Distal Radius FractureNCT05371431
The Effect of Blood Flow Restriction Training on the Patients of Distal Radius Fracture
A study testing Traditional rehabilitation training and Blood flow restriction combined with traditional rehabilitation training in people with Distal Radius Fracture, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
The aim of this study was to compare the effect of blood flow restriction (BFR) training and traditional rehabilitation training on grip strength, pinch strength (tip pinch strength, key pinch strength and tripod pinch strength), range of motion (ROM) of wrist, patient-rated wrist evaluation (PRWE) score, muscle… Read more about this study
- Who is it for?
- Ages 50 to 73 years
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Traditional rehabilitation training and Blood flow restriction combined with traditional rehabilitation training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 73 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 50 and 75 years
- Colles' fracture
- No history of wrist injury or joint deformity
- No other types of upper limb injuries occurred in the last 3 months
- No cardiovascular diseases
Who cannot join
- Concurrent ipsilateral upper limb fracture
- Concurrent bilateral upper limb fractures
- History of surgery or any invasive procedure on the upper limb
- History of peripheral arterial disease or deep vein thrombosis
- History of cancer that has generated limitations or restrictions to physical exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Individualized Blood Flow Restriction Training on the Patients Following the Conservative Treatment of Distal Radius Fracture
The aim of this study was to compare the effect of blood flow restriction (BFR) training and traditional rehabilitation training on grip strength, pinch strength (tip pinch strength, key pinch strength and tripod pinch strength), range of motion (ROM) of wrist, patient-rated wrist evaluation (PRWE) score, muscle stiffness and radiographic outcomes in distal radius fracture (DRF) patients during a post-treatment rehabilitation program.
Read the detailed description
This study is a randomized controlled study. Patients in the non-BFR group underwent a traditional rehabilitation training. Traditional rehabilitation training is designed based on post injury rehabilitation guidelines. This guideline recommends that the early rehabilitation of DRF should be progressive, with training loads ranging from self-weight to full weight bearing depending on the patient's individual situation. During the six weeks, a progressive training load has been applied to the patients. First week: no weight bearing. Second to sixth week: resistance was increased by 1LB (~0.45 kg) for individual training only if a participant could consecutively achieve at least 30/15/15/15 (75 total) repetitions for both training sessions within a given training week. The exercises include grip and pinch, wrist flexion with forearm pronated, wrist extension with forearm pronated, wrist flexion with forearm supinated, wrist extension with forearm supinated, prayer sign (wrist flexion), prayer sign (wrist extension), forearm pronation, and forearm supination. Patients participated in 2 training sessions per week with at least 48 hours rest in between for continuous 6 weeks. BFR training twice a week for at least 6 weeks has been reported to increase muscle hypertrophy and strength. The BFR group underwent the same traditional rehabilitation training program but combined with BFR implemented by a medical grade tourniquet system (ATS 4000 TS，Zimmer Surgical, Inc. Dover). The tourniquet system consists of a ATS 4000 tourniquet system, and a tourniquet cuff (10 cm × 46 cm). The ATS 4000 tourniquet system tailors the individualized tourniquet pressure to each patient following determination of the limb occlusion pressure (LOP), and studies have shown that 50% LOP is safe and effective in the rehabilitation of DRF. When the tourniquet system was used, LOPs were reassessed for every session before training, and pressures were continually monitored. Participants were to perform the entirety of each training (including intra-set rest periods) under 50% LOP with the tourniquets released during the 2-minute rest periods between sets.
- Conditions
- Distal Radius Fracture
- Being tested
- Traditional rehabilitation training, Blood flow restriction combined with traditional rehabilitation training
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional rehabilitation trainingOther
The non-BFR group undertook traditional rehabilitation training only. Patients participated in 2 training sessions per week with at least 48 hours rest in between for continuous 6 weeks. Clinical assessment of grip strength, pinch strength (tip pinch strength, key pinch strength and tripod pinch strength), ROM of wrist, PRWE score, muscle stiffness and radiographic outcomes, was conducted at the 6th and 12th week from the date of initial DRF.
Blood flow restriction combined with traditional rehabilitation trainingOther
BFR group completed the traditional rehabilitation training with a medical grade tourniquet applied on the upper arm. Patients participated in 2 training sessions per week with at least 48 hours rest in between for continuous 6 weeks. Clinical assessment of grip strength, pinch strength (tip pinch strength, key pinch strength and tripod pinch strength), ROM of wrist, PRWE score, muscle stiffness and radiographic outcomes, was conducted at the 6th and 12th week from the date of initial DRF.
| Study group | Role | What they receive |
|---|---|---|
| non-BFR groups | Experimental | Traditional rehabilitation training is designed according to postoperative orthopaedic rehabilitation guidelines. Traditional rehabilitation trainings include grip and pinch, wrist flexion with forearm pronated, wrist extension with forearm pronated, wrist flexion with forearm supinated, wrist extension with forearm supinated, prayer sign (wrist flexion), prayer sign (wrist extension), forearm pronation, forearm supination. Patients participated in 2 training sessions per week with at least 48 hours rest in between for continuous 6 weeks. Receives: Other: Traditional rehabilitation training |
| BFR groups | Experimental | Patients in the BFR group underwent the same traditional rehabilitation training protocol with non-BFR utilizing a medical grade tourniquet system (ATS 4000 TS，Zimmer Surgical, Inc. Dover). The ATS 4000 tourniquet system tailors the individualized tourniquet pressure to each patient following determination of the limb occlusion pressure (LOP), and studies have shown that 50% LOP is safe and effective in the rehabilitation of DRF. When the tourniquet system was used, LOPs were reassessed for every session before training, and pressures were continually monitored. Participants were to perform the entirety of each training (including intra-set rest periods) under 50% LOP with the tourniquets released during the 2-minute rest periods between sets. Patients participated in 2 training sessions per week with at least 48 hours rest in between for continuous 6 weeks. Receives: Other: Blood flow restriction combined with traditional rehabilitation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
grip strength
Grip strength (JA Preston, Corporation Jackson, MI, USA) was measured in method recommended by the American Society of Hand Therapists. The scale of the dynamometer indicated handgrip strength in kilograms (kg). The testing protocol consisted of three maximal voluntary isometric contractions maintained for 5 s, with rest period of at least 60 s; the highest value was used for the determination of the maximal grip strength. Participants standing, shoulder in a neutral position, arm by side, elbow fully extended. Specific verbal instructions were given to subjects before the evaluations and the experiments were performed with verbal encouragement.
Measured: Conducted at the 6th week from the date of initial gypsum immobilization.
grip strength
Grip strength (JA Preston, Corporation Jackson, MI, USA) was measured in method recommended by the American Society of Hand Therapists. The scale of the dynamometer indicated handgrip strength in kilograms (kg). The testing protocol consisted of three maximal voluntary isometric contractions maintained for 5 s, with rest period of at least 60 s; the highest value was used for the determination of the maximal grip strength. Participants standing, shoulder in a neutral position, arm by side, elbow fully extended. Specific verbal instructions were given to subjects before the evaluations and the experiments were performed with verbal encouragement.
Measured: Conducted at the 12th week from the date of initial gypsum immobilization.
Pinch Strength
Pinch strength (B\&L Engineering, Sana Ana, CA) were measured in method recommended by the American Society of Hand Therapists. Participants were seated with their shoulder adducted and neutrally rotated, elbow flexed to 90°, forearm in neutral position. Three measurements were made and the average value was used.
Measured: Conducted at the 6th week from the date of initial gypsum immobilization.
Pinch Strength
Pinch strength (B\&L Engineering, Sana Ana, CA) were measured in method recommended by the American Society of Hand Therapists. Participants were seated with their shoulder adducted and neutrally rotated, elbow flexed to 90°, forearm in neutral position. Three measurements were made and the average value was used.
Measured: Conducted at the 12th week from the date of initial gypsum immobilization.
ROM of the wrist
ROM of the wrist (wrist flexion, extension, radial deviation, ulnar deviation; forearm supination and pronation) was measured by a goniometer in positions recommended by the American Society of Hand Therapists. Three measurements were made and the average value was used.
Measured: Conducted at the 6th week from the date of initial gypsum immobilization.
ROM of the wrist
ROM of the wrist (wrist flexion, extension, radial deviation, ulnar deviation; forearm supination and pronation) was measured by a goniometer in positions recommended by the American Society of Hand Therapists. Three measurements were made and the average value was used.
Measured: Conducted at the 12th week from the date of initial gypsum immobilization.
PRWE Score
The PRWE is a region specific outcome measure that evaluates wrist-related disability. It contains 15 items: five of which evaluate pain (intensity and frequency) and 10 evaluate function (specific activities and usual activities). Participants are instructed to answer all questions by rating their average pain and level of function over the past week. To produce the function subscale score, the responses to the 10 functional items are tallied and divided by two. Adding the pain and function subscale scores produces the total PRWE score, where 0 is the best score (no pain or difficulty performing activities) and 100 is the worse score (severe continuous pain and unable to perform activities).
Measured: Conducted at the 6th week from the date of initial gypsum immobilization.
PRWE Score
The PRWE is a region specific outcome measure that evaluates wrist-related disability. It contains 15 items: five of which evaluate pain (intensity and frequency) and 10 evaluate function (specific activities and usual activities). Participants are instructed to answer all questions by rating their average pain and level of function over the past week. To produce the function subscale score, the responses to the 10 functional items are tallied and divided by two. Adding the pain and function subscale scores produces the total PRWE score, where 0 is the best score (no pain or difficulty performing activities) and 100 is the worse score (severe continuous pain and unable to perform activities).
Measured: Conducted at the 12th week from the date of initial gypsum immobilization.
Muscle Stiffness
Muscle stiffness (MyotonPRO, Myoton Ltd, Estonia) was measured in method recommended by the Ditroilo et al. Participants were required to expose their arms in the relaxed position. To maintain consistency of measurements among participants, marks were drawn on the skin in the following site on arm. Five consecutive measurements were taken. The average of the five measurements was used for later analysis.
Measured: Conducted at the 6th week from the date of initial gypsum immobilization.
Muscle Stiffness
Muscle stiffness (MyotonPRO, Myoton Ltd, Estonia) was measured in method recommended by the Ditroilo et al. Participants were required to expose their arms in the relaxed position. To maintain consistency of measurements among participants, marks were drawn on the skin in the following site on arm. Five consecutive measurements were taken. The average of the five measurements was used for later analysis.
Measured: Conducted at the 12th week from the date of initial gypsum immobilization.
Secondary outcomes (4)
Radiographic outcomes
Anteroposterior and lateral radiographs (Kodak DR, DR Evolution, Eastman Kodak) were acquired at pre and post training as safety indicators. Radiographic outcomes were measured by doctors of the same profession.
Measured: Conducted at 1th week(post injury).
Radiographic outcomes
Anteroposterior and lateral radiographs (Kodak DR, DR Evolution, Eastman Kodak) were acquired at pre and post training as safety indicators. Radiographic outcomes were measured by doctors of the same profession.
Measured: Conducted at 1th week(post reduction).
Radiographic outcomes
Anteroposterior and lateral radiographs (Kodak DR, DR Evolution, Eastman Kodak) were acquired at pre and post training as safety indicators. Radiographic outcomes were measured by doctors of the same profession.
Measured: Conducted at 6th week.
Radiographic outcomes
Anteroposterior and lateral radiographs (Kodak DR, DR Evolution, Eastman Kodak) were acquired at pre and post training as safety indicators. Radiographic outcomes were measured by doctors of the same profession.
Measured: Conducted at 12th week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start1 May 2021
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- bin Liang, Prof, Study director, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371431
- Sponsor's protocol ID
- KY20200820-01
- Status last verified
- Apr 2022
- First submitted
- 6 Apr 2022
- Last updated
- 12 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yang M, Liang B, Zhao X, Wang Y, Xue M, Song Q, Wang D. The effectiveness of individualized blood flow restriction training following patellar fracture surgery: a case series. BMC Musculoskelet Disord. 2025 Mar 12;26(1):247. doi: 10.1186/s12891-025-08424-2.
PubMed 40075367Yang M, Liang B, Zhao X, Wang Y, Xue M, Wang D. BFR Training Improves Patients' Reported Outcomes, Strength, and Range of Motion After Casting for Colles' Fracture. Med Sci Sports Exerc. 2023 Nov 1;55(11):1985-1994. doi: 10.1249/MSS.0000000000003228. Epub 2023 Jun 1.
PubMed 37259253
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Individualized Blood Flow Restriction Training on the Patients Following the Conservative Treatment of Distal Radius Fracture
- ClinicalTrials.gov ID
- NCT05371431
- Acronym / sponsor ID
- KY20200820-01
- Conditions
- Distal Radius Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 12 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to compare the effect of blood flow restriction (BFR) training and traditional rehabilitation training on grip strength, pinch strength (tip pinch strength, key pinch strength and tripod pinch strength), range of motion (ROM) of wrist, patient-rated wrist evaluation (PRWE) score, muscle stiffness and radiographic outcomes in distal radius fracture (DRF) patients during a post-treatment rehabilitation program.
Detailed description
This study is a randomized controlled study. Patients in the non-BFR group underwent a traditional rehabilitation training. Traditional rehabilitation training is designed based on post injury rehabilitation guidelines. This guideline recommends that the early rehabilitation of DRF should be progressive, with training loads ranging from self-weight to full weight bearing depending on the patient's individual situation. During the six weeks, a progressive training load has been applied to the patients. First week: no weight bearing. Second to sixth week: resistance was increased by 1LB (~0.45 kg) for individual training only if a participant could consecutively achieve at least 30/15/15/15 (75 total) repetitions for both training sessions within a given training week. The exercises include grip and pinch, wrist flexion with forearm pronated, wrist extension with forearm pronated, wrist flexion with forearm supinated, wrist extension with forearm supinated, prayer sign (wrist flexion), prayer sign (wrist extension), forearm pronation, and forearm supination. Patients participated in 2 training sessions per week with at least 48 hours rest in between for continuous 6 weeks. BFR training twice a week for at least 6 weeks has been reported to increase muscle hypertrophy and strength. The BFR group underwent the same traditional rehabilitation training program but combined with BFR implemented by a medical grade tourniquet system (ATS 4000 TS，Zimmer Surgical, Inc. Dover). The tourniquet system consists of a ATS 4000 tourniquet system, and a tourniquet cuff (10 cm × 46 cm). The ATS 4000 tourniquet system tailors the individualized tourniquet pressure to each patient following determination of the limb occlusion pressure (LOP), and studies have shown that 50% LOP is safe and effective in the rehabilitation of DRF. When the tourniquet system was used, LOPs were reassessed for every session before training, and pressures were continually monitored. Participants were to perform the entirety of each training (including intra-set rest periods) under 50% LOP with the tourniquets released during the 2-minute rest periods between sets.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-BFR groups | Experimental | Other: Traditional rehabilitation trainingTraditional rehabilitation training is designed according to postoperative orthopaedic rehabilitation guidelines. Traditional rehabilitation trainings include grip and pinch, wrist flexion with forearm pronated, wrist extension with forearm pronated, wrist flexion with forearm supinated, wrist extension with forearm supinated, prayer sign (wrist flexion), prayer sign (wrist extension), forearm pronation, forearm supination. Patients participated in 2 training sessions per week with at least 48 hours rest in between for continuous 6 weeks. |
| BFR groups | Experimental | Other: Blood flow restriction combined with traditional rehabilitation trainingPatients in the BFR group underwent the same traditional rehabilitation training protocol with non-BFR utilizing a medical grade tourniquet system (ATS 4000 TS，Zimmer Surgical, Inc. Dover). The ATS 4000 tourniquet system tailors the individualized tourniquet pressure to each patient following determination of the limb occlusion pressure (LOP), and studies have shown that 50% LOP is safe and effective in the rehabilitation of DRF. When the tourniquet system was used, LOPs were reassessed for every session before training, and pressures were continually monitored. Participants were to perform the entirety of each training (including intra-set rest periods) under 50% LOP with the tourniquets released during the 2-minute rest periods between sets. Patients participated in 2 training sessions per week with at least 48 hours rest in between for continuous 6 weeks. |
Who may qualify
- Ages
- 50 to 73 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Between the ages of 50 and 75 years
- Colles' fracture
- No history of wrist injury or joint deformity
- No other types of upper limb injuries occurred in the last 3 months
- No cardiovascular diseases
Key exclusion criteria (5 listed)
- Concurrent ipsilateral upper limb fracture
- Concurrent bilateral upper limb fractures
- History of surgery or any invasive procedure on the upper limb
- History of peripheral arterial disease or deep vein thrombosis
- History of cancer that has generated limitations or restrictions to physical exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional rehabilitation trainingThe non-BFR group undertook traditional rehabilitation training only. Patients participated in 2 training sessions per week with at least 48 hours rest in between for continuous 6 weeks. Clinical assessment of grip strength, pinch strength (tip pinch strength, key pinch strength and tripod pinch strength), ROM of wrist, PRWE score, muscle stiffness and radiographic outcomes, was conducted at the 6th and 12th week from the date of initial DRF. | Other | non-BFR groups |
| Blood flow restriction combined with traditional rehabilitation trainingBFR group completed the traditional rehabilitation training with a medical grade tourniquet applied on the upper arm. Patients participated in 2 training sessions per week with at least 48 hours rest in between for continuous 6 weeks. Clinical assessment of grip strength, pinch strength (tip pinch strength, key pinch strength and tripod pinch strength), ROM of wrist, PRWE score, muscle stiffness and radiographic outcomes, was conducted at the 6th and 12th week from the date of initial DRF. | Other | BFR groups |
Primary outcome
grip strength
Time frame: Conducted at the 6th week from the date of initial gypsum immobilization.
Grip strength (JA Preston, Corporation Jackson, MI, USA) was measured in method recommended by the American Society of Hand Therapists. The scale of the dynamometer indicated handgrip strength in kilograms (kg). The testing protocol consisted of three maximal voluntary isometric contractions maintained for 5 s, with rest period of at least 60 s; the highest value was used for the determination of the maximal grip strength. Participants standing, shoulder in a neutral position, arm by side, elbow fully extended. Specific verbal instructions were given to subjects before the evaluations and the experiments were performed with verbal encouragement.
grip strength
Time frame: Conducted at the 12th week from the date of initial gypsum immobilization.
Grip strength (JA Preston, Corporation Jackson, MI, USA) was measured in method recommended by the American Society of Hand Therapists. The scale of the dynamometer indicated handgrip strength in kilograms (kg). The testing protocol consisted of three maximal voluntary isometric contractions maintained for 5 s, with rest period of at least 60 s; the highest value was used for the determination of the maximal grip strength. Participants standing, shoulder in a neutral position, arm by side, elbow fully extended. Specific verbal instructions were given to subjects before the evaluations and the experiments were performed with verbal encouragement.
Pinch Strength
Time frame: Conducted at the 6th week from the date of initial gypsum immobilization.
Pinch strength (B\&L Engineering, Sana Ana, CA) were measured in method recommended by the American Society of Hand Therapists. Participants were seated with their shoulder adducted and neutrally rotated, elbow flexed to 90°, forearm in neutral position. Three measurements were made and the average value was used.
Pinch Strength
Time frame: Conducted at the 12th week from the date of initial gypsum immobilization.
Pinch strength (B\&L Engineering, Sana Ana, CA) were measured in method recommended by the American Society of Hand Therapists. Participants were seated with their shoulder adducted and neutrally rotated, elbow flexed to 90°, forearm in neutral position. Three measurements were made and the average value was used.
ROM of the wrist
Time frame: Conducted at the 6th week from the date of initial gypsum immobilization.
ROM of the wrist (wrist flexion, extension, radial deviation, ulnar deviation; forearm supination and pronation) was measured by a goniometer in positions recommended by the American Society of Hand Therapists. Three measurements were made and the average value was used.
ROM of the wrist
Time frame: Conducted at the 12th week from the date of initial gypsum immobilization.
ROM of the wrist (wrist flexion, extension, radial deviation, ulnar deviation; forearm supination and pronation) was measured by a goniometer in positions recommended by the American Society of Hand Therapists. Three measurements were made and the average value was used.
PRWE Score
Time frame: Conducted at the 6th week from the date of initial gypsum immobilization.
The PRWE is a region specific outcome measure that evaluates wrist-related disability. It contains 15 items: five of which evaluate pain (intensity and frequency) and 10 evaluate function (specific activities and usual activities). Participants are instructed to answer all questions by rating their average pain and level of function over the past week. To produce the function subscale score, the responses to the 10 functional items are tallied and divided by two. Adding the pain and function subscale scores produces the total PRWE score, where 0 is the best score (no pain or difficulty performing activities) and 100 is the worse score (severe continuous pain and unable to perform activities).
PRWE Score
Time frame: Conducted at the 12th week from the date of initial gypsum immobilization.
The PRWE is a region specific outcome measure that evaluates wrist-related disability. It contains 15 items: five of which evaluate pain (intensity and frequency) and 10 evaluate function (specific activities and usual activities). Participants are instructed to answer all questions by rating their average pain and level of function over the past week. To produce the function subscale score, the responses to the 10 functional items are tallied and divided by two. Adding the pain and function subscale scores produces the total PRWE score, where 0 is the best score (no pain or difficulty performing activities) and 100 is the worse score (severe continuous pain and unable to perform activities).
Muscle Stiffness
Time frame: Conducted at the 6th week from the date of initial gypsum immobilization.
Muscle stiffness (MyotonPRO, Myoton Ltd, Estonia) was measured in method recommended by the Ditroilo et al. Participants were required to expose their arms in the relaxed position. To maintain consistency of measurements among participants, marks were drawn on the skin in the following site on arm. Five consecutive measurements were taken. The average of the five measurements was used for later analysis.
Muscle Stiffness
Time frame: Conducted at the 12th week from the date of initial gypsum immobilization.
Muscle stiffness (MyotonPRO, Myoton Ltd, Estonia) was measured in method recommended by the Ditroilo et al. Participants were required to expose their arms in the relaxed position. To maintain consistency of measurements among participants, marks were drawn on the skin in the following site on arm. Five consecutive measurements were taken. The average of the five measurements was used for later analysis.
4 secondary outcomes
Radiographic outcomes
Time frame: Conducted at 1th week(post injury).
Radiographic outcomes
Time frame: Conducted at 1th week(post reduction).
Radiographic outcomes
Time frame: Conducted at 6th week.
Radiographic outcomes
Time frame: Conducted at 12th week.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
- Derived from this study: PubMed 40075367Yang M, Liang B, Zhao X, Wang Y, Xue M, Song Q, Wang D. The effectiveness of individualized blood flow restriction training following patellar fracture surgery: a case series. BMC Musculoskelet Disord. 2025 Mar 12;26(1):247. doi: 10.1186/s12891-025-08424-2.
- Derived from this study: PubMed 37259253Yang M, Liang B, Zhao X, Wang Y, Xue M, Wang D. BFR Training Improves Patients' Reported Outcomes, Strength, and Range of Motion After Casting for Colles' Fracture. Med Sci Sports Exerc. 2023 Nov 1;55(11):1985-1994. doi: 10.1249/MSS.0000000000003228. Epub 2023 Jun 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
bin Liang, Prof study director
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional rehabilitation training and Blood flow restriction combined with traditional rehabilitation training in people with Distal Radius Fracture, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
grip strength (time frame: Conducted at the 6th week from the date of initial gypsum immobilization.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05371431, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2022.