Clinical Trial: Acute effects of blood flow restriction-augmented passive manual therapy on hip flexion range of motion (Straight Leg Raise) and muscle stiffness: A within-subject controlled trial (Japan)

Tokyo, April 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061381) titled 'Acute effects of blood flow restriction-augmented passive manual therapy on hip flexion range of motion (Straight Leg Raise) and muscle stiffness: A within-subject controlled trial' on April 27.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Givers Holdings Co., Ltd.

Condition: Condition - Healthy adults (musculoskeletal flexibility assessment) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To investigate the acute effects of blood flow restriction (BFR)-augmented passive manual therapy on hip flexion range of motion (ROM) measured by the Straight Leg Raise (SLR) test and muscle stiffness in healthy adults, compared with the same therapy without BFR. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - BFR condition: A pneumatic cuff (FAST BELT, 28 cm width; Inifia Co., Ltd., Tokyo, Japan) is applied to the proximal thigh and inflated to 200-250 mmHg. Six consecutive passive manual techniques are performed for 20 seconds each, totaling approximately 2 minutes: (1) hip joint mobilization (internal and external rotation, supine); (2) passive stretching of the hamstrings and lower leg (supine); (3) passive stretching of the gluteus medius (supine); (4) passive stretching of the gluteus maximus (supine); (5) passive stretching of the hip adductors (supine); (6) passive stretching of the quadriceps (side-lying). All techniques are performed by the clinician to the participant's tolerable end range. The cuff is deflated immediately after the final technique. Intervention time: approximately 2 minutes per limb. Interventions/Control_2 - Control condition: The contralateral limb undergoes the same six-technique protocol without BFR. The same clinician performs identical techniques in the same standardized order and duration (20 seconds each). Intervention time: approximately 2 minutes per limb.

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - (1) Healthy adults aged 20-65 years; (2) No current lower limb injuries; (3) No contraindications to blood flow restriction (BFR), such as deep vein thrombosis, peripheral vascular disease, or pregnancy; (4) Able to provide written informed consent; (5) Able to undergo passive manual therapy on both lower limbs. Key exclusion criteria - (1) Deep vein thrombosis (DVT) or history thereof; (2) Peripheral vascular disease; (3) Pregnancy; (4) Severe hypertension (systolic >=180 mmHg or diastolic >=110 mmHg); (5) Use of anticoagulant medication; (6) Acute musculoskeletal injury; (7) Other conditions deemed unsafe by the principal investigator. Target Size - 26

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2026 Year 03 Month 29 Day Date of IRB - 2026 Year 03 Month 29 Day Anticipated trial start date - 2026 Year 03 Month 30 Day Last follow-up date - 2026 Year 04 Month 07 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070228

Disclaimer: Curated by HT Syndication.