Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01921062
Other study ID # MIDRF
Secondary ID NL36638.042.11
Status Terminated
Phase N/A
First received
Last updated
Start date July 2011
Est. completion date December 15, 2020

Study information

Verified date July 2023
Source University Medical Center Groningen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to determine whether motor imagery training during the immobilisation period in patients with a distal radius fracture, results in an improved functional outcome compared to patients who do not perform motor imagery.


Description:

Rationale: Distal radius fracture (DRF) is a common injury that may lead to prolonged function restrictions, decreased range of motion, reduced grip strength and pain. These symptoms may be caused by physical changes due to the injury and/or by the 4-6 weeks immobilization that is part of the conservative treatment. However, it might also be that neural changes during the immobilization play an important role. Such changes might be prevented by motor imagery training during the immobilization period. So, when neural changes are prevented, this may lead to a better functional outcome. Objective: The objective is to improve the functional outcome in distal radius fracture patients, specified as an increase in function, dexterity, grip strength, range of motion, and decrease of pain. Study design: Parallel group randomized controlled trial, with a post-test only control group design. Patients in the experimental group perform motor imagery training during the immobilization period, in addition to the regular treatment. Patients in the control group receive regular treatment. Study population: Female DRF-patients who are conservatively treated by a cast, aged 45-75 years. The fracture must be a low energy trauma caused by a fall. Patients with a score higher than 72 on the Vividness of Motor Imagery Questionnaire (VMIQ) are excluded, as well as patients with co-morbidities that might influence the wrist function, or motor imagery-ability, and patients with no understanding of Dutch language. The patients are randomly allocated to the experimental or control group by restricted randomization to ensure equal group sizes. Intervention: Motor imagery training during the immobilization period). Main study parameters/endpoints: The main study parameter is function. Secondary study parameters are dexterity, range of motion, grip strength, and pain.


Recruitment information / eligibility

Status Terminated
Enrollment 66
Est. completion date December 15, 2020
Est. primary completion date October 31, 2019
Accepts healthy volunteers No
Gender Female
Age group 45 Years to 75 Years
Eligibility Inclusion Criteria: - female patients - non-comminutive distal radius fracture - 45 to 75 years of age Exclusion Criteria: - distal radius fracture caused by HET - comorbidities possibly influencing wrist function - comorbidities possibly influencing motor imagery ability - score higher than 72 on the Vividness of Motor Imagery Questionnaire

Study Design


Intervention

Behavioral:
Motor imagery
The kinesthetic motor imagery training consists of the imagination of flexion, extension, abduction, adduction, pronation and supination of their injured wrist.

Locations

Country Name City State
Netherlands University Medical Centre Groningen Groningen

Sponsors (1)

Lead Sponsor Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Broekstra DC, Mouton LJ, van der Sluis CK, IJpma FFA, Stenekes MW. Hand function in patients with distal radius factures after home-based kinaesthetic motor imagery training. J Hand Surg Eur Vol. 2022 Jun;47(6):656-658. doi: 10.1177/17531934221075945. Epu — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Grip Strength (Difference Unaffected - Affected) Four different strength measurements were assessed; power grip, three-jaw chuck pinch, key pinch, and two-point pinch (Mathiowetz et al., 1984), using a digital Jamar dynamometer and pinch grip meter (H500 Hand Kit, Biometrics Ltd., Newport, United Kingdom), expressed in kilograms. Grip and pinch strength of the non-affected hand were measured as reference. The averages of three measurements were used in all analyses. 2 weeks after cast removal
Other Dexterity Dexterity (construct) as measured using the Sequential Occupational Dexterity Assessment (SODA, scale). The SODA is a valid and reliable instrument that measures bimanual dexterity during activities of daily living (van Lankveld et al. 1996). The SODA consists of 12 tasks, and it takes 20 minutes to complete it. The performance on the tasks is scored by the experimenter. The score for each task is build up by two different components. One component concerns how the task is performed, and the other component concerns the difficulty the patient experiences during the execution of the task. For some tasks, only one hand is scored, while for other tasks both hands are scored. The final score ranges from 0-108, where 0 means that the patient is unable to perform any of the tasks, and 108 means that all tasks were performed as requested without any difficulty (van Lankveld et al. 1996). Directly after cast removal
Other Current Pain Level Current pain level, measured using a Visual Analogue Scale (VAS), 0 (best) - 100 (worst) Directly after cast removal
Other Pain Relief Current pain relief, measured using a Visual Analogue Scale (VAS), 0 (worst) - 100 (best) Directly after cast removal
Other Range of Motion Active range of motion (flexion, extension, radial deviation, ulnar deviation, pronation and supination)(Gajdosik and Bohannon, 1987) was measured in degrees once using a digital goniometer (R500 Range of Motion Kit, Biometrics Ltd., Newport, United Kingdom). ROM of the non-affected hand was also measured as reference. Directly after cast removal.
Other Hand Function Self-perceived hand function (construct) measured using the Patient Rated Wrist Hand Evaluation (PRWHE, scale). The score can range between 0 (no functional complaints) to 100 (unable to function) 2 weeks after cast removal
Other Grip Strength Four different strength measurements were assessed; power grip, three-jaw chuck pinch, key pinch, and two-point pinch (Mathiowetz et al., 1984), using a digital Jamar dynamometer and pinch grip meter (H500 Hand Kit, Biometrics Ltd., Newport, United Kingdom), expressed in kilograms. Grip and pinch strength of the non-affected hand were measured as reference. The averages of three measurements were used in all analyses. Directly after cast removal
Other Dexterity Dexterity (construct) as measured using the Sequential Occupational Dexterity Assessment (SODA, scale). The SODA is a valid and reliable instrument that measures bimanual dexterity during activities of daily living (van Lankveld et al. 1996). The SODA consists of 12 tasks, and it takes 20 minutes to complete it. The performance on the tasks is scored by the experimenter. The score for each task is build up by two different components. One component concerns how the task is performed, and the other component concerns the difficulty the patient experiences during the execution of the task. For some tasks, only one hand is scored, while for other tasks both hands are scored. The final score ranges from 0-108, where 0 means that the patient is unable to perform any of the tasks, and 108 means that all tasks were performed as requested without any difficulty (van Lankveld et al. 1996). 2 weeks after cast removal
Other Current Pain Level Current pain level, measured using a Visual Analogue Scale (VAS), 0 (best) - 100 (worst) 2 weeks after cast removal
Other Pain Relief Current pain relief, measured using a Visual Analogue Scale (VAS), 0 (worst) - 100 (best) 2 weeks after cast removal
Other Range of Motion Active range of motion (flexion, extension, radial deviation, ulnar deviation, pronation and supination)(Gajdosik and Bohannon, 1987) was measured in degrees once using a digital goniometer (R500 Range of Motion Kit, Biometrics Ltd., Newport, United Kingdom). ROM of the non-affected hand was also measured as reference. 2 weeks after cast removal.
Primary Hand Function Self-perceived hand function (construct) measured using the Patient Rated Wrist Hand Evaluation (PRWHE, scale). The score can range between 0 (no functional complaints) to 100 (unable to function) 2 days after cast removal
See also
  Status Clinical Trial Phase
Recruiting NCT05736068 - Is Casting of Displaced Pediatric Distal Forearm Fractures Non-inferior to Reduction in General Anesthesia? N/A
Completed NCT04554472 - Usefulness of Intraoperative Ultrasound in a Volar Plate Distal Radius Fixation
Completed NCT03613922 - Effects of Early Manual Therapy on Functional Outcomes After Volar Plating of Distal Radius Fractures N/A
Completed NCT01823692 - Evaluating Validity of Ultrasonography in Determining Distal Radius Fracture Reduction Phase 2
Completed NCT02286661 - Short-Arm Casting Effective in Type A2 Fractures in the Distal Radius N/A
Completed NCT01062997 - Volar Locked Plating Versus Bridging External Fixation N/A
Not yet recruiting NCT04100317 - Spanning Bridged Plate in Comminuted Distal Radius Fractures
Recruiting NCT04976335 - Quantitative and Clinical Assessment of Flexor Tendon Gliding Following Application of a Bioresorbable Hydrogel: A Prospective, Randomized Study in Patients Undergoing Distal Radius Fracture Repair N/A
Completed NCT03635060 - Distraction Osteogenesis for Distal Radius Fractures vs. Volar Plating N/A
Not yet recruiting NCT05095415 - Occupational Therapy Pre-operative Education in the Orthopedic Hand Setting N/A
Terminated NCT02744352 - Single Shot vs Catheter Infraclavicular Brachial Plexus Block After Distal Radius Fracture Repair N/A
Completed NCT05558306 - Radiological vs Clinical Outcome in DRF N/A
Completed NCT01778673 - Cortical Comminution and Intra-articular Involvement in Distal Radius Fractures Can Predict Radiological Outcome. A Prospective Multicenter Study N/A
Active, not recruiting NCT03349216 - Bier's Block Versus Systemic Analgesia Phase 2
Completed NCT04357470 - Manual Dexterity in Ulnar Styloid Fracture Patients N/A
Completed NCT05360836 - The Effect of Motor Imagery in Patients With Radius Distal End Fracture N/A
Recruiting NCT02957240 - Graded Motor Imagery for Women at Risk for Developing Type I CRPS Following Closed Treatment of Distal Radius Fractures N/A
Completed NCT03240471 - Cast OFF Trial: One Versus Four-five Weeks of Plaster Cast Immobilization N/A
Terminated NCT04089709 - Well-arm Exercise in Distal Radius Fractures N/A
Completed NCT05623865 - The Effect of Kinesio Taping on Edema Control and Wrist Functions in Conservatively Followed Distal Radius Fractures. N/A