Combined Effects of LIRT-BFR Therapy in Post- Stroke Patients

NCT07646418 | Recruiting DMC

• 1 other identifier: REC/RCR&AHS/25/0242
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke

Keywords

Balance; BFR Therapy; Low intensity Resistance Training; Muscle Strength

Outcome Measures

Primary Outcomes (3)

• Sensory Motor Function of upper Limb

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

  Baseline and post 6 weeks

• Upper Extremity strength

  Action Research Arm Test (ARAT)

  Baseline and post 6 weeks

• Forward reach Distance

  Functional Reach Test (FRT)

  Baseline and post 6 weeks

Study Arms (2)

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

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

Other: Conventional Physical Therapy Protocol

Interventions

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.

Conventional Physical Therapy Protocol

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

Low intensity resistance training with Blood flow restriction therapy

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Amin Welfare & Teaching Hospital

Sialkot, Punjab Province, 39000, Pakistan

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Aiza Yousaf, MS-OMPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, PhD

CONTACT

03324390125; imran.amjad@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: investigator, an independent assessor, who is blinded to the group allocations, will be responsible for evaluating outcomes, including sensorimotor function, strength, and forward reaching distance of upper limb of post-stroke patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised Controlled Trial

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 12, 2026
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 5, 2026
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)