UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061381 |
|---|---|
| Receipt number | R000070228 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2026/04/27 |
| Last modified on | 2026/04/26 19:10:42 |
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Basic information
Public title
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
Acronym
BFR-SLR Study
Scientific Title
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
Scientific Title:Acronym
BFR-SLR Study
Region
| Japan |
Condition
Condition
Healthy adults (musculoskeletal flexibility assessment)
Classification by specialty
| Orthopedics | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Pre-to-post change in passive hip flexion range of motion (ROM) measured by the Straight Leg Raise (SLR) test. With the participant in the supine position and both lower limbs in extension on the examination table, the examiner passively elevates the test limb while maintaining the knee in full extension, until the participant's tolerable maximum (point of discomfort). Hip flexion angle is measured using a standard goniometer with the axis aligned at the greater trochanter, with the stationary arm parallel to the examination table and the movable arm aligned with the long axis of the femur (greater trochanter to lateral femoral epicondyle). Three measurements are taken at each time point; the mean value is used for analysis. Timing: immediately before and immediately after the intervention.
Key secondary outcomes
1) Pre-to-post change in tissue hardness of the rectus femoris (quadriceps), measured using NEUTONE TDM-N1 (TRY-ALL Corp., Chiba, Japan). The device measures the penetration resistance of a hemispherical indenter at standardized contact pressure, providing relative hardness values on a unitless 0-100 scale. Three measurements per site; the mean value is used for analysis. Timing: immediately before and immediately after the intervention.
2) Pre-to-post change in tissue hardness of the biceps femoris (hamstrings), measured using the same device, method, and timing as above.
3) Adverse events (numbness/subcutaneous bleeding at the cuff application site, pain during the intervention, etc.), evaluated throughout and after the intervention.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 65 | 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 sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Aki |
Organization
Givers Holdings Co., Ltd.
Division name
Headquarters
Zip code
160-0022
Address
Shinjuku East Court 8F, 6-28-7 Shinjuku, Shinjuku-ku, Tokyo 160-0022, Japan
TEL
09082822314
cocoro.aki@gmail.com
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Aki |
Organization
Givers Holdings Co., Ltd.
Division name
Headquarters
Zip code
160-0022
Address
Shinjuku East Court 8F, 6-28-7 Shinjuku, Shinjuku-ku, Tokyo 160-0022, Japan
TEL
09082822314
Homepage URL
https://givers.co.jp
cocoro.aki@gmail.com
Sponsor or person
Institute
Givers Holdings Co., Ltd.
Institute
Department
Personal name
Yasuhiro Aki
Funding Source
Organization
Givers Holdings Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Givers Inc. Ethics Review Board
Address
Shinjuku East Court 8F, 6-28-7 Shinjuku, Shinjuku-ku, Tokyo 160-0022, Japan
Tel
09063193977
cocoro.tsuyama@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
giversホールディングス株式会社 本部（東京都）
giversホールディングス株式会社 研修所（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
26
Results
The BFR limb showed significantly greater hip flexion ROM (SLR) improvement compared with the control limb (mean difference +6.6 degrees; 95% CI 3.2-10.0; paired t-test, p < 0.001; Cohen's dz = 0.81). Tissue hardness of the rectus femoris (p = 0.572; dz = 0.11) and biceps femoris (p = 0.694; dz = 0.08) did not differ significantly between conditions. No adverse events occurred.
Results date posted
| 2026 | Year | 04 | Month | 26 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
The manuscript is being prepared for submission to BMC Sports Science, Medicine and Rehabilitation. Results will be updated after publication.
Date of the first journal publication of results
Baseline Characteristics
Twenty-six healthy adults (13 males, 13 females). Age 33.0 +/- 10.5 years (range 23-60 years). No current lower limb injuries, no contraindications to BFR application. BFR limb assignment: 13 participants on the right limb, 13 on the left (counterbalanced).
Participant flow
All 26 participants completed the study protocol. No dropouts or exclusions. Outcome measurements were performed immediately before and after the intervention in all participants.
Adverse events
No adverse events occurred. None of the participants reported pain, numbness, or discomfort beyond ordinary stretching sensation during or after BFR application. No subcutaneous bleeding at the cuff site, neurological symptoms, or other adverse events were recorded.
Outcome measures
Primary outcome: Hip flexion ROM (SLR); BFR limb +15.2 +/- 7.9 degrees, control limb +8.6 +/- 7.5 degrees, between-limb difference +6.6 degrees (95% CI 3.2-10.0; paired t-test p<0.001; Cohen's dz=0.81).
Secondary outcomes: (1) Pre-to-post change in rectus femoris hardness; between-limb difference -1.0 (95% CI -4.5, 2.5; p=0.572; dz=0.11). (2) Pre-to-post change in biceps femoris hardness; between-limb difference -0.5 (95% CI -3.8, 2.8; p=0.694; dz=0.08).
Plan to share IPD
No formal plan to share individual participant data (IPD). However, anonymized data may be shared upon reasonable request, at the discretion of the principal investigator (Yasuhiro Aki).
IPD sharing Plan description
Researchers wishing to access the data should submit a written request to the corresponding author (Yasuhiro Aki, aki@givers.co.jp), specifying the research purpose, analysis plan, and researcher affiliation.
Progress
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 |
Date of closure to data entry
| 2026 | Year | 04 | Month | 08 | Day |
Date trial data considered complete
| 2026 | Year | 04 | Month | 08 | Day |
Date analysis concluded
| 2026 | Year | 04 | Month | 09 | Day |
Other
Other related information
This trial was registered retrospectively with the UMIN Clinical Trials Registry (UMIN-CTR) after participant enrollment and data collection had been completed. The protocol was approved by the Givers Ethics Review Board (MHLW Registration No. 26000021) on March 29, 2026. Data collection was conducted from March 30 to April 7, 2026. Statistical analysis was completed by April 9, 2026.
Management information
Registered date
| 2026 | Year | 04 | Month | 26 | Day |
Last modified on
| 2026 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070228
