The Effect of Blood Flow Restriction Training on the Patients of Distal Radius Fracture

NCT05371431 | Completed

• 1 other identifier: KY20200820-01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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 stiffness and radiographic outcomes in distal radius fracture (DRF) patients during a post-treatment rehabilitation program.

Conditions

Distal Radius Fracture

Outcome Measures

Primary Outcomes (10)

• 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.

  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.

  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.

  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.

  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.

  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.

  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).

  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).

  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.

  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.

  Conducted at the 12th week from the date of initial gypsum immobilization.

Secondary Outcomes (4)

• Radiographic outcomes

  Conducted at 1th week(post injury).

• Radiographic outcomes

  Conducted at 1th week(post reduction).

• Radiographic outcomes

  Conducted at 6th week.

• Radiographic outcomes

  Conducted at 12th week.

Study Arms (2)

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.

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.

Other: Blood flow restriction combined with traditional rehabilitation training

Interventions

Traditional rehabilitation training OTHER

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.

non-BFR groups

Blood flow restriction combined with traditional rehabilitation training OTHER

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.

BFR groups

Eligibility Criteria

• Age: 50 Years - 73 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210000, China

Location

Related Publications (2)

• 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.

  PMID: 40075367 DERIVED

• Yang 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.

  PMID: 37259253 DERIVED

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• bin Liang, Prof

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: May 12, 2022
• Study Start: May 1, 2021
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: May 12, 2022

Record last verified: 2022-04

Locations

CN (1)