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

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

Overview

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

Interventions

• Other Low intensity resistance training with Blood flow restriction therapy
  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 Conventional Physical Therapy Protocol
  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,

Primary outcome measures

• Sensory Motor Function of upper Limb [Time frame: Baseline and post 6 weeks]
• Upper Extremity strength [Time frame: Baseline and post 6 weeks]
• Forward reach Distance [Time frame: Baseline and post 6 weeks]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Pakistan · 1 center

• Amin Welfare & Teaching Hospital — Sialkot

Identifiers

NCT: NCT07646418 · REC/RCR&AHS/25/0242

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗