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NCT Number: NCT07646418

Combined Effects of LIRT-BFR Therapy 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.

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Key information

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amin Welfare & Teaching Hospital

Sialkot, Punjab Province, 39000, Pakistan

Location status: Recruiting

Location contact

Dr. Aqsa Gulzar Ahmed, Mbbs

CONTACT

[email protected]

03484071699

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • 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)

Exclusion criteria

  • • 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)

Treatment and study plan

Low intensity resistance training with Blood flow restriction therapy

Other

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 Protocol

Other

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.

Primary outcomes

  1. Sensory Motor Function of upper Limb

    Time frame: Baseline and post 6 weeks

    Fugl-Meyer Assessment test for Upper extremity (FMA-UE)

  2. Upper Extremity strength

    Time frame: Baseline and post 6 weeks

    Action Research Arm Test (ARAT)

  3. Forward reach Distance

    Time frame: Baseline and post 6 weeks

    Functional Reach Test (FRT)

Study contacts

Contact information is provided by the study sponsor or research team.

Imran Amjad, PhD

CONTACT

[email protected]

03324390125

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 12, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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