most impairment, while a score of 2 represents independence. The individual scores are then combined to form three measures; an overall gait assessment score, and overall balance assessment score, ad a combined gait and balance score
Measured: week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start1 Aug 2020
- Primary completion20 Feb 2021
- Study completion28 Feb 2021
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
- Factorial
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ayesha Afridi, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757467
- Sponsor's protocol ID
- REC/00754 Sonia Hussain
- Status last verified
- Jun 2021
- First submitted
- 2 Feb 2021
- Last updated
- 21 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Warlow CP. Epidemiology of stroke. Lancet. 1998 Oct;352 Suppl 3:SIII1-4. doi: 10.1016/s0140-6736(98)90086-1. No abstract available.
PubMed 9803954Sacco 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 23652265Sridharan SE, Unnikrishnan JP, Sukumaran S, Sylaja PN, Nayak SD, Sarma PS, Radhakrishnan K. Incidence, types, risk factors, and outcome of stroke in a developing country: the Trivandrum Stroke Registry. Stroke. 2009 Apr;40(4):1212-8. doi: 10.1161/STROKEAHA.108.531293. Epub 2009 Feb 19.
PubMed 19228849Hartman-Maeir A, Soroker N, Oman SD, Katz N. Awareness of disabilities in stroke rehabilitation--a clinical trial. Disabil Rehabil. 2003 Jan 7;25(1):35-44.
PubMed 12554390Fuzaro AC, Guerreiro CT, Galetti FC, Juca RB, Araujo JE. Modified constraint-induced movement therapy and modified forced-use therapy for stroke patients are both effective to promote balance and gait improvements. Rev Bras Fisioter. 2012 Apr;16(2):157-65. doi: 10.1590/s1413-35552012005000010. Epub 2012 Mar 1.
PubMed 22378476Hakkennes S, Keating JL. Constraint-induced movement therapy following stroke: a systematic review of randomised controlled trials. Aust J Physiother. 2005;51(4):221-31. doi: 10.1016/s0004-9514(05)70003-9.
PubMed 16321129Zipp GP, Winning S. Effects of constraint-induced movement therapy on gait, balance, and functional locomotor mobility. Pediatr Phys Ther. 2012 Spring;24(1):64-8. doi: 10.1097/PEP.0b013e31823e0245.
PubMed 22207472
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Frequency & Duration of Task Practice During Constraint-Induced Movement Therapy on Lower Limb in Stroke Patients
- ClinicalTrials.gov ID
- NCT04757467
- Acronym / sponsor ID
- REC/00754 Sonia Hussain
- Conditions
- Stroke
- Keywords
- stroke, constraint induced movement therapy, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 20 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 17 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stroke is a very serious medical condition, classically categorized as a neurological disorder that occurs due to obstructed blood flow to specific parts of the brain, and resultant death of that area.This obstructed blood supply results in compromised function of that part of the brain, resulting in paralysis or interference with the normal function of the body controlled by that specific region of the brain. Stroke is usually of two types i.e. Ischemic and hemorrhagic. Ischemic stroke results in reduced or complete obstruction in blood flow in the vessels resulting in ischemia, while a hemorrhagic stroke occurs due to rupture of blood carrying vessels and results in clotting. CIMT has proven effective in rehabilitation of motor functions of lower limbs in many pieces of evidence but still, the evidence is less as compared to the upper extremity. Evidence about improvement in balance and gait using CIMT is very little. In some studies, hours of daily practice for the task has used as a total therapeutic dose measurement. While, in other studies, repetitions of the task have used to calculate the total amount of therapeutic intervention. This study will evaluate the effects of frequency and duration of the task in CIMT on motor functions, gait \& balance of lower limb stroke patients by intervention using these two protocols of CIMT.
Detailed description
Stroke is a very serious medical condition, classically categorized as a neurological disorder that occurs due to obstructed blood flow to specific parts of the brain, and resultant death of that area. This obstructed blood supply results in compromised function of that part of the brain, resulting in paralysis or interference with the normal function of the body controlled by that specific region of the brain. Stroke is usually of two types i.e. Ischemic and hemorrhagic. Ischemic stroke results in reduced or complete obstruction in blood flow in the vessels resulting in ischemia, while a hemorrhagic stroke occurs due to rupture of blood carrying vessels and results in clotting. Both types reduce the supply of oxygen to the parts of the brain and result in cognitive and physical disabilities. Most common physical disabilities e.g. moving certain parts, swallowing, speaking, bowel bladder, coordination \& balance. Other commonly occurring underlying disabilities range from cognitive, emotional to behavioural issues. Constrained Induced Moment Therapy (CIMT) is a therapeutic intervention involving the family of techniques, used most commonly to treat physical disabilities in patients of stroke. These techniques involve restraint of the intact or normal limb over an extended period, in combination with several movement repetitions of task-specific training by the affected limb and lead to improved functional status. Frequency and duration of tasks performed by affected limbs can affect outcomes effectively. Physiologically brain has characteristics of plasticity, which is the basis for CIMT as a treatment. The neurophysiological mechanism that is believed to be underline treatment benefits of CIMT includes overcoming learned outcomes and plastic reorganization of the brain. The brain changes itself when effected extremity is used intensively and repetitively. The physiological effects of CIMT are explained as cortical reorganization, dendritic branching, redundancy learned and synaptic strength Evidence on CIMT interventions for lower limb was quite rare. But many pieces of research supported that CIMT can be used as an equally effective intervention for a lower limb as it is being used for the upper limb. Constraining the lower extremity was difficult and complex as compared to the upper extremity. Improved functional status of the lower limb by treating with CIMT was accompanied by less balance, coordination and short stepped gate. Some researchers focused on repetitions while others focused on forced movements. All the evidence showed improved functional level in the post-stroke lower limb.
Stroke can be managed by a variety of different techniques, one of which is constraint-induced movement therapy (CIMT). This form of rehabilitation focuses on the intensive use of the affected limb while restricting the use of the unaffected limb. The types of restraints used include a splint, a sling, a glove, a mitt and a combination of a sling and a resting hand splint. CIMT has been more commonly practised in the upper limb but after positive results were obtained from the upper extremity protocol, a protocol was developed for the lower extremity as well. A vast number of studies have shown the success of CIMT in treating the reduction of upper limb use in the practical world after traumatic brain injury, cerebral palsy, multiple sclerosis and stroke. A specially adapted form of CIMT for the lower limb has also been successful in treating deficits in the lower limb after spinal cord injury and stroke
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard physiotherapy neuro-rehabilitation | Active comparator | Other: Standard physiotherapy neuro-rehabilitationControl Group: Patients included in the control group will receive standard physiotherapy neurorehabilitation protocols. |
| Repetition-CIMT | Experimental | Other: Repetition-CIMTIn this group of patients, the CIMT technique will be used for treatment. Following tasks will be performed by the patient, the unaffected limb will be constrained using a tight knee brace for about3 hr |
| Hour-CIMT | Experimental | Other: Hour-CIMTThe task that performed by the participants in this group will be the same as performed by the rep-CIMT group. The unaffected limb will be in constrained for 3 hours. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Stroke population (ACA)
- Lower limb impairment
- Ability to follow verbal and visual instructions
- No significant cognitive impairment (MMSE score ≥ 24)
- Moderate risk of fall (Tinetti gait and balance score 19-23).
Key exclusion criteria (2 listed)
- Other neurological conditions
- Lower limb impairment due to any other reason (fracture, diabetic neuropathy etc.)
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 |
|---|---|---|
| Standard physiotherapy neuro-rehabilitationTreatment interventions which will be used for this group Passive range of movement exercises. Therapeutic positioning of the lower limb. Strengthening exercise for the lower limb. Over-ground gait training 5 times a week for 4 weeks. First week= 30 min exercise Second week= 1hour exercise Third week= 1hour and 30 min exercise Fourth week= 2 hours exercise All the treatment protocols will be applied to the patient for 5 times a week for consecutive 4 weeks. Interventions will be performed in the clinic and through home-based exercises using patient education | Other | Standard physiotherapy neuro-rehabilitation |
| Repetition-CIMTIn this group of patients, the CIMT technique will be used for treatment. Following tasks will be performed by the patient, the unaffected limb will be constrained using a tight knee brace for about3 hr. * Sit-to-Stand * Forward and Backward stepping * Stair Climbing and Descending (only the first stair will be used) * Side-to-Side stepping with the affected limb Each task will be performed 10 times per session in the first week and 2 sessions a day. In the second week, each task will be performed 20 times per session for 2 sessions a day. In the third week, each task will be performed 30 times per session for 2 sessions a day.In the fourth week, each task will be performed 40 times per session for 2 sessions a day. The session will be held 5 days in a week for the period of consecutive 4 weeks. Total of 1000 repetitions of the above mentions tasks will be performed in 4 weeks' study time by every participant | Other | Repetition-CIMT |
| Hour-CIMTA task that performed by the participants in this group will be the same as performed by the rep-CIMT group. The unaffected limb will be in constrained for 3 hours. (15) Sessions will be held 5 days in the week for a period of consecutive 4 weeks. | Other | Hour-CIMT |
Primary outcome
Fugl-Meyer assessment scale- lower extremity (FMA-LE)
Time frame: week 4
Fugl-Meyer Assessment (FMA) scale is an index to assess the sensorimotor impairment in individuals who have had a stroke. FMA scale has shown high validity and moderate to high reliability. Researches have shown stable responsiveness for this scale, lower extremity (maximum score of 34 points) are recommended as core measures to be used in every stroke recovery and rehabilitation trial.
Tinetti gait and balance test
Time frame: week 4
Tinetti Balance and Gate Test is a reliable and valid tool to measure gait ability in stroke patients. The Tinetti-gait and balance scale is a reliable and valid tool to measure gait ability in patients with chronic stroke. The inter-rater reliability of the Tinetti-gait scale is high. Scoring of the Tinetti Assessment Tool is done on a three point ordinal scale with a range of 0 to 2. A score of 0 represents the most impairment, while a score of 2 represents independence. The individual scores are then combined to form three measures; an overall gait assessment score, and overall balance assessment score, ad a combined gait and balance score
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 Jun 2021.
- Background: PubMed 9803954Warlow CP. Epidemiology of stroke. Lancet. 1998 Oct;352 Suppl 3:SIII1-4. doi: 10.1016/s0140-6736(98)90086-1. No abstract available.
- 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 19228849Sridharan SE, Unnikrishnan JP, Sukumaran S, Sylaja PN, Nayak SD, Sarma PS, Radhakrishnan K. Incidence, types, risk factors, and outcome of stroke in a developing country: the Trivandrum Stroke Registry. Stroke. 2009 Apr;40(4):1212-8. doi: 10.1161/STROKEAHA.108.531293. Epub 2009 Feb 19.
- Background: PubMed 12554390Hartman-Maeir A, Soroker N, Oman SD, Katz N. Awareness of disabilities in stroke rehabilitation--a clinical trial. Disabil Rehabil. 2003 Jan 7;25(1):35-44.
- Background: PubMed 22378476Fuzaro AC, Guerreiro CT, Galetti FC, Juca RB, Araujo JE. Modified constraint-induced movement therapy and modified forced-use therapy for stroke patients are both effective to promote balance and gait improvements. Rev Bras Fisioter. 2012 Apr;16(2):157-65. doi: 10.1590/s1413-35552012005000010. Epub 2012 Mar 1.
- Background: PubMed 16321129Hakkennes S, Keating JL. Constraint-induced movement therapy following stroke: a systematic review of randomised controlled trials. Aust J Physiother. 2005;51(4):221-31. doi: 10.1016/s0004-9514(05)70003-9.
- Background: PubMed 22207472Zipp GP, Winning S. Effects of constraint-induced movement therapy on gait, balance, and functional locomotor mobility. Pediatr Phys Ther. 2012 Spring;24(1):64-8. doi: 10.1097/PEP.0b013e31823e0245.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayesha Afridi, PhD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard physiotherapy neuro-rehabilitation, Repetition-CIMT and Hour-CIMT 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 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 Jun 2021. 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?
Fugl-Meyer assessment scale- lower extremity (FMA-LE) (time frame: week 4). 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 NCT04757467, 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 Jun 2021.