StrokeNCT05191524
Constraint Induced Movement Therapy and Proprioceptive Neuromuscular Facilitation on Lower Limb Motor Function
A study testing Constrained induced movement and Proprioceptive Neuromuscular facilitation in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
Stroke, described as a neurological deficit caused by the interruption of cerebral blood flow, is one of the leading causes of mortality and morbidity throughout the world. It is the second most common medical condition and the major cause of disability in adults. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Stroke
- What is being tested?
- Constrained induced movement and Proprioceptive Neuromuscular facilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jan 2022to 27 Jun 2022
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both male and female
- Patients who will be diagnosed with hemiplegia due to stroke
- Patient who has an asymmetrical stance, ability to walk and stand with minimal assistance
- Patient must have 15 degrees of knee flexion in the affected limb
- Mini mental state examination Mini Mental State Examination >23
Who cannot join
- Patients who cannot perform the active movement of a limb due to pre stroke musculoskeletal problems
- Cardiopulmonary diseases which could hinder their ability to take part in rehabilitation
- Patient with impaired cognition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Constraint Induced Movement Therapy and Proprioceptive Neuromuscular Facilitation on Lower Limb Motor Function in Stroke Patients
Stroke, described as a neurological deficit caused by the interruption of cerebral blood flow, is one of the leading causes of mortality and morbidity throughout the world. It is the second most common medical condition and the major cause of disability in adults. Recovery following stroke revolves around the severity of sensory, motor, and cognitive impairments. Lower extremity impairment is one of the major post-stroke conditions which can cause difficulty in performing activities of daily living, gait abnormalities, increased risk of fall, and restriction in social participation. Rehabilitation after stroke is the primary mechanism through which it can achieve functional recovery and independence, which is based on the principles of motor learning and neuroplasticity.
Read the detailed description
There have been many rehabilitation techniques to treat post-stroke impairments. These include aerobic exercises, the Bobath approach, proprioceptive neuromuscular facilitation (PNF) constraint-induced movement therapy (CIMT), and mobilization and stimulation of neuromuscular tissue. The selection of techniques at the defined level of recovery varies among clinicians.
Constraint-induced movement therapy (CIMT) is a neurological rehabilitation technique that has been used in various neurological disorders including stroke both in acute and chronic stages, traumatic brain injury, cerebral palsy, multiple sclerosis, and spinal cord injury to improve motor function and strengthen weak muscles which are characterized by the restraint of the less affected extremity accompanied by the shaping and repetitive task-oriented training of more affected extremity.
Proprioceptive facilitation (PNF) is one of the major therapeutic techniques aimed at enhancing the essential characteristics required for the functional ambulation of patients with hemiplegia, such as muscular control, strength, and flexibility. Changes in the excitation of the cortical motor area mediate this and the corresponding.
Motor neurons. Previous researches are on the separate effect of CIMT and they have conducted PNF approaches, but there is no study available on the comparison of the effect of both techniques on lower limb function in stroke patients. Most of the studies administered PNF in combination with other approaches and the duration of intervention in these studies was in favor of CIMT groups compared to PNF. Therefore, this study is aimed at determining the comparative effect of CIMT and PNF on lower limb recovery.
- Conditions
- Stroke
- Being tested
- Constrained induced movement, Proprioceptive Neuromuscular facilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constrained induced movementOther
Practice in two sessions per day (supervised) for 3 days per week, for six consecutive weeks. The unaffected limb will be constraint using a knee immobilizer only during practice sessions. We will perform the interventions under the supervision of a trained physiotherapist.
Proprioceptive Neuromuscular facilitationOther
Group B will receive PNF intervention given for 30 minutes to the lower limb 3 times a week for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Constrained induced movement therapy | Experimental | In this group of patients, they will use the CIMT technique for treatment. Patient will perform following tasks, while unaffected limb in constrains for 3 hours/day
* 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 Receives: Other: Constrained induced movement |
| Proprioceptive Neuromuscular facilitation therapy | Active comparator | Different PNF components (such as commands, stretching, timing, and manual resistance) will be used for optimizing patients' output. We will do ten repetitions of each pattern before
Proceeding to the next pattern. The PNF patterns in the set used in the study will be :
Lower extremity:
< Flexion-abduction-external rotation (knee flexed and knee extended) < Extension-adduction-internal rotation (knee flexed and knee extended) < Flexion-adduction-internal rotation (knee flexed and knee extended) < Extension-abduction-external rotation (knee flexed and knee extended Receives: Other: Proprioceptive Neuromuscular facilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment (FMA)
The FMA scale is a 226-point multi-item Likert-type scale developed as an evaluative measure of recovery from hemiplegic stroke. They divided it into 5 domains: motor function, sensory function, balance, joint range of motion, and joint pain. Each domain contains multiple items, each scored on a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully).
Measured: week 6
Timed up and go test
The Timed Up and Go (TUG) is a screening tool used to test basic mobility skills of frail elderly patients (60-90 years old). They can use the TUG with but is not limited to, persons with stroke.
10s Completely independent With or without walking aid for ambulation and transfers
< 20s Independent for main transfers With or without walking aid, independent for basic tub or shower transfers and able to climb most stairs and go outside alone
> 30s Requires assistance dependent in most activities
Measured: week 6
Berg Balance Scale
The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item comprising a five-point ordinal scale ranging from 0 to 4, with 0 showing the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete.
Measured: week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start15 Jan 2022
- Primary completion27 Jun 2022
- Study completion27 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 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
- NCT05191524
- Sponsor's protocol ID
- REC/00818 Aqdas
- Status last verified
- Sep 2022
- First submitted
- 29 Dec 2021
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Çoban O. İnmeli hastalarda mekanik hippoterapi cihazı ile yapılan egzersizin postural kontrol ve denge üzerine etkisi. 2019
Abba M, Muhammad A, Badaru U, Abdullahi A. Comparative effect of constraint-induced movement therapy and proprioceptive neuromuscular facilitation on upper limb function of chronic stroke survivors. Physiotherapy Quarterly. 2020;28(1):1-5
He L, Wang J, Wang F, Zhang L, Zhang L, Zhao W. Increased neutrophil-to-lymphocyte ratio predicts the development of post-stroke infections in patients with acute ischemic stroke. BMC Neurol. 2020 Sep 1;20(1):328. doi: 10.1186/s12883-020-01914-x.
PubMed 32873248Randolph SA. Ischemic Stroke. Workplace Health Saf. 2016 Sep;64(9):444. doi: 10.1177/2165079916665400.
PubMed 27621261Yu L, Tao J, Zhao Q, Xu C, Zhang Q. Confirmation of potential neuroprotective effects of natural bioactive compounds from traditional medicinal herbs in cerebral ischemia treatment. J Integr Neurosci. 2020 Jun 30;19(2):373-384. doi: 10.31083/j.jin.2020.02.63.
PubMed 32706202Lakhan SE, Kirchgessner A, Hofer M. Inflammatory mechanisms in ischemic stroke: therapeutic approaches. J Transl Med. 2009 Nov 17;7:97. doi: 10.1186/1479-5876-7-97.
PubMed 19919699Ojaghihaghighi S, Vahdati SS, Mikaeilpour A, Ramouz A. Comparison of neurological clinical manifestation in patients with hemorrhagic and ischemic stroke. World J Emerg Med. 2017;8(1):34-38. doi: 10.5847/wjem.j.1920-8642.2017.01.006.
PubMed 28123618Chen S, Zeng L, Hu Z. Progressing haemorrhagic stroke: categories, causes, mechanisms and managements. J Neurol. 2014 Nov;261(11):2061-78. doi: 10.1007/s00415-014-7291-1. Epub 2014 Mar 5.
PubMed 24595959GBD 2015 Neurological Disorders Collaborator Group. Global, regional, and national burden of neurological disorders during 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet Neurol. 2017 Nov;16(11):877-897. doi: 10.1016/S1474-4422(17)30299-5. Epub 2017 Sep 17.
PubMed 28931491
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Constraint Induced Movement Therapy and Proprioceptive Neuromuscular Facilitation on Lower Limb Motor Function in Stroke Patients
- ClinicalTrials.gov ID
- NCT05191524
- Acronym / sponsor ID
- REC/00818 Aqdas
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 27 Jun 2022 (actual)
- Study completion
- 27 Jun 2022 (actual)
- First posted
- 13 Jan 2022 (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, described as a neurological deficit caused by the interruption of cerebral blood flow, is one of the leading causes of mortality and morbidity throughout the world. It is the second most common medical condition and the major cause of disability in adults. Recovery following stroke revolves around the severity of sensory, motor, and cognitive impairments. Lower extremity impairment is one of the major post-stroke conditions which can cause difficulty in performing activities of daily living, gait abnormalities, increased risk of fall, and restriction in social participation. Rehabilitation after stroke is the primary mechanism through which it can achieve functional recovery and independence, which is based on the principles of motor learning and neuroplasticity.
Detailed description
There have been many rehabilitation techniques to treat post-stroke impairments. These include aerobic exercises, the Bobath approach, proprioceptive neuromuscular facilitation (PNF) constraint-induced movement therapy (CIMT), and mobilization and stimulation of neuromuscular tissue. The selection of techniques at the defined level of recovery varies among clinicians.
Constraint-induced movement therapy (CIMT) is a neurological rehabilitation technique that has been used in various neurological disorders including stroke both in acute and chronic stages, traumatic brain injury, cerebral palsy, multiple sclerosis, and spinal cord injury to improve motor function and strengthen weak muscles which are characterized by the restraint of the less affected extremity accompanied by the shaping and repetitive task-oriented training of more affected extremity.
Proprioceptive facilitation (PNF) is one of the major therapeutic techniques aimed at enhancing the essential characteristics required for the functional ambulation of patients with hemiplegia, such as muscular control, strength, and flexibility. Changes in the excitation of the cortical motor area mediate this and the corresponding.
Motor neurons. Previous researches are on the separate effect of CIMT and they have conducted PNF approaches, but there is no study available on the comparison of the effect of both techniques on lower limb function in stroke patients. Most of the studies administered PNF in combination with other approaches and the duration of intervention in these studies was in favor of CIMT groups compared to PNF. Therefore, this study is aimed at determining the comparative effect of CIMT and PNF on lower limb recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Constrained induced movement therapy | Experimental | Other: Constrained induced movementIn this group of patients, they will use the CIMT technique for treatment. Patient will perform following tasks, while unaffected limb in constrains for 3 hours/day * 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 |
| Proprioceptive Neuromuscular facilitation therapy | Active comparator | Other: Proprioceptive Neuromuscular facilitationDifferent PNF components (such as commands, stretching, timing, and manual resistance) will be used for optimizing patients' output. We will do ten repetitions of each pattern before Proceeding to the next pattern. The PNF patterns in the set used in the study will be : Lower extremity: < Flexion-abduction-external rotation (knee flexed and knee extended) < Extension-adduction-internal rotation (knee flexed and knee extended) < Flexion-adduction-internal rotation (knee flexed and knee extended) < Extension-abduction-external rotation (knee flexed and knee extended |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Both male and female
- Patients who will be diagnosed with hemiplegia due to stroke
- Patient who has an asymmetrical stance, ability to walk and stand with minimal assistance
- Patient must have 15 degrees of knee flexion in the affected limb
- Mini mental state examination Mini Mental State Examination >23
Key exclusion criteria (3 listed)
- Patients who cannot perform the active movement of a limb due to pre stroke musculoskeletal problems
- Cardiopulmonary diseases which could hinder their ability to take part in rehabilitation
- Patient with impaired cognition
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 |
|---|---|---|
| Constrained induced movementPractice in two sessions per day (supervised) for 3 days per week, for six consecutive weeks. The unaffected limb will be constraint using a knee immobilizer only during practice sessions. We will perform the interventions under the supervision of a trained physiotherapist. | Other | Constrained induced movement therapy |
| Proprioceptive Neuromuscular facilitationGroup B will receive PNF intervention given for 30 minutes to the lower limb 3 times a week for 6 weeks | Other | Proprioceptive Neuromuscular facilitation therapy |
Primary outcome
Fugl-Meyer Assessment (FMA)
Time frame: week 6
The FMA scale is a 226-point multi-item Likert-type scale developed as an evaluative measure of recovery from hemiplegic stroke. They divided it into 5 domains: motor function, sensory function, balance, joint range of motion, and joint pain. Each domain contains multiple items, each scored on a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully).
Timed up and go test
Time frame: week 6
The Timed Up and Go (TUG) is a screening tool used to test basic mobility skills of frail elderly patients (60-90 years old). They can use the TUG with but is not limited to, persons with stroke. 10s Completely independent With or without walking aid for ambulation and transfers < 20s Independent for main transfers With or without walking aid, independent for basic tub or shower transfers and able to climb most stairs and go outside alone > 30s Requires assistance dependent in most activities
Berg Balance Scale
Time frame: week 6
The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item comprising a five-point ordinal scale ranging from 0 to 4, with 0 showing the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete.
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 2022.
- BackgroundÇoban O. İnmeli hastalarda mekanik hippoterapi cihazı ile yapılan egzersizin postural kontrol ve denge üzerine etkisi. 2019
- BackgroundAbba M, Muhammad A, Badaru U, Abdullahi A. Comparative effect of constraint-induced movement therapy and proprioceptive neuromuscular facilitation on upper limb function of chronic stroke survivors. Physiotherapy Quarterly. 2020;28(1):1-5
- Background: PubMed 32873248He L, Wang J, Wang F, Zhang L, Zhang L, Zhao W. Increased neutrophil-to-lymphocyte ratio predicts the development of post-stroke infections in patients with acute ischemic stroke. BMC Neurol. 2020 Sep 1;20(1):328. doi: 10.1186/s12883-020-01914-x.
- Background: PubMed 27621261Randolph SA. Ischemic Stroke. Workplace Health Saf. 2016 Sep;64(9):444. doi: 10.1177/2165079916665400.
- Background: PubMed 32706202Yu L, Tao J, Zhao Q, Xu C, Zhang Q. Confirmation of potential neuroprotective effects of natural bioactive compounds from traditional medicinal herbs in cerebral ischemia treatment. J Integr Neurosci. 2020 Jun 30;19(2):373-384. doi: 10.31083/j.jin.2020.02.63.
- Background: PubMed 19919699Lakhan SE, Kirchgessner A, Hofer M. Inflammatory mechanisms in ischemic stroke: therapeutic approaches. J Transl Med. 2009 Nov 17;7:97. doi: 10.1186/1479-5876-7-97.
- Background: PubMed 28123618Ojaghihaghighi S, Vahdati SS, Mikaeilpour A, Ramouz A. Comparison of neurological clinical manifestation in patients with hemorrhagic and ischemic stroke. World J Emerg Med. 2017;8(1):34-38. doi: 10.5847/wjem.j.1920-8642.2017.01.006.
- Background: PubMed 24595959Chen S, Zeng L, Hu Z. Progressing haemorrhagic stroke: categories, causes, mechanisms and managements. J Neurol. 2014 Nov;261(11):2061-78. doi: 10.1007/s00415-014-7291-1. Epub 2014 Mar 5.
- Background: PubMed 28931491GBD 2015 Neurological Disorders Collaborator Group. Global, regional, and national burden of neurological disorders during 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet Neurol. 2017 Nov;16(11):877-897. doi: 10.1016/S1474-4422(17)30299-5. Epub 2017 Sep 17.
- 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 Constrained induced movement and Proprioceptive Neuromuscular facilitation 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 5 inclusion and 3 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 2022. 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 (FMA) (time frame: week 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05191524, which also lists 9 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 2022.