Chronic StrokeNCT06292481
Combine Effects of Brunnstorm Movement Therapy and LLLT in Chronic Stroke Patient
A study testing Brunnstorm movement therapy and Combined Brunnstorm Movement therapy and low level laser therapy in people with Chronic Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
The primary objective of this study is to determine the combined effects of Brunnstorm movement therapy and low level laser therapy on upper limb function in chronic stroke patient. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- Brunnstorm movement therapy and Combined Brunnstorm Movement therapy and low level laser therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2023to 10 Oct 2023
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age range between 40 \& 60 years (16)
- Both males and females.
- Combined Effects of Brunnstorm movement therapy and LLLT on Upper limb function Hand dexterity in stroke
- Patient with maximum Grade 1 and 1+ spasticity according to Modified
- Ashworth scale and minimum muscle strength of 1 in the biceps brachii muscle.
- Onset of injury : (1 to 2 years)
Who cannot join
- Any comorbidity such as malignancy, inflammatory rheumatologic disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, lupus erythematosus, etc.
- Have a pacemaker or a history of serious cardiac events or of cardiorespiratory dysfunction.
- Visual impairment
- Any other musculoskeletal disorders of extremity
- Severe cognitive impairment or aphasia leading to difficulty in communication, Participants unwilling to comply with the protocol.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Govt. Mian Munshi DHQ Teaching hospital
Lahore, Punjab Province, 54000
About this study
Official title: Combine Effects of Brunnstorm Movement Therapy and LLLT on Upper Limb Functioning and Hand Dexterity in Chronic Stroke Patient
The primary objective of this study is to determine the combined effects of Brunnstorm movement therapy and low level laser therapy on upper limb function in chronic stroke patient.
- Conditions
- Chronic Stroke
- Being tested
- Brunnstorm movement therapy, Combined Brunnstorm Movement therapy and low level laser therapy
- Keywords
- Brunnstorm movement therapy, Hand dexterity, Low-level laser therapy, Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brunnstorm movement therapyOther
this group received Brunnstorm Movement therapy for 3 to 5 sessions per week, each lasting approximately 30 to 60 minutes for 6 weeks
Combined Brunnstorm Movement therapy and low level laser therapyOther
this group received Combined Brunnstorm Movement therapy and low level laser therapy for 3 to 5 sessions per week, each lasting approximately 30 to 60 minutes for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Brunnstorm Movement therapy | Experimental | this group received Brunnstorm Movement therapy for 3 to 5 sessions per week, each lasting approximately 30 to 60 minutes for 6 weeks Receives: Other: Brunnstorm movement therapy |
| Combined Brunnstorm Movement therapy and low level laser therapy | Experimental | this group received Combined Brunnstorm Movement therapy and low level laser therapy for 3 to 5 sessions per week, each lasting approximately 30 to 60 minutes for 6 weeks Receives: Other: Combined Brunnstorm Movement therapy and low level laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugle meyer Assessment test
Measured: 6th week
Box and block test
Measured: 6th week
Nine peg hole test
Measured: 6th week
to check Muscle tone
Modified Ashworth Scale
Measured: 6th week
to measure grip Strength
Hand handled dynamometer
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 posted5 Mar 2024
- Study start1 Aug 2023
- Primary completion30 Sep 2023
- Study completion10 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 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
- NCT06292481
- Sponsor's protocol ID
- REC/RCR&AHS/23/0240
- Status last verified
- Mar 2024
- First submitted
- 28 Jan 2024
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
das 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 31823135da 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 31574822Azuma RHE, Merlo JK, Jacinto JL, Borim JM, da Silva RA, Pacagnelli FL, Nunes JP, Ribeiro AS, Aguiar AF. Photobiomodulation Therapy at 808 nm Does Not Improve Biceps Brachii Performance to Exhaustion and Delayed-Onset Muscle Soreness in Young Adult Women: A Randomized, Controlled, Crossover Trial. Front Physiol. 2021 Jun 10;12:664582. doi: 10.3389/fphys.2021.664582. eCollection 2021.
PubMed 34177615Stamborowski SF, de Oliveira Spinelli BM, Lima FPS, Costa DR, de Silveira Souza GA, Lima MO, Lopes Martins RAB. The influence of photobiomodulation on the temperature of the brachial biceps during muscle fatigue protocol. Lasers Med Sci. 2021 Oct;36(8):1741-1749. doi: 10.1007/s10103-021-03360-8. Epub 2021 Jul 13.
PubMed 34255219Vassao PG, Baldini GS, Vieira KVSG, Balao AB, Pinfildi CE, Campos RMDS, Tucci HT, Renno ACM. Acute Photobiomodulation Effects Through a Cluster Device on Skeletal Muscle Fatigue of Biceps Brachii in Young and Healthy Males: A Randomized Double-Blind Session. Photobiomodul Photomed Laser Surg. 2020 Dec;38(12):773-779. doi: 10.1089/photob.2019.4786.
PubMed 33332234Harada T, Miyagi M, Izukura H, Endou G, Ushigome N, Tsuruoka H, Mizutani A, Ohshiro T, Ebihara S. The effect of low level laser therapy for pain in major muscles controlling two joints. Laser Ther. 2019 Jun 30;28(2):111-115. doi: 10.5978/islsm.19-OR-07.
PubMed 32921909
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combine Effects of Brunnstorm Movement Therapy and LLLT on Upper Limb Functioning and Hand Dexterity in Chronic Stroke Patient
- ClinicalTrials.gov ID
- NCT06292481
- Acronym / sponsor ID
- REC/RCR&AHS/23/0240
- Conditions
- Chronic Stroke
- Keywords
- Brunnstorm movement therapy, Hand dexterity, Low-level laser therapy, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 10 Oct 2023 (actual)
- First posted
- 5 Mar 2024 (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.
The primary objective of this study is to determine the combined effects of Brunnstorm movement therapy and low level laser therapy on upper limb function in chronic stroke patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brunnstorm Movement therapy | Experimental | Other: Brunnstorm movement therapythis group received Brunnstorm Movement therapy for 3 to 5 sessions per week, each lasting approximately 30 to 60 minutes for 6 weeks |
| Combined Brunnstorm Movement therapy and low level laser therapy | Experimental | Other: Combined Brunnstorm Movement therapy and low level laser therapythis group received Combined Brunnstorm Movement therapy and low level laser therapy for 3 to 5 sessions per week, each lasting approximately 30 to 60 minutes for 6 weeks |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age range between 40 \& 60 years (16)
- Both males and females.
- Combined Effects of Brunnstorm movement therapy and LLLT on Upper limb function Hand dexterity in stroke
- Patient with maximum Grade 1 and 1+ spasticity according to Modified
- Ashworth scale and minimum muscle strength of 1 in the biceps brachii muscle.
Key exclusion criteria (5 listed)
- Any comorbidity such as malignancy, inflammatory rheumatologic disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, lupus erythematosus, etc.
- Have a pacemaker or a history of serious cardiac events or of cardiorespiratory dysfunction.
- Visual impairment
- Any other musculoskeletal disorders of extremity
- Severe cognitive impairment or aphasia leading to difficulty in communication, Participants unwilling to comply with the protocol.
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 |
|---|---|---|
| Brunnstorm movement therapythis group received Brunnstorm Movement therapy for 3 to 5 sessions per week, each lasting approximately 30 to 60 minutes for 6 weeks | Other | Brunnstorm Movement therapy |
| Combined Brunnstorm Movement therapy and low level laser therapythis group received Combined Brunnstorm Movement therapy and low level laser therapy for 3 to 5 sessions per week, each lasting approximately 30 to 60 minutes for 6 weeks | Other | Combined Brunnstorm Movement therapy and low level laser therapy |
Primary outcome
Fugle meyer Assessment test
Time frame: 6th week
Box and block test
Time frame: 6th week
Nine peg hole test
Time frame: 6th week
to check Muscle tone
Time frame: 6th week
Modified Ashworth Scale
to measure grip Strength
Time frame: 6th week
Hand handled dynamometer
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 5 Mar 2024.
- 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 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 34177615Azuma RHE, Merlo JK, Jacinto JL, Borim JM, da Silva RA, Pacagnelli FL, Nunes JP, Ribeiro AS, Aguiar AF. Photobiomodulation Therapy at 808 nm Does Not Improve Biceps Brachii Performance to Exhaustion and Delayed-Onset Muscle Soreness in Young Adult Women: A Randomized, Controlled, Crossover Trial. Front Physiol. 2021 Jun 10;12:664582. doi: 10.3389/fphys.2021.664582. eCollection 2021.
- Background: PubMed 34255219Stamborowski SF, de Oliveira Spinelli BM, Lima FPS, Costa DR, de Silveira Souza GA, Lima MO, Lopes Martins RAB. The influence of photobiomodulation on the temperature of the brachial biceps during muscle fatigue protocol. Lasers Med Sci. 2021 Oct;36(8):1741-1749. doi: 10.1007/s10103-021-03360-8. Epub 2021 Jul 13.
- Background: PubMed 33332234Vassao PG, Baldini GS, Vieira KVSG, Balao AB, Pinfildi CE, Campos RMDS, Tucci HT, Renno ACM. Acute Photobiomodulation Effects Through a Cluster Device on Skeletal Muscle Fatigue of Biceps Brachii in Young and Healthy Males: A Randomized Double-Blind Session. Photobiomodul Photomed Laser Surg. 2020 Dec;38(12):773-779. doi: 10.1089/photob.2019.4786.
- Background: PubMed 32921909Harada T, Miyagi M, Izukura H, Endou G, Ushigome N, Tsuruoka H, Mizutani A, Ohshiro T, Ebihara S. The effect of low level laser therapy for pain in major muscles controlling two joints. Laser Ther. 2019 Jun 30;28(2):111-115. doi: 10.5978/islsm.19-OR-07.
- 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 Brunnstorm movement therapy and Combined Brunnstorm Movement therapy and low level laser therapy in people with Chronic 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 5 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 5 Mar 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?
Fugle meyer Assessment test (time frame: 6th week). The study lists 5 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 NCT06292481, which also lists 6 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 5 Mar 2024.