StrokeNCT07646418
Combined Effects of LIRT-BFR Therapy in Post- Stroke Patients
A study testing Low intensity resistance training with Blood flow restriction therapy and Conventional Physical Therapy Protocol in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
Stroke is a focal neurological deficit of sudden onset, with symptoms lasting more than 24 hours leading to consequences like impacting physical abilities, cognitive functions and emotional well-being, speech and language difficulties. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- Low intensity resistance training with Blood flow restriction therapy and Conventional Physical Therapy Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2025to 5 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 50 to 70 year of age (5)
- Both males and females (5)
- Generalized stroke population (both ischemic and hemorrhagic stroke) (9).
- Post stroke patient after 1 month (5)
- Barthel index scores ≥ 20 (10)
- Spasticity level according to Modified Ashworth scale should be 1/+1 grade in the affected upper limb(7)
- Muscle strength at grade 3 according to MMT of affected upper limb (7)
Who cannot join
- • People with a history of mental/cognitive illness (9)
- History of transient ischemic attack (TIA) or recurrent stroke (8)
- Diabetes with peripheral neuropathy (5)
- Having resting blood pressure above 160/100 mmHg even after taking medications
- Cardiovascular comorbidity (heart failure, unstable angina, aortic stenosis)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Amin Welfare & Teaching Hospital
Sialkot, Punjab Province, 39000
Dr. Aqsa Gulzar Ahmed, Mbbs, 03484071699, aqsachodhary504@gmail.com
About this study
Official title: Combined Effects of Low Intensity Resistance Training With Blood Flow Restriction Therapy on Upper Limb Strength, Forward Reach and Sensorimotor Function in Post-Stroke Patients
Stroke is a focal neurological deficit of sudden onset, with symptoms lasting more than 24 hours leading to consequences like impacting physical abilities, cognitive functions and emotional well-being, speech and language difficulties. Among various rehabilitation program, Blood flow restriction (BFR) therapy with low intensity resistance training has shown its promising results. Blood flow restriction training, also called Kaatsu, originated in Japan. So this study aims to determine the combined effects of Low Intensity Resistance Training with Blood Flow Restriction Therapy on Upper Limb Strength, Forward Reach and Sensorimotor function in Post-Stroke Patients.
Read the detailed description
It will be a single-blinded randomized controlled trial. Non-probability convenience sampling technique will be used to recruit 64 participants aged 50 to 70 years, one-month post-stroke from hospitals of Sialkot. Sealed opaque method will be used to evenly divide to either Group-BFR therapy or Group-conventional physical therapy. Group-BFR therapy will perform low-intensity resistance exercises at 40% of their 1-RM using 2 kg weights and resistance bands, cuff will be applied at proximal site of upper limb at 150-160 mmHg. Group-conventional physical therapy will perform sensorimotor exercises and strength training with 2-3 kg weights, bands and forward reaching activities. Both groups will perform their respective exercises for 40 minutes, 4 days/week, for 6 weeks. Participants will be evaluated at the baseline and post-intervention exercise program. Outcome measures include the Fugl-Meyer Assessment for upper extremity function, the Functional Reach Test for forward reach, and the Action Research Arm Test for strength. Data will be analyzed using SPSS software 25. After normality testing of the data, the Paired sample t-test will be used for parametric data while Wilcoxon test will be used for non-parametric data in intragroup comparison, while for intergroup comparison, the independent t-test will be for parametric data and Mann-Whitney U test will be used for non-parametric data
- Conditions
- Stroke
- Being tested
- Low intensity resistance training with Blood flow restriction therapy, Conventional Physical Therapy Protocol
- Keywords
- Balance, BFR Therapy, Low intensity Resistance Training, Muscle Strength
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low intensity resistance training with Blood flow restriction therapyOther
Low intensity resistance training with BFR in U.L Using B.P cuff at proximal site of U.L 40% of 1RM Resistance training of U.L will be performed using small weights (1-2kg) and resistance bands.
Cuff pressure should be 150-160 mmHg
Conventional Physical Therapy ProtocolOther
Upper extremity Motor skills:
Reaching, Grasping Strengthening Exercises, CIMT
Sensory skills:
By manually exploring different objects, temperature and pressure Dull stroke through cotton, Sharp stroke through common pin, needle to retrain sensory inputs.
Upper extremity Strengthening exercises Strengthening Exercises through Thera bands, 1 or 2 kg dumbels Forward Reaching exercises with stable lower extremity Reaching exercises with stable lower extremity Standing position,core engagement, Arm position controlled movement minimizing trunk and hip movement, perturbations technique to improve stability.
| Study group | Role | What they receive |
|---|---|---|
| Low intensity resistance training with Blood flow restriction therapy | Experimental | Low intensity resistance training with BFR in U.L Using B.P cuff at proximal site of U.L 40% of 1RM Resistance training of U.L will be performed using small weights (1-2kg) and resistance bands.
Cuff pressure should be 150-160 mmHg Receives: Other: Low intensity resistance training with Blood flow restriction therapy |
| Conventional Physical Therapy Protocol | Active comparator | Upper extremity Motor skills:
Reaching, Grasping Strengthening Exercises, CIMT
Sensory skills:
By manually exploring different objects, temperature and pressure Dull stroke through cotton, Sharp stroke through common pin, needle to retrain sensory inputs.
Upper extremity Strengthening exercises Strengthening Exercises through Thera bands, 1 or 2 kg dumbels Forward Reaching exercises with stable lower extremity Reaching exercises with stable lower extremity Standing position,core engagement, Arm position controlled movement minimizing trunk and hip movement, perturbations technique to improve stability Receives: Other: Conventional Physical Therapy Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory Motor Function of upper Limb
Fugl-Meyer Assessment test for Upper extremity (FMA-UE)
Measured: Baseline and post 6 weeks
Upper Extremity strength
Action Research Arm Test (ARAT)
Measured: Baseline and post 6 weeks
Forward reach Distance
Functional Reach Test (FRT)
Measured: Baseline and post 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start1 Jun 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion5 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aiza Yousaf, MS-OMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07646418
- Sponsor's protocol ID
- REC/RCR&AHS/25/0242
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of Low Intensity Resistance Training With Blood Flow Restriction Therapy on Upper Limb Strength, Forward Reach and Sensorimotor Function in Post-Stroke Patients
- ClinicalTrials.gov ID
- NCT07646418
- Acronym / sponsor ID
- REC/RCR&AHS/25/0242
- Conditions
- Stroke
- Keywords
- Balance, BFR Therapy, Low intensity Resistance Training, Muscle Strength
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 5 Jul 2026 (estimated)
- First posted
- 12 Jun 2026 (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 focal neurological deficit of sudden onset, with symptoms lasting more than 24 hours leading to consequences like impacting physical abilities, cognitive functions and emotional well-being, speech and language difficulties. Among various rehabilitation program, Blood flow restriction (BFR) therapy with low intensity resistance training has shown its promising results. Blood flow restriction training, also called Kaatsu, originated in Japan. So this study aims to determine the combined effects of Low Intensity Resistance Training with Blood Flow Restriction Therapy on Upper Limb Strength, Forward Reach and Sensorimotor function in Post-Stroke Patients.
Detailed description
It will be a single-blinded randomized controlled trial. Non-probability convenience sampling technique will be used to recruit 64 participants aged 50 to 70 years, one-month post-stroke from hospitals of Sialkot. Sealed opaque method will be used to evenly divide to either Group-BFR therapy or Group-conventional physical therapy. Group-BFR therapy will perform low-intensity resistance exercises at 40% of their 1-RM using 2 kg weights and resistance bands, cuff will be applied at proximal site of upper limb at 150-160 mmHg. Group-conventional physical therapy will perform sensorimotor exercises and strength training with 2-3 kg weights, bands and forward reaching activities. Both groups will perform their respective exercises for 40 minutes, 4 days/week, for 6 weeks. Participants will be evaluated at the baseline and post-intervention exercise program. Outcome measures include the Fugl-Meyer Assessment for upper extremity function, the Functional Reach Test for forward reach, and the Action Research Arm Test for strength. Data will be analyzed using SPSS software 25. After normality testing of the data, the Paired sample t-test will be used for parametric data while Wilcoxon test will be used for non-parametric data in intragroup comparison, while for intergroup comparison, the independent t-test will be for parametric data and Mann-Whitney U test will be used for non-parametric data
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Low intensity resistance training with Blood flow restriction therapy | Experimental | Other: Low intensity resistance training with Blood flow restriction therapyLow intensity resistance training with BFR in U.L Using B.P cuff at proximal site of U.L 40% of 1RM Resistance training of U.L will be performed using small weights (1-2kg) and resistance bands. Cuff pressure should be 150-160 mmHg |
| Conventional Physical Therapy Protocol | Active comparator | Other: Conventional Physical Therapy ProtocolUpper extremity Motor skills: Reaching, Grasping Strengthening Exercises, CIMT Sensory skills: By manually exploring different objects, temperature and pressure Dull stroke through cotton, Sharp stroke through common pin, needle to retrain sensory inputs. Upper extremity Strengthening exercises Strengthening Exercises through Thera bands, 1 or 2 kg dumbels Forward Reaching exercises with stable lower extremity Reaching exercises with stable lower extremity Standing position,core engagement, Arm position controlled movement minimizing trunk and hip movement, perturbations technique to improve stability |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- • 50 to 70 year of age (5)
Key exclusion criteria (5 listed)
- • People with a history of mental/cognitive illness (9)
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 intensity resistance training with Blood flow restriction therapyLow intensity resistance training with BFR in U.L Using B.P cuff at proximal site of U.L 40% of 1RM Resistance training of U.L will be performed using small weights (1-2kg) and resistance bands. Cuff pressure should be 150-160 mmHg | Other | Low intensity resistance training with Blood flow restriction therapy |
| Conventional Physical Therapy ProtocolUpper extremity Motor skills: Reaching, Grasping Strengthening Exercises, CIMT Sensory skills: By manually exploring different objects, temperature and pressure Dull stroke through cotton, Sharp stroke through common pin, needle to retrain sensory inputs. Upper extremity Strengthening exercises Strengthening Exercises through Thera bands, 1 or 2 kg dumbels Forward Reaching exercises with stable lower extremity Reaching exercises with stable lower extremity Standing position,core engagement, Arm position controlled movement minimizing trunk and hip movement, perturbations technique to improve stability. | Other | Conventional Physical Therapy Protocol |
Primary outcome
Sensory Motor Function of upper Limb
Time frame: Baseline and post 6 weeks
Fugl-Meyer Assessment test for Upper extremity (FMA-UE)
Upper Extremity strength
Time frame: Baseline and post 6 weeks
Action Research Arm Test (ARAT)
Forward reach Distance
Time frame: Baseline and post 6 weeks
Functional Reach Test (FRT)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aiza Yousaf, MS-OMPT 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 Low intensity resistance training with Blood flow restriction therapy and Conventional Physical Therapy Protocol 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 7 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: looking for participants now, as of the sponsor's last update on 12 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, PhD (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensory Motor Function of upper Limb (time frame: Baseline and post 6 weeks). 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?
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 12 Jun 2026.