Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NL36638.042.11 | Other Identifier | Central Committee on Research Involving Human Subjects |
Not provided
Not provided
Severe difficulties with recruiting participants
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Patients allocated to the control group only receive standard treatment. | |
| Motor imagery | Experimental | Patients allocated to this arm perform kinesthetic motor imagery during the immobilisation period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motor imagery | Behavioral | The kinesthetic motor imagery training consists of the imagination of flexion, extension, abduction, adduction, pronation and supination of their injured wrist. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Martin W. Stenekes, MD, PhD | University Medical Center Groningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Centre Groningen | Groningen | 9700 RB | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35102780 | Result | 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. Epub 2022 Feb 1. No abstract available. |
Not provided
Not provided
No plan currently available, but we are open for collaborations.
Not provided
Not provided
Not provided
Not provided
Out of 117 patients, 3 did not respond to the invitation and 42 responded that they did not want to participate
Recruited through invitation letter after ER visit. Recruitment took place between July 2011 and January 2020
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Control | Patients allocated to the control group only receive standard treatment. |
| FG001 | Motor Imagery | Patients allocated to this arm perform kinesthetic motor imagery during the immobilisation period. Motor imagery: The kinesthetic motor imagery training consists of the imagination of flexion, extension, abduction, adduction, pronation and supination of their injured wrist. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Control | Patients allocated to the control group only receive standard treatment. |
| BG001 | Motor Imagery | Patients allocated to this arm perform kinesthetic motor imagery during the immobilisation period. Motor imagery: The kinesthetic motor imagery training consists of the imagination of flexion, extension, abduction, adduction, pronation and supination of their injured wrist. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Mean | Standard Deviation | score on a scale | 2 days after cast removal |
|
2 months
Non-fusion of a fracture after 5 weeks of immobilisation
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Patients allocated to the control group only receive standard treatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-fusion of conservatively treated distal radius fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
Not provided
The SODA scores appeared to be very much influenced by hand dominance, because of the nature of the activities assessed in the SODA. We therefore decided not to statistically test the SODA scores, but only provide descriptive statistics.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dieuwke Broekstra, PhD; postdoctoral researcher | University Medical Center Groningen | 0031503613531 | d.c.broekstra@umcg.nl |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2016 | Jul 26, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000092503 | Wrist Fractures |
| ID | Term |
|---|---|
| D014954 | Wrist Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 2 weeks after cast removal |
| 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 |
| Current Pain Level | Current pain level, measured using a Visual Analogue Scale (VAS), 0 (best) - 100 (worst) | Directly after cast removal |
| Pain Relief | Current pain relief, measured using a Visual Analogue Scale (VAS), 0 (worst) - 100 (best) | Directly after cast removal |
| 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. |
| 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 |
| 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 |
| 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 |
| Current Pain Level | Current pain level, measured using a Visual Analogue Scale (VAS), 0 (best) - 100 (worst) | 2 weeks after cast removal |
| Pain Relief | Current pain relief, measured using a Visual Analogue Scale (VAS), 0 (worst) - 100 (best) | 2 weeks after cast removal |
| 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. |
| Protocol Violation |
|
| VMIQ score > 72 |
|
| Logistic error |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Fracture type (extra-articular) | Count of Participants | Participants |
|
| AO classification | Fracture type in terms of AO classification for the distal radius (code 23), being classified as extra-articular (A), partial articular (B), or intra-articular (C) | Count of Participants | Participants |
|
| Dominant hand affected | Count of Participants | Participants |
|
| Hand dominance | Count of Participants | Participants |
|
|
|
| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | kg | 2 weeks after cast removal |
|
|
|
| Other Pre-specified | 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). | Not all patients were able to perform the tasks of the SODA, explaining lower number of participants included in the analysis | Posted | Median | Inter-Quartile Range | score on a scale | Directly after cast removal |
|
|
|
| Other Pre-specified | Current Pain Level | Current pain level, measured using a Visual Analogue Scale (VAS), 0 (best) - 100 (worst) | Posted | Median | Inter-Quartile Range | score on a scale | Directly after cast removal |
|
|
|
| Other Pre-specified | Pain Relief | Current pain relief, measured using a Visual Analogue Scale (VAS), 0 (worst) - 100 (best) | Posted | Median | Inter-Quartile Range | score on a scale | Directly after cast removal |
|
|
|
| Other Pre-specified | 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. | Some participants could not do all movements, which explains that some ROMs have a lower number of participants in the analysis | Posted | Mean | Standard Deviation | degrees | Directly after cast removal. |
|
|
|
| Other Pre-specified | 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) | Posted | Mean | Standard Deviation | score on a scale | 2 weeks after cast removal |
|
|
|
| Other Pre-specified | 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. | Not all participants were able to perform the grips or pinch movements requested, explaining why some outcome measures have less patients included in the analysis | Posted | Mean | Standard Deviation | kg | Directly after cast removal |
|
|
|
| Other Pre-specified | 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). | Some participants dropped out between T1 and T2 | Posted | Median | Inter-Quartile Range | points | 2 weeks after cast removal |
|
|
|
| Other Pre-specified | Current Pain Level | Current pain level, measured using a Visual Analogue Scale (VAS), 0 (best) - 100 (worst) | Posted | Median | Inter-Quartile Range | score on a scale | 2 weeks after cast removal |
|
|
|
| Other Pre-specified | Pain Relief | Current pain relief, measured using a Visual Analogue Scale (VAS), 0 (worst) - 100 (best) | Some participants dropped out between T1 and T2 | Posted | Median | Inter-Quartile Range | score on a scale | 2 weeks after cast removal |
|
|
|
| Other Pre-specified | 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. | Some participants could not do all movements, which explains that some ROMs have a lower number of participants in the analysis | Posted | Mean | Standard Deviation | degrees | 2 weeks after cast removal. |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Motor Imagery | Patients allocated to this arm perform kinesthetic motor imagery during the immobilisation period. Motor imagery: The kinesthetic motor imagery training consists of the imagination of flexion, extension, abduction, adduction, pronation and supination of their injured wrist. | 0 | 24 | 1 | 24 | 0 | 24 |
Not provided
Not provided
Not provided
| 23C |
|
| Three-jaw pinch |
|
| Two-point pinch |
|
| Flexion |
|
|
| Pronation |
|
|
| Supination |
|
|
| Radial deviation |
|
|
| Ulnar deviation |
|
|
| Key pinch |
|
|
| Three-jaw pinch |
|
|
| Two-point pinch |
|
|
| Flexion |
|
|
| Pronation |
|
|
| Supination |
|
|
| Radial deviation |
|
|
| Ulnar deviation |
|
|