StrokeNCT05425225
Low Level LASER Therapy in Chronic Stroke Patients With Spastic Planter Flexors.
A study testing Low level LASER therapy and Conventional physical therapy in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
Low-intensity LASER therapy on the spastic muscle, would result in improving muscle performance and improving the functional capacity of individuals under the exercises imposed by physical therapy. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- Low level LASER therapy and Conventional physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 sitePakistan
- Study dates
- 4 Mar 2022to 15 Nov 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 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 45-70 years.
- Both male and female patients with chronic stroke.
- Patients diagnosed with stroke for at least 1 year.
- Medical referral for physiotherapy.
- Cognitive preserved, being able to respond to verbal stimuli.
- Modified Ashworth scale, with a maximum of 2 degree of spasticity in planter flexor.
Who cannot join
- Patients with other neurologic conditions, orthopedic problems, and uncontrolled metabolic diseases eliminate confounding factors affecting balance performance.
- Unable to understand and answer a simple verbal command.
- Severe hearing and visual loss.
- Patients who are already performing structured physical activities such as muscle strengthening exercises, Pilates, yoga or high intensity aerobic exercises.
- Patients with Hypoesthesia and/or Hyperesthesia of the side to be studied.
- The presence of active infection and rashes at the site of application of the laser Application.
- Uncontrolled arterial hypertension.
- Presence of neoplastic lesion at the site of application
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Low Level LASER Therapy on Spasticity and Gait Parameters in Chronic Stroke Patients With Spastic Planter Flexors.
Low-intensity LASER therapy on the spastic muscle, would result in improving muscle performance and improving the functional capacity of individuals under the exercises imposed by physical therapy. In this study the effect of low level LASER therapy will be evaluated on spastic planter flexor of chronic stroke patients and on their gait parameters. After this study post stroke planter flexor spasticity will be cured by low level LASER which will help to improve their gait mechanics.
Read the detailed description
Cerebrovascular accident (CVA) is defined as interruption of brain blood supply, which may affect basic motor functions, including spasticity. This post-stroke spasticity causes pain, muscle force reduction, changes in gait parameters and decreases the time to onset of muscle fatigue. These factors may lead to difficulty in maintaining an effective and comfortable speed when walking due to high-energy demand and the deficit of aerobic endurance, compromising the functional mobility in chronic stroke patients. Several therapeutic resources have been employed to treat post-stroke spasticity and functional recovery, one of the latest therapy which is used for muscular rehabilitation is Low-level LASER therapy (LLLT). The effect of LLLT on specific spastic muscle groups has not yet been studied in detail in those of chronic stroke patients.
The aim of this study is to evaluate the effect of the application of LLLT on spastic plantar flexor muscles and on gait parameters in patients with chronic stroke.Lower limb spasticity can result in the sustained over activity of the triceps surae muscle, which then leads to the equinus of the foot. The equinus foot can cause ankle instability during the loading response phase and poor toe clearance during the swing phase of gait.
Spastic drop foot is around 20% in stroke survivors. Spastic foot drop occurs primarily due to a combination of weakness of ankle dorsiflexors and spasticity of plantar flexors, associated with weakness of ankle evertors and/or spasticity of invertors. Spastic drop foot prevents heel strike, impairs walking, limits the activities of daily living, and contributes to injuries) LLLT is widely used in the clinic and encompasses a range of non-invasive therapeutic aspects. LLLT is commonly used clinically as a red light near-infrared wave with a length of 600 to 1000 nm and 5 to 500 mW.5 On the contrary, lasers used in surgery have a wavelength of 300 nm.6 Low-power lasers are capable of penetrating deep into the skin so that the surface of the skin does not burn and damage Low-power or cold lasers have been enhanced to the point of being able to produce analgesia and healing acceleration for many clinical conditions.A wide range of LLLT and related techniques have been used. Therefore, the results of treatment with low-power lasers may contradict each other.
The randomized controlled trial will recruit patients according to consecutive sampling into the control group and intervention group. The Control group will receive conventional treatment of spasticity, hot pack for 15 to 20 minutes followed by 10 repetitions of sustained stretching (10 seconds hold), strengthening exercise, balance training and gait training for eight weeks and two sessions each week and the interventional group will receive Low-level LASER therapy for eight weeks and two session per week in addition to the conventional therapy. For this study, we will use The Modified Ashworth Scale (for spasticity), goniometer (for muscle angle), and Wisconsin gait scale (for gait parameters) as tools of assessment. Data will be analyzed on SPSS software version 25.
- Conditions
- Stroke
- Being tested
- Low level LASER therapy, Conventional physical therapy
- Keywords
- Stroke, Muscle Spasticity, Gait Analysis, Low-Level Laser Therapy
- Medical subject headings
- Stroke, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low level LASER therapyOther
Three consecutive treatments will be given in a session, with 5 seconds break in between, giving a total irradiation time of 90 seconds. Two sessions will be given per week for total of 6 weeks.(20)
Conventional physical therapyOther
Hot pack for 15 to 20 minutes followed by 10 repetitions of sustained stretching (10 seconds hold), for 3 days a week for 6 week
| Study group | Role | What they receive |
|---|---|---|
| Low level LASER therapy | Experimental | low level laser therapy in continues wave at a wavelength in the near infrared of 830nm. Power density will be 670 mW/cm2. The treatment time per point will be 30 seconds. Probe head will be placed with light pressure on the calf muscles. Three consecutive treatments will be given in a session, with 5 seconds break in between, giving a total irradiation time of 90 seconds Receives: Other: Low level LASER therapy |
| Conventional physical therapy | Active comparator | sustained stretching (10 seconds hold), strengthening exercise, balance training and gait training Receives: Other: Conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashwarth scale
Use: The Modified Ashworth Scale is a 6-point scale. Scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity
Measured: 6th week
Wisconsin gait scale
Use: The Wisconsin Gait Scale (WGS) can be used to evaluate the gait problems experienced by a patient with stroke
Measured: 6th week
Goniometer
Use: A goniometer is a device used in physical therapy to measure a joint's range of motion (ROM).
Measured: 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start4 Mar 2022
- Primary completion15 Sep 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Binash Afzal, PHD*, Principal investigator, Riphah international university lahore campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05425225
- Sponsor's protocol ID
- REC/Lhr/22/0227 Humza
- Status last verified
- Jan 2024
- First submitted
- 15 Jun 2022
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
da Silva BP, Souza GADS, Filho AADN, Pinto AP, Guimaraes CL, Pereira APC, Neves MFD, Martins PSLL, Lima FPS, Lopes-Martins RAB, Lima MO. Analysis of the effects of low-level laser therapy on muscle fatigue of the biceps brachii muscle of healthy individuals and spastic individuals: Study protocol for a single-center, randomized, double-blind, and controlled clinical trial. Medicine (Baltimore). 2019 Sep;98(39):e17166. doi: 10.1097/MD.0000000000017166.
PubMed 31574822Mansouri V, Arjmand B, Rezaei Tavirani M, Razzaghi M, Rostami-Nejad M, Hamdieh M. Evaluation of Efficacy of Low-Level Laser Therapy. J Lasers Med Sci. 2020 Fall;11(4):369-380. doi: 10.34172/jlms.2020.60. Epub 2020 Oct 3.
PubMed 33425286Robbins SR, Alfredo PP, Junior WS, Marques AP. Low-level laser therapy and static stretching exercises for patients with knee osteoarthritis: A randomised controlled trial. Clin Rehabil. 2022 Feb;36(2):204-213. doi: 10.1177/02692155211047017. Epub 2021 Oct 29.
PubMed 34714175Kholoosy L, Elyaspour D, Akhgari MR, Razzaghi Z, Khodamardi Z, Bayat M. Evaluation of the Therapeutic Effect of Low Level Laser in Controlling Low Back Pain: A Randomized Controlled Trial. J Lasers Med Sci. 2020 Spring;11(2):120-125. doi: 10.34172/jlms.2020.21. Epub 2020 Mar 15.
PubMed 32273951Chung H, Dai T, Sharma SK, Huang YY, Carroll JD, Hamblin MR. The nuts and bolts of low-level laser (light) therapy. Ann Biomed Eng. 2012 Feb;40(2):516-33. doi: 10.1007/s10439-011-0454-7. Epub 2011 Nov 2.
PubMed 22045511Vogel DDS, Ortiz-Villatoro NN, Araujo NS, Marques MJG, Aimbire F, Scorza FA, Scorza CA, Albertini R. Transcranial low-level laser therapy in an in vivo model of stroke: Relevance to the brain infarct, microglia activation and neuroinflammation. J Biophotonics. 2021 Jun;14(6):e202000500. doi: 10.1002/jbio.202000500. Epub 2021 Mar 8.
PubMed 33580734Jan F, Naeem A, Malik AN, Amjad I, Malik T. Comparison of low level laser therapy and interferential current on post stroke shoulder pain. J Pak Med Assoc. 2017 May;67(5):788-789.
PubMed 28507373Huang YY, Gupta A, Vecchio D, de Arce VJ, Huang SF, Xuan W, Hamblin MR. Transcranial low level laser (light) therapy for traumatic brain injury. J Biophotonics. 2012 Nov;5(11-12):827-37. doi: 10.1002/jbio.201200077. Epub 2012 Jul 17.
PubMed 22807422das Neves MF, Dos Reis MC, de Andrade EA, Lima FP, Nicolau RA, Arisawa EA, Andrade AO, Lima MO. Effects of low-level laser therapy (LLLT 808 nm) on lower limb spastic muscle activity in chronic stroke patients. Lasers Med Sci. 2016 Sep;31(7):1293-300. doi: 10.1007/s10103-016-1968-x. Epub 2016 May 31.
PubMed 27299571das Neves MF, Aleixo DC, Mendes IS, Lima FPS, Nicolau RA, Arisawa EAL, Lopes-Martins RAB, Lima MO. Long-term analyses of spastic muscle behavior in chronic poststroke patients after near-infrared low-level laser therapy (808 nm): a double-blinded placebo-controlled clinical trial. Lasers Med Sci. 2020 Sep;35(7):1459-1467. doi: 10.1007/s10103-019-02920-3. Epub 2019 Dec 10.
PubMed 31823135dos Reis MC, de Andrade EA, Borges AC, de Souza DQ, Lima FP, Nicolau RA, Andrade AO, Lima MO. Immediate effects of low-intensity laser (808 nm) on fatigue and strength of spastic muscle. Lasers Med Sci. 2015 Apr;30(3):1089-96. doi: 10.1007/s10103-014-1702-5. Epub 2015 Jan 23.
PubMed 25614133Boonswang NA, Chicchi M, Lukachek A, Curtiss D. A new treatment protocol using photobiomodulation and muscle/bone/joint recovery techniques having a dramatic effect on a stroke patient's recovery: a new weapon for clinicians. BMJ Case Rep. 2012 Sep 11;2012:bcr0820114689. doi: 10.1136/bcr.08.2011.4689.
PubMed 22967677
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low Level LASER Therapy on Spasticity and Gait Parameters in Chronic Stroke Patients With Spastic Planter Flexors.
- ClinicalTrials.gov ID
- NCT05425225
- Acronym / sponsor ID
- REC/Lhr/22/0227 Humza
- Conditions
- Stroke
- Keywords
- Stroke, Muscle Spasticity, Gait Analysis, Low-Level Laser Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 4 Mar 2022 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 21 Jun 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.
Low-intensity LASER therapy on the spastic muscle, would result in improving muscle performance and improving the functional capacity of individuals under the exercises imposed by physical therapy. In this study the effect of low level LASER therapy will be evaluated on spastic planter flexor of chronic stroke patients and on their gait parameters. After this study post stroke planter flexor spasticity will be cured by low level LASER which will help to improve their gait mechanics.
Detailed description
Cerebrovascular accident (CVA) is defined as interruption of brain blood supply, which may affect basic motor functions, including spasticity. This post-stroke spasticity causes pain, muscle force reduction, changes in gait parameters and decreases the time to onset of muscle fatigue. These factors may lead to difficulty in maintaining an effective and comfortable speed when walking due to high-energy demand and the deficit of aerobic endurance, compromising the functional mobility in chronic stroke patients. Several therapeutic resources have been employed to treat post-stroke spasticity and functional recovery, one of the latest therapy which is used for muscular rehabilitation is Low-level LASER therapy (LLLT). The effect of LLLT on specific spastic muscle groups has not yet been studied in detail in those of chronic stroke patients.
The aim of this study is to evaluate the effect of the application of LLLT on spastic plantar flexor muscles and on gait parameters in patients with chronic stroke.Lower limb spasticity can result in the sustained over activity of the triceps surae muscle, which then leads to the equinus of the foot. The equinus foot can cause ankle instability during the loading response phase and poor toe clearance during the swing phase of gait.
Spastic drop foot is around 20% in stroke survivors. Spastic foot drop occurs primarily due to a combination of weakness of ankle dorsiflexors and spasticity of plantar flexors, associated with weakness of ankle evertors and/or spasticity of invertors. Spastic drop foot prevents heel strike, impairs walking, limits the activities of daily living, and contributes to injuries) LLLT is widely used in the clinic and encompasses a range of non-invasive therapeutic aspects. LLLT is commonly used clinically as a red light near-infrared wave with a length of 600 to 1000 nm and 5 to 500 mW.5 On the contrary, lasers used in surgery have a wavelength of 300 nm.6 Low-power lasers are capable of penetrating deep into the skin so that the surface of the skin does not burn and damage Low-power or cold lasers have been enhanced to the point of being able to produce analgesia and healing acceleration for many clinical conditions.A wide range of LLLT and related techniques have been used. Therefore, the results of treatment with low-power lasers may contradict each other.
The randomized controlled trial will recruit patients according to consecutive sampling into the control group and intervention group. The Control group will receive conventional treatment of spasticity, hot pack for 15 to 20 minutes followed by 10 repetitions of sustained stretching (10 seconds hold), strengthening exercise, balance training and gait training for eight weeks and two sessions each week and the interventional group will receive Low-level LASER therapy for eight weeks and two session per week in addition to the conventional therapy. For this study, we will use The Modified Ashworth Scale (for spasticity), goniometer (for muscle angle), and Wisconsin gait scale (for gait parameters) as tools of assessment. Data will be analyzed on SPSS software version 25.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low level LASER therapy | Experimental | Other: Low level LASER therapylow level laser therapy in continues wave at a wavelength in the near infrared of 830nm. Power density will be 670 mW/cm2. The treatment time per point will be 30 seconds. Probe head will be placed with light pressure on the calf muscles. Three consecutive treatments will be given in a session, with 5 seconds break in between, giving a total irradiation time of 90 seconds |
| Conventional physical therapy | Active comparator | Other: Conventional physical therapysustained stretching (10 seconds hold), strengthening exercise, balance training and gait training |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 45-70 years.
- Both male and female patients with chronic stroke.
- Patients diagnosed with stroke for at least 1 year.
- Medical referral for physiotherapy.
- Cognitive preserved, being able to respond to verbal stimuli.
Key exclusion criteria (8 listed)
- Patients with other neurologic conditions, orthopedic problems, and uncontrolled metabolic diseases eliminate confounding factors affecting balance performance.
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 |
|---|---|---|
| Low level LASER therapyThree consecutive treatments will be given in a session, with 5 seconds break in between, giving a total irradiation time of 90 seconds. Two sessions will be given per week for total of 6 weeks.(20) | Other | Low level LASER therapy |
| Conventional physical therapyHot pack for 15 to 20 minutes followed by 10 repetitions of sustained stretching (10 seconds hold), for 3 days a week for 6 week | Other | Conventional physical therapy |
Primary outcome
Modified Ashwarth scale
Time frame: 6th week
Use: The Modified Ashworth Scale is a 6-point scale. Scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity
Wisconsin gait scale
Time frame: 6th week
Use: The Wisconsin Gait Scale (WGS) can be used to evaluate the gait problems experienced by a patient with stroke
Goniometer
Time frame: 6th week
Use: A goniometer is a device used in physical therapy to measure a joint's range of motion (ROM).
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 30 Jan 2024.
- Background: PubMed 31574822da Silva BP, Souza GADS, Filho AADN, Pinto AP, Guimaraes CL, Pereira APC, Neves MFD, Martins PSLL, Lima FPS, Lopes-Martins RAB, Lima MO. Analysis of the effects of low-level laser therapy on muscle fatigue of the biceps brachii muscle of healthy individuals and spastic individuals: Study protocol for a single-center, randomized, double-blind, and controlled clinical trial. Medicine (Baltimore). 2019 Sep;98(39):e17166. doi: 10.1097/MD.0000000000017166.
- Background: PubMed 33425286Mansouri V, Arjmand B, Rezaei Tavirani M, Razzaghi M, Rostami-Nejad M, Hamdieh M. Evaluation of Efficacy of Low-Level Laser Therapy. J Lasers Med Sci. 2020 Fall;11(4):369-380. doi: 10.34172/jlms.2020.60. Epub 2020 Oct 3.
- Background: PubMed 34714175Robbins SR, Alfredo PP, Junior WS, Marques AP. Low-level laser therapy and static stretching exercises for patients with knee osteoarthritis: A randomised controlled trial. Clin Rehabil. 2022 Feb;36(2):204-213. doi: 10.1177/02692155211047017. Epub 2021 Oct 29.
- Background: PubMed 32273951Kholoosy L, Elyaspour D, Akhgari MR, Razzaghi Z, Khodamardi Z, Bayat M. Evaluation of the Therapeutic Effect of Low Level Laser in Controlling Low Back Pain: A Randomized Controlled Trial. J Lasers Med Sci. 2020 Spring;11(2):120-125. doi: 10.34172/jlms.2020.21. Epub 2020 Mar 15.
- Background: PubMed 22045511Chung H, Dai T, Sharma SK, Huang YY, Carroll JD, Hamblin MR. The nuts and bolts of low-level laser (light) therapy. Ann Biomed Eng. 2012 Feb;40(2):516-33. doi: 10.1007/s10439-011-0454-7. Epub 2011 Nov 2.
- Background: PubMed 33580734Vogel DDS, Ortiz-Villatoro NN, Araujo NS, Marques MJG, Aimbire F, Scorza FA, Scorza CA, Albertini R. Transcranial low-level laser therapy in an in vivo model of stroke: Relevance to the brain infarct, microglia activation and neuroinflammation. J Biophotonics. 2021 Jun;14(6):e202000500. doi: 10.1002/jbio.202000500. Epub 2021 Mar 8.
- Background: PubMed 28507373Jan F, Naeem A, Malik AN, Amjad I, Malik T. Comparison of low level laser therapy and interferential current on post stroke shoulder pain. J Pak Med Assoc. 2017 May;67(5):788-789.
- Background: PubMed 22807422Huang YY, Gupta A, Vecchio D, de Arce VJ, Huang SF, Xuan W, Hamblin MR. Transcranial low level laser (light) therapy for traumatic brain injury. J Biophotonics. 2012 Nov;5(11-12):827-37. doi: 10.1002/jbio.201200077. Epub 2012 Jul 17.
- Background: PubMed 27299571das Neves MF, Dos Reis MC, de Andrade EA, Lima FP, Nicolau RA, Arisawa EA, Andrade AO, Lima MO. Effects of low-level laser therapy (LLLT 808 nm) on lower limb spastic muscle activity in chronic stroke patients. Lasers Med Sci. 2016 Sep;31(7):1293-300. doi: 10.1007/s10103-016-1968-x. Epub 2016 May 31.
- Background: PubMed 31823135das Neves MF, Aleixo DC, Mendes IS, Lima FPS, Nicolau RA, Arisawa EAL, Lopes-Martins RAB, Lima MO. Long-term analyses of spastic muscle behavior in chronic poststroke patients after near-infrared low-level laser therapy (808 nm): a double-blinded placebo-controlled clinical trial. Lasers Med Sci. 2020 Sep;35(7):1459-1467. doi: 10.1007/s10103-019-02920-3. Epub 2019 Dec 10.
- Background: PubMed 25614133dos Reis MC, de Andrade EA, Borges AC, de Souza DQ, Lima FP, Nicolau RA, Andrade AO, Lima MO. Immediate effects of low-intensity laser (808 nm) on fatigue and strength of spastic muscle. Lasers Med Sci. 2015 Apr;30(3):1089-96. doi: 10.1007/s10103-014-1702-5. Epub 2015 Jan 23.
- Background: PubMed 22967677Boonswang NA, Chicchi M, Lukachek A, Curtiss D. A new treatment protocol using photobiomodulation and muscle/bone/joint recovery techniques having a dramatic effect on a stroke patient's recovery: a new weapon for clinicians. BMJ Case Rep. 2012 Sep 11;2012:bcr0820114689. doi: 10.1136/bcr.08.2011.4689.
- 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.
Binash Afzal, PHD* principal investigator
Riphah international university lahore campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low level LASER therapy and Conventional physical 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 6 inclusion and 8 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 30 Jan 2024. 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?
Modified Ashwarth scale (time frame: 6th week). 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 NCT05425225, which also lists 12 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 30 Jan 2024.