An interventional study of Blood flow restriction with low intensity resistance training and Sham Blood flow restriction with low intensity resistance training in Hemiparesis of the Upper Limb Following Stroke, sponsored by University of Maryland, Baltimore. Not yet recruiting. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by University of Maryland, Baltimore · Not applicable, Interventional, and Treatment
This early translational project investigates the effects of combined blood flow restriction and low intensity resistance training on upper extremity strength, recovery, and neuromuscular mechanisms in chronic stroke survivors. Results from this project will provide much needed preliminary data to optimize the design of a larger Phase II/Phase III randomized controlled trials to improve arm function after stroke. This novel treatment is low-cost, clinically feasible and has the potential to substantially improve arm rehabilitation of stroke and other neurological conditions.
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Of its 92 completed or terminated interventional studies of FDA-regulated products, 66 (72%) have results posted.
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Inclusion Criteria: (1) 21-80 years old, (2) history of unilateral stroke at least 6 months ago, (3) Upper extremity Fugl-Meyer (UEFM) score between 25 and 60 with ability to actively perform at least 25 degrees of shoulder abduction, 10-15 degrees of elbow extension against gravity and 5-10 degrees of wrist flexion and extension (compensations allowed), (4) Presence of TMS-evoked MEPs in the paretic ECRL35, (5) Mini-mental score>24
Exclusion Criteria: (1) neurological disorders other than stroke, (2) History of epilepsy, peripheral vascular disease, blood diasthesis, coagulation disorders, hemophilia, cancer, bleeding disorders, (3) uncontrolled hypertension, diabetes, congestive heart failure (4) severe aphasia/ neglect, (5) complex regional pain syndrome, UE pain or swelling, (5) to TMS.
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Participants will receive LIRT of the shoulder abductors, elbow extensors, wrist flexors and extensors- on the more involved (paretic) side. LIRT will then be administered at 30% of that weekly 1RM for each muscle group. During each session, participants will perform 4 sets of 30,15, 15, 15 sets of shoulder abduction, elbow extension, wrist flexion and extension each with 1-min rest between sets, and 2-3 min rest between muscles. For BFR, a tourniquet cuff connected to a Delphi Personalized Tourniquet system will be donned to the paretic upper arm and the cuff will be inflated to 50% AOP during LIRT of paretic muscles. The pressure will be deflated for 3-4 minutes between each muscle training. Providing familiarization and slow AOP progression (starting with 20%AOP and progressing to 50%) in week 1 minimizes participant discomfort and improves patient tolerance to the protocol.
Behavioral: Blood flow restriction with low intensity resistance training
Participants will receive LIRT of the shoulder abductors, elbow extensors, wrist flexors and extensors- on the more involved (paretic) side. LIRT will then be administered at 30% of that weekly 1RM for each muscle group. During each session, participants will perform 4 sets of 30,15, 15, 15 sets of shoulder abduction, elbow extension, wrist flexion and extension each with 1-min rest between sets, and 2-3 min rest between muscles. In the sham-LIRT group, the cuff will be inflated to 50% AOP for 10 seconds and then deflated for the entire duration of LIRT.
Behavioral: Sham Blood flow restriction with low intensity resistance training
Participants will complete 8 weeks of supervised blood flow restriction plus low-intensity resistance training (BFR-LIRT), 2-3 sessions/week, targeting the paretic shoulder abductors, elbow extensors, wrist flexors, and wrist extensors. At the start of each week, one-repetition maximum (1RM) will be measured for each muscle group. Training will be performed at 30% of weekly 1RM using 4 sets of 30-15-15-15 repetitions, with 1-minute rest between sets and 2-3 minutes between muscle groups. A tourniquet cuff will be placed on the proximal paretic arm and inflated to 50% of individualized arterial occlusion pressure during exercise, with pressure released for 3-4 minutes between muscle groups. In week 1, cuff pressure may progress from 20% to 50% for tolerance. Unlike sham training, BFR will be maintained during exercise.
Participants will complete 8 weeks of supervised sham blood flow restriction plus low-intensity resistance training (Sham+LIRT), 2-3 sessions/week, targeting the paretic shoulder abductors, elbow extensors, wrist flexors, and wrist extensors. At the start of each week, one-repetition maximum (1RM) will be measured for each muscle group. Training will be performed at 30% of weekly 1RM using 4 sets of 30-15-15-15 repetitions, with 1-minute rest between sets and 2-3 minutes between muscle groups. A tourniquet cuff will be placed on the proximal paretic arm and inflated to 50% of individualized arterial occlusion pressure for 10 seconds, then deflated for the remainder of training. Thus, participants receive the same exercise dose as BFR-LIRT without sustained blood flow restriction.
Change in Upper Extremity Muscle Strength
Upper extremity muscle strength will be quantified as active peak joint torque of the paretic shoulder abductors, elbow extensors, wrist flexors, and wrist extensors during concentric contractions with upper extremity hemiparetic attachments. Changes in muscle strength will be compared between the BFR-LIRT and Sham+LIRT groups over the intervention period.
Time frame: Baseline and after 3, 6, and 8 weeks of intervention commencement
Reach-to-Grasp Movement Time
Reach-to-grasp performance of the paretic upper extremity will be recorded using a 3-dimensional motion-tracking system. Participants will reach from a standardized starting position and grasp a dowel placed at 90% of their individual maximum reaching distance. Total movement time will be calculated from movement onset to successful grasp of the object. Shorter movement time indicates improved reaching performance.
Time frame: Baseline and after 3, 6, and 8 weeks of intervention commencement
Reach Path Curvature
Reach path curvature will be measured during the same reach-to-grasp task using 3-dimensional motion tracking. Curvature will be calculated as the deviation of the wrist trajectory from a straight path between movement onset and object grasp. Lower values indicate a straighter and more direct reaching movement.
Time frame: Baseline and after 3, 6, and 8 weeks of intervention commencement
Upper Extremity Motor Impairment
Upper extremity motor impairment will be assessed using the Upper Extremity Fugl-Meyer Assessment (UEFM), a standardized clinical measure of motor impairment after stroke. Higher scores indicate less upper extremity motor impairment.
Time frame: Baseline and after 3, 6, and 8 weeks of intervention commencement
Corticospinal Excitability
Corticospinal excitability of the paretic extensor carpi radialis longus (ECRL) will be assessed using transcranial magnetic stimulation (TMS). A TMS recruitment curve will be generated by stimulating the ipsilesional motor cortex at increasing stimulation intensities. Corticospinal excitability will be quantified using the slope of the fitted recruitment curve. A steeper recruitment curve reflects greater corticospinal excitability.
Time frame: Baseline and after 3, 6, and 8 weeks of intervention commencement
Corticoreticulospinal Pathway Excitability
Corticoreticulospinal pathway excitability will be assessed using TMS delivered over the motor cortex contralateral to the paretic arm while recording ipsilateral motor-evoked potentials from the paretic ECRL. Excitability will be quantified using the normalized area of the ipsilateral motor-evoked potential response. Greater response area indicates greater excitability of this pathway.
Time frame: Baseline and after 3, 6, and 8 weeks of intervention commencement
Spinal Segmental Excitability
Spinal segmental excitability will be assessed using the H-reflex recorded from the paretic ECRL during peripheral stimulation of the radial nerve. The maximum H-reflex response will be normalized to the maximum motor response and expressed as the Hmax/Mmax ratio. This measure will be used to quantify changes in spinal pathway excitability.
Time frame: Baseline and after 3, 6, and 8 weeks of intervention commencement
Cross-Sectional Area of the Extensor Carpi Radialis Longus Muscle
Muscle size will be assessed using B-mode ultrasound to measure the cross-sectional area of the paretic extensor carpi radialis longus muscle. Three measurements will be obtained using standardized arm and probe positioning, and the average cross-sectional area will be used for analysis. Greater cross-sectional area indicates greater muscle size.
Time frame: Baseline and after 3, 6, and 8 weeks of intervention commencement
No study locations are listed for this record.
Plan to share: Undecided
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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University of Maryland, Baltimore →